EQIPD - User contributions [en]

3.2.3 Implementation of the EQIPD Quality System

2025-10-20T18:54:01Z

Bjoerngerlach: /* Take a closer look at the expectations of EQIPD */

== Get familiar with the key terms defined by EQIPD ==
{{#ev:youtube|https://youtu.be/bK6emsX5G1Y|400|right}}
=== What means quality? ===
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).

=== Research rigor ===
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.

=== Raw data ===
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:
* 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;
* data directly entered into a computer through an automatic instrument interface, which are the results of primary observations and activities in a study;
* copies of original laboratory records and documentation that are complete and of good quality.

=== Knowledge-claiming research ===
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 protocol) to research that is conducted with the prior intention of informing a knowledge claim.
Examples of research requiring the maximal rigor possible include:
* 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])
*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)
* 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])
* Labor-, resource- and/or time-intensive studies that cannot be easily repeated

=== Must vs. should ===
When reviewing materials provided by EQIPD, please note the use of "must" vs "should".
* "Must" indicates actions that EQIPD considers as imperative and mandatory or as a requirement.
* 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.
* 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.

For more definitions, please see [[Glossary]].

== Take a closer look at the expectations of EQIPD ==
{{#ev:youtube|https://youtu.be/D_Wl6kcs9vU|400|right}}
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.

Next, you may want to go through the [https://paasp.sharepoint.com/:b:/s/EQIPD/EWvqq6oej6lEuGj9twOLtYQBK7o77XtOEHrA1UjC5r4PSA?e=4bvKzb self-assessment overview]] in order to check how many [[Core Requirements]] do you already meet and where potential challenges can be encountered.

Once this review is complete, you will be prepared to answer a question - Are most core requirements met?

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@go-eqipd.org info@go-eqipd.org] or simply complete the remaining core requirements using information provided by EQIPD online ([[4.1.2 Self assessment]]).

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.

== Implementation guide ==
The following table provides an overview on how to approach the implementation of the quality system. These are suggestions from the EQIPD team to guide you when you start at zero. However, any other approach that might work better for you and leading to the implementation of the 18 [[Core Requirements]] is perfect as well.

{|class="wikitable"
|
|'''Preparation'''
|'''Phase 1'''
|'''Phase 2'''
|'''Phase 3'''
|-
|'''Recommended Action'''
|[[3.2.3 Implementation of the EQIPD Quality System#Get familiar with the key terms defined by EQIPD|Get familiar with EQIPD terminology]]
[[3.2.3 Implementation of the EQIPD Quality System#Take a closer look at the expectations of EQIPD|Take a closer look at EQIPD expectations]]
|
# [[1.5.2.3 Process owner|Define Process Owner]]
# [[1.1 Mission|Set-up Mission Statement]]
# [[1.2 Scope|Set-up Communication Plan]]
# Set-up Documentation (three resources: [[2.3.1 Generation, recording, handling and archiving of raw data|1]] [[3.1.3 Data security|2]] [[3.1.2.1 Traceability of data and any person having impact on data|3]])
# [[3.4.1 Animal characteristics, care and use|Set-up ACU document if applicable]]
# [[2.1.4 Purpose of research|Get familiar with knowledge-claiming research ]]
|[[NEED|Identify additional NEEDS]]
Develop solutions to address CR and NEEDs
|Finalize implementation
[[4.1.2 Self assessment|Check yourself again with Self-assessment]]
|-
|'''Optional Action'''
|[https://paasp.sharepoint.com/:u:/s/EQIPD/ERWfS3Yuw6NJodMY_iz8A5MBxESAFCjPzWMu-DFd3xUrfw?e=4O5622 Download Planning Tool and Dossier]
[[4.3.2.1 Using the Planning Tool|Introduction to the Planning Tool]]
|
# [[4.3.2.1 Using the Planning Tool#2. Setting up the Dashboard with the Wizard|Open Planning Tool and activate Makros to start Wizard]]
# [[4.3.2.1 Using the Planning Tool#2. Setting up the Dashboard with the Wizard|Guided implementation of items above with Wizard]]
|[[4.3.2.1 Using the Planning Tool#3. Getting familiar with the Dashboard|Track your progress on the Dashboard]]
|[[Implementation_Strategy#Assessment by the EQIPD team| Apply for EQIPD certification]]
|}

For more information, please contact the EQIPD team at [mailto:info@go-eqipd.org/ info@go-eqipd.org].

== Assessment by the EQIPD team ==
Once all core requirements are considered to be met, please approach the EQIPD team [mailto:info@go-eqipd.org info@go-eqipd.org] that can do an assessment and, in case of a positive evaluation, will certify the successful implementation of the Quality System.

----------------
back to [[EQIPD Quality System]]

back to [[Toolbox]]

Item: [[3.2.4 Training on specific methods, tasks and activities]]

Talk:1.5.2.3 Process owner

2025-07-30T08:09:47Z

Bjoerngerlach:

Björn: Does this site need clarification?
It seems like it could be confusing, since the first paragraph says it must not be the ultimate authority, however, the later it sounds slightly different:

* First: Process owner is a person within the organization (research unit) who has the necessary competence and resources or access to them, and typically has the authority to implement the steps needed to establish the EQIPD Quality System (QS). It is understood that the process owner is not always the head (director, president, CEO, etc.) of the research unit and may, therefore, have no ultimate authority.

* Later: It is typically expected that the Process Owner is someone who directs the work of the research unit (e.g. a professor, group leader, principal investigator, CEO or department head)

Talk:1.5.2.3 Process owner

2025-07-30T08:09:36Z

Bjoerngerlach:

Björn: Does this site need clarification?
It seems like it could be confusing, since the first paragraph says it must not be the ultimate authority, however, the later it sounds slightly different:

* First:Process owner is a person within the organization (research unit) who has the necessary competence and resources or access to them, and typically has the authority to implement the steps needed to establish the EQIPD Quality System (QS). It is understood that the process owner is not always the head (director, president, CEO, etc.) of the research unit and may, therefore, have no ultimate authority.

* Later: It is typically expected that the Process Owner is someone who directs the work of the research unit (e.g. a professor, group leader, principal investigator, CEO or department head)

Talk:1.5.2.3 Process owner

2025-07-30T08:09:01Z

Bjoerngerlach: Created page with "Björn: Does this site need clarification? It seems like it could be confusing, since the first paragraph says it must not be the ultimate authority, however, the later it sou..."

Björn:
Does this site need clarification?
It seems like it could be confusing, since the first paragraph says it must not be the ultimate authority, however, the later it sounds slightly different:

First:
Process owner is a person within the organization (research unit) who has the necessary competence and resources or access to them, and typically has the authority to implement the steps needed to establish the EQIPD Quality System (QS). It is understood that the process owner is not always the head (director, president, CEO, etc.) of the research unit and may, therefore, have no ultimate authority.

Later:
It is typically expected that the Process Owner is someone who directs the work of the research unit (e.g. a professor, group leader, principal investigator, CEO or department head)

Talk:1.2 Scope

2025-06-25T07:56:44Z

Bjoerngerlach:

It could make sense to include examples here in a specific box:
* background and example of an organigram
* the table/matrix from the communication plan

Talk:EQIPD Quality System

2025-06-10T09:55:39Z

Bjoerngerlach: /* General */

On this page we can collect ideas and errors within the entire Wiki.

===New pages needed===
* Sex differences in animal research

===Errors on the pages===
https://www.eda.nc3rs.org.uk/ - link doesn't work

===Dedicated working groups===
====General====
* Checking incorrect items:
** Sara: Section 2
** Leo / Björn: Section 1
*** To clarify: Does the mission statement and the template still make sense? E.g. is it useful? https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=U3bWIn
*** Any thoughts for resources for the page [[1.3.1 Transparency]]
***Error
** René: Section 3
* Checking missing pages
**Everyone when screening though the website, with René as a contact
* Find mechanisms to keep it up-to-date
**Tbd

====Specific task forces formed already:====
* Quality culture and improvmenent
** Arnoud, Sandrine, Jonathan
* Antibodies and validation
** Harv, Marija
* Creating page on sex differences
** Christina, Vootele

====Orphans-Do not link to any other EQIPD pages:====
1.4.3.2 Quality in collaborative research - https://eqipd-toolbox.paasp.net/wiki/1.4.3.2_Quality_in_collaborative_research

EQIPD - https://eqipd-toolbox.paasp.net/wiki/EQIPD

EQIPD for Core Facilities - https://eqipd-toolbox.paasp.net/wiki/EQIPD_for_Core_Facilities

Examples of implementing a unique study ID - https://eqipd-toolbox.paasp.net/wiki/Examples_of_implementing_a_unique_study_ID

Experimental Record - https://eqipd-toolbox.paasp.net/wiki/Experimental_Record

Hauptseite - https://eqipd-toolbox.paasp.net/wiki/Hauptseite

Performance Standards - https://eqipd-toolbox.paasp.net/wiki/Performance_Standards

Spot checks - https://eqipd-toolbox.paasp.net/wiki/Spot_checks

Why quality matters - https://eqipd-toolbox.paasp.net/wiki/Why_quality_matters

====Glossary: might need extension====
SABV

FAIR (data)

====Pages needed ====
- Questionable Research Practices

- CoARA process, research evaluation

- protocols (reusable, reproducible, management)

- AI in research quality?

