https://wiki.go-eqipd.org/api.php?action=feedcontributions&feedformat=atom&user=Anton.bespalovEQIPD - User contributions [en]2026-05-14T19:30:11ZUser contributionsMediaWiki 1.31.0https://wiki.go-eqipd.org/index.php?title=2.1.1_Study_protocol&diff=190422.1.1 Study protocol2025-06-02T10:58:07Z<p>Anton.bespalov: /* A. Background & Definitions */</p>
<hr />
<div>== A. Background & Definitions ==<br />
<br />
The term "study protocol" refers to a document that describes and summarizes information related to a specific study (experiment). <br />
<br />
A single study protocol may contain references to one or more research methods and assays. For protocols for specific research protocols and assays, please refer to item [[3.5.2 Protocols for methods and assays]].<br />
<br />
== B. Guidance & Expectations ==<br />
<br />
<br />
It is strongly recommended that, for every study (experiment), there is a study protocol prepared prior to the study being conducted. <br />
<br />
Each study protocol should identify author(s), date when it was created and a unique ID of the study that it describes.<br />
<br />
EQIPD has developed a template (please see below) that outlines the suggested structure and content of a study protocol.<br />
<br />
This template is provided as a general guidance and serves only as an example:<br />
# Title of the study<br />
# Study hypothesis<br />
# [[2.1.4 Purpose of research]]<br />
## Indicate whether the research is undertaken with the intention to inform a formal knowledge claim <br />
# Choice of experimental model(s) or method(s)<br />
## Describe how and why specific models and/or methods were chosen (e.g. based on [[2.1.3 Appraisal of literature and systematic reviews]]<br />
## If animal subjects are involved, justify why alternative are not suitable; as well as the selection of species, strain, age, and sex (if applicable) <br />
# Choice of controls<br />
## Describe the controls (negative, positive, shams), why and how these were chosen (e.g. based on [[2.1.3 Appraisal of literature and systematic reviews]]<br />
## If a positive control is included, indicate explicitly how the study outcome will be interpreted if positive control fails.<br />
# Measures against risks of bias<br />
## [[2.1.8 Randomisation]] (if selected, a randomisation protocol must be available)<br />
## [[2.1.7 Blinding]] (if selected, a blinding protocol must be available)<br />
## If randomization and/or blinding are not applied, please describe the reasons as well as any other measures to control the risks of bias that will be applied.<br />
# Sample size<br />
## Describe methods used to estimate the sample size (such as power analysis).<br />
## For definitions and guidance see section [[2.1.6 Sample size and power analysis]]<br />
## Specify the primary outcome measure that was used to determine the sample size (see [[ARRIVE Essential - Outcome measures]])<br />
## The sample size is the number of experimental units per group (for definition of experimental unit – see [[ARRIVE Essential - Study design]])<br />
## Specify the exact number of experimental units allocated to each group, and the total number in each experiment.<br />
## For definitions and guidance on sample size estimation and power analysis, please follow the link.<br />
# Inclusion and exclusion criteria<br />
## Indicate any [[2.1.9 Inclusion and exclusion criteria]] to be applied<br />
# Animal resources, reagents and materials<br />
## Include a detailed description of reagents and materials and/or provide references to separate document(s) with the relevant information (e.g. use the description in [[3.3.3 Management of research materials and reagents]] to add information to your Dossier)<br />
##If animals are used, provide sufficient details expected for reporting ([[ARRIVE 2.0]])<br />
# Study design overview<br />
## For complex study designs, include a visual representation that more easily interpreted than a text description (e.g. a timeline diagram, table or flow chart – e.g. using an Experimental Design Assistant).<br />
# Experimental procedures<br />
## Include a detailed description of methods and experimental procedures and/or provide references to separate document(s) with the relevant information (e.g. if you chose to use section 3.5.2 of the Dossier for storing [[3.5.2 Protocols for methods and assays]])<br />
## If experimental methods are not described in separate documents, follow [[ARRIVE 2.0]] Recommended Set suggestions (items 14-17 here as well as guidance provided here)<br />
## If more than one method or procedure is used, describe sequence or experimental workflow<br />
## For each experimental group, including controls, describe the procedures in enough detail to allow others to replicate them, including (more guidance - [[ARRIVE Essential - Experimental procedures]])<br />
### What was done, how it was done and what was used<br />
### When and how often<br />
### Where (including detail of any acclimation periods)<br />
### Why (provide rationale for procedures)<br />
# Data analysis<br />
## Describe the processing of raw data (for definition of raw data – see section [[2.3.1 Generation, recording, handling and archiving of raw data]])<br />
## Describe statistical method(s) to be applied for each analysis ([[2.3.3 Statistical analysis]])<br />
## Describe any methods used to assess whether the data met the assumptions of the statistical approach ([[ARRIVE Essential - Statistical methods]])<br />
# Amendments<br />
## Describe what was changed in the original study protocol, why, when and by whom<br />
## When amending the study protocol, please make sure not to over-write the original version<br />
## Amendments may be saved as documents separate from the original study protocol<br />
# References<br />
## If necessary, include references<br />
# Preregistration<br />
## EQIPD strongly recommends to pre-register study protocol (more information – [[2.1.11 Preregistration]])<br />
## If pre-registered, please indicate the platform used, registration link and other relevant reference information<br />
<br />
<br />
'''RISK ASSESSMENT'''<br />
* If study protocol references to other protocols or documents (e.g. protocol for a specific experimental method), is the reference made to the current (relevant) version)?<br />
<br />
== C. Resources ==<br />
Template to create a study protocol based on the above guidance - [https://paasp.sharepoint.com/:w:/s/EQIPD/EbuGPqIAiTtKlmRQJ7bSy_0BfmYNqXl-W6Reh3tW5vAIzQ?e=b6nxpH 2.1.1 Study protocol.docx], [https://paasp.sharepoint.com/:w:/s/EQIPD/EXmh9e3w78ZLqPjOd1WNdaQBpt4FZ0mTctaQCRTM8NisMw?e=1wrV2o 2.1.1 Study protocol with macro.docm]<br />
<br />
Experimental design tools:<br />
* MANILA (Matched Animal Analysis): link to the original article ([https://www.nature.com/articles/srep30723]) and the tool ([https://biomedportal.utu.fi/utu-apps/Rvivo/])<br />
* NC3Rs’ Experimental Design Assistant [https://www.nc3rs.org.uk/experimental-design-assistant-eda]<br />
<br />
----------------<br />
back to [[Toolbox]]<br />
<br />
Next item: [[2.1.2 Unique study ID]]</div>Anton.bespalovhttps://wiki.go-eqipd.org/index.php?title=EQIPD&diff=18971EQIPD2024-02-26T07:01:05Z<p>Anton.bespalov: </p>
<hr />
<div>The Enhancing Quality in Preclinical Data (EQIPD; originally called European Quality in Preclinical Data) consortium was formed in 2017 with founding members from 29 institutions across 8 different countries with the primary aim to support robustness and reliability of preclinical biomedical research in a collaborative manner. <br />
<br />
This project received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 777364. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.<br />
<br />
The consortium worked closely with a large group of associated collaborators, advisors and stakeholders representing research institutions, publishers, funders, learned societies and professional societies, from nearly 110 organizations in Europe and North America.<br />
<br />
The EQIPD consortium developed various tools to ensure high data quality without impacting innovation and freedom of research. <br />
<br />
[[File:Example.jpg]]<br />
<br />
We often discuss quality of research data only after a study had been planned and an experiment has finished (a scheme on the left) – resulting in many cases in a waste of time and resources.<br />
<br />
EQIPD’s mission is to ensure that all critical quality requirements are considered and implemented during the study design phase and before a study is executed (scheme on the right). <br />
<br />
To achieve these objectives, EQIPD developed:<br />
* a [https://eqipd-toolbox.paasp.net/wiki/EQIPD_Quality_System Quality System] and supports its implementation<br />
* a program to support research teams from preparing a new project proposal through the execution phase<br />
* a series of training seminars and workshops for young scientists<br />
<br />
Please visit the [https://go-eqipd.org Guarantors of EQIPD e.V.’s website] for additional information</div>Anton.bespalovhttps://wiki.go-eqipd.org/index.php?title=EQIPD&diff=18970EQIPD2024-02-26T06:59:27Z<p>Anton.bespalov: </p>
<hr />
<div>The Enhancing Quality in Preclinical Data (EQIPD; originally called European Quality in Preclinical Data) consortium was formed in 2017 with founding members from 29 institutions across 8 different countries with the primary aim to support robustness and reliability of preclinical biomedical research in a collaborative manner. <br />
<br />
This project received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 777364. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.<br />
<br />
The consortium worked closely with a large group of associated collaborators, advisors and stakeholders representing research institutions, publishers, funders, learned societies and professional societies, from nearly 110 organizations in Europe and North America.<br />
<br />
The EQIPD consortium developed various tools to ensure high data quality without impacting innovation and freedom of research. <br />
<br />
[[File:Example.jpg]]<br />
<br />
We often discuss quality of research data only after a study had been planned and an experiment has finished (a scheme on the left) – resulting in many cases in a waste of time and resources.<br />
<br />
EQIPD’s mission is to ensure that all critical quality requirements are considered and implemented during the study design phase and before a study is executed (scheme on the right). <br />
<br />
To achieve these objectives, EQIPD developed:<br />
* a [[https://eqipd-toolbox.paasp.net/wiki/EQIPD_Quality_System Quality System]] and supports its implementation<br />
* a program to support research teams from preparing a new project proposal through the execution phase<br />
* a series of training seminars and workshops for young scientists<br />
<br />
Please visit the Guarantors of EQIPD e.V.’s website for additional information https://go-eqipd.org</div>Anton.bespalovhttps://wiki.go-eqipd.org/index.php?title=EQIPD_Quality_System&diff=18969EQIPD Quality System2024-02-23T13:58:16Z<p>Anton.bespalov: </p>
<hr />
<div>=General Information=<br />
{{#ev:youtube|https://youtu.be/xLIdxUiaNzo|400|right}}<br />
The EQIPD Framework comprises the research quality concept, [[Core Requirements]], [[Implementation Strategy]] and tools developed by [[EQIPD]] to direct and support the users in building a flexible and lean Quality System. Key elements of the EQIPD Framework consists of [[Toolbox]], [[4.3.2 Using the EQIPD applications|Planning Tool]], [[Dossier]] and external [[NEED]]s.<br />
<br />
<br />
[[EQIPD]] defines quality as research data being fit for intended use. Fitness is defined by the scientists based on the needs of their organizations, funders, collaborators, and publishers. EQIPD has developed specific terminology that is used to describe the framework and the quality system [[Glossary]] (see also a list of [[Abbreviations]]).<br />
<br />
<br />
Why does quality matter? The answer depends on who you are, what your objectives are and which environment you are working in. [[EQIPD]] has tried to summarize some of the key arguments that may motivate you to implement and maintain the EQIPD Quality System in the video [[Why quality matters]].<br />
<br />
<br />
[[FAQ]] section provides more answers to questions about EQIPD Quality System, its implementation and use.<br />
<br />
<br />
Contact us if you have any questions: [mailto:info@paasp.net info@paasp.net]<br />
<br />
=Key principles of the EQIPD QS=<br />
<br />
# Engage with autonomy<br />
# Grow through reflection<br />
# Focus on the goal<br />
# Be transparent<br />
# Leave a trace<br />
<br />
[[EQIPD principles| More details]]<br />
<br />
=Why a quality system?=<br />
Introductory video by Prof Malcolm Macleod to the EQIPD Quality System:<br />
{{#ev:youtube|https://youtu.be/hOaCILTwcU4}}<br />
<br />
=Where to start?=<br />
The page '''[[Implementation Strategy]]''' provides a good starting point and answers the questions '''"What is it about?"''' and '''"How to implement it?"'''.</div>Anton.bespalovhttps://wiki.go-eqipd.org/index.php?title=EQIPD_Quality_System&diff=18968EQIPD Quality System2024-02-23T13:57:51Z<p>Anton.bespalov: /* General Information */</p>
<hr />
<div>=General Information=<br />
{{#ev:youtube|https://youtu.be/xLIdxUiaNzo|400|right}}<br />
The EQIPD Framework comprises the research quality concept, [[Core Requirements]], [[Implementation Strategy]] and tools developed by [[EQIPD]] to direct and support the users in building a flexible and lean Quality System. Key elements of the EQIPD Framework consists of [[Toolbox]], [[4.3.2 Using the EQIPD applications|Planning Tool]], [[Dossier]] and external [[NEED]]s.<br />
<br />
<br />
[[EQIPD]] defines quality as research data being fit for intended use. Fitness is defined by the scientists based on the needs of their organizations, funders, collaborators, and publishers. EQIPD has developed specific terminology that is used to describe the framework and the quality system [[Glossary]] (see also a list of [[Abbreviations]]).<br />
<br />
<br />
Why does quality matter? The answer depends on who you are, what your objectives are and which environment you are working in. [[EQIPD]] has tried to summarize some of the key arguments that may motivate you to implement and maintain the EQIPD Quality System EQIPD in the video [[Why quality matters]].<br />
<br />
<br />
[[FAQ]] section provides more answers to questions about EQIPD Quality System, its implementation and use.<br />
<br />
<br />
Contact us if you have any questions: [mailto:info@paasp.net info@paasp.net]<br />
<br />
=Key principles of the EQIPD QS=<br />
<br />
# Engage with autonomy<br />
# Grow through reflection<br />
# Focus on the goal<br />
# Be transparent<br />
# Leave a trace<br />
<br />
[[EQIPD principles| More details]]<br />
<br />
=Why a quality system?=<br />
Introductory video by Prof Malcolm Macleod to the EQIPD Quality System:<br />
{{#ev:youtube|https://youtu.be/hOaCILTwcU4}}<br />
<br />
=Where to start?=<br />
The page '''[[Implementation Strategy]]''' provides a good starting point and answers the questions '''"What is it about?"''' and '''"How to implement it?"'''.</div>Anton.bespalovhttps://wiki.go-eqipd.org/index.php?title=EQIPD&diff=18967EQIPD2024-02-23T13:56:32Z<p>Anton.bespalov: </p>
<hr />
<div>The Enhancing Quality in Preclinical Data (EQIPD; originally called European Quality in Preclinical Data) consortium was formed in 2017 with founding members from 29 institutions across 8 different countries with the primary aim to support robustness and reliability of preclinical biomedical research in a collaborative manner. <br />
<br />
This project received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 777364. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.<br />
<br />
The consortium worked closely with a large group of associated collaborators, advisors and stakeholders representing research institutions, publishers, funders, learned societies and professional societies, from nearly 110 organizations in Europe and North America.<br />
<br />
The EQIPD consortium developed various tools to ensure high data quality without impacting innovation and freedom of research. <br />
<br />
[[File:Example.jpg]]<br />
<br />
We often discuss quality of research data only after a study had been planned and an experiment has finished (a scheme on the left) – resulting in many cases in a waste of time and resources.<br />
<br />
EQIPD’s mission is to ensure that all critical quality requirements are considered and implemented during the study design phase and before a study is executed (scheme on the right). <br />
<br />
To achieve these objectives, EQIPD developed:<br />
* a Quality System and supports its implementation<br />
* a program to support research teams from preparing a new project proposal through the execution phase<br />
* a series of training seminars and workshops for young scientists<br />
<br />
Please visit the Guarantors of EQIPD e.V.’s website for additional information https://go-eqipd.org</div>Anton.bespalovhttps://wiki.go-eqipd.org/index.php?title=EQIPD&diff=18966EQIPD2024-02-23T13:55:12Z<p>Anton.bespalov: </p>
<hr />
<div>The Enhancing Quality in Preclinical Data (EQIPD; originally called European Quality in Preclinical Data) consortium was formed in 2017 with founding members from 29 institutions across 8 different countries with the primary aim to support robustness and reliability of preclinical biomedical research in a collaborative manner. <br />
<br />
This project received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 777364. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.<br />
<br />
The consortium worked closely with a large group of associated collaborators, advisors and stakeholders representing research institutions, publishers, funders, learned societies and professional societies, from nearly 110 organizations in Europe and North America.<br />
<br />
The EQIPD consortium developed various tools to ensure high data quality without impacting innovation and freedom of research. <br />
<br />
[[File:Example.jpg]]<br />
<br />
We often discuss quality of research data only after a study had been planned and an experiment has finished (a scheme on the left) – resulting in many cases in a waste of time and resources.<br />
<br />
EQIPD’s mission is to ensure that all critical quality requirements are considered and implemented during the study design phase and before a study is executed (scheme on the right). <br />
<br />
To achieve these objectives, EQIPD developed:<br />
• a Quality System and supports its implementation<br />
• a program to support research teams from preparing a new project proposal through the execution phase<br />
• a series of training seminars and workshops for young scientists<br />
<br />
Please visit the Guarantors of EQIPD e.V.’s website for additional information https://go-eqipd.org</div>Anton.bespalovhttps://wiki.go-eqipd.org/index.php?title=EQIPD&diff=18965EQIPD2024-02-23T13:54:53Z<p>Anton.bespalov: </p>
<hr />
<div>The Enhancing Quality in Preclinical Data (EQIPD; originally called European Quality in Preclinical Data) consortium was formed in 2017 with founding members from 29 institutions across 8 different countries with the primary aim to support robustness and reliability of preclinical biomedical research in a collaborative manner. <br />
<br />
This project received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 777364. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.<br />
<br />
The consortium worked closely with a large group of associated collaborators, advisors and stakeholders representing research institutions, publishers, funders, learned societies and professional societies, from nearly 110 organizations in Europe and North America.<br />
<br />
The EQIPD consortium developed various tools to ensure high data quality without impacting innovation and freedom of research. <br />
<br />
[[File:Example.jpg]]/Users/antonbespalov/Downloads/EQIPDway.png<br />
<br />
We often discuss quality of research data only after a study had been planned and an experiment has finished (a scheme on the left) – resulting in many cases in a waste of time and resources.<br />
<br />
EQIPD’s mission is to ensure that all critical quality requirements are considered and implemented during the study design phase and before a study is executed (scheme on the right). <br />
<br />
To achieve these objectives, EQIPD developed:<br />
• a Quality System and supports its implementation<br />
• a program to support research teams from preparing a new project proposal through the execution phase<br />
• a series of training seminars and workshops for young scientists<br />
<br />
Please visit the Guarantors of EQIPD e.V.’s website for additional information https://go-eqipd.org</div>Anton.bespalovhttps://wiki.go-eqipd.org/index.php?title=EQIPD&diff=18964EQIPD2024-02-23T13:51:55Z<p>Anton.bespalov: </p>
<hr />
<div>The Enhancing Quality in Preclinical Data (EQIPD; originally called European Quality in Preclinical Data) consortium was formed in 2017 with founding members from 29 institutions across 8 different countries with the primary aim to support robustness and reliability of preclinical biomedical research in a collaborative manner. <br />
<br />
This project received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 777364. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.<br />
<br />
The consortium worked closely with a large group of associated collaborators, advisors and stakeholders representing research institutions, publishers, funders, learned societies and professional societies, from nearly 110 organizations in Europe and North America.<br />
<br />
The EQIPD consortium developed various tools to ensure high data quality without impacting innovation and freedom of research. <br />
<br />
[[File:Example.jpg]]<br />
<br />
We often discuss quality of research data only after a study had been planned and an experiment has finished (a scheme on the left) – resulting in many cases in a waste of time and resources.<br />
<br />
EQIPD’s mission is to ensure that all critical quality requirements are considered and implemented during the study design phase and before a study is executed (scheme on the right). <br />
<br />
To achieve these objectives, EQIPD developed:<br />
• a Quality System and supports its implementation<br />
• a program to support research teams from preparing a new project proposal through the execution phase<br />
• a series of training seminars and workshops for young scientists<br />
<br />
Please visit the Guarantors of EQIPD e.V.’s website for additional information https://go-eqipd.org</div>Anton.bespalovhttps://wiki.go-eqipd.org/index.php?title=EQIPD&diff=18963EQIPD2024-02-23T13:41:09Z<p>Anton.bespalov: Created page with "The Enhancing Quality in Preclinical Data (EQIPD) consortium has developed simple and sustainable tools to ensure high data quality without impacting innovation and freedom of..."</p>
<hr />
<div>The Enhancing Quality in Preclinical Data (EQIPD) consortium has developed simple and sustainable tools to ensure high data quality without impacting innovation and freedom of research. <br />
The EQIPD consortium, founded in 2017, works closely with a large group of stakeholders from research institutions, publishers, funders, learned societies and professional societies from nearly 110 organizations in Europe and the US.<br />
This website has been created and is maintained by the EQIPD task force responsible for long-term maintenance and dissemination of the EQIPD Quality System and associated resources and services.<br />
Please visit the EQIPD consortium’s website for more information beyond the Quality System www.eqipd.org</div>Anton.bespalovhttps://wiki.go-eqipd.org/index.php?title=EQIPD_Quality_System&diff=18962EQIPD Quality System2024-02-23T13:38:13Z<p>Anton.bespalov: /* General Information */</p>
<hr />
<div>=General Information=<br />
{{#ev:youtube|https://youtu.be/xLIdxUiaNzo|400|right}}<br />
The EQIPD Framework comprises the research quality concept, [[Core Requirements]], [[Implementation Strategy]] and tools developed by [[EQIPD]] to direct and support the users in building a flexible and lean Quality System. Key elements of the EQIPD Framework consists of [[Toolbox]], [[4.3.2 Using the EQIPD applications|Planning Tool]], [[Dossier]] and external [[NEED]]s.<br />
<br />
<br />
EQIPD defines quality as research data being fit for intended use. Fitness is defined by the scientists based on the needs of their organizations, funders, collaborators, and publishers. EQIPD has developed specific terminology that is used to describe the framework and the quality system [[Glossary]] (see also a list of [[Abbreviations]]).<br />
<br />
<br />
Why does quality matter? The answer depends on who you are, what your objectives are and which environment you are working in. EQIPD has tried to summarize some of the key arguments that may motivate you to implement and maintain the EQIPD Quality System EQIPD in the video [[Why quality matters]].<br />
<br />
<br />
[[FAQ]] section provides more answers to questions about EQIPD Quality System, its implementation and use.<br />
<br />
<br />
Contact us if you have any questions: [mailto:info@paasp.net info@paasp.net]<br />
<br />
=Key principles of the EQIPD QS=<br />
<br />
# Engage with autonomy<br />
# Grow through reflection<br />
# Focus on the goal<br />
# Be transparent<br />
# Leave a trace<br />
<br />
[[EQIPD principles| More details]]<br />
<br />
=Why a quality system?=<br />
Introductory video by Prof Malcolm Macleod to the EQIPD Quality System:<br />
{{#ev:youtube|https://youtu.be/hOaCILTwcU4}}<br />
<br />
=Where to start?=<br />
The page '''[[Implementation Strategy]]''' provides a good starting point and answers the questions '''"What is it about?"''' and '''"How to implement it?"'''.</div>Anton.bespalovhttps://wiki.go-eqipd.org/index.php?title=EQIPD_Quality_System&diff=18961EQIPD Quality System2024-02-23T13:36:55Z<p>Anton.bespalov: /* General Information */</p>
<hr />
<div>=General Information=<br />
{{#ev:youtube|https://youtu.be/xLIdxUiaNzo|400|right}}<br />
The EQIPD Framework comprises the research quality concept, [[Core Requirements]], [[Implementation Strategy]] and tools developed by EQIPD to direct and support the users in building a flexible and lean Quality System. Key elements of the EQIPD Framework consists of [[Toolbox]], [[4.3.2 Using the EQIPD applications|Planning Tool]], [[Dossier]] and external [[NEED]]s.<br />
<br />
<br />
EQIPD defines quality as research data being fit for intended use. Fitness is defined by the scientists based on the needs of their organizations, funders, collaborators, and publishers. EQIPD has developed specific terminology that is used to describe the framework and the quality system [[Glossary]] (see also a list of [[Abbreviations]]).<br />
<br />
<br />
Why does quality matter? The answer depends on who you are, what your objectives are and which environment you are working in. EQIPD has tried to summarize some of the key arguments that may motivate you to implement and maintain the EQIPD Quality System EQIPD in the video [[Why quality matters]].<br />
<br />
<br />
[[FAQ]] section provides more answers to questions about EQIPD Quality System, its implementation and use.<br />
<br />
<br />
Contact us if you have any questions: [mailto:info@paasp.net info@paasp.net]<br />
<br />
=Key principles of the EQIPD QS=<br />
<br />
# Engage with autonomy<br />
# Grow through reflection<br />
# Focus on the goal<br />
# Be transparent<br />
# Leave a trace<br />
<br />
[[EQIPD principles| More details]]<br />
<br />
=Why a quality system?=<br />
Introductory video by Prof Malcolm Macleod to the EQIPD Quality System:<br />
{{#ev:youtube|https://youtu.be/hOaCILTwcU4}}<br />
<br />
=Where to start?=<br />
The page '''[[Implementation Strategy]]''' provides a good starting point and answers the questions '''"What is it about?"''' and '''"How to implement it?"'''.</div>Anton.bespalovhttps://wiki.go-eqipd.org/index.php?title=3.2.3_Implementation_of_the_EQIPD_Quality_System&diff=185003.2.3 Implementation of the EQIPD Quality System2021-03-16T18:38:05Z<p>Anton.bespalov: /* Step 2 - Take a closer look at EQIPD‘s expectations */</p>
<hr />
<div>__NOTOC__<br />
== Step 1 - Get familiar with the key terms defined by EQIPD ==<br />
{{#ev:youtube|https://youtu.be/bK6emsX5G1Y|400|right}}<br />
=== What means quality? === <br />
EQIPD defines research quality as the extent to which research data are fit for intended use. Fitness, in this context, is defined by the stakeholders, who can be scientists themselves, but also patients, funders, sponsors, publishers and collaboration partners (e.g., peers in a multi-site research project).<br />
<br />
=== Research rigor === <br />
Research rigor refers to measures against systematic error(s) in the estimated effect of an intervention, caused by inadequacies in the design, conduct, or analysis of an experiment.<br />
<br />
=== Raw data === <br />
Raw data (please see [[2.3.1 Generation, recording, handling and archiving of raw data]]) means all original records and documentation, which are the result of the observations and activities in a study, such as:<br />
* photographs, videotapes, blots, chromatograms, computer readable media, dictated observations, recorded data from automated instruments, or any other medium capable of providing secure storage of information for a time period required by law or other applicable regulations;<br />
* data directly entered into a computer through an automatic instrument interface, which are the results of primary observations and activities in a study;<br />
* copies of original laboratory records and documentation that are complete and of good quality.<br />
<br />
=== Knowledge-claiming research === <br />
Knowledge-claiming research (please see [[2.1.4 Purpose of research]]): EQIPD requires that the maximal rigor possible is applied (and exceptions explained / documented in the study plan) to research that is conducted with the prior intention of informing a knowledge claim.<br />
Examples of research requiring the maximal rigor possible include:<br />
* Experimental studies to scrutinize preclinical findings through replication of results alongside investigations into boundary conditions and robustness through conduct of additional (control) conditions and multicenter studies ([https://journals.plos.org/plosbiology/article?id=10.1371/journal.pbio.1001863 Kimmelman et al. 2014])<br />
*Research aimed to generate evidence that enables decisions such as critical studies that, dependent on the outcome, will trigger a chain of activities and events associated with significant resource and time costs (e.g. a decision to initiate a new drug development project or to initiate GLP safety assessment of a new drug candidate)<br />
* Studies for which any outcome would be considered diagnostic evidence about a claim from prior research ([https://doi.org/10.1371/journal.pbio.3000691 Nosek and Errington 2020])<br />
* Labor-, resource- and/or time-intensive studies that cannot be easily repeated<br />
<br />
=== Must vs. should === <br />
When reviewing materials provided by EQIPD, please note the use of "must" vs "should".<br />
* "Must" indicates actions that EQIPD considers as imperative and mandatory or as a requirement.<br />
* The system acknowledged that in some cases, the research environment, a specific research project or a research organization do not allow or make it less relevant to adhere to the requirements formulated below.<br />
* In such cases, instead of using the word “must”, the expectations are communicated as “should” or “strongly recommended”. This means that failure to comply with these expectations will not be automatically regarded as a “red flag” but the research organization may need to present a good rationale for not following this strong recommendation. <br />
<br />
For more definitions, please see [[Glossary]].<br />
<br />
<br />
== Step 2 - Take a closer look at EQIPD‘s expectations ==<br />
{{#ev:youtube|https://youtu.be/D_Wl6kcs9vU|400|right}}<br />
Please start with [https://paasp.sharepoint.com/:p:/s/EQIPD/ER4cDNHUMBVGqbtCd6vkFzEBkZM-rJvp5so_-i_N-Zarqg?e=MCebax viewing the presentation] prepared by the EQIPD team that explains why a Quality System is a good solution for research rigor needs, what it is about and how to move forward.<br />
<br />
Next, you may want to check how many [[Core Requirements]] do you meet by going through the self-assessment [https://paasp.sharepoint.com/:b:/s/EQIPD/EWXf1VnZ8ytNr2jl97dGnV0BDJCfEFnO-TH_R71BegJCiQ?e=ZXy39E overview]. <br />
<br />
This analysis will help you reveal already at this early stage whether and where major challenges can be encountered. <br />
<br />
Once this review is complete, you will be prepared to answer a question - Are most core requirements met?<br />
<br />
If the answer is “yes”, we suggest that you complete the self-assessment using the provided template, send it to the EQIPD team for consultation [mailto:info@eqipd.online info@EQIPD.online] or simply complete the remaining core requirements using information provided by EQIPD online ([[4.1.2 Self assessment]]).<br />
<br />
If the answer is "no", we suggest that you use the EQIPD tools and follow the suggested implementation path, guided by information provided by EQIPD team.<br />
<br />
== Step 3 - Guided implementation ==<br />
Implementation has to focus on the Core Requirements. <br />
However, implementation can be guided by an Excel tool developed by EQIPD, the EQIPD Planning Tool. This tool includes a Wizard guiding through the first steps of implementation and links to information which are online in the Toolbox and locally in the Dossier. The Planning Tool and a layout for the Dossier can be downloaded [https://paasp.sharepoint.com/:u:/s/EQIPD/EaHycK56LmNLtxmYJieMt6ABV-AEp5CX_kjDGYBSbjUK8w?e=vusfgZ here]. (for more information, please contact the EQIPD team at info@eqipd.online).<br />
<br />
<br />
== Step 4 - Assessment by the EQIPD team ==<br />
Once all core requirements are considered to be met, please approach the EQIPD team [mailto:info@eqipd.online info@EQIPD.online] that can do an assessment and, in case of a positive evaluation, will certify the successful implementation of the Quality System.<br />
<br />
<br />
<br />
----------------<br />
back to [[EQIPD Quality System]]<br />
<br />
back to [[Toolbox]]<br />
<br />
Item: [[3.2.4 Training on specific methods, tasks and activities]]</div>Anton.bespalovhttps://wiki.go-eqipd.org/index.php?title=EQIPD_principles&diff=18497EQIPD principles2021-03-16T08:45:29Z<p>Anton.bespalov: /* Objective */</p>
<hr />
<div>__NOTOC__<br />
=Objective=<br />
The aim of EQIPD is for the quality system to be perceived as lean, flexible, fit-for-purpose, and user-friendly. To describe these high level terms in more details, 5 principles were phrased to present descriptive statements to describe "what the system is about".<br />
<br />
The following 5 principles summarize the essence of the EQIPD quality system.<br />
They are not meant to replace the [[Core Requirements]]. Core requirements are operational implementations of these key principles.<br />
<br />
=Key principles=<br />
{| class="wikitable"<br />
|'''Principle'''<br />
|'''Explanation'''<br />
|'''Example'''<br />
|-<br />
|Engage with autonomy<br />
|Decisions about specific needs and solutions are made by researchers, and not by EQIPD. EQIPD has formulated core requirements for the QS implementation and, as a partner in this process, EQIPD asks critical questions and provides recommendations that are voluntary to follow and are provided only to help the researchers throughout the implementation and use.<br />
|EQIPD recommends applying randomization to all studies but it is up to the researcher to decide whether randomization is applying to a particular study or a particular study design<br />
|-<br />
|Grow through reflection ([[Performance Standards]])<br />
|What it means to have the right quality level in place is suggested by your environment (collaborators, funders, institution, etc.). EQIPD does not “invent” needs or requirements of your funders or your collaborators. As a partner in this process, EQIPD QS only allows you to see these requirements better and suggests ways of implementing them.<br />
|EQIPD identifies overlapping requirements from different stakeholders towards the use and reporting of randomization.<br />
|-<br />
|Focus on goal[https://www.nature.com/articles/laban0210-49]<br />
|Focus on the outcome (performance standards), not on the path, timelines or the tools to get there. <br />
|EQIPD highlights the importance of “randomness” (lack of pattern or predictability) in the correctly developed randomization sequence but leaves it up to the user to select a specific method or tool.<br />
|-<br />
|Be transparent<br />
|Key research processes must be transparent. This principle applies specifically to retention and accessibility of information related to key decisions related to study design, conduct or analysis (e.g., decisions to include or exclude certain data points in the analysis).<br />
|If you decide not to apply randomization, the decision must be stated and must be justified, recorded and reported.<br />
|-<br />
|Leave a trace<br />
|Key research processes must be traceable. Complementary to the principle above, this principle refers to retention and accessibility of all information that is necessary for a complete reconstruction of a key research process (e.g., Raw data related to reported data are findable, and reported data are reconstructable from raw data).<br />
|If you do apply randomization, the way you apply randomization must be traceable and reported<br />
| -<br />
|}</div>Anton.bespalovhttps://wiki.go-eqipd.org/index.php?title=Documentation_in_EQIPD&diff=12404Documentation in EQIPD2021-02-09T18:23:24Z<p>Anton.bespalov: </p>
<hr />
<div>EQIPD Quality System is lean and does not require excessive documentation.<br />
<br />
The following table describes the documentation required to address the EQIPD core requirements.<br />
<br />
In some cases, these are stand-alone documents. In others, expected information is typically available in other documents - mandated by the institutional regulations or being part of another process.<br />
<br />
{| class="wikitable"<br />
|rowspan="2"|'''Categories''' <br />
|rowspan="2"|'''No'''<br />
|rowspan="2"|'''Core Requirement'''<br />
|rowspan="2"|'''Toolbox reference'''<br />
|colspan="2"|'''Implementation of the Core Requirements'''<br />
|-<br />
|'''Stand-alone document'''<br />
|'''EQIPD expectations'''<br />
|-<br />
|rowspan="2"|'''Research team''' <br />
|1<br />
|Process owner must be identified for the Quality System<br />
|[[1.5.2.3 Process owner|1.5.2.3]]<br />
|No<br />
|Process Owner should act and be recognized as such by the research unit members. <br />
|-<br />
|2<br />
|Communication process must be in place<br />
|[[1.2 Scope|1.2]]<br />
|Yes<br />
|A concise overview of the organisational structure and the communication lines can be described using the [https://paasp.sharepoint.com/:w:/s/EQIPD/ERyfFP_pBytDiEfqCutDAJQBFbaGQEx3G1pyOmDl50o_LQ?e=wlkvHJ Communication plan template] provided by EQIPD or in a similar document.<br />
|-<br />
|rowspan="3"|'''Quality culture'''<br />
|3<br />
|The research unit must have defined quality objectives <br />
|[[1.1 Mission|1.1]]<br />
|Yes<br />
|The [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Mission statement template] of EQIPD or a similar document can be used to describe quality goals of a research unit. These quality objectives should be known to and shared by all members of a research unit.<br />
|-<br />
|4<br />
|All activities must comply with relevant legislation and policies<br />
|[[1.4.2 Adherence to legal and regulatory considerations|1.4.2]]<br />
|No<br />
|Research unit complies with all applicable national and international legislation and policies and there are no compliance issues.<br />
|-<br />
|5<br />
|The research unit must have a procedure to act upon concerns of potential misconduct<br />
|[[4.2.3 Responsible conduct of research|4.2.3]]<br />
|No<br />
|It is expected that a research unit or its parent organization has a research integrity policy, office and/or officer (or ombudsman) and all research unit members have access to this information.<br />
|-<br />
|rowspan="4"|'''Data integrity'''<br />
|6<br />
|Generation, handling and changes to data records must be documented<br />
|[[2.3.1 Generation, recording, handling and archiving of raw data|2.3.1]]<br />
|rowspan="3"|Yes<br />
|Can be described using the [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan template] provided by EQIPD or in a similar document.<br />
|-<br />
|7<br />
|Data storage must be secured at least for as long as required by legal, contractual or other obligations or business needs<br />
|[[3.1.3 Data security|3.1.3]]<br />
|Can be described using the [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan template] provided by EQIPD or in a similar document.<br />
|-<br />
|8<br />
|Reported research outcomes must be traceable to experimental data<br />
|[[3.1.2.1 Traceability of data and any person having impact on data|3.1.2.1]]<br />
|Can be described using the [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan template] provided by EQIPD or in a similar document.<br />
|-<br />
|9<br />
|Reported data must disclose all repetitions of a study, an experiment, or a test regardless of the outcome<br />
|[[2.4 Reporting|2.4]]<br />
|No<br />
|it is expected that the Process Owner conducts spot checks on reported studies to make sure that all repetitions are reported.<br />
|-<br />
|rowspan="5"|'''Research processes'''<br />
|10<br />
|Investigator must declare in advance whether a study is intended to inform a formal knowledge claim<br />
|[[2.1.4 Purpose of research|2.1.4]]<br />
|No<br />
|This requirement is most optimally met by providing corresponding information in the study (experimental) plan, see [[2.1.1 Study (experimental) plan]].<br />
|-<br />
|11<br />
|All personnel involved in research must have adequate training and competence to perform assigned tasks<br />
|[[3.2.1 General guidance on training|3.2.1]]<br />
|No<br />
|For legally required / mandatory training, training records are typically available. For other training, Process Owner decides on whether and what form of documentation should be maintained. EQIPD expects that all research units members are trained on training on what is considered to be raw data and how to record and handle data. Further. EQIPD expects a training program for new members of the research unit.<br />
|-<br />
|12<br />
|Protocols for experimental methods must be available<br />
|[[3.5.2 Protocols for methods and assays|3.5.2]]<br />
|No<br />
|Methods can be described in either standalone protocols or be part of study (experimental) plans. ([https://paasp.sharepoint.com/:w:/s/EQIPD/EfUO3B7RFxdHgxQ8JY5hhFoBEDUiPGK4C8n6BBHEprwroA?e=8IezWV template])<br />
|-<br />
|13<br />
|Adequate handling and storage of samples and materials must be ensured<br />
|[[3.3.3 Management of research materials and reagents|3.3.3]]<br />
|No<br />
|Although there is no requirement to have a standalone document describing the overall process of handling and storage, it is nevertheless in many circumstances to be expected that certain aspects of handling and storage are supported by relevant documentation (e.g. electronic or paper-based system for keeping a control over research chemicals and reagents).<br />
|-<br />
|14<br />
|Research equipment and tools must be suitable for intended use and ensure data integrity<br />
|[[3.3.2 Processes to enable computerized and non-computerized systems being suitable for intended use|3.3.2]]<br />
|No<br />
|It is expected that protocols of experimental methods clearly state whether maintenance or calibration is needed and, if yes, describe the procedure.<br />
|-<br />
|rowspan="3"|'''Continuous performance'''<br />
|15<br />
|Risk assessment must be performed to identify factors affecting the generation, processing and reporting of research data<br />
|[[4.1.1 Risk assessment|4.1.1]]<br />
|No<br />
|Study (experimental) plans are expected to have a dedicated section summarizing measures against risks of bias, see [[2.1.1 Study (experimental) plan]]. Deviations from practices recommended by EQIPD as well as the risk assessment at the level of the research unit can be handled using the [https://paasp.sharepoint.com/:x:/s/EQIPD/ETo9OwIvZpNHtepp6IvxylQBjtjhk2AmRnypLCIOrGwMvA?e=n1zy3X Risk assessment template].<br />
|-<br />
|16<br />
|Critical incidents and errors during study conduct must be analyzed and appropriately managed<br />
|[[4.2.2 Error and incident management|4.2.2]]<br />
|No<br />
|Critical incidents and errors can be recorded in laboratory notebooks or using [https://paasp.sharepoint.com/:w:/s/EQIPD/EatOAFgLbctEvxRZTuSCdU4Bv8J1I_BitfKl-JJiieOTLA?e=z99RR1 Error reporting template] or using another electronic or paper-based system.<br />
|-<br />
|17<br />
|An approach must be in place to monitor the performance of the EQIPD Quality System, and address identified issues<br />
|[[4.1.2 Self assessment|4.1.2]]<br />
|No<br />
|Evidence for such approach is provided indirectly by the information described in the [https://paasp.sharepoint.com/:x:/s/EQIPD/EWbE3AdV5jhHglumN_MlrugBQX_KsZQDpJVNYbBJk6svTQ?e=qkW68H Self assessment template] that is completed at regular intervals (as a minimum, annually).<br />
|-<br />
|'''Sustainability'''<br />
|18<br />
|Resources for sustaining the EQIPD Quality System must be available<br />
|[[1.5.5 Sustainability|1.5.5]]<br />
|No<br />
|No documentation needed but EQIPD does not accept lack of resources as an argument for not following the best research practices.<br />
|}<br />
<br />
<br />
Back to the [[EQIPD Quality System]] or [[Core Requirements]].</div>Anton.bespalovhttps://wiki.go-eqipd.org/index.php?title=Documentation_in_EQIPD&diff=12394Documentation in EQIPD2021-02-09T17:19:11Z<p>Anton.bespalov: </p>
<hr />
<div>EQIPD Quality System is lean and does not require excessive documentation.<br />
<br />
The following table describes the documentation required to address the EQIPD core requirements.<br />
<br />
In some cases, these are stand-alone documents. In others, expected information is typically available in other documents - mandated by the institutional regulations or being part of another process.<br />
<br />
{| class="wikitable"<br />
|rowspan="2"|'''Categories''' <br />
|rowspan="2"|'''No'''<br />
|rowspan="2"|'''Core Requirement'''<br />
|rowspan="2"|'''Toolbox reference'''<br />
|colspan="2"|'''Implementation of the Core Requirements'''<br />
|-<br />
|'''Stand-alone document'''<br />
|'''EQIPD expectations'''<br />
|-<br />
|rowspan="2"|'''Research team''' <br />
|1<br />
|Process owner must be identified for the Quality System<br />
|[[1.5.2.3 Process owner|1.5.2.3]]<br />
|No<br />
|Process Owner should act and be recognized as such by the research unit members. <br />
|-<br />
|2<br />
|Communication process must be in place<br />
|[[1.2 Scope|1.2]]<br />
|Yes<br />
|A concise overview of the organisational structure and the communication lines can be described in the [https://paasp.sharepoint.com/:w:/s/EQIPD/ERyfFP_pBytDiEfqCutDAJQBFbaGQEx3G1pyOmDl50o_LQ?e=wlkvHJ Communication plan template] provided by EQIPD or in a similar document.<br />
|-<br />
|rowspan="3"|'''Quality culture'''<br />
|3<br />
|The research unit must have defined quality objectives <br />
|[[1.1 Mission|1.1]]<br />
|Yes<br />
|The [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Mission statement template] of EQIPD or a similar document can be used to describe quality goals of a research unit. These quality objectives should be known to and shared by all members of a research unit.<br />
|-<br />
|4<br />
|All activities must comply with relevant legislation and policies<br />
|[[1.4.2 Adherence to legal and regulatory considerations|1.4.2]]<br />
|No<br />
|Research unit complies with all applicable national and international legislation and policies and there are no compliance issues.<br />
|-<br />
|5<br />
|The research unit must have a procedure to act upon concerns of potential misconduct<br />
|[[4.2.3 Responsible conduct of research|4.2.3]]<br />
|No<br />
|It is expected that a research unit or its parent organization has a research integrity policy, office and/or officer (or ombudsman) and all research unit members have access to this information.<br />
|-<br />
|rowspan="4"|'''Data integrity'''<br />
|6<br />
|Generation, handling and changes to data records must be documented<br />
|[[2.3.1 Generation, recording, handling and archiving of raw data|2.3.1]]<br />
|rowspan="3"|Yes<br />
|Can be described in the [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan] or in a similar document.<br />
|-<br />
|7<br />
|Data storage must be secured at least for as long as required by legal, contractual or other obligations or business needs<br />
|[[3.1.3 Data security|3.1.3]]<br />
|Could be documented in the [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan] or in a similar document.<br />
|-<br />
|8<br />
|Reported research outcomes must be traceable to experimental data<br />
|[[3.1.2.1 Traceability of data and any person having impact on data|3.1.2.1]]<br />
|Could be documented in the [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan] or in a similar document.<br />
|-<br />
|9<br />
|Reported data must disclose all repetitions of a study, an experiment, or a test regardless of the outcome<br />
|[[2.4 Reporting|2.4]]<br />
|No<br />
|it is expected that the Process Owner conducts spot checks on reported studies to make sure that all repetitions are reported.<br />
|-<br />
|rowspan="5"|'''Research processes'''<br />
|10<br />
|Investigator must declare in advance whether a study is intended to inform a formal knowledge claim<br />
|[[2.1.4 Purpose of research|2.1.4]]<br />
|No<br />
|This requirement is met by providing corresponding information in the study (experimental) plan, see [[2.1.1 Study (experimental) plan]]<br />
|-<br />
|11<br />
|All personnel involved in research must have adequate training and competence to perform assigned tasks<br />
|[[3.2.1 General guidance on training|3.2.1]]<br />
|No<br />
|Participation in training could be hold available with the training records<br />
|-<br />
|12<br />
|Protocols for experimental methods must be available<br />
|[[3.5.2 Protocols for methods and assays|3.5.2]]<br />
|No<br />
|All procedures used in experiments could be hold available in the study/experimental protocol ([https://paasp.sharepoint.com/:w:/s/EQIPD/EfUO3B7RFxdHgxQ8JY5hhFoBEDUiPGK4C8n6BBHEprwroA?e=8IezWV template])<br />
|-<br />
|13<br />
|Adequate handling and storage of samples and materials must be ensured<br />
|[[3.3.3 Management of research materials and reagents|3.3.3]]<br />
|No<br />
|This information could be hold available, e.g. as chemical data sheets or within study/experimental protocol<br />
|-<br />
|14<br />
|Research equipment and tools must be suitable for intended use and ensure data integrity<br />
|[[3.3.2 Processes to enable computerized and non-computerized systems being suitable for intended use|3.3.2]]<br />
|No<br />
|Study/experimental protocols could reference or document that equipment was fit-for-purpose, e.g. by using reference substances<br />
|-<br />
|rowspan="3"|'''Continuous performance'''<br />
|15<br />
|Risk assessment must be performed to identify factors affecting the generation, processing and reporting of research data<br />
|[[4.1.1 Risk assessment|4.1.1]]<br />
|No<br />
|Study/experimental protocols could have a dedicated section for risk of bias in experimental processes, see [[2.1.1 Study (experimental) plan]] and for a risk assessment on the level of the research unit, it could be documented in the [https://paasp.sharepoint.com/:x:/s/EQIPD/ETo9OwIvZpNHtepp6IvxylQBjtjhk2AmRnypLCIOrGwMvA?e=n1zy3X Risk assessment template]<br />
|-<br />
|16<br />
|Critical incidents and errors during study conduct must be analyzed and appropriately managed<br />
|[[4.2.2 Error and incident management|4.2.2]]<br />
|No<br />
|Critical incidents and errors could be documented with the experimental protocol if on experimental level and in a separate [https://paasp.sharepoint.com/:w:/s/EQIPD/EatOAFgLbctEvxRZTuSCdU4Bv8J1I_BitfKl-JJiieOTLA?e=z99RR1 Error reporting document] for the research unit level<br />
|-<br />
|17<br />
|An approach must be in place to monitor the performance of the EQIPD Quality System, and address identified issues<br />
|[[4.1.2 Self assessment|4.1.2]]<br />
|Yes<br />
|This could be documented in the [https://paasp.sharepoint.com/:x:/s/EQIPD/EWbE3AdV5jhHglumN_MlrugBQX_KsZQDpJVNYbBJk6svTQ?e=qkW68H Self assessment template]<br />
|-<br />
|'''Sustainability'''<br />
|18<br />
|Resources for sustaining the EQIPD Quality System must be available<br />
|[[1.5.5 Sustainability|1.5.5]]<br />
|No<br />
|No documentation needed<br />
|}<br />
<br />
<br />
Back to the [[EQIPD Quality System]] or [[Core Requirements]].</div>Anton.bespalovhttps://wiki.go-eqipd.org/index.php?title=Documentation_in_EQIPD&diff=12391Documentation in EQIPD2021-02-09T17:15:30Z<p>Anton.bespalov: </p>
<hr />
<div>EQIPD Quality System is lean and does not require excessive documentation.<br />
<br />
The following table describes the documentation required to address the EQIPD core requirements.<br />
<br />
In some cases, these are stand-alone documents. In others, expected information is typically available in other documents - mandated by the institutional regulations or being part of another process.<br />
<br />
{| class="wikitable"<br />
|rowspan="2"|'''Categories''' <br />
|rowspan="2"|'''No'''<br />
|rowspan="2"|'''Core Requirement'''<br />
|rowspan="2"|'''Toolbox reference'''<br />
|colspan="2"|'''Implementation of the Core Requirements'''<br />
|-<br />
|'''Stand-alone document'''<br />
|'''EQIPD expectations'''<br />
|-<br />
|rowspan="2"|'''Research team''' <br />
|1<br />
|Process owner must be identified for the Quality System<br />
|[[1.5.2.3 Process owner|1.5.2.3]]<br />
|No<br />
|Process Owner should act and be recognized as such by the research unit members. <br />
|-<br />
|2<br />
|Communication process must be in place<br />
|[[1.2 Scope|1.2]]<br />
|Yes<br />
|A concise overview of the organisational structure and the communication lines can be described in the [https://paasp.sharepoint.com/:w:/s/EQIPD/ERyfFP_pBytDiEfqCutDAJQBFbaGQEx3G1pyOmDl50o_LQ?e=wlkvHJ Communication plan template] provided by EQIPD or in a similar document.<br />
|-<br />
|rowspan="3"|'''Quality culture'''<br />
|3<br />
|The research unit must have defined quality objectives <br />
|[[1.1 Mission|1.1]]<br />
|Yes<br />
|The [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Mission statement template] of EQIPD or a similar document can be used to describe quality goals of a research unit. These quality objectives should be known to and shared by all members of a research unit.<br />
|-<br />
|4<br />
|All activities must comply with relevant legislation and policies<br />
|[[1.4.2 Adherence to legal and regulatory considerations|1.4.2]]<br />
|No<br />
|Research unit complies with all applicable national and international legislation and policies and there are no compliance issues.<br />
|-<br />
|5<br />
|The research unit must have a procedure to act upon concerns of potential misconduct<br />
|[[4.2.3 Responsible conduct of research|4.2.3]]<br />
|No<br />
|It is expected that a research unit or its parent organization has a research integrity policy, office and/or officer (or ombudsman) and all research unit members have access to this information.<br />
|-<br />
|rowspan="4"|'''Data integrity'''<br />
|6<br />
|Generation, handling and changes to data records must be documented<br />
|[[2.3.1 Generation, recording, handling and archiving of raw data|2.3.1]]<br />
|rowspan="3"|Yes<br />
|Can be described in the [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan] or in a similar document.<br />
|-<br />
|7<br />
|Data storage must be secured at least for as long as required by legal, contractual or other obligations or business needs<br />
|[[3.1.3 Data security|3.1.3]]<br />
|Could be documented in the [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan] or in a similar document.<br />
|-<br />
|8<br />
|Reported research outcomes must be traceable to experimental data<br />
|[[3.1.2.1 Traceability of data and any person having impact on data|3.1.2.1]]<br />
|Could be documented in the [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan] or in a similar document.<br />
|-<br />
|9<br />
|Reported data must disclose all repetitions of a study, an experiment, or a test regardless of the outcome<br />
|[[2.4 Reporting|2.4]]<br />
|No<br />
|This information could for example be found in presentation as reference to the original experiments<br />
|-<br />
|rowspan="5"|'''Research processes'''<br />
|10<br />
|Investigator must declare in advance whether a study is intended to inform a formal knowledge claim<br />
|[[2.1.4 Purpose of research|2.1.4]]<br />
|No<br />
|This information could be documented in the study/experimental protocol, see [[2.1.1 Study (experimental) plan]]<br />
|-<br />
|11<br />
|All personnel involved in research must have adequate training and competence to perform assigned tasks<br />
|[[3.2.1 General guidance on training|3.2.1]]<br />
|No<br />
|Participation in training could be hold available with the training records<br />
|-<br />
|12<br />
|Protocols for experimental methods must be available<br />
|[[3.5.2 Protocols for methods and assays|3.5.2]]<br />
|No<br />
|All procedures used in experiments could be hold available in the study/experimental protocol ([https://paasp.sharepoint.com/:w:/s/EQIPD/EfUO3B7RFxdHgxQ8JY5hhFoBEDUiPGK4C8n6BBHEprwroA?e=8IezWV template])<br />
|-<br />
|13<br />
|Adequate handling and storage of samples and materials must be ensured<br />
|[[3.3.3 Management of research materials and reagents|3.3.3]]<br />
|No<br />
|This information could be hold available, e.g. as chemical data sheets or within study/experimental protocol<br />
|-<br />
|14<br />
|Research equipment and tools must be suitable for intended use and ensure data integrity<br />
|[[3.3.2 Processes to enable computerized and non-computerized systems being suitable for intended use|3.3.2]]<br />
|No<br />
|Study/experimental protocols could reference or document that equipment was fit-for-purpose, e.g. by using reference substances<br />
|-<br />
|rowspan="3"|'''Continuous performance'''<br />
|15<br />
|Risk assessment must be performed to identify factors affecting the generation, processing and reporting of research data<br />
|[[4.1.1 Risk assessment|4.1.1]]<br />
|No<br />
|Study/experimental protocols could have a dedicated section for risk of bias in experimental processes, see [[2.1.1 Study (experimental) plan]] and for a risk assessment on the level of the research unit, it could be documented in the [https://paasp.sharepoint.com/:x:/s/EQIPD/ETo9OwIvZpNHtepp6IvxylQBjtjhk2AmRnypLCIOrGwMvA?e=n1zy3X Risk assessment template]<br />
|-<br />
|16<br />
|Critical incidents and errors during study conduct must be analyzed and appropriately managed<br />
|[[4.2.2 Error and incident management|4.2.2]]<br />
|No<br />
|Critical incidents and errors could be documented with the experimental protocol if on experimental level and in a separate [https://paasp.sharepoint.com/:w:/s/EQIPD/EatOAFgLbctEvxRZTuSCdU4Bv8J1I_BitfKl-JJiieOTLA?e=z99RR1 Error reporting document] for the research unit level<br />
|-<br />
|17<br />
|An approach must be in place to monitor the performance of the EQIPD Quality System, and address identified issues<br />
|[[4.1.2 Self assessment|4.1.2]]<br />
|Yes<br />
|This could be documented in the [https://paasp.sharepoint.com/:x:/s/EQIPD/EWbE3AdV5jhHglumN_MlrugBQX_KsZQDpJVNYbBJk6svTQ?e=qkW68H Self assessment template]<br />
|-<br />
|'''Sustainability'''<br />
|18<br />
|Resources for sustaining the EQIPD Quality System must be available<br />
|[[1.5.5 Sustainability|1.5.5]]<br />
|No<br />
|No documentation needed<br />
|}<br />
<br />
<br />
Back to the [[EQIPD Quality System]] or [[Core Requirements]].</div>Anton.bespalovhttps://wiki.go-eqipd.org/index.php?title=Documentation_in_EQIPD&diff=12389Documentation in EQIPD2021-02-09T17:11:19Z<p>Anton.bespalov: </p>
<hr />
<div>EQIPD Quality System is lean and does not require excessive documentation.<br />
<br />
The following table describes the documentation required to address the EQIPD core requirements.<br />
<br />
In some cases, these are stand-alone documents. In others, expected information is typically available in other documents - mandated by the institutional regulations or being part of another process.<br />
<br />
{| class="wikitable"<br />
|rowspan="2"|'''Categories''' <br />
|rowspan="2"|'''No'''<br />
|rowspan="2"|'''Core Requirement'''<br />
|rowspan="2"|'''Toolbox reference'''<br />
|colspan="2"|'''Implementation of the Core Requirements'''<br />
|-<br />
|'''Stand-alone document'''<br />
|'''EQIPD expectations'''<br />
|-<br />
|rowspan="2"|'''Research team''' <br />
|1<br />
|Process owner must be identified for the Quality System<br />
|[[1.5.2.3 Process owner|1.5.2.3]]<br />
|No<br />
|Process Owner should act and be recognized as such by the research unit members. <br />
|-<br />
|2<br />
|Communication process must be in place<br />
|[[1.2 Scope|1.2]]<br />
|Yes<br />
|A concise overview of the organisational structure and the communication lines can be described in the [https://paasp.sharepoint.com/:w:/s/EQIPD/ERyfFP_pBytDiEfqCutDAJQBFbaGQEx3G1pyOmDl50o_LQ?e=wlkvHJ Communication plan template] provided by EQIPD or in a similar document.<br />
|-<br />
|rowspan="3"|'''Quality culture'''<br />
|3<br />
|The research unit must have defined quality objectives <br />
|[[1.1 Mission|1.1]]<br />
|Yes<br />
|The [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Mission statement template] of EQIPD or a similar document can be used to describe quality goals of a research unit. These quality objectives should be known to and shared by all members of a research unit.<br />
|-<br />
|4<br />
|All activities must comply with relevant legislation and policies<br />
|[[1.4.2 Adherence to legal and regulatory considerations|1.4.2]]<br />
|No<br />
|Research unit complies with all applicable national and international legislation and policies and there are no compliance issues.<br />
|-<br />
|5<br />
|The research unit must have a procedure to act upon concerns of potential misconduct<br />
|[[4.2.3 Responsible conduct of research|4.2.3]]<br />
|No<br />
|It is expected that a research unit or its parent organization has a research integrity policy, office and/or officer (or ombudsman) and all research unit members have access to this information.<br />
|-<br />
|rowspan="4"|'''Data integrity'''<br />
|6<br />
|Generation, handling and changes to data records must be documented<br />
|[[2.3.1 Generation, recording, handling and archiving of raw data|2.3.1]]<br />
|rowspan="3"|Yes<br />
|Can be described in the [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan] and information about this Core Requirement should be available in the experimental/study protocol, e.g. identification of the author(s), time of data generation and ensured that data is readable and permanent<br />
|-<br />
|7<br />
|Data storage must be secured at least for as long as required by legal, contractual or other obligations or business needs<br />
|[[3.1.3 Data security|3.1.3]]<br />
|Could be documented in the [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan]<br />
|-<br />
|8<br />
|Reported research outcomes must be traceable to experimental data<br />
|[[3.1.2.1 Traceability of data and any person having impact on data|3.1.2.1]]<br />
|Could be documented in the [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan] and additional information should be available within the study plan and along the data usage chain, e.g. an unique study ID<br />
|-<br />
|9<br />
|Reported data must disclose all repetitions of a study, an experiment, or a test regardless of the outcome<br />
|[[2.4 Reporting|2.4]]<br />
|No<br />
|This information could for example be found in presentation as reference to the original experiments<br />
|-<br />
|rowspan="5"|'''Research processes'''<br />
|10<br />
|Investigator must declare in advance whether a study is intended to inform a formal knowledge claim<br />
|[[2.1.4 Purpose of research|2.1.4]]<br />
|No<br />
|This information could be documented in the study/experimental protocol, see [[2.1.1 Study (experimental) plan]]<br />
|-<br />
|11<br />
|All personnel involved in research must have adequate training and competence to perform assigned tasks<br />
|[[3.2.1 General guidance on training|3.2.1]]<br />
|No<br />
|Participation in training could be hold available with the training records<br />
|-<br />
|12<br />
|Protocols for experimental methods must be available<br />
|[[3.5.2 Protocols for methods and assays|3.5.2]]<br />
|No<br />
|All procedures used in experiments could be hold available in the study/experimental protocol ([https://paasp.sharepoint.com/:w:/s/EQIPD/EfUO3B7RFxdHgxQ8JY5hhFoBEDUiPGK4C8n6BBHEprwroA?e=8IezWV template])<br />
|-<br />
|13<br />