- feature Marten Kas as EQIPD use case examples

- data (format) community standards

- FAIR data, data repositories, DMP

- more reporting guidelines/recommendations, like RIVER (not just minimum standards)

====Pages with "to be added sections" ====

''(needs priorisation before adding content)''

1.3.1 Transparency

1.3.3 Promotion criteria within a research unit

1.4.1 Research ethics

1.4.2 Adherence to legal and regulatory considerations

1.4.2.7 Animal care and use

1.4.2.8 Human data protection

1.4.3.4 Academia-academia: Research as collaboration

1.5.2 Roles and responsibilities of involved personnel and organization

1.5.2.1 Organigram

1.5.2.2 Management

1.5.2.4 Principal investigators and study directors

1.5.2.5 Research team

1.5.2.6 Supporting team

1.5.2.7 Quality professionals

1.5.3 Management of resources

1.5.3.1 Personnel

1.5.3.2 Facilities

1.5.3.3 Laboratory and experimental equipment used for measurement

1.5.3.4 Electronic information system

1.5.3.5 Organization-specific know how

1.5.3.6 Documentation requirement for sample and material

1.5.3.7 Retained personnel records

1.5.4.1 Independence of internal compliance assessment

1.5.4.2 Internal assessment of the organizations' quality professionals

1.5.5 Sustainability

2.1.6 Sample size and power analysis

2.1.10 Plausibility check => resource: e.g. arrive guidelines + link with risk analysis?

2.2.2 Use of template for (manual) data recording

2.3.1.1 Converting non-electronic information into an electronic form

2.3.2 Primary analysis and evaluation of raw data

2.4 Reporting

2.4.1 Non-public reporting

3.2.1 General guidance on training

3.5.1 Animal and non-animal method and assay qualification

4.1.3 External assessment

4.2.1 Installation of solutions, actions and mitigation strategies

4.3.1.2 Deleting items

==== Dead links ====
2.1.11 Preregistration: https://openscience.bmj.com/

==== training resources needed to be embedded ====
https://go-eqipd.org/about-eqipd/webinar-2023/

https://go-eqipd.org/resources/eqipd-e-learning/

https://research.columbia.edu/ReaDI-program

find more more online templates

===proof reading===
- 2.1.11 Preregistration: example on timeline would be useful (to convince people to do it)

- 2.1.1: 2 pages with same content but different name: study protocol; study experimental plan

- 2.1 Plausibility check - suggestion for resource: ARRIVE Guidelines 2.0; text that can be used: Although the term plausibility check is not explicitly mentioned in the ARRIVE 2.0 guidelines, several of its key items promote similar quality practices. For example, sections on Study Design, Statistical Methods, and Interpretation encourage researchers to justify their choices, report results in context, and ensure that analyses are appropriate. These align closely with the goals of a plausibility check—namely, verifying whether assumptions, methods, and outcomes are biologically and methodologically credible.

2.2.3 Documentation of the experiment and deviations - link to 3.1.2.2 doesn't work; link to study protocol doesn't work

===overall to do's===

- proof reading sections: look for errors, outdated information, broken links, plausibility?

- QUALITY (evaluation) aspects (criteria, checks, checklists, how-to) should be in focus and a priority..to generate products and data with secured high quality

1.3.2 Sources of pressure and bias-producing communication of pressure

2025-06-08T15:01:02Z

Bjoerngerlach: /* C. Resources */

== A. Background & Definitions ==

The EQIPD Quality System relies on, and should become part of, the overall organizational quality culture.

An essential element of this quality culture is awareness of, and control over, pressures that may lead to unacceptable practices or introduce bias into the planning, conduct, or reporting of research.

[[4.1.1 Risk assessment]] is one of the core components of the EQIPD Quality System. It highlights the importance of gathering all relevant information before deciding to accept a particular risk.

The likelihood of poor practices or biased research outcomes is often closely linked to the pressures researchers are exposed to.

== B. Guidance & Expectations ==

EQIPD does not require any formal documentation or detailed analysis for this item. However, it is strongly recommended that the Process Owner reviews potential sources of pressure that may introduce bias and evaluates whether adequate safeguards are in place (such as training or rigorous study design).

Examples of such pressures may include:

* '''Financial:''' for instance, when financial incentives are directly or indirectly tied to research outcomes
* '''Business-related:''' such as when a research unit’s success depends on the performance of a single method or technology
* '''Personal:''' for example, if members of a research unit are not treated equally or fairly

The Process Owner is also expected to make every effort to avoid placing unnecessary pressure on team members. This includes avoiding the communication of overly optimistic expectations that could create incentives for biased or selective results.

'''PLEASE DO NOT FORGET'''

* To discuss potential sources of pressure and appropriate protective measures with team members

== C. Resources ==
* Competitive pressure in biomedical research [https://www.pnas.org/content/111/16/5773.long| Alberts et al., 2014]

----------------
back to [[Toolbox]]

Next item: [[1.3.3 Promotion criteria within a research unit]]

1.3.2 Sources of pressure and bias-producing communication of pressure

2025-06-08T15:00:39Z

Bjoerngerlach: /* C. Resources */

== A. Background & Definitions ==

The EQIPD Quality System relies on, and should become part of, the overall organizational quality culture.

An essential element of this quality culture is awareness of, and control over, pressures that may lead to unacceptable practices or introduce bias into the planning, conduct, or reporting of research.

[[4.1.1 Risk assessment]] is one of the core components of the EQIPD Quality System. It highlights the importance of gathering all relevant information before deciding to accept a particular risk.

The likelihood of poor practices or biased research outcomes is often closely linked to the pressures researchers are exposed to.

== B. Guidance & Expectations ==

EQIPD does not require any formal documentation or detailed analysis for this item. However, it is strongly recommended that the Process Owner reviews potential sources of pressure that may introduce bias and evaluates whether adequate safeguards are in place (such as training or rigorous study design).

Examples of such pressures may include:

* '''Financial:''' for instance, when financial incentives are directly or indirectly tied to research outcomes
* '''Business-related:''' such as when a research unit’s success depends on the performance of a single method or technology
* '''Personal:''' for example, if members of a research unit are not treated equally or fairly

The Process Owner is also expected to make every effort to avoid placing unnecessary pressure on team members. This includes avoiding the communication of overly optimistic expectations that could create incentives for biased or selective results.

'''PLEASE DO NOT FORGET'''

* To discuss potential sources of pressure and appropriate protective measures with team members

== C. Resources ==
* Competitive pressure in biomedical research [https://www.pnas.org/content/111/16/5773.long|Alberts et al., 2014]

----------------
back to [[Toolbox]]

Next item: [[1.3.3 Promotion criteria within a research unit]]

1.3.2 Sources of pressure and bias-producing communication of pressure

2025-06-08T14:58:53Z

Bjoerngerlach: /* B. Guidance & Expectations */

== A. Background & Definitions ==

The EQIPD Quality System relies on, and should become part of, the overall organizational quality culture.

An essential element of this quality culture is awareness of, and control over, pressures that may lead to unacceptable practices or introduce bias into the planning, conduct, or reporting of research.

[[4.1.1 Risk assessment]] is one of the core components of the EQIPD Quality System. It highlights the importance of gathering all relevant information before deciding to accept a particular risk.

The likelihood of poor practices or biased research outcomes is often closely linked to the pressures researchers are exposed to.

== B. Guidance & Expectations ==

EQIPD does not require any formal documentation or detailed analysis for this item. However, it is strongly recommended that the Process Owner reviews potential sources of pressure that may introduce bias and evaluates whether adequate safeguards are in place (such as training or rigorous study design).

Examples of such pressures may include:

* '''Financial:''' for instance, when financial incentives are directly or indirectly tied to research outcomes
* '''Business-related:''' such as when a research unit’s success depends on the performance of a single method or technology
* '''Personal:''' for example, if members of a research unit are not treated equally or fairly

The Process Owner is also expected to make every effort to avoid placing unnecessary pressure on team members. This includes avoiding the communication of overly optimistic expectations that could create incentives for biased or selective results.

'''PLEASE DO NOT FORGET'''

* To discuss potential sources of pressure and appropriate protective measures with team members

== C. Resources ==
* Competitive pressure in biomedical research [https://www.pnas.org/content/111/16/5773.long]

----------------
back to [[Toolbox]]

Next item: [[1.3.3 Promotion criteria within a research unit]]

1.3.2 Sources of pressure and bias-producing communication of pressure

2025-06-08T14:57:45Z

Bjoerngerlach:

== A. Background & Definitions ==

The EQIPD Quality System relies on, and should become part of, the overall organizational quality culture.

An essential element of this quality culture is awareness of, and control over, pressures that may lead to unacceptable practices or introduce bias into the planning, conduct, or reporting of research.

[[4.1.1 Risk assessment]] is one of the core components of the EQIPD Quality System. It highlights the importance of gathering all relevant information before deciding to accept a particular risk.

The likelihood of poor practices or biased research outcomes is often closely linked to the pressures researchers are exposed to.

== B. Guidance & Expectations ==

EQIPD does not require any formal documentation or detailed analysis for this item. However, it is strongly recommended that the Process Owner reviews potential sources of pressure that may introduce bias and evaluates whether adequate safeguards are in place (such as training or rigorous study design).

Examples of such pressures may include:

* **Financial:** for instance, when financial incentives are directly or indirectly tied to research outcomes
* **Business-related:** such as when a research unit’s success depends on the performance of a single method or technology
* **Personal:** for example, if members of a research unit are not treated equally or fairly

The Process Owner is also expected to make every effort to avoid placing unnecessary pressure on team members. This includes avoiding the communication of overly optimistic expectations that could create incentives for biased or selective results.

'''PLEASE DO NOT FORGET'''

* To discuss potential sources of pressure and appropriate protective measures with team members

== C. Resources ==
* Competitive pressure in biomedical research [https://www.pnas.org/content/111/16/5773.long]

----------------
back to [[Toolbox]]

Next item: [[1.3.3 Promotion criteria within a research unit]]

Talk:EQIPD Quality System

2025-06-08T14:54:37Z

Bjoerngerlach: /* General */

On this page we can collect ideas and errors within the entire Wiki.

===New pages needed===
* Sex differences in animal research

===Errors on the pages===
https://www.eda.nc3rs.org.uk/ - link doesn't work

===Dedicated working groups===
====General====
* Checking incorrect items:
** Sara: Section 2
** Björn: Section 1
*** To clarify: Does the mission statement and the template still make sense? E.g. is it useful? https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=U3bWIn
*** Any thoughts for resources for the page [[1.3.1 Transparency]]
***Error
** René: Section 3
* Checking missing pages
**Everyone when screening though the website, with René as a contact
* Find mechanisms to keep it up-to-date
**Tbd

====Specific task forces formed already:====
* Quality culture and improvmenent
** Arnoud, Sandrine, Jonathan
* Antibodies and validation
** Harv, Marija
* Creating page on sex differences
** Christina, Vootele

====Orphans-Do not link to any other EQIPD pages:====
1.4.3.2 Quality in collaborative research - https://eqipd-toolbox.paasp.net/wiki/1.4.3.2_Quality_in_collaborative_research

EQIPD - https://eqipd-toolbox.paasp.net/wiki/EQIPD

EQIPD for Core Facilities - https://eqipd-toolbox.paasp.net/wiki/EQIPD_for_Core_Facilities

Examples of implementing a unique study ID - https://eqipd-toolbox.paasp.net/wiki/Examples_of_implementing_a_unique_study_ID

Experimental Record - https://eqipd-toolbox.paasp.net/wiki/Experimental_Record

Hauptseite - https://eqipd-toolbox.paasp.net/wiki/Hauptseite

Performance Standards - https://eqipd-toolbox.paasp.net/wiki/Performance_Standards

Spot checks - https://eqipd-toolbox.paasp.net/wiki/Spot_checks

Why quality matters - https://eqipd-toolbox.paasp.net/wiki/Why_quality_matters

====Glossary: might need extension====
SABV

FAIR (data)

====Pages needed ====
- Questionable Research Practices

- CoARA process, research evaluation

- protocols (reusable, reproducible, management)

- AI in research quality?

- feature Marten Kas as EQIPD use case examples

- data (format) community standards

- FAIR data, data repositories, DMP

- more reporting guidelines/recommendations, like RIVER (not just minimum standards)

====Pages with "to be added sections" ====

''(needs priorisation before adding content)''

1.3.1 Transparency

1.3.3 Promotion criteria within a research unit

1.4.1 Research ethics

1.4.2 Adherence to legal and regulatory considerations

1.4.2.7 Animal care and use

1.4.2.8 Human data protection

1.4.3.4 Academia-academia: Research as collaboration

1.5.2 Roles and responsibilities of involved personnel and organization

1.5.2.1 Organigram

1.5.2.2 Management

1.5.2.4 Principal investigators and study directors

1.5.2.5 Research team

1.5.2.6 Supporting team

1.5.2.7 Quality professionals

1.5.3 Management of resources

1.5.3.1 Personnel

1.5.3.2 Facilities

1.5.3.3 Laboratory and experimental equipment used for measurement

1.5.3.4 Electronic information system

1.5.3.5 Organization-specific know how

1.5.3.6 Documentation requirement for sample and material

1.5.3.7 Retained personnel records

1.5.4.1 Independence of internal compliance assessment

1.5.4.2 Internal assessment of the organizations' quality professionals

1.5.5 Sustainability

2.1.6 Sample size and power analysis

2.1.10 Plausibility check => resource: e.g. arrive guidelines + link with risk analysis?

2.2.2 Use of template for (manual) data recording

2.3.1.1 Converting non-electronic information into an electronic form

2.3.2 Primary analysis and evaluation of raw data

2.4 Reporting

2.4.1 Non-public reporting

3.2.1 General guidance on training

3.5.1 Animal and non-animal method and assay qualification

4.1.3 External assessment

4.2.1 Installation of solutions, actions and mitigation strategies

4.3.1.2 Deleting items

==== Dead links ====
2.1.11 Preregistration: https://openscience.bmj.com/

==== training resources needed to be embedded ====
https://go-eqipd.org/about-eqipd/webinar-2023/

https://go-eqipd.org/resources/eqipd-e-learning/

https://research.columbia.edu/ReaDI-program

find more more online templates

===proof reading===
- 2.1.11 Preregistration: example on timeline would be useful (to convince people to do it)

- 2.1.1: 2 pages with same content but different name: study protocol; study experimental plan

- 2.1 Plausibility check - suggestion for resource: ARRIVE Guidelines 2.0; text that can be used: Although the term plausibility check is not explicitly mentioned in the ARRIVE 2.0 guidelines, several of its key items promote similar quality practices. For example, sections on Study Design, Statistical Methods, and Interpretation encourage researchers to justify their choices, report results in context, and ensure that analyses are appropriate. These align closely with the goals of a plausibility check—namely, verifying whether assumptions, methods, and outcomes are biologically and methodologically credible.

2.2.3 Documentation of the experiment and deviations - link to 3.1.2.2 doesn't work; link to study protocol doesn't work

===overall to do's===

- proof reading sections: look for errors, outdated information, broken links, plausibility?

- QUALITY (evaluation) aspects (criteria, checks, checklists, how-to) should be in focus and a priority..to generate products and data with secured high quality

Talk:EQIPD Quality System

2025-06-08T14:54:24Z

Bjoerngerlach: /* General */

On this page we can collect ideas and errors within the entire Wiki.

===New pages needed===
* Sex differences in animal research

===Errors on the pages===
https://www.eda.nc3rs.org.uk/ - link doesn't work

===Dedicated working groups===
====General====
* Checking incorrect items:
** Sara: Section 2
** Björn: Section 1
*** To clarify: Does the mission statement and the template still make sense? E.g. is it useful? https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=U3bWIn
*** Any thoughts for resources for the page [1.3.1 Transparency]]
***Error
** René: Section 3
* Checking missing pages
**Everyone when screening though the website, with René as a contact
* Find mechanisms to keep it up-to-date
**Tbd

====Specific task forces formed already:====
* Quality culture and improvmenent
** Arnoud, Sandrine, Jonathan
* Antibodies and validation
** Harv, Marija
* Creating page on sex differences
** Christina, Vootele

====Orphans-Do not link to any other EQIPD pages:====
1.4.3.2 Quality in collaborative research - https://eqipd-toolbox.paasp.net/wiki/1.4.3.2_Quality_in_collaborative_research

EQIPD - https://eqipd-toolbox.paasp.net/wiki/EQIPD

EQIPD for Core Facilities - https://eqipd-toolbox.paasp.net/wiki/EQIPD_for_Core_Facilities

Examples of implementing a unique study ID - https://eqipd-toolbox.paasp.net/wiki/Examples_of_implementing_a_unique_study_ID

Experimental Record - https://eqipd-toolbox.paasp.net/wiki/Experimental_Record

Hauptseite - https://eqipd-toolbox.paasp.net/wiki/Hauptseite

Performance Standards - https://eqipd-toolbox.paasp.net/wiki/Performance_Standards

Spot checks - https://eqipd-toolbox.paasp.net/wiki/Spot_checks

Why quality matters - https://eqipd-toolbox.paasp.net/wiki/Why_quality_matters

====Glossary: might need extension====
SABV

FAIR (data)

====Pages needed ====
- Questionable Research Practices

- CoARA process, research evaluation

- protocols (reusable, reproducible, management)

- AI in research quality?

- feature Marten Kas as EQIPD use case examples

- data (format) community standards

- FAIR data, data repositories, DMP

- more reporting guidelines/recommendations, like RIVER (not just minimum standards)

====Pages with "to be added sections" ====

''(needs priorisation before adding content)''

1.3.1 Transparency

1.3.3 Promotion criteria within a research unit

1.4.1 Research ethics

1.4.2 Adherence to legal and regulatory considerations

1.4.2.7 Animal care and use

1.4.2.8 Human data protection

1.4.3.4 Academia-academia: Research as collaboration

1.5.2 Roles and responsibilities of involved personnel and organization

1.5.2.1 Organigram

1.5.2.2 Management

1.5.2.4 Principal investigators and study directors

1.5.2.5 Research team

1.5.2.6 Supporting team

1.5.2.7 Quality professionals

1.5.3 Management of resources

1.5.3.1 Personnel

1.5.3.2 Facilities

1.5.3.3 Laboratory and experimental equipment used for measurement

1.5.3.4 Electronic information system

1.5.3.5 Organization-specific know how

1.5.3.6 Documentation requirement for sample and material

1.5.3.7 Retained personnel records

1.5.4.1 Independence of internal compliance assessment

1.5.4.2 Internal assessment of the organizations' quality professionals

1.5.5 Sustainability

2.1.6 Sample size and power analysis

2.1.10 Plausibility check => resource: e.g. arrive guidelines + link with risk analysis?

2.2.2 Use of template for (manual) data recording

2.3.1.1 Converting non-electronic information into an electronic form

2.3.2 Primary analysis and evaluation of raw data

2.4 Reporting

2.4.1 Non-public reporting

3.2.1 General guidance on training

3.5.1 Animal and non-animal method and assay qualification

4.1.3 External assessment

4.2.1 Installation of solutions, actions and mitigation strategies

4.3.1.2 Deleting items

==== Dead links ====
2.1.11 Preregistration: https://openscience.bmj.com/

==== training resources needed to be embedded ====
https://go-eqipd.org/about-eqipd/webinar-2023/

https://go-eqipd.org/resources/eqipd-e-learning/

https://research.columbia.edu/ReaDI-program

find more more online templates

===proof reading===
- 2.1.11 Preregistration: example on timeline would be useful (to convince people to do it)

- 2.1.1: 2 pages with same content but different name: study protocol; study experimental plan

- 2.1 Plausibility check - suggestion for resource: ARRIVE Guidelines 2.0; text that can be used: Although the term plausibility check is not explicitly mentioned in the ARRIVE 2.0 guidelines, several of its key items promote similar quality practices. For example, sections on Study Design, Statistical Methods, and Interpretation encourage researchers to justify their choices, report results in context, and ensure that analyses are appropriate. These align closely with the goals of a plausibility check—namely, verifying whether assumptions, methods, and outcomes are biologically and methodologically credible.