|Adequate handling and storage of samples and materials must be ensured<br />
|[[3.3.3 Management of research materials and reagents|3.3.3]]<br />
|No<br />
|This information could be hold available, e.g. as chemical data sheets or within study/experimental protocol<br />
|-<br />
|14<br />
|Research equipment and tools must be suitable for intended use and ensure data integrity<br />
|[[3.3.2 Processes to enable computerized and non-computerized systems being suitable for intended use|3.3.2]]<br />
|No<br />
|Study/experimental protocols could reference or document that equipment was fit-for-purpose, e.g. by using reference substances<br />
|-<br />
|rowspan="3"|'''Continuous performance'''<br />
|15<br />
|Risk assessment must be performed to identify factors affecting the generation, processing and reporting of research data<br />
|[[4.1.1 Risk assessment|4.1.1]]<br />
|No<br />
|Study/experimental protocols could have a dedicated section for risk of bias in experimental processes, see [[2.1.1 Study (experimental) plan]] and for a risk assessment on the level of the research unit, it could be documented in the [https://paasp.sharepoint.com/:x:/s/EQIPD/ETo9OwIvZpNHtepp6IvxylQBjtjhk2AmRnypLCIOrGwMvA?e=n1zy3X Risk assessment template]<br />
|-<br />
|16<br />
|Critical incidents and errors during study conduct must be analyzed and appropriately managed<br />
|[[4.2.2 Error and incident management|4.2.2]]<br />
|No<br />
|Critical incidents and errors could be documented with the experimental protocol if on experimental level and in a separate [https://paasp.sharepoint.com/:w:/s/EQIPD/EatOAFgLbctEvxRZTuSCdU4Bv8J1I_BitfKl-JJiieOTLA?e=z99RR1 Error reporting document] for the research unit level<br />
|-<br />
|17<br />
|An approach must be in place to monitor the performance of the EQIPD Quality System, and address identified issues<br />
|[[4.1.2 Self assessment|4.1.2]]<br />
|Yes<br />
|This could be documented in the [https://paasp.sharepoint.com/:x:/s/EQIPD/EWbE3AdV5jhHglumN_MlrugBQX_KsZQDpJVNYbBJk6svTQ?e=qkW68H Self assessment template]<br />
|-<br />
|'''Sustainability'''<br />
|18<br />
|Resources for sustaining the EQIPD Quality System must be available<br />
|[[1.5.5 Sustainability|1.5.5]]<br />
|No<br />
|No documentation needed<br />
|}<br />
<br />
<br />
Back to the [[EQIPD Quality System]] or [[Core Requirements]].</div>Anton.bespalovhttps://wiki.go-eqipd.org/index.php?title=Documentation_in_EQIPD&diff=12388Documentation in EQIPD2021-02-09T17:05:34Z<p>Anton.bespalov: </p>
<hr />
<div>EQIPD Quality System is lean and does not require excessive documentation.<br />
<br />
The following table describes the documentation required to address the EQIPD core requirements.<br />
<br />
In some cases, these are stand-alone documents. In others, expected information is typically available in other documents - mandated by the institutional regulations or being part of another process.<br />
<br />
{| class="wikitable"<br />
|rowspan="2"|'''Categories''' <br />
|rowspan="2"|'''No'''<br />
|rowspan="2"|'''Core Requirement'''<br />
|rowspan="2"|'''Toolbox reference'''<br />
|colspan="2"|'''Implementation of the Core Requirements'''<br />
|-<br />
|'''Stand-alone document'''<br />
|'''EQIPD expectations'''<br />
|-<br />
|rowspan="2"|'''Research team''' <br />
|1<br />
|Process owner must be identified for the Quality System<br />
|[[1.5.2.3 Process owner|1.5.2.3]]<br />
|No<br />
|No documentation needed. Process Owner should act and be recognized as such by the research unit members. <br />
|-<br />
|2<br />
|Communication process must be in place<br />
|[[1.2 Scope|1.2]]<br />
|Yes<br />
|A concise overview of the organisational structure and the communication lines can be described in the [https://paasp.sharepoint.com/:w:/s/EQIPD/ERyfFP_pBytDiEfqCutDAJQBFbaGQEx3G1pyOmDl50o_LQ?e=wlkvHJ Communication plan template] provided by EQIPD or in a similar document<br />
|-<br />
|rowspan="3"|'''Quality culture'''<br />
|3<br />
|The research unit must have defined quality objectives <br />
|[[1.1 Mission|1.1]]<br />
|Yes<br />
|The [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Mission statement template] of EQIPD or a similar document can be used to describe quality goals of a research unit. These quality objectives should be known to and shared by all members of a research unit.<br />
|-<br />
|4<br />
|All activities must comply with relevant legislation and policies<br />
|[[1.4.2 Adherence to legal and regulatory considerations|1.4.2]]<br />
|No<br />
|Research unit complies with all applicable national and international legislation and policies and there are no compliance issues.<br />
|-<br />
|5<br />
|The research unit must have a procedure to act upon concerns of potential misconduct<br />
|[[4.2.3 Responsible conduct of research|4.2.3]]<br />
|No<br />
|It is expected that a formal research integrity policy and ombudsman is in place (e.g. by the parent organization) and that training documentation is available<br />
|-<br />
|rowspan="4"|'''Data integrity'''<br />
|6<br />
|Generation, handling and changes to data records must be documented<br />
|[[2.3.1 Generation, recording, handling and archiving of raw data|2.3.1]]<br />
|rowspan="3"|Yes<br />
|Could be documented in the [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan] and information about this Core Requirement should be available in the experimental/study protocol, e.g. identification of the author(s), time of data generation and ensured that data is readable and permanent<br />
|-<br />
|7<br />
|Data storage must be secured at least for as long as required by legal, contractual or other obligations or business needs<br />
|[[3.1.3 Data security|3.1.3]]<br />
|Could be documented in the [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan]<br />
|-<br />
|8<br />
|Reported research outcomes must be traceable to experimental data<br />
|[[3.1.2.1 Traceability of data and any person having impact on data|3.1.2.1]]<br />
|Could be documented in the [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan] and additional information should be available within the study plan and along the data usage chain, e.g. an unique study ID<br />
|-<br />
|9<br />
|Reported data must disclose all repetitions of a study, an experiment, or a test regardless of the outcome<br />
|[[2.4 Reporting|2.4]]<br />
|No<br />
|This information could for example be found in presentation as reference to the original experiments<br />
|-<br />
|rowspan="5"|'''Research processes'''<br />
|10<br />
|Investigator must declare in advance whether a study is intended to inform a formal knowledge claim<br />
|[[2.1.4 Purpose of research|2.1.4]]<br />
|No<br />
|This information could be documented in the study/experimental protocol, see [[2.1.1 Study (experimental) plan]]<br />
|-<br />
|11<br />
|All personnel involved in research must have adequate training and competence to perform assigned tasks<br />
|[[3.2.1 General guidance on training|3.2.1]]<br />
|No<br />
|Participation in training could be hold available with the training records<br />
|-<br />
|12<br />
|Protocols for experimental methods must be available<br />
|[[3.5.2 Protocols for methods and assays|3.5.2]]<br />
|No<br />
|All procedures used in experiments could be hold available in the study/experimental protocol ([https://paasp.sharepoint.com/:w:/s/EQIPD/EfUO3B7RFxdHgxQ8JY5hhFoBEDUiPGK4C8n6BBHEprwroA?e=8IezWV template])<br />
|-<br />
|13<br />
|Adequate handling and storage of samples and materials must be ensured<br />
|[[3.3.3 Management of research materials and reagents|3.3.3]]<br />
|No<br />
|This information could be hold available, e.g. as chemical data sheets or within study/experimental protocol<br />
|-<br />
|14<br />
|Research equipment and tools must be suitable for intended use and ensure data integrity<br />
|[[3.3.2 Processes to enable computerized and non-computerized systems being suitable for intended use|3.3.2]]<br />
|No<br />
|Study/experimental protocols could reference or document that equipment was fit-for-purpose, e.g. by using reference substances<br />
|-<br />
|rowspan="3"|'''Continuous performance'''<br />
|15<br />
|Risk assessment must be performed to identify factors affecting the generation, processing and reporting of research data<br />
|[[4.1.1 Risk assessment|4.1.1]]<br />
|No<br />
|Study/experimental protocols could have a dedicated section for risk of bias in experimental processes, see [[2.1.1 Study (experimental) plan]] and for a risk assessment on the level of the research unit, it could be documented in the [https://paasp.sharepoint.com/:x:/s/EQIPD/ETo9OwIvZpNHtepp6IvxylQBjtjhk2AmRnypLCIOrGwMvA?e=n1zy3X Risk assessment template]<br />
|-<br />
|16<br />
|Critical incidents and errors during study conduct must be analyzed and appropriately managed<br />
|[[4.2.2 Error and incident management|4.2.2]]<br />
|No<br />
|Critical incidents and errors could be documented with the experimental protocol if on experimental level and in a separate [https://paasp.sharepoint.com/:w:/s/EQIPD/EatOAFgLbctEvxRZTuSCdU4Bv8J1I_BitfKl-JJiieOTLA?e=z99RR1 Error reporting document] for the research unit level<br />
|-<br />
|17<br />
|An approach must be in place to monitor the performance of the EQIPD Quality System, and address identified issues<br />
|[[4.1.2 Self assessment|4.1.2]]<br />
|Yes<br />
|This could be documented in the [https://paasp.sharepoint.com/:x:/s/EQIPD/EWbE3AdV5jhHglumN_MlrugBQX_KsZQDpJVNYbBJk6svTQ?e=qkW68H Self assessment template]<br />
|-<br />
|'''Sustainability'''<br />
|18<br />
|Resources for sustaining the EQIPD Quality System must be available<br />
|[[1.5.5 Sustainability|1.5.5]]<br />
|No<br />
|No documentation needed<br />
|}<br />
<br />
<br />
Back to the [[EQIPD Quality System]] or [[Core Requirements]].</div>Anton.bespalovhttps://wiki.go-eqipd.org/index.php?title=Documentation_in_EQIPD&diff=12387Documentation in EQIPD2021-02-09T17:03:56Z<p>Anton.bespalov: </p>
<hr />
<div>EQIPD Quality System is lean and does not require excessive documentation.<br />
<br />
The following table describes the documentation required to address the EQIPD core requirements.<br />
<br />
In some cases, these are stand-alone documents. In others, expected information is typically available in other documents - mandated by the institutional regulations or being part of another process.<br />
<br />
{| class="wikitable"<br />
|rowspan="2"|'''Categories''' <br />
|rowspan="2"|'''No'''<br />
|rowspan="2"|'''Core Requirement'''<br />
|rowspan="2"|'''Toolbox reference'''<br />
|colspan="2"|'''Implementation of the Core Requirements'''<br />
|-<br />
|'''Stand-alone document'''<br />
|'''EQIPD expectations'''<br />
|-<br />
|rowspan="2"|'''Research team''' <br />
|1<br />
|Process owner must be identified for the Quality System<br />
|[[1.5.2.3 Process owner|1.5.2.3]]<br />
|No<br />
|No documentation needed. Process Owner should act and be recognized as such by the research unit members. <br />
|-<br />
|2<br />
|Communication process must be in place<br />
|[[1.2 Scope|1.2]]<br />
|Yes<br />
|A concise overview of the organisational structure and the communication lines can be described in the [https://paasp.sharepoint.com/:w:/s/EQIPD/ERyfFP_pBytDiEfqCutDAJQBFbaGQEx3G1pyOmDl50o_LQ?e=wlkvHJ Communication plan template] provided by EQIPD or in a similar document<br />
|-<br />
|rowspan="3"|'''Quality culture'''<br />
|3<br />
|The research unit must have defined quality objectives <br />
|[[1.1 Mission|1.1]]<br />
|Yes<br />
|The [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Mission statement template] of EQIPD or a similar document can be used to describe quality goals of a research unit. These quality objectives should be known to and shared by all members of a research unit.<br />
|-<br />
|4<br />
|All activities must comply with relevant legislation and policies<br />
|[[1.4.2 Adherence to legal and regulatory considerations|1.4.2]]<br />
|No<br />
|These documents are usually available due to legal reasons and are usually stored at a dedicated place in the research unit or could be hold available in the Dossier in a digital format<br />
|-<br />
|5<br />
|The research unit must have a procedure to act upon concerns of potential misconduct<br />
|[[4.2.3 Responsible conduct of research|4.2.3]]<br />
|No<br />
|It is expected that a formal research integrity policy and ombudsman is in place (e.g. by the parent organization) and that training documentation is available<br />
|-<br />
|rowspan="4"|'''Data integrity'''<br />
|6<br />
|Generation, handling and changes to data records must be documented<br />
|[[2.3.1 Generation, recording, handling and archiving of raw data|2.3.1]]<br />
|rowspan="3"|Yes<br />
|Could be documented in the [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan] and information about this Core Requirement should be available in the experimental/study protocol, e.g. identification of the author(s), time of data generation and ensured that data is readable and permanent<br />
|-<br />
|7<br />
|Data storage must be secured at least for as long as required by legal, contractual or other obligations or business needs<br />
|[[3.1.3 Data security|3.1.3]]<br />
|Could be documented in the [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan]<br />
|-<br />
|8<br />
|Reported research outcomes must be traceable to experimental data<br />
|[[3.1.2.1 Traceability of data and any person having impact on data|3.1.2.1]]<br />
|Could be documented in the [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan] and additional information should be available within the study plan and along the data usage chain, e.g. an unique study ID<br />
|-<br />
|9<br />
|Reported data must disclose all repetitions of a study, an experiment, or a test regardless of the outcome<br />
|[[2.4 Reporting|2.4]]<br />
|No<br />
|This information could for example be found in presentation as reference to the original experiments<br />
|-<br />
|rowspan="5"|'''Research processes'''<br />
|10<br />
|Investigator must declare in advance whether a study is intended to inform a formal knowledge claim<br />
|[[2.1.4 Purpose of research|2.1.4]]<br />
|No<br />
|This information could be documented in the study/experimental protocol, see [[2.1.1 Study (experimental) plan]]<br />
|-<br />
|11<br />
|All personnel involved in research must have adequate training and competence to perform assigned tasks<br />
|[[3.2.1 General guidance on training|3.2.1]]<br />
|No<br />
|Participation in training could be hold available with the training records<br />
|-<br />
|12<br />
|Protocols for experimental methods must be available<br />
|[[3.5.2 Protocols for methods and assays|3.5.2]]<br />
|No<br />
|All procedures used in experiments could be hold available in the study/experimental protocol ([https://paasp.sharepoint.com/:w:/s/EQIPD/EfUO3B7RFxdHgxQ8JY5hhFoBEDUiPGK4C8n6BBHEprwroA?e=8IezWV template])<br />
|-<br />
|13<br />
|Adequate handling and storage of samples and materials must be ensured<br />
|[[3.3.3 Management of research materials and reagents|3.3.3]]<br />
|No<br />
|This information could be hold available, e.g. as chemical data sheets or within study/experimental protocol<br />
|-<br />
|14<br />
|Research equipment and tools must be suitable for intended use and ensure data integrity<br />
|[[3.3.2 Processes to enable computerized and non-computerized systems being suitable for intended use|3.3.2]]<br />
|No<br />
|Study/experimental protocols could reference or document that equipment was fit-for-purpose, e.g. by using reference substances<br />
|-<br />
|rowspan="3"|'''Continuous performance'''<br />
|15<br />
|Risk assessment must be performed to identify factors affecting the generation, processing and reporting of research data<br />
|[[4.1.1 Risk assessment|4.1.1]]<br />
|No<br />
|Study/experimental protocols could have a dedicated section for risk of bias in experimental processes, see [[2.1.1 Study (experimental) plan]] and for a risk assessment on the level of the research unit, it could be documented in the [https://paasp.sharepoint.com/:x:/s/EQIPD/ETo9OwIvZpNHtepp6IvxylQBjtjhk2AmRnypLCIOrGwMvA?e=n1zy3X Risk assessment template]<br />
|-<br />
|16<br />
|Critical incidents and errors during study conduct must be analyzed and appropriately managed<br />
|[[4.2.2 Error and incident management|4.2.2]]<br />
|No<br />
|Critical incidents and errors could be documented with the experimental protocol if on experimental level and in a separate [https://paasp.sharepoint.com/:w:/s/EQIPD/EatOAFgLbctEvxRZTuSCdU4Bv8J1I_BitfKl-JJiieOTLA?e=z99RR1 Error reporting document] for the research unit level<br />
|-<br />
|17<br />
|An approach must be in place to monitor the performance of the EQIPD Quality System, and address identified issues<br />
|[[4.1.2 Self assessment|4.1.2]]<br />
|Yes<br />
|This could be documented in the [https://paasp.sharepoint.com/:x:/s/EQIPD/EWbE3AdV5jhHglumN_MlrugBQX_KsZQDpJVNYbBJk6svTQ?e=qkW68H Self assessment template]<br />
|-<br />
|'''Sustainability'''<br />
|18<br />
|Resources for sustaining the EQIPD Quality System must be available<br />
|[[1.5.5 Sustainability|1.5.5]]<br />
|No<br />
|No documentation needed<br />
|}<br />
<br />
<br />
Back to the [[EQIPD Quality System]] or [[Core Requirements]].</div>Anton.bespalovhttps://wiki.go-eqipd.org/index.php?title=Documentation_in_EQIPD&diff=12383Documentation in EQIPD2021-02-09T16:56:23Z<p>Anton.bespalov: </p>
<hr />
<div>EQIPD Quality System is lean and does not require excessive documentation.<br />
<br />
The following table describes the documentation required to address the EQIPD core requirements.<br />
<br />
In some cases, these are stand-alone documents. In others, expected information is typically available in other documents - mandated by the institutional regulations or being part of another process.<br />
<br />
{| class="wikitable"<br />
|rowspan="2"|'''Categories''' <br />
|rowspan="2"|'''No'''<br />
|rowspan="2"|'''Core Requirement'''<br />
|rowspan="2"|'''Toolbox reference'''<br />
|colspan="2"|'''Documentation of the Core Requirements'''<br />
|-<br />
|'''Stand-alone document'''<br />
|'''Expected documentation'''<br />
|-<br />
|rowspan="2"|'''Research team''' <br />
|1<br />
|Process owner must be identified for the Quality System<br />
|[[1.5.2.3 Process owner|1.5.2.3]]<br />
|No<br />
|No documentation needed<br />
|-<br />
|2<br />
|Communication process must be in place<br />
|[[1.2 Scope|1.2]]<br />
|Yes<br />
|A brief overview of the organisational structure and the communication lines can be described in the [https://paasp.sharepoint.com/:w:/s/EQIPD/ERyfFP_pBytDiEfqCutDAJQBFbaGQEx3G1pyOmDl50o_LQ?e=wlkvHJ Communication plan template] provided by EQIPD or in a similar document<br />
|-<br />
|rowspan="3"|'''Quality culture'''<br />
|3<br />
|The research unit must have defined quality objectives <br />
|[[1.1 Mission|1.1]]<br />
|Yes<br />
|The [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Mission statement template] could be used to document quality goals of a research unit<br />
|-<br />
|4<br />
|All activities must comply with relevant legislation and policies<br />
|[[1.4.2 Adherence to legal and regulatory considerations|1.4.2]]<br />
|No<br />
|These documents are usually available due to legal reasons and are usually stored at a dedicated place in the research unit or could be hold available in the Dossier in a digital format<br />
|-<br />
|5<br />
|The research unit must have a procedure to act upon concerns of potential misconduct<br />
|[[4.2.3 Responsible conduct of research|4.2.3]]<br />
|No<br />
|It is expected that a formal research integrity policy and ombudsman is in place (e.g. by the parent organization) and that training documentation is available<br />
|-<br />
|rowspan="4"|'''Data integrity'''<br />
|6<br />
|Generation, handling and changes to data records must be documented<br />
|[[2.3.1 Generation, recording, handling and archiving of raw data|2.3.1]]<br />
|rowspan="3"|Yes<br />
|Could be documented in the [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan] and information about this Core Requirement should be available in the experimental/study protocol, e.g. identification of the author(s), time of data generation and ensured that data is readable and permanent<br />
|-<br />
|7<br />
|Data storage must be secured at least for as long as required by legal, contractual or other obligations or business needs<br />
|[[3.1.3 Data security|3.1.3]]<br />
|Could be documented in the [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan]<br />
|-<br />
|8<br />
|Reported research outcomes must be traceable to experimental data<br />
|[[3.1.2.1 Traceability of data and any person having impact on data|3.1.2.1]]<br />
|Could be documented in the [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan] and additional information should be available within the study plan and along the data usage chain, e.g. an unique study ID<br />
|-<br />
|9<br />
|Reported data must disclose all repetitions of a study, an experiment, or a test regardless of the outcome<br />
|[[2.4 Reporting|2.4]]<br />
|No<br />
|This information could for example be found in presentation as reference to the original experiments<br />
|-<br />
|rowspan="5"|'''Research processes'''<br />
|10<br />
|Investigator must declare in advance whether a study is intended to inform a formal knowledge claim<br />
|[[2.1.4 Purpose of research|2.1.4]]<br />
|No<br />
|This information could be documented in the study/experimental protocol, see [[2.1.1 Study (experimental) plan]]<br />
|-<br />
|11<br />
|All personnel involved in research must have adequate training and competence to perform assigned tasks<br />
|[[3.2.1 General guidance on training|3.2.1]]<br />
|No<br />
|Participation in training could be hold available with the training records<br />
|-<br />
|12<br />
|Protocols for experimental methods must be available<br />
|[[3.5.2 Protocols for methods and assays|3.5.2]]<br />
|No<br />
|All procedures used in experiments could be hold available in the study/experimental protocol ([https://paasp.sharepoint.com/:w:/s/EQIPD/EfUO3B7RFxdHgxQ8JY5hhFoBEDUiPGK4C8n6BBHEprwroA?e=8IezWV template])<br />
|-<br />
|13<br />
|Adequate handling and storage of samples and materials must be ensured<br />
|[[3.3.3 Management of research materials and reagents|3.3.3]]<br />
|No<br />
|This information could be hold available, e.g. as chemical data sheets or within study/experimental protocol<br />
|-<br />
|14<br />
|Research equipment and tools must be suitable for intended use and ensure data integrity<br />
|[[3.3.2 Processes to enable computerized and non-computerized systems being suitable for intended use|3.3.2]]<br />
|No<br />
|Study/experimental protocols could reference or document that equipment was fit-for-purpose, e.g. by using reference substances<br />
|-<br />
|rowspan="3"|'''Continuous performance'''<br />
|15<br />
|Risk assessment must be performed to identify factors affecting the generation, processing and reporting of research data<br />
|[[4.1.1 Risk assessment|4.1.1]]<br />
|No<br />
|Study/experimental protocols could have a dedicated section for risk of bias in experimental processes, see [[2.1.1 Study (experimental) plan]] and for a risk assessment on the level of the research unit, it could be documented in the [https://paasp.sharepoint.com/:x:/s/EQIPD/ETo9OwIvZpNHtepp6IvxylQBjtjhk2AmRnypLCIOrGwMvA?e=n1zy3X Risk assessment template]<br />
|-<br />
|16<br />
|Critical incidents and errors during study conduct must be analyzed and appropriately managed<br />
|[[4.2.2 Error and incident management|4.2.2]]<br />
|No<br />
|Critical incidents and errors could be documented with the experimental protocol if on experimental level and in a separate [https://paasp.sharepoint.com/:w:/s/EQIPD/EatOAFgLbctEvxRZTuSCdU4Bv8J1I_BitfKl-JJiieOTLA?e=z99RR1 Error reporting document] for the research unit level<br />
|-<br />
|17<br />
|An approach must be in place to monitor the performance of the EQIPD Quality System, and address identified issues<br />
|[[4.1.2 Self assessment|4.1.2]]<br />
|Yes<br />
|This could be documented in the [https://paasp.sharepoint.com/:x:/s/EQIPD/EWbE3AdV5jhHglumN_MlrugBQX_KsZQDpJVNYbBJk6svTQ?e=qkW68H Self assessment template]<br />
|-<br />
|'''Sustainability'''<br />
|18<br />
|Resources for sustaining the EQIPD Quality System must be available<br />
|[[1.5.5 Sustainability|1.5.5]]<br />
|No<br />
|No documentation needed<br />
|}<br />
<br />
<br />
Back to the [[EQIPD Quality System]] or [[Core Requirements]].</div>Anton.bespalovhttps://wiki.go-eqipd.org/index.php?title=Documentation_in_EQIPD&diff=12382Documentation in EQIPD2021-02-09T16:54:51Z<p>Anton.bespalov: </p>
<hr />
<div>EQIPD Quality System is lean and does not require excessive documentation.<br />
<br />
The following table describes the documentation required to address the EQIPD core requirements.<br />
<br />
In some cases, these are stand-alone documents. In others, expected information is typically available in other documents - mandated by the institutional regulations or being part of another process.<br />
<br />
{| class="wikitable"<br />
|rowspan="2"|'''Categories''' <br />
|rowspan="2"|'''No'''<br />
|rowspan="2"|'''Core Requirement'''<br />
|rowspan="2"|'''Toolbox reference'''<br />
|colspan="2"|'''Documentation of the Core Requirements'''<br />
|-<br />
|'''Stand-alone document'''<br />
|'''Expected documentation'''<br />
|-<br />
|rowspan="2"|'''Research team''' <br />
|1<br />
|Process owner must be identified for the Quality System<br />
|[[1.5.2.3 Process owner|1.5.2.3]]<br />
|No<br />
|No documentation needed<br />
|-<br />
|2<br />
|Communication process must be in place<br />
|[[1.2 Scope|1.2]]<br />
|Yes<br />
|A brief overview of the organisational structure and the communication lines could be documented in the [https://paasp.sharepoint.com/:w:/s/EQIPD/ERyfFP_pBytDiEfqCutDAJQBFbaGQEx3G1pyOmDl50o_LQ?e=wlkvHJ Communication plan template]<br />
|-<br />
|rowspan="3"|'''Quality culture'''<br />
|3<br />
|The research unit must have defined quality objectives <br />
|[[1.1 Mission|1.1]]<br />
|Yes<br />
|The [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Mission statement template] could be used to document quality goals of a research unit<br />
|-<br />
|4<br />
|All activities must comply with relevant legislation and policies<br />
|[[1.4.2 Adherence to legal and regulatory considerations|1.4.2]]<br />
|No<br />
|These documents are usually available due to legal reasons and are usually stored at a dedicated place in the research unit or could be hold available in the Dossier in a digital format<br />
|-<br />
|5<br />
|The research unit must have a procedure to act upon concerns of potential misconduct<br />
|[[4.2.3 Responsible conduct of research|4.2.3]]<br />
|No<br />
|It is expected that a formal research integrity policy and ombudsman is in place (e.g. by the parent organization) and that training documentation is available<br />
|-<br />
|rowspan="4"|'''Data integrity'''<br />
|6<br />
|Generation, handling and changes to data records must be documented<br />
|[[2.3.1 Generation, recording, handling and archiving of raw data|2.3.1]]<br />
|rowspan="3"|Yes<br />
|Could be documented in the [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan] and information about this Core Requirement should be available in the experimental/study protocol, e.g. identification of the author(s), time of data generation and ensured that data is readable and permanent<br />
|-<br />
|7<br />
|Data storage must be secured at least for as long as required by legal, contractual or other obligations or business needs<br />
|[[3.1.3 Data security|3.1.3]]<br />
|Could be documented in the [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan]<br />
|-<br />
|8<br />
|Reported research outcomes must be traceable to experimental data<br />
|[[3.1.2.1 Traceability of data and any person having impact on data|3.1.2.1]]<br />
|Could be documented in the [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan] and additional information should be available within the study plan and along the data usage chain, e.g. an unique study ID<br />
|-<br />
|9<br />
|Reported data must disclose all repetitions of a study, an experiment, or a test regardless of the outcome<br />
|[[2.4 Reporting|2.4]]<br />
|No<br />
|This information could for example be found in presentation as reference to the original experiments<br />
|-<br />
|rowspan="5"|'''Research processes'''<br />
|10<br />
|Investigator must declare in advance whether a study is intended to inform a formal knowledge claim<br />
|[[2.1.4 Purpose of research|2.1.4]]<br />
|No<br />
|This information could be documented in the study/experimental protocol, see [[2.1.1 Study (experimental) plan]]<br />
|-<br />
|11<br />
|All personnel involved in research must have adequate training and competence to perform assigned tasks<br />
|[[3.2.1 General guidance on training|3.2.1]]<br />
|No<br />
|Participation in training could be hold available with the training records<br />
|-<br />
|12<br />
|Protocols for experimental methods must be available<br />
|[[3.5.2 Protocols for methods and assays|3.5.2]]<br />
|No<br />
|All procedures used in experiments could be hold available in the study/experimental protocol ([https://paasp.sharepoint.com/:w:/s/EQIPD/EfUO3B7RFxdHgxQ8JY5hhFoBEDUiPGK4C8n6BBHEprwroA?e=8IezWV template])<br />
|-<br />
|13<br />
|Adequate handling and storage of samples and materials must be ensured<br />
|[[3.3.3 Management of research materials and reagents|3.3.3]]<br />
|No<br />
|This information could be hold available, e.g. as chemical data sheets or within study/experimental protocol<br />
|-<br />
|14<br />
|Research equipment and tools must be suitable for intended use and ensure data integrity<br />
|[[3.3.2 Processes to enable computerized and non-computerized systems being suitable for intended use|3.3.2]]<br />
|No<br />
|Study/experimental protocols could reference or document that equipment was fit-for-purpose, e.g. by using reference substances<br />
|-<br />
|rowspan="3"|'''Continuous performance'''<br />
|15<br />
|Risk assessment must be performed to identify factors affecting the generation, processing and reporting of research data<br />
|[[4.1.1 Risk assessment|4.1.1]]<br />
|No<br />
|Study/experimental protocols could have a dedicated section for risk of bias in experimental processes, see [[2.1.1 Study (experimental) plan]] and for a risk assessment on the level of the research unit, it could be documented in the [https://paasp.sharepoint.com/:x:/s/EQIPD/ETo9OwIvZpNHtepp6IvxylQBjtjhk2AmRnypLCIOrGwMvA?e=n1zy3X Risk assessment template]<br />
|-<br />
|16<br />
|Critical incidents and errors during study conduct must be analyzed and appropriately managed<br />
|[[4.2.2 Error and incident management|4.2.2]]<br />
|No<br />
|Critical incidents and errors could be documented with the experimental protocol if on experimental level and in a separate [https://paasp.sharepoint.com/:w:/s/EQIPD/EatOAFgLbctEvxRZTuSCdU4Bv8J1I_BitfKl-JJiieOTLA?e=z99RR1 Error reporting document] for the research unit level<br />
|-<br />
|17<br />
|An approach must be in place to monitor the performance of the EQIPD Quality System, and address identified issues<br />
|[[4.1.2 Self assessment|4.1.2]]<br />
|Yes<br />
|This could be documented in the [https://paasp.sharepoint.com/:x:/s/EQIPD/EWbE3AdV5jhHglumN_MlrugBQX_KsZQDpJVNYbBJk6svTQ?e=qkW68H Self assessment template]<br />
|-<br />
|'''Sustainability'''<br />
|18<br />
|Resources for sustaining the EQIPD Quality System must be available<br />
|[[1.5.5 Sustainability|1.5.5]]<br />
|No<br />
|No documentation needed<br />
|}<br />
<br />
<br />
Back to the [[EQIPD Quality System]] or [[Core Requirements]].</div>Anton.bespalovhttps://wiki.go-eqipd.org/index.php?title=Documentation_in_EQIPD&diff=12380Documentation in EQIPD2021-02-09T16:53:07Z<p>Anton.bespalov: </p>
<hr />
<div>EQIPD Quality System is lean and does not require excessive documentation.<br />
<br />
The following table describes the documentation required to address the EQIPD core requirements.<br />
<br />
In some cases, these are stand-alone documents. In others, expected information is typically available in other documents - mandated by the institutional regulations or being part of another process.<br />
<br />
{| class="wikitable"<br />
|rowspan="2"|'''Categories''' <br />
|rowspan="2"|'''No'''<br />
|rowspan="2"|'''Core Requirement'''<br />
|rowspan="2"|'''Toolbox reference'''<br />
|colspan="2"|'''Documentation of the Core Requirements'''<br />
|-<br />
|'''Stand-alone document'''<br />
|'''Expected documentation'''<br />
|-<br />
|rowspan="2"|'''Research team''' <br />
|1<br />
|Process owner must be identified for the Quality System<br />
|[[1.5.2.3 Process owner|1.5.2.3]]<br />
|No<br />
|No documentation needed, verbal agreement sufficient<br />
|-<br />
|2<br />
|Communication process must be in place<br />
|[[1.2 Scope|1.2]]<br />
|Yes<br />
|A brief overview of the organisational structure and the communication lines could be documented in the [https://paasp.sharepoint.com/:w:/s/EQIPD/ERyfFP_pBytDiEfqCutDAJQBFbaGQEx3G1pyOmDl50o_LQ?e=wlkvHJ Communication plan template]<br />
|-<br />
|rowspan="3"|'''Quality culture'''<br />
|3<br />
|The research unit must have defined quality objectives <br />
|[[1.1 Mission|1.1]]<br />
|Yes<br />
|The [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Mission statement template] could be used to document quality goals of a research unit<br />
|-<br />
|4<br />
|All activities must comply with relevant legislation and policies<br />
|[[1.4.2 Adherence to legal and regulatory considerations|1.4.2]]<br />
|No<br />
|These documents are usually available due to legal reasons and are usually stored at a dedicated place in the research unit or could be hold available in the Dossier in a digital format<br />
|-<br />
|5<br />
|The research unit must have a procedure to act upon concerns of potential misconduct<br />
|[[4.2.3 Responsible conduct of research|4.2.3]]<br />
|No<br />
|It is expected that a formal research integrity policy and ombudsman is in place (e.g. by the parent organization) and that training documentation is available<br />
|-<br />
|rowspan="4"|'''Data integrity'''<br />
|6<br />
|Generation, handling and changes to data records must be documented<br />
|[[2.3.1 Generation, recording, handling and archiving of raw data|2.3.1]]<br />
|rowspan="3"|Yes<br />
|Could be documented in the [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan] and information about this Core Requirement should be available in the experimental/study protocol, e.g. identification of the author(s), time of data generation and ensured that data is readable and permanent<br />
|-<br />
|7<br />
|Data storage must be secured at least for as long as required by legal, contractual or other obligations or business needs<br />
|[[3.1.3 Data security|3.1.3]]<br />
|Could be documented in the [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan]<br />
|-<br />
|8<br />
|Reported research outcomes must be traceable to experimental data<br />
|[[3.1.2.1 Traceability of data and any person having impact on data|3.1.2.1]]<br />
|Could be documented in the [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan] and additional information should be available within the study plan and along the data usage chain, e.g. an unique study ID<br />
|-<br />
|9<br />
|Reported data must disclose all repetitions of a study, an experiment, or a test regardless of the outcome<br />
|[[2.4 Reporting|2.4]]<br />
|No<br />
|This information could for example be found in presentation as reference to the original experiments<br />
|-<br />
|rowspan="5"|'''Research processes'''<br />
|10<br />
|Investigator must declare in advance whether a study is intended to inform a formal knowledge claim<br />
|[[2.1.4 Purpose of research|2.1.4]]<br />
|No<br />
|This information could be documented in the study/experimental protocol, see [[2.1.1 Study (experimental) plan]]<br />
|-<br />
|11<br />
|All personnel involved in research must have adequate training and competence to perform assigned tasks<br />
|[[3.2.1 General guidance on training|3.2.1]]<br />
|No<br />
|Participation in training could be hold available with the training records<br />
|-<br />
|12<br />
|Protocols for experimental methods must be available<br />
|[[3.5.2 Protocols for methods and assays|3.5.2]]<br />
|No<br />
|All procedures used in experiments could be hold available in the study/experimental protocol ([https://paasp.sharepoint.com/:w:/s/EQIPD/EfUO3B7RFxdHgxQ8JY5hhFoBEDUiPGK4C8n6BBHEprwroA?e=8IezWV template])<br />
|-<br />
|13<br />
|Adequate handling and storage of samples and materials must be ensured<br />
|[[3.3.3 Management of research materials and reagents|3.3.3]]<br />
|No<br />
|This information could be hold available, e.g. as chemical data sheets or within study/experimental protocol<br />
|-<br />
|14<br />
|Research equipment and tools must be suitable for intended use and ensure data integrity<br />
|[[3.3.2 Processes to enable computerized and non-computerized systems being suitable for intended use|3.3.2]]<br />
|No<br />
|Study/experimental protocols could reference or document that equipment was fit-for-purpose, e.g. by using reference substances<br />
|-<br />
|rowspan="3"|'''Continuous performance'''<br />
|15<br />
|Risk assessment must be performed to identify factors affecting the generation, processing and reporting of research data<br />
|[[4.1.1 Risk assessment|4.1.1]]<br />
|No<br />
|Study/experimental protocols could have a dedicated section for risk of bias in experimental processes, see [[2.1.1 Study (experimental) plan]] and for a risk assessment on the level of the research unit, it could be documented in the [https://paasp.sharepoint.com/:x:/s/EQIPD/ETo9OwIvZpNHtepp6IvxylQBjtjhk2AmRnypLCIOrGwMvA?e=n1zy3X Risk assessment template]<br />
|-<br />
|16<br />
|Critical incidents and errors during study conduct must be analyzed and appropriately managed<br />
|[[4.2.2 Error and incident management|4.2.2]]<br />
|No<br />
|Critical incidents and errors could be documented with the experimental protocol if on experimental level and in a separate [https://paasp.sharepoint.com/:w:/s/EQIPD/EatOAFgLbctEvxRZTuSCdU4Bv8J1I_BitfKl-JJiieOTLA?e=z99RR1 Error reporting document] for the research unit level<br />
|-<br />
|17<br />
|An approach must be in place to monitor the performance of the EQIPD Quality System, and address identified issues<br />
|[[4.1.2 Self assessment|4.1.2]]<br />
|Yes<br />
|This could be documented in the [https://paasp.sharepoint.com/:x:/s/EQIPD/EWbE3AdV5jhHglumN_MlrugBQX_KsZQDpJVNYbBJk6svTQ?e=qkW68H Self assessment template]<br />
|-<br />
|'''Sustainability'''<br />
|18<br />
|Resources for sustaining the EQIPD Quality System must be available<br />
|[[1.5.5 Sustainability|1.5.5]]<br />
|No<br />
|No documentation needed<br />
|}<br />
<br />
<br />
Back to the [[EQIPD Quality System]] or [[Core Requirements]].</div>Anton.bespalovhttps://wiki.go-eqipd.org/index.php?title=Documentation_in_EQIPD&diff=12379Documentation in EQIPD2021-02-09T16:51:15Z<p>Anton.bespalov: Reverted edits by Anton.bespalov (talk) to last revision by Bjoerngerlach</p>
<hr />
<div>The following table describes the documentation required for EQIPD either as stand-alone document or in the context of the research process.<br />
<br />
{| class="wikitable"<br />
|rowspan="2"|'''Categories''' <br />
|rowspan="2"|'''No'''<br />
|rowspan="2"|'''Core Requirement'''<br />
|rowspan="2"|'''Toolbox reference'''<br />
|colspan="2"|'''Documentation of the Core Requirements'''<br />
|-<br />
|'''Stand-alone document'''<br />
|'''Expected documentation'''<br />
|-<br />
|rowspan="2"|'''Research team''' <br />
|1<br />
|Process owner must be identified for the Quality System<br />
|[[1.5.2.3 Process owner|1.5.2.3]]<br />
|No<br />
|No documentation needed, verbal agreement sufficient<br />
|-<br />
|2<br />
|Communication process must be in place<br />
|[[1.2 Scope|1.2]]<br />
|Yes<br />
|A brief overview of the organisational structure and the communication lines could be documented in the [https://paasp.sharepoint.com/:w:/s/EQIPD/ERyfFP_pBytDiEfqCutDAJQBFbaGQEx3G1pyOmDl50o_LQ?e=wlkvHJ Communication plan template]<br />
|-<br />
|rowspan="3"|'''Quality culture'''<br />
|3<br />
|The research unit must have defined quality objectives <br />
|[[1.1 Mission|1.1]]<br />
|Yes<br />
|The [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Mission statement template] could be used to document quality goals of a research unit<br />
|-<br />
|4<br />
|All activities must comply with relevant legislation and policies<br />
|[[1.4.2 Adherence to legal and regulatory considerations|1.4.2]]<br />
|No<br />
|These documents are usually available due to legal reasons and are usually stored at a dedicated place in the research unit or could be hold available in the Dossier in a digital format<br />
|-<br />
|5<br />
|The research unit must have a procedure to act upon concerns of potential misconduct<br />
|[[4.2.3 Responsible conduct of research|4.2.3]]<br />
|No<br />
|It is expected that a formal research integrity policy and ombudsman is in place (e.g. by the parent organization) and that training documentation is available<br />
|-<br />
|rowspan="4"|'''Data integrity'''<br />
|6<br />
|Generation, handling and changes to data records must be documented<br />
|[[2.3.1 Generation, recording, handling and archiving of raw data|2.3.1]]<br />
|rowspan="3"|Yes<br />
|Could be documented in the [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan] and information about this Core Requirement should be available in the experimental/study protocol, e.g. identification of the author(s), time of data generation and ensured that data is readable and permanent<br />
|-<br />
|7<br />
|Data storage must be secured at least for as long as required by legal, contractual or other obligations or business needs<br />
|[[3.1.3 Data security|3.1.3]]<br />
|Could be documented in the [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan]<br />
|-<br />
|8<br />
|Reported research outcomes must be traceable to experimental data<br />
|[[3.1.2.1 Traceability of data and any person having impact on data|3.1.2.1]]<br />
|Could be documented in the [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan] and additional information should be available within the study plan and along the data usage chain, e.g. an unique study ID<br />
|-<br />
|9<br />
|Reported data must disclose all repetitions of a study, an experiment, or a test regardless of the outcome<br />
|[[2.4 Reporting|2.4]]<br />
|No<br />
|This information could for example be found in presentation as reference to the original experiments<br />
|-<br />
|rowspan="5"|'''Research processes'''<br />
|10<br />
|Investigator must declare in advance whether a study is intended to inform a formal knowledge claim<br />
|[[2.1.4 Purpose of research|2.1.4]]<br />
|No<br />
|This information could be documented in the study/experimental protocol, see [[2.1.1 Study (experimental) plan]]<br />
|-<br />
|11<br />
|All personnel involved in research must have adequate training and competence to perform assigned tasks<br />
|[[3.2.1 General guidance on training|3.2.1]]<br />
|No<br />
|Participation in training could be hold available with the training records<br />
|-<br />
|12<br />
|Protocols for experimental methods must be available<br />
|[[3.5.2 Protocols for methods and assays|3.5.2]]<br />
|No<br />
|All procedures used in experiments could be hold available in the study/experimental protocol ([https://paasp.sharepoint.com/:w:/s/EQIPD/EfUO3B7RFxdHgxQ8JY5hhFoBEDUiPGK4C8n6BBHEprwroA?e=8IezWV template])<br />
|-<br />
|13<br />
|Adequate handling and storage of samples and materials must be ensured<br />
|[[3.3.3 Management of research materials and reagents|3.3.3]]<br />
|No<br />
|This information could be hold available, e.g. as chemical data sheets or within study/experimental protocol<br />
|-<br />
|14<br />
|Research equipment and tools must be suitable for intended use and ensure data integrity<br />
|[[3.3.2 Processes to enable computerized and non-computerized systems being suitable for intended use|3.3.2]]<br />
|No<br />
|Study/experimental protocols could reference or document that equipment was fit-for-purpose, e.g. by using reference substances<br />
|-<br />
|rowspan="3"|'''Continuous performance'''<br />
|15<br />
|Risk assessment must be performed to identify factors affecting the generation, processing and reporting of research data<br />
|[[4.1.1 Risk assessment|4.1.1]]<br />
|No<br />
|Study/experimental protocols could have a dedicated section for risk of bias in experimental processes, see [[2.1.1 Study (experimental) plan]] and for a risk assessment on the level of the research unit, it could be documented in the [https://paasp.sharepoint.com/:x:/s/EQIPD/ETo9OwIvZpNHtepp6IvxylQBjtjhk2AmRnypLCIOrGwMvA?e=n1zy3X Risk assessment template]<br />
|-<br />
|16<br />
|Critical incidents and errors during study conduct must be analyzed and appropriately managed<br />
|[[4.2.2 Error and incident management|4.2.2]]<br />
|No<br />
|Critical incidents and errors could be documented with the experimental protocol if on experimental level and in a separate [https://paasp.sharepoint.com/:w:/s/EQIPD/EatOAFgLbctEvxRZTuSCdU4Bv8J1I_BitfKl-JJiieOTLA?e=z99RR1 Error reporting document] for the research unit level<br />
|-<br />
|17<br />
|An approach must be in place to monitor the performance of the EQIPD Quality System, and address identified issues<br />
|[[4.1.2 Self assessment|4.1.2]]<br />
|Yes<br />
|This could be documented in the [https://paasp.sharepoint.com/:x:/s/EQIPD/EWbE3AdV5jhHglumN_MlrugBQX_KsZQDpJVNYbBJk6svTQ?e=qkW68H Self assessment template]<br />
|-<br />
|'''Sustainability'''<br />
|18<br />
|Resources for sustaining the EQIPD Quality System must be available<br />
|[[1.5.5 Sustainability|1.5.5]]<br />
|No<br />
|No documentation needed<br />
|}<br />
<br />
<br />
Back to the [[EQIPD Quality System]] or [[Core Requirements]].</div>Anton.bespalovhttps://wiki.go-eqipd.org/index.php?title=Documentation_in_EQIPD&diff=12378Documentation in EQIPD2021-02-09T16:48:23Z<p>Anton.bespalov: </p>
<hr />
<div>EQIPD Quality System is lean and does not require excessive documentation.<br />
<br />
The following table describes the documentation required to address the EQIPD core requirements.<br />
<br />
In some cases, these are stand-alone documents. In others, expected information is typically available in other documents - mandated by the institutional regulations or being part of another process.<br />
<br />
{| class="wikitable"<br />
|rowspan="2"|'''Categories''' <br />
|rowspan="2"|'''No'''<br />
|rowspan="2"|'''Core Requirement'''<br />
|rowspan="2"|'''Toolbox reference'''<br />
|colspan="2"|'''Stand-alone document'''<br />
|colspan="2"|'''Expected documentation'''<br />
|rowspan="2"|'''Research team''' <br />
|1<br />
|Process owner must be identified for the Quality System<br />
|[[1.5.2.3 Process owner|1.5.2.3]]<br />
|No<br />
|No documentation needed, verbal agreement sufficient<br />
|-<br />
|2<br />
|Communication process must be in place<br />
|[[1.2 Scope|1.2]]<br />
|Yes<br />
|A brief overview of the organisational structure and the communication lines could be documented in the [https://paasp.sharepoint.com/:w:/s/EQIPD/ERyfFP_pBytDiEfqCutDAJQBFbaGQEx3G1pyOmDl50o_LQ?e=wlkvHJ Communication plan template]<br />
|-<br />
|rowspan="3"|'''Quality culture'''<br />
|3<br />
|The research unit must have defined quality objectives <br />
|[[1.1 Mission|1.1]]<br />
|Yes<br />
|The [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Mission statement template] could be used to document quality goals of a research unit<br />
|-<br />
|4<br />
|All activities must comply with relevant legislation and policies<br />
|[[1.4.2 Adherence to legal and regulatory considerations|1.4.2]]<br />
|No<br />
|These documents are usually available due to legal reasons and are usually stored at a dedicated place in the research unit or could be hold available in the Dossier in a digital format<br />
|-<br />
|5<br />
|The research unit must have a procedure to act upon concerns of potential misconduct<br />
|[[4.2.3 Responsible conduct of research|4.2.3]]<br />
|No<br />
|It is expected that a formal research integrity policy and ombudsman is in place (e.g. by the parent organization) and that training documentation is available<br />
|-<br />
|rowspan="4"|'''Data integrity'''<br />
|6<br />
|Generation, handling and changes to data records must be documented<br />
|[[2.3.1 Generation, recording, handling and archiving of raw data|2.3.1]]<br />
|rowspan="3"|Yes<br />
|Could be documented in the [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan] and information about this Core Requirement should be available in the experimental/study protocol, e.g. identification of the author(s), time of data generation and ensured that data is readable and permanent<br />
|-<br />
|7<br />
|Data storage must be secured at least for as long as required by legal, contractual or other obligations or business needs<br />
|[[3.1.3 Data security|3.1.3]]<br />
|Could be documented in the [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan]<br />
|-<br />
|8<br />
|Reported research outcomes must be traceable to experimental data<br />
|[[3.1.2.1 Traceability of data and any person having impact on data|3.1.2.1]]<br />
|Could be documented in the [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan] and additional information should be available within the study plan and along the data usage chain, e.g. an unique study ID<br />
|-<br />
|9<br />
|Reported data must disclose all repetitions of a study, an experiment, or a test regardless of the outcome<br />
|[[2.4 Reporting|2.4]]<br />
|No<br />
|This information could for example be found in presentation as reference to the original experiments<br />
|-<br />
|rowspan="5"|'''Research processes'''<br />
|10<br />
|Investigator must declare in advance whether a study is intended to inform a formal knowledge claim<br />
|[[2.1.4 Purpose of research|2.1.4]]<br />
|No<br />
|This information could be documented in the study/experimental protocol, see [[2.1.1 Study (experimental) plan]]<br />
|-<br />
|11<br />
|All personnel involved in research must have adequate training and competence to perform assigned tasks<br />
|[[3.2.1 General guidance on training|3.2.1]]<br />
|No<br />
|Participation in training could be hold available with the training records<br />
|-<br />
|12<br />
|Protocols for experimental methods must be available<br />
|[[3.5.2 Protocols for methods and assays|3.5.2]]<br />
|No<br />
|All procedures used in experiments could be hold available in the study/experimental protocol ([https://paasp.sharepoint.com/:w:/s/EQIPD/EfUO3B7RFxdHgxQ8JY5hhFoBEDUiPGK4C8n6BBHEprwroA?e=8IezWV template])<br />
|-<br />
|13<br />
|Adequate handling and storage of samples and materials must be ensured<br />
|[[3.3.3 Management of research materials and reagents|3.3.3]]<br />
|No<br />
|This information could be hold available, e.g. as chemical data sheets or within study/experimental protocol<br />
|-<br />
|14<br />
|Research equipment and tools must be suitable for intended use and ensure data integrity<br />
|[[3.3.2 Processes to enable computerized and non-computerized systems being suitable for intended use|3.3.2]]<br />
|No<br />
|Study/experimental protocols could reference or document that equipment was fit-for-purpose, e.g. by using reference substances<br />
|-<br />
|rowspan="3"|'''Continuous performance'''<br />
|15<br />
|Risk assessment must be performed to identify factors affecting the generation, processing and reporting of research data<br />
|[[4.1.1 Risk assessment|4.1.1]]<br />
|No<br />
|Study/experimental protocols could have a dedicated section for risk of bias in experimental processes, see [[2.1.1 Study (experimental) plan]] and for a risk assessment on the level of the research unit, it could be documented in the [https://paasp.sharepoint.com/:x:/s/EQIPD/ETo9OwIvZpNHtepp6IvxylQBjtjhk2AmRnypLCIOrGwMvA?e=n1zy3X Risk assessment template]<br />
|-<br />
|16<br />
|Critical incidents and errors during study conduct must be analyzed and appropriately managed<br />
|[[4.2.2 Error and incident management|4.2.2]]<br />
|No<br />
|Critical incidents and errors could be documented with the experimental protocol if on experimental level and in a separate [https://paasp.sharepoint.com/:w:/s/EQIPD/EatOAFgLbctEvxRZTuSCdU4Bv8J1I_BitfKl-JJiieOTLA?e=z99RR1 Error reporting document] for the research unit level<br />
|-<br />
|17<br />
|An approach must be in place to monitor the performance of the EQIPD Quality System, and address identified issues<br />
|[[4.1.2 Self assessment|4.1.2]]<br />
|Yes<br />
|This could be documented in the [https://paasp.sharepoint.com/:x:/s/EQIPD/EWbE3AdV5jhHglumN_MlrugBQX_KsZQDpJVNYbBJk6svTQ?e=qkW68H Self assessment template]<br />
|-<br />
|'''Sustainability'''<br />
|18<br />
|Resources for sustaining the EQIPD Quality System must be available<br />
|[[1.5.5 Sustainability|1.5.5]]<br />
|No<br />
|No documentation needed<br />
|}<br />
<br />
<br />
Back to the [[EQIPD Quality System]] or [[Core Requirements]].</div>Anton.bespalovhttps://wiki.go-eqipd.org/index.php?title=Documentation_in_EQIPD&diff=12375Documentation in EQIPD2021-02-09T16:44:17Z<p>Anton.bespalov: </p>
<hr />
<div>EQIPD Quality System is lean and does not require excessive documentation.<br />
<br />
The following table describes the documentation required to address the EQIPD core requirements.<br />
<br />
In some cases, these are stand-alone documents. In others, expected information is typically available in other documents - mandated by the institutional regulations or being part of another process.<br />
<br />
{| class="wikitable"<br />
|rowspan="2"|'''Categories''' <br />
|rowspan="2"|'''No'''<br />
|rowspan="2"|'''Core Requirement'''<br />
|rowspan="2"|'''Toolbox reference'''<br />
|colspan="2"|'''Documentation of the Core Requirements'''<br />
|-<br />
|'''Stand-alone document'''<br />
|'''Expected documentation'''<br />
|-<br />
|rowspan="2"|'''Research team''' <br />
|1<br />
|Process owner must be identified for the Quality System<br />
|[[1.5.2.3 Process owner|1.5.2.3]]<br />
|No<br />
|No documentation needed, verbal agreement sufficient<br />
|-<br />
|2<br />
|Communication process must be in place<br />
|[[1.2 Scope|1.2]]<br />
|Yes<br />
|A brief overview of the organisational structure and the communication lines could be documented in the [https://paasp.sharepoint.com/:w:/s/EQIPD/ERyfFP_pBytDiEfqCutDAJQBFbaGQEx3G1pyOmDl50o_LQ?e=wlkvHJ Communication plan template]<br />
|-<br />
|rowspan="3"|'''Quality culture'''<br />
|3<br />
|The research unit must have defined quality objectives <br />
|[[1.1 Mission|1.1]]<br />
|Yes<br />
|The [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Mission statement template] could be used to document quality goals of a research unit<br />
|-<br />
|4<br />
|All activities must comply with relevant legislation and policies<br />
|[[1.4.2 Adherence to legal and regulatory considerations|1.4.2]]<br />
|No<br />
|These documents are usually available due to legal reasons and are usually stored at a dedicated place in the research unit or could be hold available in the Dossier in a digital format<br />
|-<br />
|5<br />
|The research unit must have a procedure to act upon concerns of potential misconduct<br />
|[[4.2.3 Responsible conduct of research|4.2.3]]<br />
|No<br />
|It is expected that a formal research integrity policy and ombudsman is in place (e.g. by the parent organization) and that training documentation is available<br />
|-<br />
|rowspan="4"|'''Data integrity'''<br />
|6<br />
|Generation, handling and changes to data records must be documented<br />
|[[2.3.1 Generation, recording, handling and archiving of raw data|2.3.1]]<br />
|rowspan="3"|Yes<br />
|Could be documented in the [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan] and information about this Core Requirement should be available in the experimental/study protocol, e.g. identification of the author(s), time of data generation and ensured that data is readable and permanent<br />
|-<br />
|7<br />
|Data storage must be secured at least for as long as required by legal, contractual or other obligations or business needs<br />
|[[3.1.3 Data security|3.1.3]]<br />
|Could be documented in the [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan]<br />
|-<br />
|8<br />
|Reported research outcomes must be traceable to experimental data<br />
|[[3.1.2.1 Traceability of data and any person having impact on data|3.1.2.1]]<br />
|Could be documented in the [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan] and additional information should be available within the study plan and along the data usage chain, e.g. an unique study ID<br />
|-<br />
|9<br />
|Reported data must disclose all repetitions of a study, an experiment, or a test regardless of the outcome<br />
|[[2.4 Reporting|2.4]]<br />
|No<br />
|This information could for example be found in presentation as reference to the original experiments<br />
|-<br />
|rowspan="5"|'''Research processes'''<br />
|10<br />
|Investigator must declare in advance whether a study is intended to inform a formal knowledge claim<br />
|[[2.1.4 Purpose of research|2.1.4]]<br />
|No<br />
|This information could be documented in the study/experimental protocol, see [[2.1.1 Study (experimental) plan]]<br />
|-<br />
|11<br />
|All personnel involved in research must have adequate training and competence to perform assigned tasks<br />
|[[3.2.1 General guidance on training|3.2.1]]<br />
|No<br />
|Participation in training could be hold available with the training records<br />
|-<br />
|12<br />
|Protocols for experimental methods must be available<br />
|[[3.5.2 Protocols for methods and assays|3.5.2]]<br />
|No<br />
|All procedures used in experiments could be hold available in the study/experimental protocol ([https://paasp.sharepoint.com/:w:/s/EQIPD/EfUO3B7RFxdHgxQ8JY5hhFoBEDUiPGK4C8n6BBHEprwroA?e=8IezWV template])<br />
|-<br />
|13<br />
|Adequate handling and storage of samples and materials must be ensured<br />
|[[3.3.3 Management of research materials and reagents|3.3.3]]<br />
|No<br />
|This information could be hold available, e.g. as chemical data sheets or within study/experimental protocol<br />
|-<br />
|14<br />
|Research equipment and tools must be suitable for intended use and ensure data integrity<br />
|[[3.3.2 Processes to enable computerized and non-computerized systems being suitable for intended use|3.3.2]]<br />
|No<br />
|Study/experimental protocols could reference or document that equipment was fit-for-purpose, e.g. by using reference substances<br />
|-<br />
|rowspan="3"|'''Continuous performance'''<br />
|15<br />
|Risk assessment must be performed to identify factors affecting the generation, processing and reporting of research data<br />
|[[4.1.1 Risk assessment|4.1.1]]<br />
|No<br />
|Study/experimental protocols could have a dedicated section for risk of bias in experimental processes, see [[2.1.1 Study (experimental) plan]] and for a risk assessment on the level of the research unit, it could be documented in the [https://paasp.sharepoint.com/:x:/s/EQIPD/ETo9OwIvZpNHtepp6IvxylQBjtjhk2AmRnypLCIOrGwMvA?e=n1zy3X Risk assessment template]<br />
|-<br />
|16<br />
|Critical incidents and errors during study conduct must be analyzed and appropriately managed<br />
|[[4.2.2 Error and incident management|4.2.2]]<br />
|No<br />
|Critical incidents and errors could be documented with the experimental protocol if on experimental level and in a separate [https://paasp.sharepoint.com/:w:/s/EQIPD/EatOAFgLbctEvxRZTuSCdU4Bv8J1I_BitfKl-JJiieOTLA?e=z99RR1 Error reporting document] for the research unit level<br />
|-<br />
|17<br />
|An approach must be in place to monitor the performance of the EQIPD Quality System, and address identified issues<br />
|[[4.1.2 Self assessment|4.1.2]]<br />
|Yes<br />
|This could be documented in the [https://paasp.sharepoint.com/:x:/s/EQIPD/EWbE3AdV5jhHglumN_MlrugBQX_KsZQDpJVNYbBJk6svTQ?e=qkW68H Self assessment template]<br />
|-<br />
|'''Sustainability'''<br />
|18<br />
|Resources for sustaining the EQIPD Quality System must be available<br />
|[[1.5.5 Sustainability|1.5.5]]<br />
|No<br />
|No documentation needed<br />
|}<br />
<br />
<br />
Back to the [[EQIPD Quality System]] or [[Core Requirements]].</div>Anton.bespalovhttps://wiki.go-eqipd.org/index.php?title=3.2.3_Implementation_of_the_EQIPD_Quality_System&diff=13763.2.3 Implementation of the EQIPD Quality System2021-01-15T09:59:48Z<p>Anton.bespalov: /* Step 3 - Guided implementation */</p>
<hr />
<div>__NOTOC__<br />
== Step 1 - Get familiar with the key terms defined by EQIPD ==<br />
<br />
=== What means quality? === <br />
EQIPD defines research quality as the extent to which research data are fit for intended use. Fitness, in this context, is defined by the stakeholders, who can be scientists themselves, but also patients, funders, sponsors, publishers and collaboration partners (e.g., peers in a multi-site research project).<br />
<br />
=== Research rigor === <br />
Research rigor refers to measures against systematic error(s) in the estimated effect of an intervention, caused by inadequacies in the design, conduct, or analysis of an experiment.<br />
<br />
=== Raw data === <br />
Raw data (please see [[2.3.1 Generation, recording, handling and archiving of raw data]]) means all original records and documentation, which are the result of the observations and activities in a study, such as:<br />
* photographs, videotapes, blots, chromatograms, computer readable media, dictated observations, recorded data from automated instruments, or any other medium capable of providing secure storage of information for a time period required by law or other applicable regulations;<br />
* data directly entered into a computer through an automatic instrument interface, which are the results of primary observations and activities in a study;<br />
* copies of original laboratory records and documentation that are complete and of good quality.<br />
<br />
=== Knowledge-claiming research === <br />
Knowledge-claiming research (please see [[2.1.4 Purpose of research]]): EQIPD requires that the maximal rigor possible is applied (and exceptions explained / documented in the study plan) to research that is conducted with the prior intention of informing a knowledge claim.<br />
Examples of research requiring the maximal rigor possible include:<br />
* Experimental studies to scrutinize preclinical findings through replication of results alongside investigations into boundary conditions and robustness through conduct of additional (control) conditions and multicenter studies ([https://journals.plos.org/plosbiology/article?id=10.1371/journal.pbio.1001863 Kimmelman et al. 2014])<br />
*Research aimed to generate evidence that enables decisions such as critical studies that, dependent on the outcome, will trigger a chain of activities and events associated with significant resource and time costs (e.g. a decision to initiate a new drug development project or to initiate GLP safety assessment of a new drug candidate)<br />
* Studies for which any outcome would be considered diagnostic evidence about a claim from prior research ([https://doi.org/10.1371/journal.pbio.3000691 Nosek and Errington 2020])<br />
* Labor-, resource- and/or time-intensive studies that cannot be easily repeated<br />
<br />
=== Must vs. should === <br />
When reviewing materials provided by EQIPD, please note the use of "must" vs "should".<br />
* "Must" indicates actions that EQIPD considers as imperative and mandatory or as a requirement.<br />
* The system acknowledged that in some cases, the research environment, a specific research project or a research organization do not allow or make it less relevant to adhere to the requirements formulated below.<br />
* In such cases, instead of using the word “must”, the expectations are communicated as “should” or “strongly recommended”. This means that failure to comply with these expectations will not be automatically regarded as a “red flag” but the research organization may need to present a good rationale for not following this strong recommendation. <br />
<br />
For more definitions, please see [[Glossary]].<br />
<br />
<br />
== Step 2 - Take a closer look at EQIPD‘s expectations ==<br />
<br />
Please start with [https://paasp.sharepoint.com/:p:/s/EQIPD/ER4cDNHUMBVGqbtCd6vkFzEBkZM-rJvp5so_-i_N-Zarqg?e=MCebax viewing the presentation] prepared by the EQIPD team that explains why a Quality System is a good solution for research rigor needs, what it is about and how to move forward.<br />
<br />
Next, you may want to check how many [[Core Requirements]] do you meet by going through the self-assessment [https://paasp.sharepoint.com/:b:/s/EQIPD/EZFXsai_b2VHgZM2U44XTyMBWgwncIayAyOdl5Y0bE9VAA?e=ADbOfg overview]. <br />
<br />
This analysis will help you reveal already at this early stage whether and where major challenges can be encountered. <br />
<br />
Once this review is complete, you will be prepared to answer a question - Are most core requirements met?<br />
<br />