2.2.3 Documentation of the experiment and deviations - link to 3.1.2.2 doesn't work; link to study protocol doesn't work

===overall to do's===

- proof reading sections: look for errors, outdated information, broken links, plausibility?

- QUALITY (evaluation) aspects (criteria, checks, checklists, how-to) should be in focus and a priority..to generate products and data with secured high quality

1.3.1 Transparency

2025-06-08T14:53:16Z

Bjoerngerlach: /* C. Resources */

== A. Background & Definitions ==

The EQIPD Quality System relies on, and should become part of, the overall organizational quality culture.

Research quality is not just about following formal rules or regulations for how data is collected, processed, and reported. It is also about cultivating habits and attitudes that support integrity and transparency throughout the research process.

Many initiatives aimed at increasing the value of research data focus on enhancing transparency in various research-related activities — from improving openness within the research organization to clearly disclosing conflicts of interest when communicating with external stakeholders.

== B. Guidance & Expectations ==

EQIPD does not require any formal documentation or in-depth analysis for this item. However, it is strongly encouraged that the Process Owner — and the organization more broadly — promote transparency at all levels.

Examples of transparent practices include, but are not limited to:

* Members of a research unit being aware of who is responsible for what. For example:
** maintaining a shared list or inventory of ongoing projects and experiments
** ensuring clarity about individual roles in projects, experiments, and upcoming publications
* Awareness among team members of any potential conflicts of interest
* Clear communication within the team about decisions and the criteria behind them, for example:
** how decisions are made regarding publications, conference participation, or whether to advance or terminate a project

== C. Resources ==
* The [https://allea.org/code-of-conduct/ European Code of Conduct for Research Integrity] provides guiding principles for responsible research conduct, including transparency and accountability, and is a valuable reference when establishing a research culture that aligns with the EQIPD QS.

----------------
back to [[Toolbox]]

Next item: [[1.3.2 Sources of pressure and bias-producing communication of pressure]]

1.3.1 Transparency

2025-06-08T14:53:06Z

Bjoerngerlach: /* C. Resources */

== A. Background & Definitions ==

The EQIPD Quality System relies on, and should become part of, the overall organizational quality culture.

Research quality is not just about following formal rules or regulations for how data is collected, processed, and reported. It is also about cultivating habits and attitudes that support integrity and transparency throughout the research process.

Many initiatives aimed at increasing the value of research data focus on enhancing transparency in various research-related activities — from improving openness within the research organization to clearly disclosing conflicts of interest when communicating with external stakeholders.

== B. Guidance & Expectations ==

EQIPD does not require any formal documentation or in-depth analysis for this item. However, it is strongly encouraged that the Process Owner — and the organization more broadly — promote transparency at all levels.

Examples of transparent practices include, but are not limited to:

* Members of a research unit being aware of who is responsible for what. For example:
** maintaining a shared list or inventory of ongoing projects and experiments
** ensuring clarity about individual roles in projects, experiments, and upcoming publications
* Awareness among team members of any potential conflicts of interest
* Clear communication within the team about decisions and the criteria behind them, for example:
** how decisions are made regarding publications, conference participation, or whether to advance or terminate a project

== C. Resources ==
* * The [https://allea.org/code-of-conduct/ European Code of Conduct for Research Integrity] provides guiding principles for responsible research conduct, including transparency and accountability, and is a valuable reference when establishing a research culture that aligns with the EQIPD QS.

----------------
back to [[Toolbox]]

Next item: [[1.3.2 Sources of pressure and bias-producing communication of pressure]]

1.3.1 Transparency

2025-06-08T14:52:46Z

Bjoerngerlach: /* C. Resources */

== A. Background & Definitions ==

The EQIPD Quality System relies on, and should become part of, the overall organizational quality culture.

Research quality is not just about following formal rules or regulations for how data is collected, processed, and reported. It is also about cultivating habits and attitudes that support integrity and transparency throughout the research process.

Many initiatives aimed at increasing the value of research data focus on enhancing transparency in various research-related activities — from improving openness within the research organization to clearly disclosing conflicts of interest when communicating with external stakeholders.

== B. Guidance & Expectations ==

EQIPD does not require any formal documentation or in-depth analysis for this item. However, it is strongly encouraged that the Process Owner — and the organization more broadly — promote transparency at all levels.

Examples of transparent practices include, but are not limited to:

* Members of a research unit being aware of who is responsible for what. For example:
** maintaining a shared list or inventory of ongoing projects and experiments
** ensuring clarity about individual roles in projects, experiments, and upcoming publications
* Awareness among team members of any potential conflicts of interest
* Clear communication within the team about decisions and the criteria behind them, for example:
** how decisions are made regarding publications, conference participation, or whether to advance or terminate a project

== C. Resources ==
* * The [[https://allea.org/code-of-conduct/ European Code of Conduct for Research Integrity]] provides guiding principles for responsible research conduct, including transparency and accountability, and is a valuable reference when establishing a research culture that aligns with the EQIPD QS.

----------------
back to [[Toolbox]]

Next item: [[1.3.2 Sources of pressure and bias-producing communication of pressure]]

1.3.1 Transparency

2025-06-08T14:45:07Z

Bjoerngerlach: /* C. Resources */

== A. Background & Definitions ==

The EQIPD Quality System relies on, and should become part of, the overall organizational quality culture.

Research quality is not just about following formal rules or regulations for how data is collected, processed, and reported. It is also about cultivating habits and attitudes that support integrity and transparency throughout the research process.

Many initiatives aimed at increasing the value of research data focus on enhancing transparency in various research-related activities — from improving openness within the research organization to clearly disclosing conflicts of interest when communicating with external stakeholders.

== B. Guidance & Expectations ==

EQIPD does not require any formal documentation or in-depth analysis for this item. However, it is strongly encouraged that the Process Owner — and the organization more broadly — promote transparency at all levels.

Examples of transparent practices include, but are not limited to:

* Members of a research unit being aware of who is responsible for what. For example:
** maintaining a shared list or inventory of ongoing projects and experiments
** ensuring clarity about individual roles in projects, experiments, and upcoming publications
* Awareness among team members of any potential conflicts of interest
* Clear communication within the team about decisions and the criteria behind them, for example:
** how decisions are made regarding publications, conference participation, or whether to advance or terminate a project

== C. Resources ==
* * The [[https://allea.org/code-of-conduct/|ALLEA European Code of Conduct for Research Integrity]] provides guiding principles for responsible research conduct, including transparency and accountability, and is a valuable reference when establishing a research culture that aligns with the EQIPD QS.

----------------
back to [[Toolbox]]

Next item: [[1.3.2 Sources of pressure and bias-producing communication of pressure]]

1.3.1 Transparency

2025-06-08T14:38:35Z

Bjoerngerlach:

== A. Background & Definitions ==

The EQIPD Quality System relies on, and should become part of, the overall organizational quality culture.

Research quality is not just about following formal rules or regulations for how data is collected, processed, and reported. It is also about cultivating habits and attitudes that support integrity and transparency throughout the research process.

Many initiatives aimed at increasing the value of research data focus on enhancing transparency in various research-related activities — from improving openness within the research organization to clearly disclosing conflicts of interest when communicating with external stakeholders.

== B. Guidance & Expectations ==

EQIPD does not require any formal documentation or in-depth analysis for this item. However, it is strongly encouraged that the Process Owner — and the organization more broadly — promote transparency at all levels.

Examples of transparent practices include, but are not limited to:

* Members of a research unit being aware of who is responsible for what. For example:
** maintaining a shared list or inventory of ongoing projects and experiments
** ensuring clarity about individual roles in projects, experiments, and upcoming publications
* Awareness among team members of any potential conflicts of interest
* Clear communication within the team about decisions and the criteria behind them, for example:
** how decisions are made regarding publications, conference participation, or whether to advance or terminate a project

== C. Resources ==
To be added

----------------
back to [[Toolbox]]

Next item: [[1.3.2 Sources of pressure and bias-producing communication of pressure]]

Talk:1.2 Scope

2025-06-08T14:34:09Z

Bjoerngerlach: Created page with "I believe it could make sense to include examples here in a specific box: * background and example of an organigram * the table/matrix from the communication plan"

I believe it could make sense to include examples here in a specific box:
* background and example of an organigram
* the table/matrix from the communication plan

1.2 Scope

2025-06-08T14:31:20Z

Bjoerngerlach: /* B. Guidance & Expectations */

== A. Background & Definitions ==
This item addresses Core Requirement 2 of the EQIPD Quality System (QS): "A communication process must be in place."
It is considered essential for successful implementation.

The EQIPD QS can only function effectively in a research environment where all team members have clearly defined roles and responsibilities, and where communication is well planned and maintained.