If the answer is “yes”, we suggest that you complete the self-assessment using the provided template, send it to the EQIPD team for consultation [mailto:info@eqipd.online info@EQIPD.online] or simply complete the remaining core requirements using information provided by EQIPD online ([[4.1.2 Self assessment]]).<br />
<br />
If the answer is "no", we suggest that you use the EQIPD tools and follow the suggested implementation path, guided by information provided by EQIPD team.<br />
<br />
== Step 3 - Guided implementation ==<br />
<br />
Implementation process is broken down into three consecutive phases (e.g., using the Wizard in the EQIPD Planning Tool - for more information, please contact the EQIPD team).<br />
<br />
== Step 4 - Assessment by the EQIPD team ==<br />
<br />
Once all core requirements are considered to be met, please approach the EQIPD team [mailto:info@eqipd.online info@EQIPD.online] that can do an assessment and, in case of a positive evaluation, will certify the successful implementation of the Quality System.<br />
<br />
<br />
<br />
----------------<br />
back to [[EQIPD Quality System]]<br />
<br />
back to [[Toolbox]]<br />
<br />
Item: [[3.2.4 Training on specific methods, tasks and activities]]</div>Anton.bespalovhttps://wiki.go-eqipd.org/index.php?title=Toolbox&diff=1223Toolbox2021-01-11T18:13:52Z<p>Anton.bespalov: </p>
<hr />
<div>As the essential part of the [[EQIPD Quality System|EQIPD Framework]], the Toolbox is a structured collection of various quality-related items, such as guidelines, protocols, and tools that can be used to build an EQIPD Quality System. <br />
<br />
The toolbox is used as a source of potential solutions by the [[4.3.2 Using the EQIPD applications|Planning tool]] to populate the [[Dossier]].<br />
<br />
EQIPD has developed a specific terminology that is used to describe the framework and the quality system [[Glossary]].<br />
<br />
__NOTOC__<br />
<br />
== 1. Objectives ==<br />
<br />
'''[[1.1 Mission]]'''<br />
<br />
'''[[1.2 Scope]]'''<br />
<br />
'''1.3 Quality Culture'''<br />
<br />
[[1.3.1 Transparency]]<br />
<br />
[[1.3.2 Sources of pressure and bias-producing communication of pressure]]<br />
<br />
[[1.3.3 Promotion criteria within a research unit]]<br />
<br />
[[1.3.4 Performance criteria and assessment]]<br />
<br />
[[1.3.5 Reward system and incentives]]<br />
<br />
<br />
'''1.4 My Need for Quality'''<br />
<br />
[[1.4.1 Research ethics]]<br />
<br />
[[1.4.1.1 Research integrity]]<br />
<br />
[[1.4.1.2 Data sharing]]<br />
<br />
[[1.4.2 Adherence to legal and regulatory considerations]]<br />
<br />
[[1.4.2.1 Biosafety]]<br />
<br />
[[1.4.2.2 Chemical safety]]<br />
<br />
[[1.4.2.3 Radioactivity]]<br />
<br />
[[1.4.2.4 Genetically modified organisms]]<br />
<br />
[[1.4.2.5 Risks to unborn life]]<br />
<br />
[[1.4.2.6 Handling of controlled substances]]<br />
<br />
[[1.4.2.7 Animal care and use]]<br />
<br />
[[1.4.2.8 Human data protection]]<br />
<br />
[[1.4.3 Quality in collaborative research]]<br />
<br />
[[1.4.3.1 Industry-academia: Research as service]]<br />
<br />
[[1.4.3.2 Industry-academia: Research as collaboration]]<br />
<br />
[[1.4.3.3 Academia-academia: Research as service]]<br />
<br />
[[1.4.3.4 Academia-academia: Research as collaboration]]<br />
<br />
<br />
<br />
'''1.5 Governance'''<br />
<br />
[[1.5.1 Quality policy]]<br />
<br />
[[1.5.2 Roles and responsibilities of involved personnel and organization]]<br />
<br />
[[1.5.2.1 Organigram]]<br />
<br />
[[1.5.2.2 Management]]<br />
<br />
[[1.5.2.3 Process owner]]<br />
<br />
[[1.5.2.4 Principal investigators and study directors]]<br />
<br />
[[1.5.2.5 Research team]]<br />
<br />
[[1.5.2.6 Supporting team]]<br />
<br />
[[1.5.2.7 Quality professionals]]<br />
<br />
[[1.5.3 Management of resources]]<br />
<br />
[[1.5.3.1 Personnel]]<br />
<br />
[[1.5.3.2 Facilities]]<br />
<br />
[[1.5.3.3 Laboratory and experimental equipment used for measurement]]<br />
<br />
[[1.5.3.4 Electronic information system]]<br />
<br />
[[1.5.3.5 Organization-specific know how]]<br />
<br />
[[1.5.3.6 Documentation requirement for sample and material]]<br />
<br />
[[1.5.3.7 Retained personnel records]]<br />
<br />
[[1.5.4 Prevention of Conflict of Interest]]<br />
<br />
[[1.5.4.1 Independence of internal compliance assessment]]<br />
<br />
[[1.5.4.2 Internal assessment of the organizations' quality professionals]]<br />
<br />
[[1.5.5 Sustainability]]<br />
<br />
== 2. Key Processes ==<br />
<br />
'''2.1 Experiment Planning'''<br />
<br />
[[2.1.1 Study (experimental) plan]]<br />
<br />
[[2.1.2 Unique study ID]]<br />
<br />
[[2.1.3 Appraisal of literature and systematic reviews]]<br />
<br />
[[2.1.4 Purpose of research]]<br />
<br />
[[2.1.5 Pre-specification]]<br />
<br />
[[2.1.6 Sample size and power analysis]]<br />
<br />
[[2.1.7 Blinding]]<br />
<br />
[[2.1.8 Randomisation]]<br />
<br />
[[2.1.9 Inclusion and exclusion criteria]]<br />
<br />
[[2.1.10 Plausibility check]]<br />
<br />
[[2.1.11 Preregistration]]<br />
<br />
<br />
'''2.2 Study execution'''<br />
<br />
[[2.2.1 Use of SOPs for standard experiments]]<br />
<br />
[[2.2.2 Use of template for (manual) data recording]]<br />
<br />
[[2.2.3 Documentation of the experiment and deviations]]<br />
<br />
<br />
'''2.3 Data handling'''<br />
<br />
[[2.3.1 Generation, recording, handling and archiving of raw data]]<br />
<br />
[[2.3.2 Primary analysis and evaluation of raw data]]<br />
<br />
[[2.3.3 Statistical analysis]]<br />
<br />
[[2.3.4 Data visualization]]<br />
<br />
<br />
'''[[2.4 Reporting]]'''<br />
<br />
[[2.4.1 Non-public reporting]]<br />
<br />
[[2.4.2 Publication]] <br />
<br />
<br />
<br />
== [[3 Support Processes]] ==<br />
<br />
<br />
'''3.1 Documentation management'''<br />
<br />
[[3.1.1 Platform to record data]] <br />
<br />
[[3.1.2 Procedures for how and when to record data]]<br />
<br />
[[3.1.2.1 Traceability of data and any person having impact on data]]<br />
<br />
[[3.1.2.2 Process for witnessing of records]]<br />
<br />
[[3.1.3 Data security]] <br />
<br />
<br />
'''3.2 Education, training and competence'''<br />
<br />
[[3.2.1 General guidance on training]]<br />
<br />
[[3.2.2 Good Research Practice training]]<br />
<br />
[[Implementation Strategy|3.2.3 Implementation of the EQIPD Quality System]]<br />
<br />
[[3.2.4 Training on specific methods, tasks and activities]]<br />
<br />
<br />
'''3.3 Laboratory resources'''<br />
<br />
[[3.3.1 Fit-for-purpose working environment]]<br />
<br />
[[3.3.2 Processes to enable computerized and non-computerized systems being suitable for intended use]]<br />
<br />
[[3.3.3 Management of research materials and reagents]]<br />
<br />
<br />
'''3.4 Experimental systems'''<br />
<br />
[[3.4.1 Animal characteristics, care and use]]<br />
<br />
[[3.4.1.1 Ethical evaluation and authorization process of animal use]]<br />
<br />
[[3.4.1.2 Animal procurement & identification]]<br />
<br />
[[3.4.1.3 Animal housing conditions]]<br />
<br />
[[3.4.1.4 Animal environmental conditions]]<br />
<br />
[[3.4.1.5 Food, watering and bedding]]<br />
<br />
[[3.4.1.6 Sanitation procedure]]<br />
<br />
[[3.4.1.7 Frequency and procedure of observation of animals]]<br />
<br />
[[3.4.1.8 Animal health and genetic monitoring]]<br />
<br />
[[3.4.1.9 Veterinary interventions during the study]]<br />
<br />
[[3.4.1.10 Surgical procedures]]<br />
<br />
[[3.4.1.11 Animal euthanasia procedures]]<br />
<br />
3.4.2 Non-animal test systems<br />
<br />
[[3.4.2.1 Cell culturing]]<br />
<br />
[[3.4.2.2 Antibody validation]]<br />
<br />
[[3.4.2.3 Biological and technical replicates]]<br />
<br />
<br />
'''3.5 Experimental methods'''<br />
<br />
[[3.5.1 Animal and non-animal method and assay qualification]]<br />
<br />
[[3.5.2 Protocols for methods and assays]]<br />
<br />
== [[4 Continuous improvement]] ==<br />
<br />
<br />
'''4.1 Assessment procedures'''<br />
<br />
[[4.1.1 Risk assessment]]<br />
<br />
[[4.1.2 Self assessment]]<br />
<br />
[[4.1.3 External assessment]]<br />
<br />
<br />
'''4.2 Prevention and improvement'''<br />
<br />
[[4.2.1 Installation of solutions, actions and mitigation strategies]]<br />
<br />
[[4.2.2 Error and incident management]]<br />
<br />
[[4.2.3 Responsible conduct of research]]<br />
<br />
[[4.2.4 Key performance indicators]]<br />
<br />
<br />
'''4.3 EQIPD framework'''<br />
<br />
4.3.1 Updating of EQIPD Dossier<br />
<br />
[[4.3.1.1 Adding new items]]<br />
<br />
[[4.3.1.2 Deleting items]]<br />
<br />
[[4.3.1.3 Revising items]]<br />
<br />
[[4.3.2 Using the EQIPD applications]]<br />
<br />
[[4.3.2.1 Using the Planning Tool]]<br />
<br />
[[4.3.2.2 Creating NEEDs]]<br />
<br />
[[4.3.2.3 Revising NEEDs]]<br />
<br />
[[4.3.2.4 Deleting NEEDs]]</div>Anton.bespalovhttps://wiki.go-eqipd.org/index.php?title=1.4.3_Quality_in_collaborative_research&diff=12201.4.3 Quality in collaborative research2021-01-11T18:10:29Z<p>Anton.bespalov: Anton.bespalov moved page 1.4.3.1 Quality in collaborative research to 1.4.3 Quality in collaborative research</p>
<hr />
<div>== A. Background & Definitions ==<br />
Research collaboration, in the context of this Toolbox article, refers to any mode of collaboration between two or more researchers or research organizations where one collaborating party depends on quality of results generated by another collaborating party. <br />
The collaboration modes range from a fee-for-service relationships to research projects executed jointly by members of a consortium where each member contributes towards shared goals.<br />
<br />
<br />
== B. Guidance & Expectations ==<br />
It is strongly recommended that:<br />
* each collaborating party defines research quality expectations prior to entering any formal collaboration agreements and certainly before initiating any experimental work;<br />
* if a collaboration is supported by a formal collaboration agreement, research quality expectations are specified as an attachment to the agreement;<br />
* all factors that can bias the research conduct (e.g. time pressure) are defined and discussed between parties;<br />
* if appropriate, individuals responsible for specific aspects of research quality are explicitly identified.<br />
<br />
Research quality expectations may also include on measurements to ensure data integrity, traceability and security:<br />
* Data generation and documentation practices<br />
** Will raw data be properly handled and stored?<br />
** Do collaborators have laboratory notebooks? <br />
* Data management practices <br />
** Are practices compliant with FAIR and ALCOAplus principles? <br />
* Platform for data sharing with collaborating parties <br />
** Does it support transparent data sharing? <br />
** Is it secure?<br />
* Reporting of results (presentation of research data between collaborating parties)<br />
** Are there any measures necessary to ensure complete reporting including all replicates?<br />
<br />
<br />
'''RISK ASSESSMENT'''<br />
<br />
* Is there any risk that inadequate quality of research practices (e.g. documentation) will endanger intellectual property rights?<br />
<br />
<br />
'''PLEASE DO NOT FORGET'''<br />
<br />
* To check whether research at the collaborating party meet required ethical standards<br />
<br />
<br />
== C. Resources ==<br />
'''Examples and templates for external collaborators:'''<br />
* [https://paasp.sharepoint.com/:w:/s/EQIPD/Edznay8k9dZAuNwmwZeuXz8B3D9lgHGyHsKna8nNfLXLeg?e=zc9VBz 1.4.3.1 Expectations for external collaborators.docx]<br />
* [https://paasp.sharepoint.com/:w:/s/EQIPD/EQ5criyu0xtDu4DJOmOTutMBuIoFK-jUxXpVSfixe_OOFw?e=DT4naO 1.4.3.1 Expectations for external collaborators one pager.docx]<br />
<br />
'''An EQIPD NEED for academia-industry collaborations:'''<br />
The pharma industry partners of EQIPD prepared a specific NEED for academic collaboration partners. This NEED can be downloaded here<br />
* [https://paasp.sharepoint.com/:x:/s/EQIPD/EUBTQDvb0J5HnUXpKdpyZUsB041zFCMf-0MHbNoG6w2t5w?e=syBDiY EQIPD external NEED Collaboration with Pharma Industry]<br />
Information on how to use such NEEDs can be found in section [[4.3.2 Using the EQIPD applications]]<br />
<br />
'''The FAIR Guiding Principles for scientific data management and stewardship [https://www.nature.com/articles/sdata201618]'''<br />
<br />
'''Webinar on Research Collaborations by Clemence Veauvy:'''<br />
{{#ev:youtube|https://youtu.be/CkTUbQ5qUJY}}<br />
<br />
<br />
----------------<br />
back to [[Toolbox]]<br />
<br />
Next item: [[1.5.1 Quality policy]]</div>Anton.bespalovhttps://wiki.go-eqipd.org/index.php?title=1.4.3.1_Quality_in_collaborative_research&diff=12211.4.3.1 Quality in collaborative research2021-01-11T18:10:29Z<p>Anton.bespalov: Anton.bespalov moved page 1.4.3.1 Quality in collaborative research to 1.4.3 Quality in collaborative research</p>
<hr />
<div>#REDIRECT [[1.4.3 Quality in collaborative research]]</div>Anton.bespalovhttps://wiki.go-eqipd.org/index.php?title=1.4.3.2_Quality_in_collaborative_research&diff=12191.4.3.2 Quality in collaborative research2021-01-11T18:09:44Z<p>Anton.bespalov: Created page with "A. Background & Definitions[edit] Research collaboration, in the context of this Toolbox article, refers to any mode of collaboration between..."</p>
<hr />
<div>A. Background & Definitions[edit]<br />
Research collaboration, in the context of this Toolbox article, refers to any mode of collaboration between two or more researchers or research organizations where one collaborating party depends on quality of results generated by another collaborating party. The collaboration modes range from a fee-for-service relationships to research projects executed jointly by members of a consortium where each member contributes towards shared goals.<br />
<br />
<br />
<br />
B. Guidance & Expectations[edit]<br />
It is strongly recommended that:<br />
<br />
each collaborating party defines research quality expectations prior to entering any formal collaboration agreements and certainly before initiating any experimental work;<br />
if a collaboration is supported by a formal collaboration agreement, research quality expectations are specified as an attachment to the agreement;<br />
all factors that can bias the research conduct (e.g. time pressure) are defined and discussed between parties;<br />
if appropriate, individuals responsible for specific aspects of research quality are explicitly identified.<br />
Research quality expectations may also include on measurements to ensure data integrity, traceability and security:<br />
<br />
Data generation and documentation practices<br />
Will raw data be properly handled and stored?<br />
Do collaborators have laboratory notebooks?<br />
Data management practices<br />
Are practices compliant with FAIR and ALCOAplus principles?<br />
Platform for data sharing with collaborating parties<br />
Does it support transparent data sharing?<br />
Is it secure?<br />
Reporting of results (presentation of research data between collaborating parties)<br />
Are there any measures necessary to ensure complete reporting including all replicates?<br />
<br />
RISK ASSESSMENT<br />
<br />
Is there any risk that inadequate quality of research practices (e.g. documentation) will endanger intellectual property rights?<br />
<br />
PLEASE DO NOT FORGET<br />
<br />
To check whether research at the collaborating party meet required ethical standards<br />
<br />
<br />
C. Resources[edit]<br />
Examples and templates for external collaborators:<br />
<br />
1.4.3.1 Expectations for external collaborators.docx<br />
1.4.3.1 Expectations for external collaborators one pager.docx<br />
An EQIPD NEED for academia-industry collaborations: The pharma industry partners of EQIPD prepared a specific NEED for academic collaboration partners. This NEED can be downloaded here<br />
<br />
EQIPD external NEED Collaboration with Pharma Industry<br />
Information on how to use such NEEDs can be found in section 4.3.2 Using the EQIPD applications<br />
<br />
The FAIR Guiding Principles for scientific data management and stewardship [1]<br />
<br />
Webinar on Research Collaborations by Clemence Veauvy:</div>Anton.bespalovhttps://wiki.go-eqipd.org/index.php?title=Toolbox&diff=1218Toolbox2021-01-11T18:09:19Z<p>Anton.bespalov: </p>
<hr />
<div>As the essential part of the [[EQIPD Quality System|EQIPD Framework]], the Toolbox is a structured collection of various quality-related items, such as guidelines, protocols, and tools that can be used to build an EQIPD Quality System. <br />
<br />
The toolbox is used as a source of potential solutions by the [[4.3.2 Using the EQIPD applications|Planning tool]] to populate the [[Dossier]].<br />
<br />
EQIPD has developed a specific terminology that is used to describe the framework and the quality system [[Glossary]].<br />
<br />
__NOTOC__<br />
<br />
== 1. Objectives ==<br />
<br />
'''[[1.1 Mission]]'''<br />
<br />
'''[[1.2 Scope]]'''<br />
<br />
'''1.3 Quality Culture'''<br />
<br />
[[1.3.1 Transparency]]<br />
<br />
[[1.3.2 Sources of pressure and bias-producing communication of pressure]]<br />
<br />
[[1.3.3 Promotion criteria within a research unit]]<br />
<br />
[[1.3.4 Performance criteria and assessment]]<br />
<br />
[[1.3.5 Reward system and incentives]]<br />
<br />
<br />
'''1.4 My Need for Quality'''<br />
<br />
[[1.4.1 Research ethics]]<br />
<br />
[[1.4.1.1 Research integrity]]<br />
<br />
[[1.4.1.2 Data sharing]]<br />
<br />
[[1.4.2 Adherence to legal and regulatory considerations]]<br />
<br />
[[1.4.2.1 Biosafety]]<br />
<br />
[[1.4.2.2 Chemical safety]]<br />
<br />
[[1.4.2.3 Radioactivity]]<br />
<br />
[[1.4.2.4 Genetically modified organisms]]<br />
<br />
[[1.4.2.5 Risks to unborn life]]<br />
<br />
[[1.4.2.6 Handling of controlled substances]]<br />
<br />
[[1.4.2.7 Animal care and use]]<br />
<br />
[[1.4.2.8 Human data protection]]<br />
<br />
[[1.4.3.2 Quality in collaborative research]]<br />
<br />
<br />
'''1.5 Governance'''<br />
<br />
[[1.5.1 Quality policy]]<br />
<br />
[[1.5.2 Roles and responsibilities of involved personnel and organization]]<br />
<br />
[[1.5.2.1 Organigram]]<br />
<br />
[[1.5.2.2 Management]]<br />
<br />
[[1.5.2.3 Process owner]]<br />
<br />
[[1.5.2.4 Principal investigators and study directors]]<br />
<br />
[[1.5.2.5 Research team]]<br />
<br />
[[1.5.2.6 Supporting team]]<br />
<br />
[[1.5.2.7 Quality professionals]]<br />
<br />
[[1.5.3 Management of resources]]<br />
<br />
[[1.5.3.1 Personnel]]<br />
<br />
[[1.5.3.2 Facilities]]<br />
<br />
[[1.5.3.3 Laboratory and experimental equipment used for measurement]]<br />
<br />
[[1.5.3.4 Electronic information system]]<br />
<br />
[[1.5.3.5 Organization-specific know how]]<br />
<br />
[[1.5.3.6 Documentation requirement for sample and material]]<br />
<br />
[[1.5.3.7 Retained personnel records]]<br />
<br />
[[1.5.4 Prevention of Conflict of Interest]]<br />
<br />
[[1.5.4.1 Independence of internal compliance assessment]]<br />
<br />
[[1.5.4.2 Internal assessment of the organizations' quality professionals]]<br />
<br />
[[1.5.5 Sustainability]]<br />
<br />
== 2. Key Processes ==<br />
<br />
'''2.1 Experiment Planning'''<br />
<br />
[[2.1.1 Study (experimental) plan]]<br />
<br />
[[2.1.2 Unique study ID]]<br />
<br />
[[2.1.3 Appraisal of literature and systematic reviews]]<br />
<br />
[[2.1.4 Purpose of research]]<br />
<br />
[[2.1.5 Pre-specification]]<br />
<br />
[[2.1.6 Sample size and power analysis]]<br />
<br />
[[2.1.7 Blinding]]<br />
<br />
[[2.1.8 Randomisation]]<br />
<br />
[[2.1.9 Inclusion and exclusion criteria]]<br />
<br />
[[2.1.10 Plausibility check]]<br />
<br />
[[2.1.11 Preregistration]]<br />
<br />
<br />
'''2.2 Study execution'''<br />
<br />
[[2.2.1 Use of SOPs for standard experiments]]<br />
<br />
[[2.2.2 Use of template for (manual) data recording]]<br />
<br />
[[2.2.3 Documentation of the experiment and deviations]]<br />
<br />
<br />
'''2.3 Data handling'''<br />
<br />
[[2.3.1 Generation, recording, handling and archiving of raw data]]<br />
<br />
[[2.3.2 Primary analysis and evaluation of raw data]]<br />
<br />
[[2.3.3 Statistical analysis]]<br />
<br />
[[2.3.4 Data visualization]]<br />
<br />
<br />
'''[[2.4 Reporting]]'''<br />
<br />
[[2.4.1 Non-public reporting]]<br />
<br />
[[2.4.2 Publication]] <br />
<br />
<br />
<br />
== [[3 Support Processes]] ==<br />
<br />
<br />
'''3.1 Documentation management'''<br />
<br />
[[3.1.1 Platform to record data]] <br />
<br />
[[3.1.2 Procedures for how and when to record data]]<br />
<br />
[[3.1.2.1 Traceability of data and any person having impact on data]]<br />
<br />
[[3.1.2.2 Process for witnessing of records]]<br />
<br />
[[3.1.3 Data security]] <br />
<br />
<br />
'''3.2 Education, training and competence'''<br />
<br />
[[3.2.1 General guidance on training]]<br />
<br />
[[3.2.2 Good Research Practice training]]<br />
<br />
[[Implementation Strategy|3.2.3 Implementation of the EQIPD Quality System]]<br />
<br />
[[3.2.4 Training on specific methods, tasks and activities]]<br />
<br />
<br />
'''3.3 Laboratory resources'''<br />
<br />
[[3.3.1 Fit-for-purpose working environment]]<br />
<br />
[[3.3.2 Processes to enable computerized and non-computerized systems being suitable for intended use]]<br />
<br />
[[3.3.3 Management of research materials and reagents]]<br />
<br />
<br />
'''3.4 Experimental systems'''<br />
<br />
[[3.4.1 Animal characteristics, care and use]]<br />
<br />
[[3.4.1.1 Ethical evaluation and authorization process of animal use]]<br />
<br />
[[3.4.1.2 Animal procurement & identification]]<br />
<br />
[[3.4.1.3 Animal housing conditions]]<br />
<br />
[[3.4.1.4 Animal environmental conditions]]<br />
<br />
[[3.4.1.5 Food, watering and bedding]]<br />
<br />
[[3.4.1.6 Sanitation procedure]]<br />
<br />
[[3.4.1.7 Frequency and procedure of observation of animals]]<br />
<br />
[[3.4.1.8 Animal health and genetic monitoring]]<br />
<br />
[[3.4.1.9 Veterinary interventions during the study]]<br />
<br />
[[3.4.1.10 Surgical procedures]]<br />
<br />
[[3.4.1.11 Animal euthanasia procedures]]<br />
<br />
3.4.2 Non-animal test systems<br />
<br />
[[3.4.2.1 Cell culturing]]<br />
<br />
[[3.4.2.2 Antibody validation]]<br />
<br />
[[3.4.2.3 Biological and technical replicates]]<br />
<br />
<br />
'''3.5 Experimental methods'''<br />
<br />
[[3.5.1 Animal and non-animal method and assay qualification]]<br />
<br />
[[3.5.2 Protocols for methods and assays]]<br />
<br />
== [[4 Continuous improvement]] ==<br />
<br />
<br />
'''4.1 Assessment procedures'''<br />
<br />
[[4.1.1 Risk assessment]]<br />
<br />
[[4.1.2 Self assessment]]<br />
<br />
[[4.1.3 External assessment]]<br />
<br />
<br />
'''4.2 Prevention and improvement'''<br />
<br />
[[4.2.1 Installation of solutions, actions and mitigation strategies]]<br />
<br />
[[4.2.2 Error and incident management]]<br />
<br />
[[4.2.3 Responsible conduct of research]]<br />
<br />
[[4.2.4 Key performance indicators]]<br />
<br />
<br />
'''4.3 EQIPD framework'''<br />
<br />
4.3.1 Updating of EQIPD Dossier<br />
<br />
[[4.3.1.1 Adding new items]]<br />
<br />
[[4.3.1.2 Deleting items]]<br />
<br />
[[4.3.1.3 Revising items]]<br />
<br />
[[4.3.2 Using the EQIPD applications]]<br />
<br />
[[4.3.2.1 Using the Planning Tool]]<br />
<br />
[[4.3.2.2 Creating NEEDs]]<br />
<br />
[[4.3.2.3 Revising NEEDs]]<br />
<br />
[[4.3.2.4 Deleting NEEDs]]</div>Anton.bespalovhttps://wiki.go-eqipd.org/index.php?title=Toolbox&diff=1216Toolbox2021-01-11T18:07:00Z<p>Anton.bespalov: </p>
<hr />
<div>As the essential part of the [[EQIPD Quality System|EQIPD Framework]], the Toolbox is a structured collection of various quality-related items, such as guidelines, protocols, and tools that can be used to build an EQIPD Quality System. <br />
<br />
The toolbox is used as a source of potential solutions by the [[4.3.2 Using the EQIPD applications|Planning tool]] to populate the [[Dossier]].<br />
<br />
EQIPD has developed a specific terminology that is used to describe the framework and the quality system [[Glossary]].<br />
<br />
__NOTOC__<br />
<br />
== 1. Objectives ==<br />
<br />
'''[[1.1 Mission]]'''<br />
<br />
'''[[1.2 Scope]]'''<br />
<br />
'''1.3 Quality Culture'''<br />
<br />
[[1.3.1 Transparency]]<br />
<br />
[[1.3.2 Sources of pressure and bias-producing communication of pressure]]<br />
<br />
[[1.3.3 Promotion criteria within a research unit]]<br />
<br />
[[1.3.4 Performance criteria and assessment]]<br />
<br />
[[1.3.5 Reward system and incentives]]<br />
<br />
<br />
'''1.4 My Need for Quality'''<br />
<br />
[[1.4.1 Research ethics]]<br />
<br />
[[1.4.1.1 Research integrity]]<br />
<br />
[[1.4.1.2 Data sharing]]<br />
<br />
[[1.4.2 Adherence to legal and regulatory considerations]]<br />
<br />
[[1.4.2.1 Biosafety]]<br />
<br />
[[1.4.2.2 Chemical safety]]<br />
<br />
[[1.4.2.3 Radioactivity]]<br />
<br />
[[1.4.2.4 Genetically modified organisms]]<br />
<br />
[[1.4.2.5 Risks to unborn life]]<br />
<br />
[[1.4.2.6 Handling of controlled substances]]<br />
<br />
[[1.4.2.7 Animal care and use]]<br />
<br />
[[1.4.2.8 Human data protection]]<br />
<br />
[[1.4.3 Quality in collaborative research]]<br />
<br />
<br />
'''1.5 Governance'''<br />
<br />
[[1.5.1 Quality policy]]<br />
<br />
[[1.5.2 Roles and responsibilities of involved personnel and organization]]<br />
<br />
[[1.5.2.1 Organigram]]<br />
<br />
[[1.5.2.2 Management]]<br />
<br />
[[1.5.2.3 Process owner]]<br />
<br />
[[1.5.2.4 Principal investigators and study directors]]<br />
<br />
[[1.5.2.5 Research team]]<br />
<br />
[[1.5.2.6 Supporting team]]<br />
<br />
[[1.5.2.7 Quality professionals]]<br />
<br />
[[1.5.3 Management of resources]]<br />
<br />
[[1.5.3.1 Personnel]]<br />
<br />
[[1.5.3.2 Facilities]]<br />
<br />
[[1.5.3.3 Laboratory and experimental equipment used for measurement]]<br />
<br />
[[1.5.3.4 Electronic information system]]<br />
<br />
[[1.5.3.5 Organization-specific know how]]<br />
<br />
[[1.5.3.6 Documentation requirement for sample and material]]<br />
<br />
[[1.5.3.7 Retained personnel records]]<br />
<br />
[[1.5.4 Prevention of Conflict of Interest]]<br />
<br />
[[1.5.4.1 Independence of internal compliance assessment]]<br />
<br />
[[1.5.4.2 Internal assessment of the organizations' quality professionals]]<br />
<br />
[[1.5.5 Sustainability]]<br />
<br />
== 2. Key Processes ==<br />
<br />
'''2.1 Experiment Planning'''<br />
<br />
[[2.1.1 Study (experimental) plan]]<br />
<br />
[[2.1.2 Unique study ID]]<br />
<br />
[[2.1.3 Appraisal of literature and systematic reviews]]<br />
<br />
[[2.1.4 Purpose of research]]<br />
<br />
[[2.1.5 Pre-specification]]<br />
<br />
[[2.1.6 Sample size and power analysis]]<br />
<br />
[[2.1.7 Blinding]]<br />
<br />
[[2.1.8 Randomisation]]<br />
<br />
[[2.1.9 Inclusion and exclusion criteria]]<br />
<br />
[[2.1.10 Plausibility check]]<br />
<br />
[[2.1.11 Preregistration]]<br />
<br />
<br />
'''2.2 Study execution'''<br />
<br />
[[2.2.1 Use of SOPs for standard experiments]]<br />
<br />
[[2.2.2 Use of template for (manual) data recording]]<br />
<br />
[[2.2.3 Documentation of the experiment and deviations]]<br />
<br />
<br />
'''2.3 Data handling'''<br />
<br />
[[2.3.1 Generation, recording, handling and archiving of raw data]]<br />
<br />
[[2.3.2 Primary analysis and evaluation of raw data]]<br />
<br />
[[2.3.3 Statistical analysis]]<br />
<br />
[[2.3.4 Data visualization]]<br />
<br />
<br />
'''[[2.4 Reporting]]'''<br />
<br />
[[2.4.1 Non-public reporting]]<br />
<br />
[[2.4.2 Publication]] <br />
<br />
<br />
<br />
== [[3 Support Processes]] ==<br />
<br />
<br />
'''3.1 Documentation management'''<br />
<br />
[[3.1.1 Platform to record data]] <br />
<br />
[[3.1.2 Procedures for how and when to record data]]<br />
<br />
[[3.1.2.1 Traceability of data and any person having impact on data]]<br />
<br />
[[3.1.2.2 Process for witnessing of records]]<br />
<br />
[[3.1.3 Data security]] <br />
<br />
<br />
'''3.2 Education, training and competence'''<br />
<br />
[[3.2.1 General guidance on training]]<br />
<br />
[[3.2.2 Good Research Practice training]]<br />
<br />
[[Implementation Strategy|3.2.3 Implementation of the EQIPD Quality System]]<br />
<br />
[[3.2.4 Training on specific methods, tasks and activities]]<br />
<br />
<br />
'''3.3 Laboratory resources'''<br />
<br />
[[3.3.1 Fit-for-purpose working environment]]<br />
<br />
[[3.3.2 Processes to enable computerized and non-computerized systems being suitable for intended use]]<br />
<br />
[[3.3.3 Management of research materials and reagents]]<br />
<br />
<br />
'''3.4 Experimental systems'''<br />
<br />
[[3.4.1 Animal characteristics, care and use]]<br />
<br />
[[3.4.1.1 Ethical evaluation and authorization process of animal use]]<br />
<br />
[[3.4.1.2 Animal procurement & identification]]<br />
<br />
[[3.4.1.3 Animal housing conditions]]<br />
<br />
[[3.4.1.4 Animal environmental conditions]]<br />
<br />
[[3.4.1.5 Food, watering and bedding]]<br />
<br />
[[3.4.1.6 Sanitation procedure]]<br />
<br />
[[3.4.1.7 Frequency and procedure of observation of animals]]<br />
<br />
[[3.4.1.8 Animal health and genetic monitoring]]<br />
<br />
[[3.4.1.9 Veterinary interventions during the study]]<br />
<br />
[[3.4.1.10 Surgical procedures]]<br />
<br />
[[3.4.1.11 Animal euthanasia procedures]]<br />
<br />
3.4.2 Non-animal test systems<br />
<br />
[[3.4.2.1 Cell culturing]]<br />
<br />
[[3.4.2.2 Antibody validation]]<br />
<br />
[[3.4.2.3 Biological and technical replicates]]<br />
<br />
<br />
'''3.5 Experimental methods'''<br />
<br />
[[3.5.1 Animal and non-animal method and assay qualification]]<br />
<br />
[[3.5.2 Protocols for methods and assays]]<br />
<br />
== [[4 Continuous improvement]] ==<br />
<br />
<br />
'''4.1 Assessment procedures'''<br />
<br />
[[4.1.1 Risk assessment]]<br />
<br />
[[4.1.2 Self assessment]]<br />
<br />
[[4.1.3 External assessment]]<br />
<br />
<br />
'''4.2 Prevention and improvement'''<br />
<br />
[[4.2.1 Installation of solutions, actions and mitigation strategies]]<br />
<br />
[[4.2.2 Error and incident management]]<br />
<br />
[[4.2.3 Responsible conduct of research]]<br />
<br />
[[4.2.4 Key performance indicators]]<br />
<br />
<br />
'''4.3 EQIPD framework'''<br />
<br />
4.3.1 Updating of EQIPD Dossier<br />
<br />
[[4.3.1.1 Adding new items]]<br />
<br />
[[4.3.1.2 Deleting items]]<br />
<br />
[[4.3.1.3 Revising items]]<br />
<br />
[[4.3.2 Using the EQIPD applications]]<br />
<br />
[[4.3.2.1 Using the Planning Tool]]<br />
<br />
[[4.3.2.2 Creating NEEDs]]<br />
<br />
[[4.3.2.3 Revising NEEDs]]<br />
<br />
[[4.3.2.4 Deleting NEEDs]]</div>Anton.bespalovhttps://wiki.go-eqipd.org/index.php?title=2.1.7_Blinding&diff=7462.1.7 Blinding2020-12-22T14:19:47Z<p>Anton.bespalov: </p>
<hr />
<div>== A. Background & Definitions ==<br />
<br />
<br />
'''Blinding''' refers to the masking of the treatment allocation for person(s) who perform the experiment, collect data and assess outcome. Blinding aims to make sure that someone has no knowledge about treatment allocation that may systematically influence his/her performance. The intended result is the equal treatment (as far as possible) of all experimental units (animals, subjects or samples) in the experiment.<br />
<br />
In the discussion below, experimental groups refer to '''all''' groups involved in an experiment, for example: control, sham, treated with drug A, treated with drug B, etc.<br />
<br />
Group allocation describes which experimental unit (animal, subject or sample) has been allocated to which experimental group.<br />
<br />
The group allocation, actions and outcome assessments are ‘'''blinded'''’. People are ‘'''blind'''’ to particular information.<br />
<br />
Blinding requires at least 2 people, one blinded person (unaware of experimental condition) and an unblinded person (knows the experimental condition and the blinding code). The unblinded person is the keeper of the blinding code which needs to be concealed until all processes under blinding are concluded.<br />
<br />
The most effective blinding covers every step in an experiment - from allocation to treatment conditions, application of treatment to data collection and analysis - this is often referred to as '''full blinding'''. <br />
<br />
Blinding should '''not''' be seen as "all or none". There are several situations when partial blinding may be applied (i.e. blinding of the most risk-prone step(s) in the experimental process). For example, partial blinding can be considered when:<br />
* a research unit with no prior experience with blinding is introducing a blinding procedure and, for organizational or other reasons, follows a stepwise implementation<br />
* a research unit has significantly constrained human resources and does not intend to conduct knowledge-claiming research<br />
<br />
In any case, full and transparent reporting of how blinding was applied is expected.<br />
<br />
== B. Guidance & Expectations ==<br />
<br />
<br />
EQIPD expects that the method(s) to implement blinding are described with as much details as possible:<br />
* either as a dedicated protocol (please see below for a template that may serve as an example on how to build such a protocol),<br />
* or as a separate section of a study plan.<br />
<br />
Dependent on the breadth of research methods in use, a given research unit may have one or more blinding protocols that can support blinding for specific types of experiments.<br />
<br />
When preparing a blinding protocol, the main objective is to have a description that is understandable for the actual users - i.e. bench scientists (especially, those that are new to the unit). Therefore, it should be written in a simple language with as many examples (specific to the research) as appropriate.<br />
<br />
A blinding protocol may describe the following:<br />
<br />
* Training and competence<br />
** is there any training needed? <br />
** are there any additional supporting tools or materials available?<br />
<br />
* Feasibility assessment (to avoid applying blinding when it makes no sense or would actually do harm) <br />
** how high is the risk of unintentional unblinding?<br />
** are the required resources available?<br />
** are emergency scenarios considered?<br />
<br />
* "Who does what?"<br />
** for those involved in the experiment and the blinding procedure, are the roles clearly defined? (e.g. see section 4 in the blinding protocol template below);<br />
** from the blinding protocol, it should be clear who is aware of the group allocation at the different stages of the experiment (during the allocation, the conduct of the experiment, the outcome assessment, and the data analysis);<br />
** to effectively blind a study, create a sequence containing all experimental steps of the study and, for each step, indicate the name of each person involved in the conduct and analysis of the study. For each experimental step, document for each person whether they are blinded or not blinded to the condition or not involved at all. Such an overview systematically creates a transparent workflow of blinded and unblinded personnel and shows when unintended unblinding might occur. Such overview (e.g. as a table) can be made part of experimental documentation and reporting. <br />
** it is generally expected and strongly recommended that any process using humans as perceptors, raters or interpreters needs to be blinded until the decision-making is concluded.<br />
<br />
* Blinding code<br />
** how is the blinding code developed and which specific steps are taken to practically apply it?<br />
** one simple blinding strategy is to assign each subject / sample a separate number of letter (or a combination thereof). This approach may create compliance issues in case of a large number of subjects / samples and the need to apply treatment repeatedly over extended periods of time.<br />
** another blinding strategy is to assign each experimental group a separate number of letter (or a combination thereof). This approach may be problematic when human processing and rating is involved in outcome assessment. The assessor may not know the condition behind the code but the knowledge of a group affiliation of a sample can influence rating.<br />
** the decision which strategy to follow is made by the researchers taking into account the details of a specific experiment and associated risks.<br />
<br />
<br />
'''PRACTICAL TIPS'''<br />
<br />
* Generation of alphanumeric codes for blinding<br />
** if possible, check whether it is possible to use a blinding scheme without repeating codes. This can be easily done with alphanumeric code consisting of 4 letter/number combinations, such as T7Z4. Such codes can be generated in Excel using the following formula:<br />
*** =CHAR(RANDBETWEEN(65;))&RANDBETWEEN(0;9)&CHAR(RANDBETWEEN(65;))&RANDBETWEEN(0;9)<br />
*** enter this formula in a row of cells for which you need coded samples and copy the outcome to another worksheet with the command Past Special-->Paste Values.<br />
<br />
* Allocation concealment in animal experiments<br />
** to prevents selection bias, the investigator shall not be aware and/or have the choice to which treatment group an animal is allocated to;<br />
** therefore, the assignment to a specific group needs to be concealed and every animal should have the same chance to be assigned to each of the groups;<br />
** this can be achieved by separating the assignment of animal_IDs to each animal (e.g. individual ear mark or subcutaneous chip) and randomization of treatments (see randomization) into two independent processes and then merging the two.<br />
<br />
<br />
'''RISK ASSESSMENT'''<br />
* Under some circumstances, unintentional unblinding (e.g. due to a different appearance of a positive control in solution or suspension) may be a risk to be assessed and/or controlled<br />
* Experimental treatments may produce adverse effects and attending veterinarians and animal care stuff may need to be informed in advance about the possibility of such adverse effects occurring and, if necessary, have emergency access to the blinding protocol.<br />
* if a blinding code is added to another code such as animal_ID, measurement_ID or file name, watch out for hidden cues in such IDs, containing temporal or sequential information that could increase rater bias. Also metadata, such as creation date and time of a file containg measurements can give away experimental conditions. <br />
<br />
<br />
'''PLEASE DO NOT FORGET'''<br />
<br />
* Blinding is sometimes not possible especially when certain cues cannot be blinded, such as skin color of transgenic mice or color of a solution in a well. It is important to document this and to communicate in reports where blinding could or could not be achieved.<br />
* Unblinding of the experimental conditions should be done when all blinded processes for the entire study are concluded. Early and partial unblinding for "checking" should be avoided and, if necessary, be part of the study protocol.<br />
* Control group(s) (e.g., positive control group) should not be excluded from the blinding procedure.<br />
* Provide training on how to apply the blinding procedure.<br />
<br />
<br />
== C. Resources ==<br />
<br />
<br />
Guidelines on reporting of blinding (in vivo research):<br />
* [[ARRIVE 2.0]] <br />
<br />
Template to develop a written description of the method used to implement blinding:<br />
* [blinding protocol]<br />
<br />
Reading material:<br />
<br />
* [https://link.springer.com/chapter/10.1007/164_2019_279 Handbook of Experimental pharmacology chapter on randomization and blinding]<br />
<br />
<br />
----------------<br />
<br />
back to [[Toolbox]]<br />
<br />
Next item: [[2.1.8 Randomisation]]<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
</div>Anton.bespalovhttps://wiki.go-eqipd.org/index.php?title=2.1.7_Blinding&diff=7452.1.7 Blinding2020-12-22T14:19:31Z<p>Anton.bespalov: /* B. Guidance & Expectations */</p>
<hr />
<div>THIS ITEM IS UNDER CONSTRUCTION<br />
<br />
<br />
<br />
<br />
== A. Background & Definitions ==<br />
<br />
<br />
'''Blinding''' refers to the masking of the treatment allocation for person(s) who perform the experiment, collect data and assess outcome. Blinding aims to make sure that someone has no knowledge about treatment allocation that may systematically influence his/her performance. The intended result is the equal treatment (as far as possible) of all experimental units (animals, subjects or samples) in the experiment.<br />
<br />
In the discussion below, experimental groups refer to '''all''' groups involved in an experiment, for example: control, sham, treated with drug A, treated with drug B, etc.<br />
<br />
Group allocation describes which experimental unit (animal, subject or sample) has been allocated to which experimental group.<br />
<br />
The group allocation, actions and outcome assessments are ‘'''blinded'''’. People are ‘'''blind'''’ to particular information.<br />
<br />
Blinding requires at least 2 people, one blinded person (unaware of experimental condition) and an unblinded person (knows the experimental condition and the blinding code). The unblinded person is the keeper of the blinding code which needs to be concealed until all processes under blinding are concluded.<br />
<br />
The most effective blinding covers every step in an experiment - from allocation to treatment conditions, application of treatment to data collection and analysis - this is often referred to as '''full blinding'''. <br />
<br />
Blinding should '''not''' be seen as "all or none". There are several situations when partial blinding may be applied (i.e. blinding of the most risk-prone step(s) in the experimental process). For example, partial blinding can be considered when:<br />
* a research unit with no prior experience with blinding is introducing a blinding procedure and, for organizational or other reasons, follows a stepwise implementation<br />
* a research unit has significantly constrained human resources and does not intend to conduct knowledge-claiming research<br />
<br />
In any case, full and transparent reporting of how blinding was applied is expected.<br />
<br />
== B. Guidance & Expectations ==<br />
<br />
<br />
EQIPD expects that the method(s) to implement blinding are described with as much details as possible:<br />
* either as a dedicated protocol (please see below for a template that may serve as an example on how to build such a protocol),<br />
* or as a separate section of a study plan.<br />
<br />
Dependent on the breadth of research methods in use, a given research unit may have one or more blinding protocols that can support blinding for specific types of experiments.<br />
<br />
When preparing a blinding protocol, the main objective is to have a description that is understandable for the actual users - i.e. bench scientists (especially, those that are new to the unit). Therefore, it should be written in a simple language with as many examples (specific to the research) as appropriate.<br />
<br />
A blinding protocol may describe the following:<br />
<br />
* Training and competence<br />
** is there any training needed? <br />
** are there any additional supporting tools or materials available?<br />
<br />
* Feasibility assessment (to avoid applying blinding when it makes no sense or would actually do harm) <br />
** how high is the risk of unintentional unblinding?<br />
** are the required resources available?<br />
** are emergency scenarios considered?<br />
<br />
* "Who does what?"<br />
** for those involved in the experiment and the blinding procedure, are the roles clearly defined? (e.g. see section 4 in the blinding protocol template below);<br />
** from the blinding protocol, it should be clear who is aware of the group allocation at the different stages of the experiment (during the allocation, the conduct of the experiment, the outcome assessment, and the data analysis);<br />
** to effectively blind a study, create a sequence containing all experimental steps of the study and, for each step, indicate the name of each person involved in the conduct and analysis of the study. For each experimental step, document for each person whether they are blinded or not blinded to the condition or not involved at all. Such an overview systematically creates a transparent workflow of blinded and unblinded personnel and shows when unintended unblinding might occur. Such overview (e.g. as a table) can be made part of experimental documentation and reporting. <br />
** it is generally expected and strongly recommended that any process using humans as perceptors, raters or interpreters needs to be blinded until the decision-making is concluded.<br />
<br />
* Blinding code<br />
** how is the blinding code developed and which specific steps are taken to practically apply it?<br />
** one simple blinding strategy is to assign each subject / sample a separate number of letter (or a combination thereof). This approach may create compliance issues in case of a large number of subjects / samples and the need to apply treatment repeatedly over extended periods of time.<br />
** another blinding strategy is to assign each experimental group a separate number of letter (or a combination thereof). This approach may be problematic when human processing and rating is involved in outcome assessment. The assessor may not know the condition behind the code but the knowledge of a group affiliation of a sample can influence rating.<br />
** the decision which strategy to follow is made by the researchers taking into account the details of a specific experiment and associated risks.<br />
<br />
<br />
'''PRACTICAL TIPS'''<br />
<br />
* Generation of alphanumeric codes for blinding<br />
** if possible, check whether it is possible to use a blinding scheme without repeating codes. This can be easily done with alphanumeric code consisting of 4 letter/number combinations, such as T7Z4. Such codes can be generated in Excel using the following formula:<br />
*** =CHAR(RANDBETWEEN(65;))&RANDBETWEEN(0;9)&CHAR(RANDBETWEEN(65;))&RANDBETWEEN(0;9)<br />
*** enter this formula in a row of cells for which you need coded samples and copy the outcome to another worksheet with the command Past Special-->Paste Values.<br />
<br />
* Allocation concealment in animal experiments<br />
** to prevents selection bias, the investigator shall not be aware and/or have the choice to which treatment group an animal is allocated to;<br />
** therefore, the assignment to a specific group needs to be concealed and every animal should have the same chance to be assigned to each of the groups;<br />
** this can be achieved by separating the assignment of animal_IDs to each animal (e.g. individual ear mark or subcutaneous chip) and randomization of treatments (see randomization) into two independent processes and then merging the two.<br />
<br />
<br />
'''RISK ASSESSMENT'''<br />
* Under some circumstances, unintentional unblinding (e.g. due to a different appearance of a positive control in solution or suspension) may be a risk to be assessed and/or controlled<br />
* Experimental treatments may produce adverse effects and attending veterinarians and animal care stuff may need to be informed in advance about the possibility of such adverse effects occurring and, if necessary, have emergency access to the blinding protocol.<br />
* if a blinding code is added to another code such as animal_ID, measurement_ID or file name, watch out for hidden cues in such IDs, containing temporal or sequential information that could increase rater bias. Also metadata, such as creation date and time of a file containg measurements can give away experimental conditions. <br />
<br />
<br />
'''PLEASE DO NOT FORGET'''<br />
<br />
* Blinding is sometimes not possible especially when certain cues cannot be blinded, such as skin color of transgenic mice or color of a solution in a well. It is important to document this and to communicate in reports where blinding could or could not be achieved.<br />
* Unblinding of the experimental conditions should be done when all blinded processes for the entire study are concluded. Early and partial unblinding for "checking" should be avoided and, if necessary, be part of the study protocol.<br />
* Control group(s) (e.g., positive control group) should not be excluded from the blinding procedure.<br />
* Provide training on how to apply the blinding procedure.<br />
<br />
<br />
== C. Resources ==<br />
<br />
<br />
Guidelines on reporting of blinding (in vivo research):<br />
* [[ARRIVE 2.0]] <br />
<br />
Template to develop a written description of the method used to implement blinding:<br />
* [blinding protocol]<br />
<br />
Reading material:<br />
<br />
* [https://link.springer.com/chapter/10.1007/164_2019_279 Handbook of Experimental pharmacology chapter on randomization and blinding]<br />
<br />
<br />
----------------<br />
<br />
back to [[Toolbox]]<br />
<br />
Next item: [[2.1.8 Randomisation]]<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
</div>Anton.bespalovhttps://wiki.go-eqipd.org/index.php?title=2.1.7_Blinding&diff=7442.1.7 Blinding2020-12-22T13:54:59Z<p>Anton.bespalov: /* B. Guidance & Expectations */</p>
<hr />
<div>THIS ITEM IS UNDER CONSTRUCTION<br />
<br />
<br />
<br />
<br />
== A. Background & Definitions ==<br />
<br />
<br />
'''Blinding''' refers to the masking of the treatment allocation for person(s) who perform the experiment, collect data and assess outcome. Blinding aims to make sure that someone has no knowledge about treatment allocation that may systematically influence his/her performance. The intended result is the equal treatment (as far as possible) of all experimental units (animals, subjects or samples) in the experiment.<br />
<br />
In the discussion below, experimental groups refer to '''all''' groups involved in an experiment, for example: control, sham, treated with drug A, treated with drug B, etc.<br />
<br />
Group allocation describes which experimental unit (animal, subject or sample) has been allocated to which experimental group.<br />
<br />
The group allocation, actions and outcome assessments are ‘'''blinded'''’. People are ‘'''blind'''’ to particular information.<br />
<br />
Blinding requires at least 2 people, one blinded person (unaware of experimental condition) and an unblinded person (knows the experimental condition and the blinding code). The unblinded person is the keeper of the blinding code which needs to be concealed until all processes under blinding are concluded.<br />
<br />
The most effective blinding covers every step in an experiment - from allocation to treatment conditions, application of treatment to data collection and analysis - this is often referred to as '''full blinding'''. <br />
<br />
Blinding should '''not''' be seen as "all or none". There are several situations when partial blinding may be applied (i.e. blinding of the most risk-prone step(s) in the experimental process). For example, partial blinding can be considered when:<br />
* a research unit with no prior experience with blinding is introducing a blinding procedure and, for organizational or other reasons, follows a stepwise implementation<br />
* a research unit has significantly constrained human resources and does not intend to conduct knowledge-claiming research<br />
<br />
In any case, full and transparent reporting of how blinding was applied is expected.<br />
<br />
== B. Guidance & Expectations ==<br />
<br />
<br />
EQIPD expects that the method(s) to implement blinding are described with as much details as possible:<br />
* either as a dedicated protocol (please see below for a template that may serve as an example on how to build such a protocol),<br />
* or as a separate section of a study plan.<br />
<br />
Dependent on the breadth of research methods in use, a given research unit may have one or more blinding protocols that can support blinding for specific types of experiments.<br />
<br />
When preparing a blinding protocol, the main objective is to have a description that is understandable for the actual users - i.e. bench scientists (especially, those that are new to the unit). Therefore, it should be written in a simple language with as many examples (specific to the research) as appropriate.<br />
<br />
A blinding protocol may describe the following:<br />
<br />
* Training and competence<br />
** is there any training needed? <br />
** are there any additional supporting tools or materials available?<br />
<br />
* Feasibility assessment (to avoid applying blinding when it makes no sense or would actually do harm) <br />
** how high is the risk of unintentional unblinding?<br />
** are the required resources available?<br />
** are emergency scenarios considered?<br />
<br />
* "Who does what?"<br />
** for those involved in the experiment and the blinding procedure, are the roles clearly defined? (e.g. see section 4 in the blinding protocol template below);<br />
** from the blinding protocol, it should be clear who is aware of the group allocation at the different stages of the experiment (during the allocation, the conduct of the experiment, the outcome assessment, and the data analysis);<br />
** to effectively blind a study, create a sequence containing all experimental steps of the study and, for each step, indicate the name of each person involved in the conduct and analysis of the study. For each experimental step, document for each person whether they are blinded or not blinded to the condition or not involved at all. Such an overview systematically creates a transparent workflow of blinded and unblinded personnel and shows when unintended unblinding might occur. Such overview (e.g. as a table) can be made part of experimental documentation and reporting. <br />
** it is generally expected and strongly recommended that any process using humans as perceptors, raters or interpreters needs to be blinded until the decision-making is concluded.<br />
<br />
* Blinding code<br />
** how is the blinding code developed and which specific steps are taken to practically apply it?<br />
** one simple blinding strategy is to assign each subject / sample a separate number of letter (or a combination thereof). This approach may create compliance issues in case of a large number of subjects / samples and the need to apply treatment repeatedly over extended periods of time.<br />
** another blinding strategy is to assign each when human processing and rating is involved in outcome assessment. The assessor may not know the condition behind the code but the knowledge of a group affiliation of a sample is a bias that can influence rating. This should be avoided.<br />
<br />
<br />
<br />
If possible, check whether it is possible to use a blinding scheme without repeating codes. This is can be easily done with alphanumeric code consisting of 4 letter/number combinations, such as T7Z4. Such codes can be easily generated in Excel <br />
<br />
=CHAR(RANDBETWEEN(65;))&RANDBETWEEN(0;9)&CHAR(RANDBETWEEN(65;))&RANDBETWEEN(0;9)<br />
<br />
Enter this formula in a row of cells for which you need coded samples. Copy the outcome to another worksheet with the command Past Special-->Paste Values.<br />
<br />
Allocation concealment in animal experiments<br />
<br />
The investigator shall not be aware and/or have the choice to which treatment group an animal is allocated to. This prevents selection bias. Therefore, the assignment to a specific group needs to be concealed and every animal should have the same chance to be assign to each of the groups. This can be achieved separating the assignment of animal_IDs to each animal (e.g. individual ear mark or subcutaneous chip) and randomization of treatments (see randomization) into two independent processes and then merge the two.<br />
<br />
Effective blinding code<br />
<br />
There are certain strategies to apply blinding. <br />
<br />
<br />
<br />
<br />
<br />
'''RISK ASSESSMENT'''<br />
* Under some circumstances, unintentional unblinding (e.g. due to a different appearance of a positive control in solution or suspension) may be a risk to be assessed and/or controlled<br />
* Experimental treatments may produce adverse effects and attending veterinarians and animal care stuff may need to be informed in advance about the possibility of such adverse effects occurring and, if necessary, have emergency access to the blinding protocol.<br />
* if a blinding code is added to another code such as animal_ID, measurement_ID or file name, watch out for hidden cues in such IDs, containing temporal or sequential information that could increase rater bias. Also metadata, such as creation date and time of a file containg measurements can give away experimental conditions. <br />
<br />
<br />
'''PLEASE DO NOT FORGET'''<br />
<br />
* Blinding is sometimes not possible especially when certain cues cannot be blinded, such as skin color of transgenic mice or color of a solution in a well. It is important to document this and to communicate in reports where blinding could or could not be achieved.<br />
* Unblinding of the experimental conditions should be done when all blinded processes for the entire study are concluded. Early and partial unblinding for "checking" should be avoided and, if necessary, be part of the study protocol.<br />
* Control group(s) (e.g., positive control group) should not be excluded from the blinding procedure.<br />
* Provide training on how to apply the blinding procedure.<br />
<br />
<br />
== C. Resources ==<br />
<br />
<br />
Guidelines on reporting of blinding (in vivo research):<br />
* [[ARRIVE 2.0]] <br />
<br />
Template to develop a written description of the method used to implement blinding:<br />
* [blinding protocol]<br />
<br />
Reading material:<br />
<br />
* [https://link.springer.com/chapter/10.1007/164_2019_279 Handbook of Experimental pharmacology chapter on randomization and blinding]<br />
<br />
<br />
----------------<br />
<br />
back to [[Toolbox]]<br />
<br />
Next item: [[2.1.8 Randomisation]]<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
</div>Anton.bespalovhttps://wiki.go-eqipd.org/index.php?title=2.1.7_Blinding&diff=7432.1.7 Blinding2020-12-22T12:18:48Z<p>Anton.bespalov: /* B. Guidance & Expectations */</p>
<hr />
<div>THIS ITEM IS UNDER CONSTRUCTION<br />
<br />
<br />
<br />
<br />
== A. Background & Definitions ==<br />
<br />
<br />
'''Blinding''' refers to the masking of the treatment allocation for person(s) who perform the experiment, collect data and assess outcome. Blinding aims to make sure that someone has no knowledge about treatment allocation that may systematically influence his/her performance. The intended result is the equal treatment (as far as possible) of all experimental units (animals, subjects or samples) in the experiment.<br />
<br />
In the discussion below, experimental groups refer to '''all''' groups involved in an experiment, for example: control, sham, treated with drug A, treated with drug B, etc.<br />
<br />
Group allocation describes which experimental unit (animal, subject or sample) has been allocated to which experimental group.<br />
<br />
The group allocation, actions and outcome assessments are ‘'''blinded'''’. People are ‘'''blind'''’ to particular information.<br />
<br />
Blinding requires at least 2 people, one blinded person (unaware of experimental condition) and an unblinded person (knows the experimental condition and the blinding code). The unblinded person is the keeper of the blinding code which needs to be concealed until all processes under blinding are concluded.<br />
<br />
The most effective blinding covers every step in an experiment - from allocation to treatment conditions, application of treatment to data collection and analysis - this is often referred to as '''full blinding'''. <br />
<br />
Blinding should '''not''' be seen as "all or none". There are several situations when partial blinding may be applied (i.e. blinding of the most risk-prone step(s) in the experimental process). For example, partial blinding can be considered when:<br />
* a research unit with no prior experience with blinding is introducing a blinding procedure and, for organizational or other reasons, follows a stepwise implementation<br />
* a research unit has significantly constrained human resources and does not intend to conduct knowledge-claiming research<br />
<br />
In any case, full and transparent reporting of how blinding was applied is expected.<br />
<br />
== B. Guidance & Expectations ==<br />
<br />
<br />
EQIPD expects that the method(s) to implement blinding are described with as much details as possible:<br />
* either as a dedicated protocol (please see below for a template that may serve as an example on how to build such a protocol),<br />
* or as a separate section of a study plan.<br />
<br />
Dependent on the breadth of research methods in use, a given research unit may have one or more blinding protocols that can support blinding for specific types of experiments.<br />
<br />
When preparing a blinding protocol, the main objective is to have a description that is understandable for the actual users - i.e. bench scientists (especially, those that are new to the unit). Therefore, it should be written in a simple language with as many examples (specific to the research) as appropriate.<br />
<br />
A blinding protocol may describe the following:<br />
<br />
* Training and competence<br />
** is there any training needed? are there any additional supporting tools or materials available?<br />
<br />
* Feasibility assessment - <br />
<br />
Describe who was aware of the group allocation at the different stages of the experiment (during the allocation, the conduct of the experiment, the outcome assessment, and the data analysis). Any process using humans as perceptors, raters or interpreters needs to be blinded as long as decision-making is concluded.<br />
<br />
Allocation concealment in animal experiments<br />
<br />
The investigator shall not be aware and/or have the choice to which treatment group an animal is allocated to. This prevents selection bias. Therefore, the assignment to a specific group needs to be concealed and every animal should have the same chance to be assign to each of the groups. This can be achieved separating the assignment of animal_IDs to each animal (e.g. individual ear mark or subcutaneous chip) and randomization of treatments (see randomization) into two independent processes and then merge the two.<br />
<br />
Effective blinding code<br />
<br />
There are certain strategies to apply blinding. The most simple one is the blinding by numbers or alphabet letters. This can be problematic when human processing and rating is involved in outcome assessment. The assessor may not know the condition behind the code but the knowledge of a group affiliation of a sample is a bias that can influence rating. This should be avoided.<br />
<br />
Sometimes blinding conditions are added to another code such as animal_ID, measurement_ID or file name. Watch out for hidden cues in such IDs, containing temporal or sequential information that could increase rater bias. Also metadata, such as creation date and time of a file containg measurements can give away experimental conditions. <br />
<br />
If possible, check whether it is possible to use a blinding scheme without repeating codes. This is can be easily done with alphanumeric code consisting of 4 letter/number combinations, such as T7Z4. Such codes can be easily generated in Excel <br />
<br />
=CHAR(RANDBETWEEN(65;))&RANDBETWEEN(0;9)&CHAR(RANDBETWEEN(65;))&RANDBETWEEN(0;9)<br />
<br />
Enter this formula in a row of cells for which you need coded samples. Copy the outcome to another worksheet with the command Past Special-->Paste Values.<br />
<br />
Planning to blind a study<br />
<br />
To effectively blind a study, create a sequence containg all experimental steps of the study. In the neighboring headers indicate the name of each person involved in the conduct and analysis of the study. For each experimental step document for each person whether they are blinded or not blinded to the condition or not involved at all. Drawing this out systematically creates a transparent workflow of blinded and unblinded personnel and shows when unintended unblinding might occur. Add the final table to all experimental documentation and reporting. <br />
<br />
<br />
<br />
'''RISK ASSESSMENT'''<br />
* Under some circumstances, unintentional unblinding (e.g. due to a different appearance of a positive control in solution or suspension) may be a risk to be assessed and/or controlled<br />
* Experimental treatments may produce adverse effects and attending veterinarians and animal care stuff may need to be informed in advance about the possibility of such adverse effects occurring and, if necessary, have emergency access to the blinding protocol.<br />
<br />
<br />
'''PLEASE DO NOT FORGET'''<br />
<br />
* Blinding is sometimes not possible especially when certain cues cannot be blinded, such as skin color of transgenic mice or color of a solution in a well. It is important to document this and to communicate in reports where blinding could or could not be achieved.<br />
* Unblinding of the experimental conditions should be done when all blinded processes for the entire study are concluded. Early and partial unblinding for "checking" should be avoided and if necessary, be part of the protocol.<br />
* Control group(s) (e.g., positive control group) should not be excluded from the blinding procedure.<br />
* Provide training on how to apply the blinding procedure.<br />
<br />
<br />
== C. Resources ==<br />
<br />
<br />