Many promising initiatives or project proposals start off well but lose momentum due to a lack of consistent communication and follow-up. To avoid this, it is important to:
* Clearly define the research unit in which the EQIPD QS will be applied. This could be a laboratory, a department, or a part of an organization.
* Identify which colleagues need to be informed about the quality system and who will be directly involved in its implementation.
* Set up a communication plan with regular meetings and clear responsibilities for information sharing.
* Ensure that communication allows for feedback, so that both existing and newly introduced practices can be continuously improved.

An effective communication process helps keep the team aligned, encourages engagement, and supports a sustainable integration of the EQIPD Quality System into everyday research.

== B. Guidance & Expectations ==

As one of the first steps in implementing the EQIPD QS, research units should set up a so-called Communication Plan that includes four main components:

# A description of the research unit (e.g., a lab, a group, or a department supervised or managed by a Process Owner).
# Identification of those within the research unit who will work together with the Process Owner to implement the EQIPD QS and develop the various elements that will be part of the system.
# A description of all other stakeholders who may need to be informed about the progress in implementing and maintaining the EQIPD QS:
## within the research unit
## outside the research unit (e.g., colleagues in other research units, support functions, management, collaborators, authorities, or the public)
# A description of how communication will take place with each of the groups listed above:
## methods of communication such as email, intranet, dedicated team meetings (for those directly involved in implementing the QS), and regular team meetings (e.g., weekly lab meetings)
## frequency of communication and meetings (e.g., weekly, biweekly, based on predefined milestones, etc.)
## indication of whether communication will be led by the Process Owner or by someone appointed by the Process Owner

It is also recommended that, during the initial meeting of the research unit where the intention to implement the EQIPD QS is introduced, the Process Owner facilitates a discussion about the relevance of quality for the unit's mission and identifies what may be at risk if quality is not maintained.
The outcomes of this discussion can be summarized as a quality policy, a manifesto, or any other format that can be stored and referred to later (see section 1.1 ''Mission'' for guidance and a sample template).

For a more detailed description of roles and responsibilities, please refer to section [[1.5.2 Roles and responsibilities of involved personnel and organization]] of the [[Toolbox]].

'''PLEASE DO NOT FORGET'''

* To consider including this topic in a training program for new employees or in refresher training, if appropriate.
* To check whether feedback channels are in place so that colleagues can identify, record, and report errors or critical incidents related to this topic, if applicable.

== C. Resources ==
* Template to create a communicate plan based on the above guidance - [https://paasp.sharepoint.com/:w:/s/EQIPD/ERyfFP_pBytDiEfqCutDAJQBFbaGQEx3G1pyOmDl50o_LQ?e=f5POo0 1.2 Communication Plan.docx]
* Responsibility Assignment Matrix (e.g. Responsible, Accountable, Consulted, and Informed) - [https://en.wikipedia.org/wiki/Responsibility_assignment_matrix#cite_note-slaguide-4 Wikipedia]

----------------
back to [[Toolbox]]

Next item: [[1.3.1 Transparency]]

1.2 Scope

2025-06-08T14:25:05Z

Bjoerngerlach:

== A. Background & Definitions ==
This item addresses Core Requirement 2 of the EQIPD Quality System (QS): "A communication process must be in place."
It is considered essential for successful implementation.

The EQIPD QS can only function effectively in a research environment where all team members have clearly defined roles and responsibilities, and where communication is well planned and maintained.

Many promising initiatives or project proposals start off well but lose momentum due to a lack of consistent communication and follow-up. To avoid this, it is important to:
* Clearly define the research unit in which the EQIPD QS will be applied. This could be a laboratory, a department, or a part of an organization.
* Identify which colleagues need to be informed about the quality system and who will be directly involved in its implementation.
* Set up a communication plan with regular meetings and clear responsibilities for information sharing.
* Ensure that communication allows for feedback, so that both existing and newly introduced practices can be continuously improved.

An effective communication process helps keep the team aligned, encourages engagement, and supports a sustainable integration of the EQIPD Quality System into everyday research.

== B. Guidance & Expectations ==
As one of the first steps of implementing the EQIPD QS, research units set up a so called Communication Plan that has four main parts:
# description of a research unit (e.g. a lab, a group or a department which is supervised or managed by a Process Owner)
# identification of those within the research unit who will work together with the Process Owner to implement EQIPD QS and develop various elements that will belong to the QS
# description of all other stakeholders who may be informed about the progress with implementing and maintaining the EQIPD QS:
## within the research unit
## outside the research unit (e.g. colleagues in other research units, support functions, management, collaborators, authorities, public)
# description of how the communication will take place for each of the groups defined above:
## email, intranet, dedicated team meetings (e.g. for those members of the research uinit who are involved in implementiung the QS) and conventional team meetings (e.g. weekly lab meetings)
## intervals of communication and meetings (e.g. weekly, biweekly, per predefined milestones, etc.)
## communication sent by a Process Owner or someone else appointed by the Process Owner

It is also advised that, during the first meeting of the research unit when the intention to implement the EQIPD QS is introduced, the Process Owner discusses with the team relevance of quality for the mission of research unit and identifies what specifically is at stake if proper quality is not maintained. Results of this discussion may be summarized in a form a quality policy or a manifesto or any other form that can be stored and referred to (see section 1.1 Mission for guidance and example of template).

For a more detailed description of Roles and Responsibilites, please refer to section [[1.5.2 Roles and responsibilities of involved personnel and organization]] of the [[Toolbox]].

'''PLEASE DO NOT FORGET'''

To consider adding this subject to a training program for new employees or refresher training (if appropriate)
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)

== C. Resources ==
* Template to create a communicate plan based on the above guidance - [https://paasp.sharepoint.com/:w:/s/EQIPD/ERyfFP_pBytDiEfqCutDAJQBFbaGQEx3G1pyOmDl50o_LQ?e=f5POo0 1.2 Communication Plan.docx]
* Responsibility Assignment Matrix (e.g. Responsible, Accountable, Consulted, and Informed) - [https://en.wikipedia.org/wiki/Responsibility_assignment_matrix#cite_note-slaguide-4 Wikipedia]

----------------
back to [[Toolbox]]

Next item: [[1.3.1 Transparency]]

Talk:EQIPD Quality System

2025-06-08T13:16:40Z

Bjoerngerlach: /* General */

On this page we can collect ideas and errors within the entire Wiki.

===New pages needed===
* Sex differences in animal research

===Errors on the pages===
https://www.eda.nc3rs.org.uk/ - link doesn't work

===Dedicated working groups===
====General====
* Checking incorrect items:
** Sara: Section 2
** Björn: Section 1
*** To clarify: Does the mission statement and the template still make sense? E.g. is it useful? https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=U3bWIn
***Error
** René: Section 3
* Checking missing pages
**Everyone when screening though the website, with René as a contact
* Find mechanisms to keep it up-to-date
**Tbd

====Specific task forces formed already:====
* Quality culture and improvmenent
** Arnoud, Sandrine, Jonathan
* Antibodies and validation
** Harv, Marija
* Creating page on sex differences
** Christina, Vootele

====Orphans-Do not link to any other EQIPD pages:====
1.4.3.2 Quality in collaborative research - https://eqipd-toolbox.paasp.net/wiki/1.4.3.2_Quality_in_collaborative_research

EQIPD - https://eqipd-toolbox.paasp.net/wiki/EQIPD

EQIPD for Core Facilities - https://eqipd-toolbox.paasp.net/wiki/EQIPD_for_Core_Facilities

Examples of implementing a unique study ID - https://eqipd-toolbox.paasp.net/wiki/Examples_of_implementing_a_unique_study_ID

Experimental Record - https://eqipd-toolbox.paasp.net/wiki/Experimental_Record

Hauptseite - https://eqipd-toolbox.paasp.net/wiki/Hauptseite

Performance Standards - https://eqipd-toolbox.paasp.net/wiki/Performance_Standards

Spot checks - https://eqipd-toolbox.paasp.net/wiki/Spot_checks

Why quality matters - https://eqipd-toolbox.paasp.net/wiki/Why_quality_matters

====Glossary: might need extension====
SABV

FAIR (data)

====Pages needed ====
- Questionable Research Practices

- CoARA process, research evaluation

- protocols (reusable, reproducible, management)

- AI in research quality?