Guidelines on reporting of blinding (in vivo research):<br />
* [[ARRIVE 2.0]] <br />
<br />
Template to develop a written description of the method used to implement blinding:<br />
* [blinding protocol]<br />
<br />
Reading material:<br />
<br />
* [https://link.springer.com/chapter/10.1007/164_2019_279 Handbook of Experimental pharmacology chapter on randomization and blinding]<br />
<br />
<br />
----------------<br />
<br />
back to [[Toolbox]]<br />
<br />
Next item: [[2.1.8 Randomisation]]<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
</div>Anton.bespalovhttps://wiki.go-eqipd.org/index.php?title=2.1.7_Blinding&diff=7422.1.7 Blinding2020-12-22T12:08:18Z<p>Anton.bespalov: /* A. Background & Definitions */</p>
<hr />
<div>THIS ITEM IS UNDER CONSTRUCTION<br />
<br />
<br />
<br />
<br />
== A. Background & Definitions ==<br />
<br />
<br />
'''Blinding''' refers to the masking of the treatment allocation for person(s) who perform the experiment, collect data and assess outcome. Blinding aims to make sure that someone has no knowledge about treatment allocation that may systematically influence his/her performance. The intended result is the equal treatment (as far as possible) of all experimental units (animals, subjects or samples) in the experiment.<br />
<br />
In the discussion below, experimental groups refer to '''all''' groups involved in an experiment, for example: control, sham, treated with drug A, treated with drug B, etc.<br />
<br />
Group allocation describes which experimental unit (animal, subject or sample) has been allocated to which experimental group.<br />
<br />
The group allocation, actions and outcome assessments are ‘'''blinded'''’. People are ‘'''blind'''’ to particular information.<br />
<br />
Blinding requires at least 2 people, one blinded person (unaware of experimental condition) and an unblinded person (knows the experimental condition and the blinding code). The unblinded person is the keeper of the blinding code which needs to be concealed until all processes under blinding are concluded.<br />
<br />
The most effective blinding covers every step in an experiment - from allocation to treatment conditions, application of treatment to data collection and analysis - this is often referred to as '''full blinding'''. <br />
<br />
Blinding should '''not''' be seen as "all or none". There are several situations when partial blinding may be applied (i.e. blinding of the most risk-prone step(s) in the experimental process). For example, partial blinding can be considered when:<br />
* a research unit with no prior experience with blinding is introducing a blinding procedure and, for organizational or other reasons, follows a stepwise implementation<br />
* a research unit has significantly constrained human resources and does not intend to conduct knowledge-claiming research<br />
<br />
In any case, full and transparent reporting of how blinding was applied is expected.<br />
<br />
== B. Guidance & Expectations ==<br />
<br />
<br />
Describe who was aware of the group allocation at the different stages of the experiment (during the allocation, the conduct of the experiment, the outcome assessment, and the data analysis). Any process using humans as perceptors, raters or interpreters needs to be blinded as long as decision-making is concluded.<br />
<br />
Allocation concealment in animal experiments<br />
<br />
The investigator shall not be aware and/or have the choice to which treatment group an animal is allocated to. This prevents selection bias. Therefore, the assignment to a specific group needs to be concealed and every animal should have the same chance to be assign to each of the groups. This can be achieved separating the assignment of animal_IDs to each animal (e.g. individual ear mark or subcutaneous chip) and randomization of treatments (see randomization) into two independent processes and then merge the two.<br />
<br />
Effective blinding code<br />
<br />
There are certain strategies to apply blinding. The most simple one is the blinding by numbers or alphabet letters. This can be problematic when human processing and rating is involved in outcome assessment. The assessor may not know the condition behind the code but the knowledge of a group affiliation of a sample is a bias that can influence rating. This should be avoided.<br />
<br />
Sometimes blinding conditions are added to another code such as animal_ID, measurement_ID or file name. Watch out for hidden cues in such IDs, containing temporal or sequential information that could increase rater bias. Also metadata, such as creation date and time of a file containg measurements can give away experimental conditions. <br />
<br />
If possible, check whether it is possible to use a blinding scheme without repeating codes. This is can be easily done with alphanumeric code consisting of 4 letter/number combinations, such as T7Z4. Such codes can be easily generated in Excel <br />
<br />
=CHAR(RANDBETWEEN(65;))&RANDBETWEEN(0;9)&CHAR(RANDBETWEEN(65;))&RANDBETWEEN(0;9)<br />
<br />
Enter this formula in a row of cells for which you need coded samples. Copy the outcome to another worksheet with the command Past Special-->Paste Values.<br />
<br />
Planning to blind a study<br />
<br />
To effectively blind a study, create a sequence containg all experimental steps of the study. In the neighboring headers indicate the name of each person involved in the conduct and analysis of the study. For each experimental step document for each person whether they are blinded or not blinded to the condition or not involved at all. Drawing this out systematically creates a transparent workflow of blinded and unblinded personnel and shows when unintended unblinding might occur. Add the final table to all experimental documentation and reporting. <br />
<br />
<br />
<br />
'''RISK ASSESSMENT'''<br />
* Under some circumstances, unintentional unblinding (e.g. due to a different appearance of a positive control in solution or suspension) may be a risk to be assessed and/or controlled<br />
* Experimental treatments may produce adverse effects and attending veterinarians and animal care stuff may need to be informed in advance about the possibility of such adverse effects occurring and, if necessary, have emergency access to the blinding protocol.<br />
<br />
<br />
'''PLEASE DO NOT FORGET'''<br />
<br />
* Blinding is sometimes not possible especially when certain cues cannot be blinded, such as skin color of transgenic mice or color of a solution in a well. It is important to document this and to communicate in reports where blinding could or could not be achieved.<br />
* Unblinding of the experimental conditions should be done when all blinded processes for the entire study are concluded. Early and partial unblinding for "checking" should be avoided and if necessary, be part of the protocol.<br />
* Control group(s) (e.g., positive control group) should not be excluded from the blinding procedure.<br />
* Provide training on how to apply the blinding procedure.<br />
<br />
<br />
== C. Resources ==<br />
<br />
<br />
Guidelines on reporting of blinding (in vivo research):<br />
* [[ARRIVE 2.0]] <br />
<br />
Template to develop a written description of the method used to implement blinding:<br />
* [blinding protocol]<br />
<br />
Reading material:<br />
<br />
* [https://link.springer.com/chapter/10.1007/164_2019_279 Handbook of Experimental pharmacology chapter on randomization and blinding]<br />
<br />
<br />
----------------<br />
<br />
back to [[Toolbox]]<br />
<br />
Next item: [[2.1.8 Randomisation]]<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
</div>Anton.bespalovhttps://wiki.go-eqipd.org/index.php?title=2.1.7_Blinding&diff=7412.1.7 Blinding2020-12-22T12:07:42Z<p>Anton.bespalov: /* A. Background & Definitions */</p>
<hr />
<div>THIS ITEM IS UNDER CONSTRUCTION<br />
<br />
<br />
<br />
<br />
== A. Background & Definitions ==<br />
<br />
<br />
'''Blinding''' refers to the masking of the treatment allocation for person(s) who perform the experiment, collect data and assess outcome. Blinding aims to make sure that someone has no knowledge about treatment allocation that may systematically influence his/her performance. The intended result is the equal treatment (as far as possible) of all experimental units (animals, subjects or samples) in the experiment.<br />
<br />
In the discussion below, experimental groups refer to '''all''' groups involved in an experiment, for example: control, sham, treated with drug A, treated with drug B, etc.<br />
<br />
Group allocation describes which experimental unit (animal, subject or sample) has been allocated to which experimental group.<br />
<br />
The group allocation, actions and outcome assessments are ‘'''blinded'''’. People are ‘'''blind'''’ to particular information.<br />
<br />
Blinding requires at least 2 people, one blinded person (unaware of experimental condition) and an unblinded person (knows the experimental condition and the blinding code). The unblinded person is the keeper of the blinding code which needs to be concealed until all processes under blinding are concluded.<br />
<br />
The most effective blinding covers every step in an experiment - from allocation to treatment conditions, application of treatment to data collection and analysis - this is often referred to as '''full blinding'''. <br />
<br />
Blinding should '''not''' be seen as all or none. There are several situations when partial blinding may be applied (i.e. blinding of the most risk-prone step(s) in the experimental process). For example, partial blinding can be considered when:<br />
* a research unit with no prior experience with blinding is introducing a blinding procedure and, for organizational or other reasons, follows a stepwise implementation<br />
* a research unit has significantly constrained human resources and does not intend to conduct knowledge-claiming research<br />
<br />
In any case, full and transparent reporting of how blinding was applied is expected.<br />
<br />
== B. Guidance & Expectations ==<br />
<br />
<br />
Describe who was aware of the group allocation at the different stages of the experiment (during the allocation, the conduct of the experiment, the outcome assessment, and the data analysis). Any process using humans as perceptors, raters or interpreters needs to be blinded as long as decision-making is concluded.<br />
<br />
Allocation concealment in animal experiments<br />
<br />
The investigator shall not be aware and/or have the choice to which treatment group an animal is allocated to. This prevents selection bias. Therefore, the assignment to a specific group needs to be concealed and every animal should have the same chance to be assign to each of the groups. This can be achieved separating the assignment of animal_IDs to each animal (e.g. individual ear mark or subcutaneous chip) and randomization of treatments (see randomization) into two independent processes and then merge the two.<br />
<br />
Effective blinding code<br />
<br />
There are certain strategies to apply blinding. The most simple one is the blinding by numbers or alphabet letters. This can be problematic when human processing and rating is involved in outcome assessment. The assessor may not know the condition behind the code but the knowledge of a group affiliation of a sample is a bias that can influence rating. This should be avoided.<br />
<br />
Sometimes blinding conditions are added to another code such as animal_ID, measurement_ID or file name. Watch out for hidden cues in such IDs, containing temporal or sequential information that could increase rater bias. Also metadata, such as creation date and time of a file containg measurements can give away experimental conditions. <br />
<br />
If possible, check whether it is possible to use a blinding scheme without repeating codes. This is can be easily done with alphanumeric code consisting of 4 letter/number combinations, such as T7Z4. Such codes can be easily generated in Excel <br />
<br />
=CHAR(RANDBETWEEN(65;))&RANDBETWEEN(0;9)&CHAR(RANDBETWEEN(65;))&RANDBETWEEN(0;9)<br />
<br />
Enter this formula in a row of cells for which you need coded samples. Copy the outcome to another worksheet with the command Past Special-->Paste Values.<br />
<br />
Planning to blind a study<br />
<br />
To effectively blind a study, create a sequence containg all experimental steps of the study. In the neighboring headers indicate the name of each person involved in the conduct and analysis of the study. For each experimental step document for each person whether they are blinded or not blinded to the condition or not involved at all. Drawing this out systematically creates a transparent workflow of blinded and unblinded personnel and shows when unintended unblinding might occur. Add the final table to all experimental documentation and reporting. <br />
<br />
<br />
<br />
'''RISK ASSESSMENT'''<br />
* Under some circumstances, unintentional unblinding (e.g. due to a different appearance of a positive control in solution or suspension) may be a risk to be assessed and/or controlled<br />
* Experimental treatments may produce adverse effects and attending veterinarians and animal care stuff may need to be informed in advance about the possibility of such adverse effects occurring and, if necessary, have emergency access to the blinding protocol.<br />
<br />
<br />
'''PLEASE DO NOT FORGET'''<br />
<br />
* Blinding is sometimes not possible especially when certain cues cannot be blinded, such as skin color of transgenic mice or color of a solution in a well. It is important to document this and to communicate in reports where blinding could or could not be achieved.<br />
* Unblinding of the experimental conditions should be done when all blinded processes for the entire study are concluded. Early and partial unblinding for "checking" should be avoided and if necessary, be part of the protocol.<br />
* Control group(s) (e.g., positive control group) should not be excluded from the blinding procedure.<br />
* Provide training on how to apply the blinding procedure.<br />
<br />
<br />
== C. Resources ==<br />
<br />
<br />
Guidelines on reporting of blinding (in vivo research):<br />
* [[ARRIVE 2.0]] <br />
<br />
Template to develop a written description of the method used to implement blinding:<br />
* [blinding protocol]<br />
<br />
Reading material:<br />
<br />
* [https://link.springer.com/chapter/10.1007/164_2019_279 Handbook of Experimental pharmacology chapter on randomization and blinding]<br />
<br />
<br />
----------------<br />
<br />
back to [[Toolbox]]<br />
<br />
Next item: [[2.1.8 Randomisation]]<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
</div>Anton.bespalovhttps://wiki.go-eqipd.org/index.php?title=2.1.7_Blinding&diff=7402.1.7 Blinding2020-12-22T11:30:13Z<p>Anton.bespalov: /* B. Guidance & Expectations */</p>
<hr />
<div>THIS ITEM IS UNDER CONSTRUCTION<br />
<br />
<br />
<br />
<br />
== A. Background & Definitions ==<br />
<br />
<br />
'''Blinding''' refers to the masking of the treatment allocation for person(s) who perform the experiment, collect data and assess outcome. Blinding aims to make sure that someone has no knowledge about treatment allocation that may systematically influence his/her performance. The intended result is the equal treatment (as far as possible) of all experimental units (animals, subjects or samples) in the experiment.<br />
<br />
In the discussion below, experimental groups refer to '''all''' groups involved in an experiment, for example: control, sham, treated with drug A, treated with drug B, etc.<br />
<br />
Group allocation describes which experimental unit (animal, subject or sample) has been allocated to which experimental group.<br />
<br />
The group allocation, actions and outcome assessments are ‘'''blinded'''’. People are ‘'''blind'''’ to particular information.<br />
<br />
== B. Guidance & Expectations ==<br />
<br />
<br />
Describe who was aware of the group allocation at the different stages of the experiment (during the allocation, the conduct of the experiment, the outcome assessment, and the data analysis). Any process using humans as perceptors, raters or interpreters needs to be blinded as long as decision-making is concluded.<br />
<br />
Allocation concealment in animal experiments<br />
<br />
The investigator shall not be aware and/or have the choice to which treatment group an animal is allocated to. This prevents selection bias. Therefore, the assignment to a specific group needs to be concealed and every animal should have the same chance to be assign to each of the groups. This can be achieved separating the assignment of animal_IDs to each animal (e.g. individual ear mark or subcutaneous chip) and randomization of treatments (see randomization) into two independent processes and then merge the two.<br />
<br />
Effective blinding code<br />
<br />
There are certain strategies to apply blinding. The most simple one is the blinding by numbers or alphabet letters. This can be problematic when human processing and rating is involved in outcome assessment. The assessor may not know the condition behind the code but the knowledge of a group affiliation of a sample is a bias that can influence rating. This should be avoided.<br />
<br />
Sometimes blinding conditions are added to another code such as animal_ID, measurement_ID or file name. Watch out for hidden cues in such IDs, containing temporal or sequential information that could increase rater bias. Also metadata, such as creation date and time of a file containg measurements can give away experimental conditions. <br />
<br />
If possible, check whether it is possible to use a blinding scheme without repeating codes. This is can be easily done with alphanumeric code consisting of 4 letter/number combinations, such as T7Z4. Such codes can be easily generated in Excel <br />
<br />
=CHAR(RANDBETWEEN(65;))&RANDBETWEEN(0;9)&CHAR(RANDBETWEEN(65;))&RANDBETWEEN(0;9)<br />
<br />
Enter this formula in a row of cells for which you need coded samples. Copy the outcome to another worksheet with the command Past Special-->Paste Values.<br />
<br />
Planning to blind a study<br />
<br />
To effectively blind a study, create a sequence containg all experimental steps of the study. In the neighboring headers indicate the name of each person involved in the conduct and analysis of the study. For each experimental step document for each person whether they are blinded or not blinded to the condition or not involved at all. Drawing this out systematically creates a transparent workflow of blinded and unblinded personnel and shows when unintended unblinding might occur. Add the final table to all experimental documentation and reporting. <br />
<br />
<br />
<br />
'''RISK ASSESSMENT'''<br />
* Under some circumstances, unintentional unblinding (e.g. due to a different appearance of a positive control in solution or suspension) may be a risk to be assessed and/or controlled<br />
* Experimental treatments may produce adverse effects and attending veterinarians and animal care stuff may need to be informed in advance about the possibility of such adverse effects occurring and, if necessary, have emergency access to the blinding protocol.<br />
<br />
<br />
'''PLEASE DO NOT FORGET'''<br />
<br />
* Blinding is sometimes not possible especially when certain cues cannot be blinded, such as skin color of transgenic mice or color of a solution in a well. It is important to document this and to communicate in reports where blinding could or could not be achieved.<br />
* Unblinding of the experimental conditions should be done when all blinded processes for the entire study are concluded. Early and partial unblinding for "checking" should be avoided and if necessary, be part of the protocol.<br />
* Control group(s) (e.g., positive control group) should not be excluded from the blinding procedure.<br />
* Provide training on how to apply the blinding procedure.<br />
<br />
<br />
== C. Resources ==<br />
<br />
<br />
Guidelines on reporting of blinding (in vivo research):<br />
* [[ARRIVE 2.0]] <br />
<br />
Template to develop a written description of the method used to implement blinding:<br />
* [blinding protocol]<br />
<br />
Reading material:<br />
<br />
* [https://link.springer.com/chapter/10.1007/164_2019_279 Handbook of Experimental pharmacology chapter on randomization and blinding]<br />
<br />
<br />
----------------<br />
<br />
back to [[Toolbox]]<br />
<br />
Next item: [[2.1.8 Randomisation]]<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
</div>Anton.bespalovhttps://wiki.go-eqipd.org/index.php?title=2.1.8_Randomisation&diff=7392.1.8 Randomisation2020-12-22T11:29:03Z<p>Anton.bespalov: /* B. Guidance & Expectations */</p>
<hr />
<div>== A. Background & Definitions ==<br />
<br />
Randomisation is a process of random assignment of experimental units to treatment conditions:<br />
<br />
* occurrence of one event should have no influence on the next event (independence principle);<br />
* randomisation sequence cannot be based on an easily memorizable and reproducible sequence (randomness principle).<br />
<br />
Randomization serves three main purposes:<br />
<br />
* enables the application of statistical tests based on the central limit theorem;<br />
* prevents a potential impact of the selection bias due to differing baseline or confounding characteristics of the subjects;<br />
* supports the implementation of other means to reduce the risks of bias (such as blinding).<br />
<br />
== B. Guidance & Expectations ==<br />
Randomisation protocol should describe the following:<br />
* Type of randomisation (simple / unrestricted, block, stratified, etc.)<br />
* Block size (if applicable)<br />
* Stratification variables (if applicable)<br />
* Tools used for randomisation (including copy of a script if R, SAS or another similar script-based software is used)<br />
* Reproducibility of the randomisation protocol such as the seed of random number generator (if applicable)<br />
* Reference to the protocol followed (if applicable)<br />
* Methods to monitor / detect deviations from the protocol (if any)<br />
* If a decision is made not to introduce a proper randomisation protocol, the reasons should be discussed in a declaration justifying the decision to use pseudo-randomisation or simple interspersion methods.<br />
<br />
'''RISK ASSESSMENT'''<br />
<br />
* Is pseudo-randomisation used instead of strongly recommended true randomisation?<br />
* Is there a risk that randomisation is introduced at allocation of subjects per experimental groups but is not maintained throughout the study conduct, outcome assessment and data analysis?<br />
<br />
<br />
'''PLEASE DO NOT FORGET'''<br />
<br />
* To consider adding this subject to a training program for new employees or refresher training (if appropriate)<br />
* To check whether there are feedback channels installed so that your colleagues can identify, record and report errors and critical incidents related to this subject (if appropriate)<br />
<br />
== C. Resources ==<br />
<br />
<br />
Guidelines on reporting of randomization (in vivo research):<br />
<br />
[[ARRIVE 2.0]] <br />
<br />
Online tools to support randomisation:<br />
<br />
* NC3Rs’ Experimental Design Assistant - [www.eda.nc3rs.org.uk]<br />
<br />
* QuickCalcs - [www.graphpad.com/quickcalcs/randMenu/]<br />
<br />
* Sealed Envelope - [https://www.sealedenvelope.com/simple-randomiser/v1/lists]<br />
<br />
* RandoMice software - [[https://doi.org/10.1371/journal.pone.0237096 read]] - [[https://github.com/Rve54/RandoMice/releases/ download and install]]<br />
<br />
<br />
Reading material:<br />
<br />
Handbook of Experimental pharmacology chapter on randomization and blinding [https://link.springer.com/chapter/10.1007/164_2019_279]<br />
<br />
<br />
<br />
----------------<br />
back to [[Toolbox]]<br />
<br />
Next item: [[2.1.9 Inclusion and exclusion criteria]]</div>Anton.bespalovhttps://wiki.go-eqipd.org/index.php?title=2.1.8_Randomisation&diff=7382.1.8 Randomisation2020-12-22T11:28:30Z<p>Anton.bespalov: /* B. Guidance & Expectations */</p>
<hr />
<div>== A. Background & Definitions ==<br />
<br />
Randomisation is a process of random assignment of experimental units to treatment conditions:<br />
<br />
* occurrence of one event should have no influence on the next event (independence principle);<br />
* randomisation sequence cannot be based on an easily memorizable and reproducible sequence (randomness principle).<br />
<br />
Randomization serves three main purposes:<br />
<br />
* enables the application of statistical tests based on the central limit theorem;<br />
* prevents a potential impact of the selection bias due to differing baseline or confounding characteristics of the subjects;<br />
* supports the implementation of other means to reduce the risks of bias (such as blinding).<br />
<br />
== B. Guidance & Expectations ==<br />
Randomisation protocol should describe the following:<br />
* Type of randomisation (simple / unrestricted, block, stratified, etc.)<br />
* Block size (if applicable)<br />
* Stratification variables (if applicable)<br />
* Tools used for randomisation (including copy of a script if R, SAS or another similar script-based software is used)<br />
* Reproducibility of the randomisation protocol such as the seed of random number generator (if applicable)<br />
* Reference to the protocol followed (if applicable)<br />
* Methods to monitor / detect deviations from the protocol (if any)<br />
* If a decision is made not to introduce a proper randomisation protocol, the reasons should be discussed in a declaration justifying the decision to use pseudo-randomisation or simple interspersion methods.<br />
<br />
'''RISK ASSESSMENT'''<br />
<br />
* Is pseudo-randomisation used instead of strongly recommended true randomisation?<br />
* Is there a risk that randomisation is introduced at allocation of subjects per experimental groups but is not maintained throughout the study conduct, outcome assessment and data analysis?<br />
<br />
<br />
'''PLEASE DO NOT FORGET'''<br />
<br />
* To consider adding this subject to a training program for new employees or refresher training (if appropriate)<br />
* To check whether there are feedback channels installed so that your colleagues can identify, record and report errors and critical incidents related to this subject (if appropriate)<br />
<br />
== C. Resources ==<br />
<br />
<br />
Guidelines on reporting of randomization (in vivo research):<br />
<br />
[[ARRIVE 2.0]] <br />
<br />
Online tools to support randomisation:<br />
<br />
* NC3Rs’ Experimental Design Assistant - [www.eda.nc3rs.org.uk]<br />
<br />
* QuickCalcs - [www.graphpad.com/quickcalcs/randMenu/]<br />
<br />
* Sealed Envelope - [https://www.sealedenvelope.com/simple-randomiser/v1/lists]<br />
<br />
* RandoMice software - [[https://doi.org/10.1371/journal.pone.0237096 read]] - [[https://github.com/Rve54/RandoMice/releases/ download and install]]<br />
<br />
<br />
Reading material:<br />
<br />
Handbook of Experimental pharmacology chapter on randomization and blinding [https://link.springer.com/chapter/10.1007/164_2019_279]<br />
<br />
<br />
<br />
----------------<br />
back to [[Toolbox]]<br />
<br />
Next item: [[2.1.9 Inclusion and exclusion criteria]]</div>Anton.bespalovhttps://wiki.go-eqipd.org/index.php?title=2.1.8_Randomisation&diff=7372.1.8 Randomisation2020-12-22T11:28:08Z<p>Anton.bespalov: /* B. Guidance & Expectations */</p>
<hr />
<div>== A. Background & Definitions ==<br />
<br />
Randomisation is a process of random assignment of experimental units to treatment conditions:<br />
<br />
* occurrence of one event should have no influence on the next event (independence principle);<br />
* randomisation sequence cannot be based on an easily memorizable and reproducible sequence (randomness principle).<br />
<br />
Randomization serves three main purposes:<br />
<br />
* enables the application of statistical tests based on the central limit theorem;<br />
* prevents a potential impact of the selection bias due to differing baseline or confounding characteristics of the subjects;<br />
* supports the implementation of other means to reduce the risks of bias (such as blinding).<br />
<br />
== B. Guidance & Expectations ==<br />
Randomisation protocol should describe the following:<br />
* Type of randomisation (simple / unrestricted, block, stratified, etc.)<br />
* Block size (if applicable)<br />
* Stratification variables (if applicable)<br />
* Tools used for randomisation (including copy of a script if R, SAS or another similar script-based software is used)<br />
* Reproducibility of the randomisation protocol such as the seed of random number generator (if applicable)<br />
* Reference to the protocol followed (if applicable)<br />
* Methods to monitor / detect deviations from the protocol (if any)<br />
* If a decision is made not to introduce a proper randomisation protocol, the reasons should be discussed in a declaration justifying the decision to use pseudo-randomisation or simple interspersion methods.<br />
<br />
'''RISK ASSESSMENT'''<br />
<br />
* Is pseudo-randomisation used instead of strongly recommended true randomisation?<br />
* Is there a risk that randomisation is introduced at allocation of subjects per experimental groups but is not maintained throughout the study conduct, outcome assessment and data analysis?<br />
<br />
'''PLEASE DO NOT FORGET'''<br />
* To consider adding this subject to a training program for new employees or refresher training (if appropriate)<br />
* To check whether there are feedback channels installed so that your colleagues can identify, record and report errors and critical incidents related to this subject (if appropriate)<br />
<br />
== C. Resources ==<br />
<br />
<br />
Guidelines on reporting of randomization (in vivo research):<br />
<br />
[[ARRIVE 2.0]] <br />
<br />
Online tools to support randomisation:<br />
<br />
* NC3Rs’ Experimental Design Assistant - [www.eda.nc3rs.org.uk]<br />
<br />
* QuickCalcs - [www.graphpad.com/quickcalcs/randMenu/]<br />
<br />
* Sealed Envelope - [https://www.sealedenvelope.com/simple-randomiser/v1/lists]<br />
<br />
* RandoMice software - [[https://doi.org/10.1371/journal.pone.0237096 read]] - [[https://github.com/Rve54/RandoMice/releases/ download and install]]<br />
<br />
<br />
Reading material:<br />
<br />
Handbook of Experimental pharmacology chapter on randomization and blinding [https://link.springer.com/chapter/10.1007/164_2019_279]<br />
<br />
<br />
<br />
----------------<br />
back to [[Toolbox]]<br />
<br />
Next item: [[2.1.9 Inclusion and exclusion criteria]]</div>Anton.bespalovhttps://wiki.go-eqipd.org/index.php?title=2.1.7_Blinding&diff=7362.1.7 Blinding2020-12-22T11:10:37Z<p>Anton.bespalov: /* C. Resources */</p>
<hr />
<div>THIS ITEM IS UNDER CONSTRUCTION<br />
<br />
<br />
<br />
<br />
== A. Background & Definitions ==<br />
<br />
<br />
'''Blinding''' refers to the masking of the treatment allocation for person(s) who perform the experiment, collect data and assess outcome. Blinding aims to make sure that someone has no knowledge about treatment allocation that may systematically influence his/her performance. The intended result is the equal treatment (as far as possible) of all experimental units (animals, subjects or samples) in the experiment.<br />
<br />
In the discussion below, experimental groups refer to '''all''' groups involved in an experiment, for example: control, sham, treated with drug A, treated with drug B, etc.<br />
<br />
Group allocation describes which experimental unit (animal, subject or sample) has been allocated to which experimental group.<br />
<br />
The group allocation, actions and outcome assessments are ‘'''blinded'''’. People are ‘'''blind'''’ to particular information.<br />
<br />
== B. Guidance & Expectations ==<br />
<br />
Effective blinding requires at least 2 people, one blinded person (unaware of experimental condition) and an unblinded person (knows the experimental condition and the blinding code). The unblinded person is the keeper of the blinding code which needs to be concealed until all processes under blinding are concluded.<br />
<br />
Describe who was aware of the group allocation at the different stages of the experiment (during the allocation, the conduct of the experiment, the outcome assessment, and the data analysis). Any process using humans as perceptors, raters or interpreters needs to be blinded as long as decision-making is concluded.<br />
<br />
Allocation concealment in animal experiments<br />
<br />