- feature Marten Kas as EQIPD use case examples

- data (format) community standards

- FAIR data, data repositories, DMP

- more reporting guidelines/recommendations, like RIVER (not just minimum standards)

====Pages with "to be added sections" ====

''(needs priorisation before adding content)''

1.3.1 Transparency

1.3.3 Promotion criteria within a research unit

1.4.1 Research ethics

1.4.2 Adherence to legal and regulatory considerations

1.4.2.7 Animal care and use

1.4.2.8 Human data protection

1.4.3.4 Academia-academia: Research as collaboration

1.5.2 Roles and responsibilities of involved personnel and organization

1.5.2.1 Organigram

1.5.2.2 Management

1.5.2.4 Principal investigators and study directors

1.5.2.5 Research team

1.5.2.6 Supporting team

1.5.2.7 Quality professionals

1.5.3 Management of resources

1.5.3.1 Personnel

1.5.3.2 Facilities

1.5.3.3 Laboratory and experimental equipment used for measurement

1.5.3.4 Electronic information system

1.5.3.5 Organization-specific know how

1.5.3.6 Documentation requirement for sample and material

1.5.3.7 Retained personnel records

1.5.4.1 Independence of internal compliance assessment

1.5.4.2 Internal assessment of the organizations' quality professionals

1.5.5 Sustainability

2.1.6 Sample size and power analysis

2.1.10 Plausibility check => resource: e.g. arrive guidelines + link with risk analysis?

2.2.2 Use of template for (manual) data recording

2.3.1.1 Converting non-electronic information into an electronic form

2.3.2 Primary analysis and evaluation of raw data

2.4 Reporting

2.4.1 Non-public reporting

3.2.1 General guidance on training

3.5.1 Animal and non-animal method and assay qualification

4.1.3 External assessment

4.2.1 Installation of solutions, actions and mitigation strategies

4.3.1.2 Deleting items

==== Dead links ====
2.1.11 Preregistration: https://openscience.bmj.com/

==== training resources needed to be embedded ====
https://go-eqipd.org/about-eqipd/webinar-2023/

https://go-eqipd.org/resources/eqipd-e-learning/

https://research.columbia.edu/ReaDI-program

find more more online templates

===proof reading===
- 2.1.11 Preregistration: example on timeline would be useful (to convince people to do it)

- 2.1.1: 2 pages with same content but different name: study protocol; study experimental plan

- 2.1 Plausibility check - suggestion for resource: ARRIVE Guidelines 2.0; text that can be used: Although the term plausibility check is not explicitly mentioned in the ARRIVE 2.0 guidelines, several of its key items promote similar quality practices. For example, sections on Study Design, Statistical Methods, and Interpretation encourage researchers to justify their choices, report results in context, and ensure that analyses are appropriate. These align closely with the goals of a plausibility check—namely, verifying whether assumptions, methods, and outcomes are biologically and methodologically credible.

2.2.3 Documentation of the experiment and deviations - link to 3.1.2.2 doesn't work; link to study protocol doesn't work

===overall to do's===

- proof reading sections: look for errors, outdated information, broken links, plausibility?

- QUALITY (evaluation) aspects (criteria, checks, checklists, how-to) should be in focus and a priority..to generate products and data with secured high quality

Talk:EQIPD Quality System

2025-06-08T13:16:09Z

Bjoerngerlach: /* General */

On this page we can collect ideas and errors within the entire Wiki.

===New pages needed===
* Sex differences in animal research

===Errors on the pages===
https://www.eda.nc3rs.org.uk/ - link doesn't work

===Dedicated working groups===
====General====
* Checking incorrect items:
** Sara: Section 2
** Björn: Section 1
*** To clarify: Does the mission statement and the template still make sense? https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=U3bWIn
***Error
** René: Section 3
* Checking missing pages
**Everyone when screening though the website, with René as a contact
* Find mechanisms to keep it up-to-date
**Tbd

====Specific task forces formed already:====
* Quality culture and improvmenent
** Arnoud, Sandrine, Jonathan
* Antibodies and validation
** Harv, Marija
* Creating page on sex differences
** Christina, Vootele

====Orphans-Do not link to any other EQIPD pages:====
1.4.3.2 Quality in collaborative research - https://eqipd-toolbox.paasp.net/wiki/1.4.3.2_Quality_in_collaborative_research

EQIPD - https://eqipd-toolbox.paasp.net/wiki/EQIPD

EQIPD for Core Facilities - https://eqipd-toolbox.paasp.net/wiki/EQIPD_for_Core_Facilities

Examples of implementing a unique study ID - https://eqipd-toolbox.paasp.net/wiki/Examples_of_implementing_a_unique_study_ID

Experimental Record - https://eqipd-toolbox.paasp.net/wiki/Experimental_Record

Hauptseite - https://eqipd-toolbox.paasp.net/wiki/Hauptseite

Performance Standards - https://eqipd-toolbox.paasp.net/wiki/Performance_Standards

Spot checks - https://eqipd-toolbox.paasp.net/wiki/Spot_checks

Why quality matters - https://eqipd-toolbox.paasp.net/wiki/Why_quality_matters

====Glossary: might need extension====
SABV

FAIR (data)

====Pages needed ====
- Questionable Research Practices

- CoARA process, research evaluation

- protocols (reusable, reproducible, management)

- AI in research quality?

- feature Marten Kas as EQIPD use case examples

- data (format) community standards

- FAIR data, data repositories, DMP

- more reporting guidelines/recommendations, like RIVER (not just minimum standards)

====Pages with "to be added sections" ====

''(needs priorisation before adding content)''

1.3.1 Transparency

1.3.3 Promotion criteria within a research unit

1.4.1 Research ethics

1.4.2 Adherence to legal and regulatory considerations

1.4.2.7 Animal care and use

1.4.2.8 Human data protection

1.4.3.4 Academia-academia: Research as collaboration

1.5.2 Roles and responsibilities of involved personnel and organization

1.5.2.1 Organigram

1.5.2.2 Management

1.5.2.4 Principal investigators and study directors

1.5.2.5 Research team

1.5.2.6 Supporting team

1.5.2.7 Quality professionals

1.5.3 Management of resources

1.5.3.1 Personnel

1.5.3.2 Facilities

1.5.3.3 Laboratory and experimental equipment used for measurement

1.5.3.4 Electronic information system

1.5.3.5 Organization-specific know how

1.5.3.6 Documentation requirement for sample and material

1.5.3.7 Retained personnel records

1.5.4.1 Independence of internal compliance assessment

1.5.4.2 Internal assessment of the organizations' quality professionals

1.5.5 Sustainability

2.1.6 Sample size and power analysis

2.1.10 Plausibility check => resource: e.g. arrive guidelines + link with risk analysis?

2.2.2 Use of template for (manual) data recording

2.3.1.1 Converting non-electronic information into an electronic form

2.3.2 Primary analysis and evaluation of raw data

2.4 Reporting

2.4.1 Non-public reporting

3.2.1 General guidance on training

3.5.1 Animal and non-animal method and assay qualification

4.1.3 External assessment

4.2.1 Installation of solutions, actions and mitigation strategies

4.3.1.2 Deleting items

==== Dead links ====
2.1.11 Preregistration: https://openscience.bmj.com/

==== training resources needed to be embedded ====
https://go-eqipd.org/about-eqipd/webinar-2023/

https://go-eqipd.org/resources/eqipd-e-learning/

https://research.columbia.edu/ReaDI-program

find more more online templates

===proof reading===
- 2.1.11 Preregistration: example on timeline would be useful (to convince people to do it)

- 2.1.1: 2 pages with same content but different name: study protocol; study experimental plan

- 2.1 Plausibility check - suggestion for resource: ARRIVE Guidelines 2.0; text that can be used: Although the term plausibility check is not explicitly mentioned in the ARRIVE 2.0 guidelines, several of its key items promote similar quality practices. For example, sections on Study Design, Statistical Methods, and Interpretation encourage researchers to justify their choices, report results in context, and ensure that analyses are appropriate. These align closely with the goals of a plausibility check—namely, verifying whether assumptions, methods, and outcomes are biologically and methodologically credible.

2.2.3 Documentation of the experiment and deviations - link to 3.1.2.2 doesn't work; link to study protocol doesn't work

===overall to do's===

- proof reading sections: look for errors, outdated information, broken links, plausibility?

- QUALITY (evaluation) aspects (criteria, checks, checklists, how-to) should be in focus and a priority..to generate products and data with secured high quality

Talk:EQIPD Quality System

2025-06-08T13:15:53Z

Bjoerngerlach:

On this page we can collect ideas and errors within the entire Wiki.

===New pages needed===
* Sex differences in animal research

===Errors on the pages===
https://www.eda.nc3rs.org.uk/ - link doesn't work

===Dedicated working groups===
====General====
* Checking incorrect items:
** Sara: Section 2
** Björn: Section 1
*** To clarify: Does the mission statement and the template still sense? https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=U3bWIn
***Error
** René: Section 3
* Checking missing pages
**Everyone when screening though the website, with René as a contact
* Find mechanisms to keep it up-to-date
**Tbd

====Specific task forces formed already:====
* Quality culture and improvmenent
** Arnoud, Sandrine, Jonathan
* Antibodies and validation
** Harv, Marija
* Creating page on sex differences
** Christina, Vootele

====Orphans-Do not link to any other EQIPD pages:====
1.4.3.2 Quality in collaborative research - https://eqipd-toolbox.paasp.net/wiki/1.4.3.2_Quality_in_collaborative_research

EQIPD - https://eqipd-toolbox.paasp.net/wiki/EQIPD

EQIPD for Core Facilities - https://eqipd-toolbox.paasp.net/wiki/EQIPD_for_Core_Facilities

Examples of implementing a unique study ID - https://eqipd-toolbox.paasp.net/wiki/Examples_of_implementing_a_unique_study_ID

Experimental Record - https://eqipd-toolbox.paasp.net/wiki/Experimental_Record

Hauptseite - https://eqipd-toolbox.paasp.net/wiki/Hauptseite

Performance Standards - https://eqipd-toolbox.paasp.net/wiki/Performance_Standards

Spot checks - https://eqipd-toolbox.paasp.net/wiki/Spot_checks

Why quality matters - https://eqipd-toolbox.paasp.net/wiki/Why_quality_matters

====Glossary: might need extension====
SABV

FAIR (data)

====Pages needed ====
- Questionable Research Practices

- CoARA process, research evaluation

- protocols (reusable, reproducible, management)

- AI in research quality?