The investigator shall not be aware and/or have the choice to which treatment group an animal is allocated to. This prevents selection bias. Therefore, the assignment to a specific group needs to be concealed and every animal should have the same chance to be assign to each of the groups. This can be achieved separating the assignment of animal_IDs to each animal (e.g. individual ear mark or subcutaneous chip) and randomization of treatments (see randomization) into two independent processes and then merge the two.<br />
<br />
Effective blinding code<br />
<br />
There are certain strategies to apply blinding. The most simple one is the blinding by numbers or alphabet letters. This can be problematic when human processing and rating is involved in outcome assessment. The assessor may not know the condition behind the code but the knowledge of a group affiliation of a sample is a bias that can influence rating. This should be avoided.<br />
<br />
Sometimes blinding conditions are added to another code such as animal_ID, measurement_ID or file name. Watch out for hidden cues in such IDs, containing temporal or sequential information that could increase rater bias. Also metadata, such as creation date and time of a file containg measurements can give away experimental conditions. <br />
<br />
If possible, check whether it is possible to use a blinding scheme without repeating codes. This is can be easily done with alphanumeric code consisting of 4 letter/number combinations, such as T7Z4. Such codes can be easily generated in Excel <br />
<br />
=CHAR(RANDBETWEEN(65;))&RANDBETWEEN(0;9)&CHAR(RANDBETWEEN(65;))&RANDBETWEEN(0;9)<br />
<br />
Enter this formula in a row of cells for which you need coded samples. Copy the outcome to another worksheet with the command Past Special-->Paste Values.<br />
<br />
Planning to blind a study<br />
<br />
To effectively blind a study, create a sequence containg all experimental steps of the study. In the neighboring headers indicate the name of each person involved in the conduct and analysis of the study. For each experimental step document for each person whether they are blinded or not blinded to the condition or not involved at all. Drawing this out systematically creates a transparent workflow of blinded and unblinded personnel and shows when unintended unblinding might occur. Add the final table to all experimental documentation and reporting. <br />
<br />
<br />
<br />
'''RISK ASSESSMENT'''<br />
* Under some circumstances, unintentional unblinding (e.g. due to a different appearance of a positive control in solution or suspension) may be a risk to be assessed and/or controlled<br />
* Experimental treatments may produce adverse effects and attending veterinarians and animal care stuff may need to be informed in advance about the possibility of such adverse effects occurring and, if necessary, have emergency access to the blinding protocol.<br />
<br />
<br />
'''PLEASE DO NOT FORGET'''<br />
<br />
* Blinding is sometimes not possible especially when certain cues cannot be blinded, such as skin color of transgenic mice or color of a solution in a well. It is important to document this and to communicate in reports where blinding could or could not be achieved.<br />
* Unblinding of the experimental conditions should be done when all blinded processes for the entire study are concluded. Early and partial unblinding for "checking" should be avoided and if necessary, be part of the protocol.<br />
* Control group(s) (e.g., positive control group) should not be excluded from the blinding procedure.<br />
* Provide training on how to apply the blinding procedure.<br />
<br />
<br />
== C. Resources ==<br />
<br />
<br />
Guidelines on reporting of blinding (in vivo research):<br />
* [[ARRIVE 2.0]] <br />
<br />
Template to develop a written description of the method used to implement blinding:<br />
* [blinding protocol]<br />
<br />
Reading material:<br />
<br />
* [https://link.springer.com/chapter/10.1007/164_2019_279 Handbook of Experimental pharmacology chapter on randomization and blinding]<br />
<br />
<br />
----------------<br />
<br />
back to [[Toolbox]]<br />
<br />
Next item: [[2.1.8 Randomisation]]<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
</div>Anton.bespalovhttps://wiki.go-eqipd.org/index.php?title=2.1.7_Blinding&diff=7352.1.7 Blinding2020-12-22T10:48:21Z<p>Anton.bespalov: /* C. Resources */</p>
<hr />
<div>THIS ITEM IS UNDER CONSTRUCTION<br />
<br />
<br />
<br />
<br />
== A. Background & Definitions ==<br />
<br />
<br />
'''Blinding''' refers to the masking of the treatment allocation for person(s) who perform the experiment, collect data and assess outcome. Blinding aims to make sure that someone has no knowledge about treatment allocation that may systematically influence his/her performance. The intended result is the equal treatment (as far as possible) of all experimental units (animals, subjects or samples) in the experiment.<br />
<br />
In the discussion below, experimental groups refer to '''all''' groups involved in an experiment, for example: control, sham, treated with drug A, treated with drug B, etc.<br />
<br />
Group allocation describes which experimental unit (animal, subject or sample) has been allocated to which experimental group.<br />
<br />
The group allocation, actions and outcome assessments are ‘'''blinded'''’. People are ‘'''blind'''’ to particular information.<br />
<br />
== B. Guidance & Expectations ==<br />
<br />
Effective blinding requires at least 2 people, one blinded person (unaware of experimental condition) and an unblinded person (knows the experimental condition and the blinding code). The unblinded person is the keeper of the blinding code which needs to be concealed until all processes under blinding are concluded.<br />
<br />
Describe who was aware of the group allocation at the different stages of the experiment (during the allocation, the conduct of the experiment, the outcome assessment, and the data analysis). Any process using humans as perceptors, raters or interpreters needs to be blinded as long as decision-making is concluded.<br />
<br />
Allocation concealment in animal experiments<br />
<br />
The investigator shall not be aware and/or have the choice to which treatment group an animal is allocated to. This prevents selection bias. Therefore, the assignment to a specific group needs to be concealed and every animal should have the same chance to be assign to each of the groups. This can be achieved separating the assignment of animal_IDs to each animal (e.g. individual ear mark or subcutaneous chip) and randomization of treatments (see randomization) into two independent processes and then merge the two.<br />
<br />
Effective blinding code<br />
<br />
There are certain strategies to apply blinding. The most simple one is the blinding by numbers or alphabet letters. This can be problematic when human processing and rating is involved in outcome assessment. The assessor may not know the condition behind the code but the knowledge of a group affiliation of a sample is a bias that can influence rating. This should be avoided.<br />
<br />
Sometimes blinding conditions are added to another code such as animal_ID, measurement_ID or file name. Watch out for hidden cues in such IDs, containing temporal or sequential information that could increase rater bias. Also metadata, such as creation date and time of a file containg measurements can give away experimental conditions. <br />
<br />
If possible, check whether it is possible to use a blinding scheme without repeating codes. This is can be easily done with alphanumeric code consisting of 4 letter/number combinations, such as T7Z4. Such codes can be easily generated in Excel <br />
<br />
=CHAR(RANDBETWEEN(65;))&RANDBETWEEN(0;9)&CHAR(RANDBETWEEN(65;))&RANDBETWEEN(0;9)<br />
<br />
Enter this formula in a row of cells for which you need coded samples. Copy the outcome to another worksheet with the command Past Special-->Paste Values.<br />
<br />
Planning to blind a study<br />
<br />
To effectively blind a study, create a sequence containg all experimental steps of the study. In the neighboring headers indicate the name of each person involved in the conduct and analysis of the study. For each experimental step document for each person whether they are blinded or not blinded to the condition or not involved at all. Drawing this out systematically creates a transparent workflow of blinded and unblinded personnel and shows when unintended unblinding might occur. Add the final table to all experimental documentation and reporting. <br />
<br />
<br />
<br />
'''RISK ASSESSMENT'''<br />
* Under some circumstances, unintentional unblinding (e.g. due to a different appearance of a positive control in solution or suspension) may be a risk to be assessed and/or controlled<br />
* Experimental treatments may produce adverse effects and attending veterinarians and animal care stuff may need to be informed in advance about the possibility of such adverse effects occurring and, if necessary, have emergency access to the blinding protocol.<br />
<br />
<br />
'''PLEASE DO NOT FORGET'''<br />
<br />
* Blinding is sometimes not possible especially when certain cues cannot be blinded, such as skin color of transgenic mice or color of a solution in a well. It is important to document this and to communicate in reports where blinding could or could not be achieved.<br />
* Unblinding of the experimental conditions should be done when all blinded processes for the entire study are concluded. Early and partial unblinding for "checking" should be avoided and if necessary, be part of the protocol.<br />
* Control group(s) (e.g., positive control group) should not be excluded from the blinding procedure.<br />
* Provide training on how to apply the blinding procedure.<br />
<br />
<br />
== C. Resources ==<br />
<br />
<br />
Guidelines on reporting of blinding (in vivo research):<br />
* [[ARRIVE 2.0]] <br />
<br />
Reading material:<br />
<br />
* [https://link.springer.com/chapter/10.1007/164_2019_279 Handbook of Experimental pharmacology chapter on randomization and blinding]<br />
<br />
<br />
----------------<br />
<br />
back to [[Toolbox]]<br />
<br />
Next item: [[2.1.8 Randomisation]]<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
</div>Anton.bespalovhttps://wiki.go-eqipd.org/index.php?title=2.1.7_Blinding&diff=7342.1.7 Blinding2020-12-22T10:48:00Z<p>Anton.bespalov: /* C. Resources */</p>
<hr />
<div>THIS ITEM IS UNDER CONSTRUCTION<br />
<br />
<br />
<br />
<br />
== A. Background & Definitions ==<br />
<br />
<br />
'''Blinding''' refers to the masking of the treatment allocation for person(s) who perform the experiment, collect data and assess outcome. Blinding aims to make sure that someone has no knowledge about treatment allocation that may systematically influence his/her performance. The intended result is the equal treatment (as far as possible) of all experimental units (animals, subjects or samples) in the experiment.<br />
<br />
In the discussion below, experimental groups refer to '''all''' groups involved in an experiment, for example: control, sham, treated with drug A, treated with drug B, etc.<br />
<br />
Group allocation describes which experimental unit (animal, subject or sample) has been allocated to which experimental group.<br />
<br />
The group allocation, actions and outcome assessments are ‘'''blinded'''’. People are ‘'''blind'''’ to particular information.<br />
<br />
== B. Guidance & Expectations ==<br />
<br />
Effective blinding requires at least 2 people, one blinded person (unaware of experimental condition) and an unblinded person (knows the experimental condition and the blinding code). The unblinded person is the keeper of the blinding code which needs to be concealed until all processes under blinding are concluded.<br />
<br />
Describe who was aware of the group allocation at the different stages of the experiment (during the allocation, the conduct of the experiment, the outcome assessment, and the data analysis). Any process using humans as perceptors, raters or interpreters needs to be blinded as long as decision-making is concluded.<br />
<br />
Allocation concealment in animal experiments<br />
<br />
The investigator shall not be aware and/or have the choice to which treatment group an animal is allocated to. This prevents selection bias. Therefore, the assignment to a specific group needs to be concealed and every animal should have the same chance to be assign to each of the groups. This can be achieved separating the assignment of animal_IDs to each animal (e.g. individual ear mark or subcutaneous chip) and randomization of treatments (see randomization) into two independent processes and then merge the two.<br />
<br />
Effective blinding code<br />
<br />
There are certain strategies to apply blinding. The most simple one is the blinding by numbers or alphabet letters. This can be problematic when human processing and rating is involved in outcome assessment. The assessor may not know the condition behind the code but the knowledge of a group affiliation of a sample is a bias that can influence rating. This should be avoided.<br />
<br />
Sometimes blinding conditions are added to another code such as animal_ID, measurement_ID or file name. Watch out for hidden cues in such IDs, containing temporal or sequential information that could increase rater bias. Also metadata, such as creation date and time of a file containg measurements can give away experimental conditions. <br />
<br />
If possible, check whether it is possible to use a blinding scheme without repeating codes. This is can be easily done with alphanumeric code consisting of 4 letter/number combinations, such as T7Z4. Such codes can be easily generated in Excel <br />
<br />
=CHAR(RANDBETWEEN(65;))&RANDBETWEEN(0;9)&CHAR(RANDBETWEEN(65;))&RANDBETWEEN(0;9)<br />
<br />
Enter this formula in a row of cells for which you need coded samples. Copy the outcome to another worksheet with the command Past Special-->Paste Values.<br />
<br />
Planning to blind a study<br />
<br />
To effectively blind a study, create a sequence containg all experimental steps of the study. In the neighboring headers indicate the name of each person involved in the conduct and analysis of the study. For each experimental step document for each person whether they are blinded or not blinded to the condition or not involved at all. Drawing this out systematically creates a transparent workflow of blinded and unblinded personnel and shows when unintended unblinding might occur. Add the final table to all experimental documentation and reporting. <br />
<br />
<br />
<br />
'''RISK ASSESSMENT'''<br />
* Under some circumstances, unintentional unblinding (e.g. due to a different appearance of a positive control in solution or suspension) may be a risk to be assessed and/or controlled<br />
* Experimental treatments may produce adverse effects and attending veterinarians and animal care stuff may need to be informed in advance about the possibility of such adverse effects occurring and, if necessary, have emergency access to the blinding protocol.<br />
<br />
<br />
'''PLEASE DO NOT FORGET'''<br />
<br />
* Blinding is sometimes not possible especially when certain cues cannot be blinded, such as skin color of transgenic mice or color of a solution in a well. It is important to document this and to communicate in reports where blinding could or could not be achieved.<br />
* Unblinding of the experimental conditions should be done when all blinded processes for the entire study are concluded. Early and partial unblinding for "checking" should be avoided and if necessary, be part of the protocol.<br />
* Control group(s) (e.g., positive control group) should not be excluded from the blinding procedure.<br />
* Provide training on how to apply the blinding procedure.<br />
<br />
<br />
== C. Resources ==<br />
<br />
<br />
Guidelines on reporting of blinding (in vivo research):<br />
[[ARRIVE 2.0]] <br />
<br />
Reading material:<br />
<br />
[https://link.springer.com/chapter/10.1007/164_2019_279 Handbook of Experimental pharmacology chapter on randomization and blinding]<br />
<br />
<br />
----------------<br />
<br />
back to [[Toolbox]]<br />
<br />
Next item: [[2.1.8 Randomisation]]<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
</div>Anton.bespalovhttps://wiki.go-eqipd.org/index.php?title=2.1.7_Blinding&diff=7332.1.7 Blinding2020-12-22T10:47:03Z<p>Anton.bespalov: /* C. Resources */</p>
<hr />
<div>THIS ITEM IS UNDER CONSTRUCTION<br />
<br />
<br />
<br />
<br />
== A. Background & Definitions ==<br />
<br />
<br />
'''Blinding''' refers to the masking of the treatment allocation for person(s) who perform the experiment, collect data and assess outcome. Blinding aims to make sure that someone has no knowledge about treatment allocation that may systematically influence his/her performance. The intended result is the equal treatment (as far as possible) of all experimental units (animals, subjects or samples) in the experiment.<br />
<br />
In the discussion below, experimental groups refer to '''all''' groups involved in an experiment, for example: control, sham, treated with drug A, treated with drug B, etc.<br />
<br />
Group allocation describes which experimental unit (animal, subject or sample) has been allocated to which experimental group.<br />
<br />
The group allocation, actions and outcome assessments are ‘'''blinded'''’. People are ‘'''blind'''’ to particular information.<br />
<br />
== B. Guidance & Expectations ==<br />
<br />
Effective blinding requires at least 2 people, one blinded person (unaware of experimental condition) and an unblinded person (knows the experimental condition and the blinding code). The unblinded person is the keeper of the blinding code which needs to be concealed until all processes under blinding are concluded.<br />
<br />
Describe who was aware of the group allocation at the different stages of the experiment (during the allocation, the conduct of the experiment, the outcome assessment, and the data analysis). Any process using humans as perceptors, raters or interpreters needs to be blinded as long as decision-making is concluded.<br />
<br />
Allocation concealment in animal experiments<br />
<br />
The investigator shall not be aware and/or have the choice to which treatment group an animal is allocated to. This prevents selection bias. Therefore, the assignment to a specific group needs to be concealed and every animal should have the same chance to be assign to each of the groups. This can be achieved separating the assignment of animal_IDs to each animal (e.g. individual ear mark or subcutaneous chip) and randomization of treatments (see randomization) into two independent processes and then merge the two.<br />
<br />
Effective blinding code<br />
<br />
There are certain strategies to apply blinding. The most simple one is the blinding by numbers or alphabet letters. This can be problematic when human processing and rating is involved in outcome assessment. The assessor may not know the condition behind the code but the knowledge of a group affiliation of a sample is a bias that can influence rating. This should be avoided.<br />
<br />
Sometimes blinding conditions are added to another code such as animal_ID, measurement_ID or file name. Watch out for hidden cues in such IDs, containing temporal or sequential information that could increase rater bias. Also metadata, such as creation date and time of a file containg measurements can give away experimental conditions. <br />
<br />
If possible, check whether it is possible to use a blinding scheme without repeating codes. This is can be easily done with alphanumeric code consisting of 4 letter/number combinations, such as T7Z4. Such codes can be easily generated in Excel <br />
<br />
=CHAR(RANDBETWEEN(65;))&RANDBETWEEN(0;9)&CHAR(RANDBETWEEN(65;))&RANDBETWEEN(0;9)<br />
<br />
Enter this formula in a row of cells for which you need coded samples. Copy the outcome to another worksheet with the command Past Special-->Paste Values.<br />
<br />
Planning to blind a study<br />
<br />
To effectively blind a study, create a sequence containg all experimental steps of the study. In the neighboring headers indicate the name of each person involved in the conduct and analysis of the study. For each experimental step document for each person whether they are blinded or not blinded to the condition or not involved at all. Drawing this out systematically creates a transparent workflow of blinded and unblinded personnel and shows when unintended unblinding might occur. Add the final table to all experimental documentation and reporting. <br />
<br />
<br />
<br />
'''RISK ASSESSMENT'''<br />
* Under some circumstances, unintentional unblinding (e.g. due to a different appearance of a positive control in solution or suspension) may be a risk to be assessed and/or controlled<br />
* Experimental treatments may produce adverse effects and attending veterinarians and animal care stuff may need to be informed in advance about the possibility of such adverse effects occurring and, if necessary, have emergency access to the blinding protocol.<br />
<br />
<br />
'''PLEASE DO NOT FORGET'''<br />
<br />
* Blinding is sometimes not possible especially when certain cues cannot be blinded, such as skin color of transgenic mice or color of a solution in a well. It is important to document this and to communicate in reports where blinding could or could not be achieved.<br />
* Unblinding of the experimental conditions should be done when all blinded processes for the entire study are concluded. Early and partial unblinding for "checking" should be avoided and if necessary, be part of the protocol.<br />
* Control group(s) (e.g., positive control group) should not be excluded from the blinding procedure.<br />
* Provide training on how to apply the blinding procedure.<br />
<br />
<br />
== C. Resources ==<br />
<br />
<br />
Guidelines on reporting of blinding (in vivo research):<br />
[[ARRIVE 2.0]] <br />
<br />
<br />
Reading material:<br />
Handbook of Experimental pharmacology chapter on randomization and blinding [https://link.springer.com/chapter/10.1007/164_2019_279]<br />
<br />
<br />
<br />
----------------<br />
<br />
back to [[Toolbox]]<br />
<br />
Next item: [[2.1.8 Randomisation]]<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
</div>Anton.bespalovhttps://wiki.go-eqipd.org/index.php?title=2.1.8_Randomisation&diff=7322.1.8 Randomisation2020-12-22T10:45:25Z<p>Anton.bespalov: /* A. Background & Definitions */</p>
<hr />
<div>== A. Background & Definitions ==<br />
<br />
Randomisation is a process of random assignment of experimental units to treatment conditions:<br />
<br />
* occurrence of one event should have no influence on the next event (independence principle);<br />
* randomisation sequence cannot be based on an easily memorizable and reproducible sequence (randomness principle).<br />
<br />
Randomization serves three main purposes:<br />
<br />
* enables the application of statistical tests based on the central limit theorem;<br />
* prevents a potential impact of the selection bias due to differing baseline or confounding characteristics of the subjects;<br />
* supports the implementation of other means to reduce the risks of bias (such as blinding).<br />
<br />
== B. Guidance & Expectations ==<br />
Randomisation protocol should describe the following:<br />
* Type of randomisation (simple / unrestricted, block, stratified, etc.)<br />
* Block size (if applicable)<br />
* Stratification variables (if applicable)<br />
* Tools used for randomisation (including copy of a script if R, SAS or another similar script-based software is used)<br />
* Reproducibility of the randomisation protocol such as the seed of random number generator (if applicable)<br />
* Reference to the protocol followed (if applicable)<br />
* Methods to monitor / detect deviations from the protocol (if any)<br />
* If a decision is made not to introduce a proper randomisation protocol, the reasons should be discussed in a declaration justifying the decision to use pseudo-randomisation or simple interspersion methods.<br />
<br />
'''RISK ASSESSMENT'''<br />
* Is pseudo-randomisation used instead of strongly recommended true randomisation?<br />
* Is there a risk that randomisation is introduced at allocation of subjects per experimental groups but is not maintained throughout the study conduct, outcome assessment and data analysis?<br />
<br />
'''PLEASE DO NOT FORGET'''<br />
* To consider adding this subject to a training program for new employees or refresher training (if appropriate)<br />
* To check whether there are feedback channels installed so that your colleagues can identify, record and report errors and critical incidents related to this subject (if appropriate)<br />
<br />
== C. Resources ==<br />
<br />
<br />
Guidelines on reporting of randomization (in vivo research):<br />
<br />
[[ARRIVE 2.0]] <br />
<br />
Online tools to support randomisation:<br />
<br />
* NC3Rs’ Experimental Design Assistant - [www.eda.nc3rs.org.uk]<br />
<br />
* QuickCalcs - [www.graphpad.com/quickcalcs/randMenu/]<br />
<br />
* Sealed Envelope - [https://www.sealedenvelope.com/simple-randomiser/v1/lists]<br />
<br />
* RandoMice software - [[https://doi.org/10.1371/journal.pone.0237096 read]] - [[https://github.com/Rve54/RandoMice/releases/ download and install]]<br />
<br />
<br />
Reading material:<br />
<br />
Handbook of Experimental pharmacology chapter on randomization and blinding [https://link.springer.com/chapter/10.1007/164_2019_279]<br />
<br />
<br />
<br />
----------------<br />
back to [[Toolbox]]<br />
<br />
Next item: [[2.1.9 Inclusion and exclusion criteria]]</div>Anton.bespalovhttps://wiki.go-eqipd.org/index.php?title=2.1.8_Randomisation&diff=7312.1.8 Randomisation2020-12-22T10:44:31Z<p>Anton.bespalov: /* A. Background & Definitions */</p>
<hr />
<div>== A. Background & Definitions ==<br />
<br />
Randomisation is a process of random assignment of experimental units to treatment conditions:<br />
<br />
* occurrence of one event should have no influence on the next event (independence principle)<br />
randomisation sequence cannot be based on an easily memorizable and reproducible sequence (randomness principle)<br />
Randomization serves three main purposes:<br />
<br />
* enables the application of statistical tests based on the central limit theorem<br />
prevents a potential impact of the selection bias due to differing baseline or confounding characteristics of the subjects<br />
supports the implementation of other means to reduce the risks of bias (such as blinding)<br />
<br />
== B. Guidance & Expectations ==<br />
Randomisation protocol should describe the following:<br />
* Type of randomisation (simple / unrestricted, block, stratified, etc.)<br />
* Block size (if applicable)<br />
* Stratification variables (if applicable)<br />
* Tools used for randomisation (including copy of a script if R, SAS or another similar script-based software is used)<br />
* Reproducibility of the randomisation protocol such as the seed of random number generator (if applicable)<br />
* Reference to the protocol followed (if applicable)<br />
* Methods to monitor / detect deviations from the protocol (if any)<br />
* If a decision is made not to introduce a proper randomisation protocol, the reasons should be discussed in a declaration justifying the decision to use pseudo-randomisation or simple interspersion methods.<br />
<br />
'''RISK ASSESSMENT'''<br />
* Is pseudo-randomisation used instead of strongly recommended true randomisation?<br />
* Is there a risk that randomisation is introduced at allocation of subjects per experimental groups but is not maintained throughout the study conduct, outcome assessment and data analysis?<br />
<br />
'''PLEASE DO NOT FORGET'''<br />
* To consider adding this subject to a training program for new employees or refresher training (if appropriate)<br />
* To check whether there are feedback channels installed so that your colleagues can identify, record and report errors and critical incidents related to this subject (if appropriate)<br />
<br />
== C. Resources ==<br />
<br />
<br />
Guidelines on reporting of randomization (in vivo research):<br />
<br />
[[ARRIVE 2.0]] <br />
<br />
Online tools to support randomisation:<br />
<br />
* NC3Rs’ Experimental Design Assistant - [www.eda.nc3rs.org.uk]<br />
<br />
* QuickCalcs - [www.graphpad.com/quickcalcs/randMenu/]<br />
<br />
* Sealed Envelope - [https://www.sealedenvelope.com/simple-randomiser/v1/lists]<br />
<br />
* RandoMice software - [[https://doi.org/10.1371/journal.pone.0237096 read]] - [[https://github.com/Rve54/RandoMice/releases/ download and install]]<br />
<br />
<br />
Reading material:<br />
<br />
Handbook of Experimental pharmacology chapter on randomization and blinding [https://link.springer.com/chapter/10.1007/164_2019_279]<br />
<br />
<br />
<br />
----------------<br />
back to [[Toolbox]]<br />
<br />
Next item: [[2.1.9 Inclusion and exclusion criteria]]</div>Anton.bespalovhttps://wiki.go-eqipd.org/index.php?title=2.1.8_Randomisation&diff=7302.1.8 Randomisation2020-12-22T10:44:17Z<p>Anton.bespalov: /* B. Guidance & Expectations */</p>
<hr />
<div>== A. Background & Definitions ==<br />
<br />
Randomisation is a process of random assignment of experimental units to treatment conditions:<br />
<br />
- occurrence of one event should have no influence on the next event (independence principle)<br />
randomisation sequence cannot be based on an easily memorizable and reproducible sequence (randomness principle)<br />
Randomization serves three main purposes:<br />
<br />
- enables the application of statistical tests based on the central limit theorem<br />
prevents a potential impact of the selection bias due to differing baseline or confounding characteristics of the subjects<br />
supports the implementation of other means to reduce the risks of bias (such as blinding)<br />
<br />
== B. Guidance & Expectations ==<br />
Randomisation protocol should describe the following:<br />
* Type of randomisation (simple / unrestricted, block, stratified, etc.)<br />
* Block size (if applicable)<br />
* Stratification variables (if applicable)<br />
* Tools used for randomisation (including copy of a script if R, SAS or another similar script-based software is used)<br />
* Reproducibility of the randomisation protocol such as the seed of random number generator (if applicable)<br />
* Reference to the protocol followed (if applicable)<br />
* Methods to monitor / detect deviations from the protocol (if any)<br />
* If a decision is made not to introduce a proper randomisation protocol, the reasons should be discussed in a declaration justifying the decision to use pseudo-randomisation or simple interspersion methods.<br />
<br />
'''RISK ASSESSMENT'''<br />
* Is pseudo-randomisation used instead of strongly recommended true randomisation?<br />
* Is there a risk that randomisation is introduced at allocation of subjects per experimental groups but is not maintained throughout the study conduct, outcome assessment and data analysis?<br />
<br />
'''PLEASE DO NOT FORGET'''<br />
* To consider adding this subject to a training program for new employees or refresher training (if appropriate)<br />
* To check whether there are feedback channels installed so that your colleagues can identify, record and report errors and critical incidents related to this subject (if appropriate)<br />
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== C. Resources ==<br />
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Guidelines on reporting of randomization (in vivo research):<br />
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[[ARRIVE 2.0]] <br />
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Online tools to support randomisation:<br />
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* NC3Rs’ Experimental Design Assistant - [www.eda.nc3rs.org.uk]<br />
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* QuickCalcs - [www.graphpad.com/quickcalcs/randMenu/]<br />
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* Sealed Envelope - [https://www.sealedenvelope.com/simple-randomiser/v1/lists]<br />
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* RandoMice software - [[https://doi.org/10.1371/journal.pone.0237096 read]] - [[https://github.com/Rve54/RandoMice/releases/ download and install]]<br />
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Reading material:<br />
<br />
Handbook of Experimental pharmacology chapter on randomization and blinding [https://link.springer.com/chapter/10.1007/164_2019_279]<br />
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back to [[Toolbox]]<br />
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Next item: [[2.1.9 Inclusion and exclusion criteria]]</div>Anton.bespalov