- feature Marten Kas as EQIPD use case examples

- data (format) community standards

- FAIR data, data repositories, DMP

- more reporting guidelines/recommendations, like RIVER (not just minimum standards)

====Pages with "to be added sections" ====

''(needs priorisation before adding content)''

1.3.1 Transparency

1.3.3 Promotion criteria within a research unit

1.4.1 Research ethics

1.4.2 Adherence to legal and regulatory considerations

1.4.2.7 Animal care and use

1.4.2.8 Human data protection

1.4.3.4 Academia-academia: Research as collaboration

1.5.2 Roles and responsibilities of involved personnel and organization

1.5.2.1 Organigram

1.5.2.2 Management

1.5.2.4 Principal investigators and study directors

1.5.2.5 Research team

1.5.2.6 Supporting team

1.5.2.7 Quality professionals

1.5.3 Management of resources

1.5.3.1 Personnel

1.5.3.2 Facilities

1.5.3.3 Laboratory and experimental equipment used for measurement

1.5.3.4 Electronic information system

1.5.3.5 Organization-specific know how

1.5.3.6 Documentation requirement for sample and material

1.5.3.7 Retained personnel records

1.5.4.1 Independence of internal compliance assessment

1.5.4.2 Internal assessment of the organizations' quality professionals

1.5.5 Sustainability

2.1.6 Sample size and power analysis

2.1.10 Plausibility check => resource: e.g. arrive guidelines + link with risk analysis?

2.2.2 Use of template for (manual) data recording

2.3.1.1 Converting non-electronic information into an electronic form

2.3.2 Primary analysis and evaluation of raw data

2.4 Reporting

2.4.1 Non-public reporting

3.2.1 General guidance on training

3.5.1 Animal and non-animal method and assay qualification

4.1.3 External assessment

4.2.1 Installation of solutions, actions and mitigation strategies

4.3.1.2 Deleting items

==== Dead links ====
2.1.11 Preregistration: https://openscience.bmj.com/

==== training resources needed to be embedded ====
https://go-eqipd.org/about-eqipd/webinar-2023/

https://go-eqipd.org/resources/eqipd-e-learning/

https://research.columbia.edu/ReaDI-program

find more more online templates

===proof reading===
- 2.1.11 Preregistration: example on timeline would be useful (to convince people to do it)

- 2.1.1: 2 pages with same content but different name: study protocol; study experimental plan

- 2.1 Plausibility check - suggestion for resource: ARRIVE Guidelines 2.0; text that can be used: Although the term plausibility check is not explicitly mentioned in the ARRIVE 2.0 guidelines, several of its key items promote similar quality practices. For example, sections on Study Design, Statistical Methods, and Interpretation encourage researchers to justify their choices, report results in context, and ensure that analyses are appropriate. These align closely with the goals of a plausibility check—namely, verifying whether assumptions, methods, and outcomes are biologically and methodologically credible.

2.2.3 Documentation of the experiment and deviations - link to 3.1.2.2 doesn't work; link to study protocol doesn't work

===overall to do's===

- proof reading sections: look for errors, outdated information, broken links, plausibility?

- QUALITY (evaluation) aspects (criteria, checks, checklists, how-to) should be in focus and a priority..to generate products and data with secured high quality

1.1 Mission

2025-06-08T13:12:23Z

Bjoerngerlach: /* B. Guidance & Expectations */

== A. Background & Definitions ==
According to the EQIPD Quality System's [[Implementation Strategy]], the first step taken by the [[1.5.2.3 Process owner]] is to prepare a statement explaining why they have chosen to implement a Quality System. It is expected that this decision will raise questions, not only from members of their own research unit but also from colleagues, collaborators, advisors, and other stakeholders. Therefore, the Process Owner should be ready to present a clear and compelling rationale that justifies the time and effort required to implement and maintain the Quality System.

In EQIPD terms, this statement is referred to as the mission statement which is a concise summary of why quality is important to the research unit. For more on how EQIPD defines quality, and for examples of how researchers from various sectors answer the question "why quality matters," please visit the [[EQIPD Quality System]] page.

EQIPD stresses that the effectiveness of the mission statement lies not in its length, but in its clarity and its ability to be understood and embraced by all members of the research unit.

This Toolbox item relates to one of the [[Core Requirements]] (Core Requirement 3 – "The research unit must have defined quality objectives").

== B. Guidance & Expectations ==
The mission statement may have the following three sections:

'''1. General statement about research data quality'''
* Define what quality means in your environment or context.
* Determine which quality aspects matter the most in your research, and which of them should be addressed in priority.
* State the goal of your research unit or parent organization with regard to research quality.

This statement should briefly describe your understanding of the term research quality. Since interpretations of research quality may vary depending on the organizational context, your focus might differ from that of others. For example, you may emphasize aspects such as data accurately representing the population, implementing measures to reduce bias, or providing adequate training.

Depending on your setting, it is advisable to approach this as a group exercise. In a CRO or biopharmaceutical company, it can be done together with leadership; in academia, it may involve all group members, including students.

'''2. What is at stake when research quality is not maintained'''
* Describe the potential consequences of non-compliance or inferior quality for your research unit and/or parent organization.
* Identify and highlight the biggest risks for non-compliance or inferior quality in your environment.
* List specific measures to be taken to address these risks.

Everyone in the research unit should understand and be aware of the consequences of not maintaining research quality. It must be clear what the potential impact can be if individual team members do not contribute to generating high-quality research data. This description should outline the key consequences—both for the research unit as a whole and for individual researchers. In this context, it is also advisable to identify measures that can help protect the research unit from negative outcomes.

'''3. Quality objectives'''
* Describe what exactly the Quality System shall improve in your research unit and/or parent organization.
* Define the specific, measurable and traceable goals that your research unit and/or parent organization wants to achieve with the EQIPD Quality System.
* Provide indicators for each objective and describe how you will use them.

A description of improvements may focus on the research process itself, such as experimental design, data analysis, or reporting. However, it can also include supporting processes like the storage of research materials, documentation of research data, or archiving practices. It is important to identify and describe the areas where your research unit has the most pressing needs. While defining measurable goals can be challenging, it is highly recommended, as such goals help assess the long-term effectiveness of the implemented measures.

'''PLEASE DO NOT FORGET'''
* To make sure that an incentive and award/reward structure is aligned with the quality objectives (please refer to items 1.3.1-1.3.4 for more information). The following questions serve as examples of how such an alignment can be tested:
** Do we encourage / support publication of "negative" or "null" results, i.e., findings that are different from those expected?
** Do we recognize / reward high-quality studies irrespective of the outcome ("positive" or "negative/null" results)?
** Do we encourage people to develop and implement risk-mitigating strategies and procedures? Do we recognize these efforts?
** Do we encourage people not to rush experiments but to invest time and resources in developing/using robust methods, optimizing experimental set-ups and to conduct experiments properly according to high-quality standards (even if it takes more time than initially allocated)?
** Do we review internal processes to make sure that there is no pressure to generate "positive results"? If there is such pressure, do we have processes to mitigate the risks?
** When hiring new people, do we consider the quality and rigor of the applicants’ research?

== C. Resources ==
Template to create a Mission Statement based on the above guidance - [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=U3bWIn]

----------------
back to [[Toolbox]]

Next item: [[1.2 Scope]]

1.1 Mission

2025-06-08T13:11:18Z

Bjoerngerlach: /* A. Background & Definitions */

== A. Background & Definitions ==
According to the EQIPD Quality System's [[Implementation Strategy]], the first step taken by the [[1.5.2.3 Process owner]] is to prepare a statement explaining why they have chosen to implement a Quality System. It is expected that this decision will raise questions, not only from members of their own research unit but also from colleagues, collaborators, advisors, and other stakeholders. Therefore, the Process Owner should be ready to present a clear and compelling rationale that justifies the time and effort required to implement and maintain the Quality System.

In EQIPD terms, this statement is referred to as the mission statement which is a concise summary of why quality is important to the research unit. For more on how EQIPD defines quality, and for examples of how researchers from various sectors answer the question "why quality matters," please visit the [[EQIPD Quality System]] page.

EQIPD stresses that the effectiveness of the mission statement lies not in its length, but in its clarity and its ability to be understood and embraced by all members of the research unit.

This Toolbox item relates to one of the [[Core Requirements]] (Core Requirement 3 – "The research unit must have defined quality objectives").

== B. Guidance & Expectations ==
The mission statement may have the following three sections:

'''1. General statement about research data quality'''
* Define what quality means in your environment or context.
* Determine which quality aspects matter the most in your research, and which of them should be addressed in priority.
* State the goal of your research unit or parent organization with regard to research quality.

This statement should briefly describe your understanding of the term research quality. Since interpretations of research quality may vary depending on the organizational context, your focus might differ from that of others. For example, you may emphasize aspects such as data accurately representing the population, implementing measures to reduce bias, or providing adequate training.

Depending on your setting, it is advisable to approach this as a group exercise. In a CRO or biopharmaceutical company, it can be done together with leadership; in academia, it may involve all group members, including students.

'''2. What is at stake when research quality is not maintained'''
* Describe the potential consequences of non-compliance or inferior quality for your research unit and/or parent organization.
* Identify and highlight the biggest risks for non-compliance or inferior quality in your environment.
* List specific measures to be taken to address these risks.

Everyone in the research unit should understand and be aware of the consequences of not maintaining research quality. It must be clear what the potential impact can be if individual team members do not contribute to generating high-quality research data. This description should outline the key consequences—both for the research unit as a whole and for individual researchers. In this context, it is also advisable to identify measures that can help protect the research unit from negative outcomes.

'''3. Quality objectives'''
* Describe what exactly the Quality System shall improve in your research unit and/or parent organization.
* Define the specific, measurable and traceable goals that your research unit and/or parent organization wants to achieve with the EQIPD Quality System.
* Provide indicators for each objective and describe how you will use them.

A description of improvements may focus on the research process itself—such as experimental design, data analysis, or reporting—but can also include supporting processes like the storage of research materials, documentation of research data, or archiving practices. It is important to identify and describe the areas where your research unit has the most pressing needs. While defining measurable goals can be challenging, it is highly recommended, as such goals help assess the long-term effectiveness of the implemented measures.

'''PLEASE DO NOT FORGET'''
* To make sure that an incentive and award/reward structure is aligned with the quality objectives (please refer to items 1.3.1-1.3.4 for more information). The following questions serve as examples of how such an alignment can be tested:
** Do we encourage / support publication of "negative" or "null" results, i.e., findings that are different from those expected?
** Do we recognize / reward high-quality studies irrespective of the outcome ("positive" or "negative/null" results)?
** Do we encourage people to develop and implement risk-mitigating strategies and procedures? Do we recognize these efforts?
** Do we encourage people not to rush experiments but to invest time and resources in developing/using robust methods, optimizing experimental set-ups and to conduct experiments properly according to high-quality standards (even if it takes more time than initially allocated)?
** Do we review internal processes to make sure that there is no pressure to generate "positive results"? If there is such pressure, do we have processes to mitigate the risks?
** When hiring new people, do we consider the quality and rigor of the applicants’ research?

== C. Resources ==
Template to create a Mission Statement based on the above guidance - [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=U3bWIn]

----------------
back to [[Toolbox]]

Next item: [[1.2 Scope]]

1.1 Mission

2025-06-08T13:10:46Z

Bjoerngerlach: /* A. Background & Definitions */

== A. Background & Definitions ==
According to the EQIPD Quality System's [[Implementation Strategy]], the first step taken by the [[1.5.2.3 Process owner]] is to prepare a statement explaining why they have chosen to implement a Quality System. It is expected that this decision will raise questions, not only from members of their own research unit but also from colleagues, collaborators, advisors, and other stakeholders. Therefore, the Process Owner should be ready to present a clear and compelling rationale that justifies the time and effort required to implement and maintain the Quality System.

In EQIPD terms, this statement is referred to as the mission statement—a concise summary of why quality is important to the research unit. For more on how EQIPD defines quality, and for examples of how researchers from various sectors answer the question "why quality matters," please visit the [[EQIPD Quality System]] page.

EQIPD stresses that the effectiveness of the mission statement lies not in its length, but in its clarity and its ability to be understood and embraced by all members of the research unit.

This Toolbox item relates to one of the [[Core Requirements]] (Core Requirement 3 – "The research unit must have defined quality objectives").

== B. Guidance & Expectations ==
The mission statement may have the following three sections:

'''1. General statement about research data quality'''
* Define what quality means in your environment or context.
* Determine which quality aspects matter the most in your research, and which of them should be addressed in priority.
* State the goal of your research unit or parent organization with regard to research quality.

This statement should briefly describe your understanding of the term research quality. Since interpretations of research quality may vary depending on the organizational context, your focus might differ from that of others. For example, you may emphasize aspects such as data accurately representing the population, implementing measures to reduce bias, or providing adequate training.

Depending on your setting, it is advisable to approach this as a group exercise. In a CRO or biopharmaceutical company, it can be done together with leadership; in academia, it may involve all group members, including students.

'''2. What is at stake when research quality is not maintained'''
* Describe the potential consequences of non-compliance or inferior quality for your research unit and/or parent organization.
* Identify and highlight the biggest risks for non-compliance or inferior quality in your environment.
* List specific measures to be taken to address these risks.

Everyone in the research unit should understand and be aware of the consequences of not maintaining research quality. It must be clear what the potential impact can be if individual team members do not contribute to generating high-quality research data. This description should outline the key consequences—both for the research unit as a whole and for individual researchers. In this context, it is also advisable to identify measures that can help protect the research unit from negative outcomes.

'''3. Quality objectives'''
* Describe what exactly the Quality System shall improve in your research unit and/or parent organization.
* Define the specific, measurable and traceable goals that your research unit and/or parent organization wants to achieve with the EQIPD Quality System.
* Provide indicators for each objective and describe how you will use them.

A description of improvements may focus on the research process itself—such as experimental design, data analysis, or reporting—but can also include supporting processes like the storage of research materials, documentation of research data, or archiving practices. It is important to identify and describe the areas where your research unit has the most pressing needs. While defining measurable goals can be challenging, it is highly recommended, as such goals help assess the long-term effectiveness of the implemented measures.

'''PLEASE DO NOT FORGET'''
* To make sure that an incentive and award/reward structure is aligned with the quality objectives (please refer to items 1.3.1-1.3.4 for more information). The following questions serve as examples of how such an alignment can be tested:
** Do we encourage / support publication of "negative" or "null" results, i.e., findings that are different from those expected?
** Do we recognize / reward high-quality studies irrespective of the outcome ("positive" or "negative/null" results)?
** Do we encourage people to develop and implement risk-mitigating strategies and procedures? Do we recognize these efforts?
** Do we encourage people not to rush experiments but to invest time and resources in developing/using robust methods, optimizing experimental set-ups and to conduct experiments properly according to high-quality standards (even if it takes more time than initially allocated)?
** Do we review internal processes to make sure that there is no pressure to generate "positive results"? If there is such pressure, do we have processes to mitigate the risks?
** When hiring new people, do we consider the quality and rigor of the applicants’ research?

== C. Resources ==
Template to create a Mission Statement based on the above guidance - [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=U3bWIn]

----------------
back to [[Toolbox]]

Next item: [[1.2 Scope]]

1.1 Mission

2025-06-08T13:09:26Z

Bjoerngerlach:

== A. Background & Definitions ==
According to the EQIPD Quality System's [[Implementation Strategy]], the first step taken by the [[1.5.2.3 Process owner]] is to prepare a statement explaining why they have chosen to implement a Quality System. It is expected that this decision will raise questions—not only from members of their own research unit but also from colleagues, collaborators, advisors, and other stakeholders. Therefore, the Process Owner should be ready to present a clear and compelling rationale that justifies the time and effort required to implement and maintain the Quality System.

In EQIPD terms, this statement is referred to as the mission statement—a concise summary of why quality is important to the research unit. For more on how EQIPD defines quality, and for examples of how researchers from various sectors answer the question "why quality matters," please visit the [[EQIPD Quality System]] page.

EQIPD stresses that the effectiveness of the mission statement lies not in its length, but in its clarity and its ability to be understood and embraced by all members of the research unit.

This Toolbox item relates to one of the [[Core Requirements]] (Core Requirement 3 – "The research unit must have defined quality objectives").

== B. Guidance & Expectations ==
The mission statement may have the following three sections:

'''1. General statement about research data quality'''
* Define what quality means in your environment or context.
* Determine which quality aspects matter the most in your research, and which of them should be addressed in priority.
* State the goal of your research unit or parent organization with regard to research quality.

This statement should briefly describe your understanding of the term research quality. Since interpretations of research quality may vary depending on the organizational context, your focus might differ from that of others. For example, you may emphasize aspects such as data accurately representing the population, implementing measures to reduce bias, or providing adequate training.

Depending on your setting, it is advisable to approach this as a group exercise. In a CRO or biopharmaceutical company, it can be done together with leadership; in academia, it may involve all group members, including students.

'''2. What is at stake when research quality is not maintained'''
* Describe the potential consequences of non-compliance or inferior quality for your research unit and/or parent organization.
* Identify and highlight the biggest risks for non-compliance or inferior quality in your environment.
* List specific measures to be taken to address these risks.

Everyone in the research unit should understand and be aware of the consequences of not maintaining research quality. It must be clear what the potential impact can be if individual team members do not contribute to generating high-quality research data. This description should outline the key consequences—both for the research unit as a whole and for individual researchers. In this context, it is also advisable to identify measures that can help protect the research unit from negative outcomes.

'''3. Quality objectives'''
* Describe what exactly the Quality System shall improve in your research unit and/or parent organization.
* Define the specific, measurable and traceable goals that your research unit and/or parent organization wants to achieve with the EQIPD Quality System.
* Provide indicators for each objective and describe how you will use them.

A description of improvements may focus on the research process itself—such as experimental design, data analysis, or reporting—but can also include supporting processes like the storage of research materials, documentation of research data, or archiving practices. It is important to identify and describe the areas where your research unit has the most pressing needs. While defining measurable goals can be challenging, it is highly recommended, as such goals help assess the long-term effectiveness of the implemented measures.

'''PLEASE DO NOT FORGET'''
* To make sure that an incentive and award/reward structure is aligned with the quality objectives (please refer to items 1.3.1-1.3.4 for more information). The following questions serve as examples of how such an alignment can be tested:
** Do we encourage / support publication of "negative" or "null" results, i.e., findings that are different from those expected?
** Do we recognize / reward high-quality studies irrespective of the outcome ("positive" or "negative/null" results)?
** Do we encourage people to develop and implement risk-mitigating strategies and procedures? Do we recognize these efforts?
** Do we encourage people not to rush experiments but to invest time and resources in developing/using robust methods, optimizing experimental set-ups and to conduct experiments properly according to high-quality standards (even if it takes more time than initially allocated)?
** Do we review internal processes to make sure that there is no pressure to generate "positive results"? If there is such pressure, do we have processes to mitigate the risks?
** When hiring new people, do we consider the quality and rigor of the applicants’ research?

== C. Resources ==
Template to create a Mission Statement based on the above guidance - [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=U3bWIn]

----------------
back to [[Toolbox]]

Next item: [[1.2 Scope]]

Talk:1.3.3 Promotion criteria within a research unit

2025-05-14T14:11:24Z

Bjoerngerlach:

I am reading this sentence: "Non-transparent or unfair promotion practices are often ..." and I wonder whether it should be re-written as: "Non-transparent or unFAIR promotion practices are often ..."
Where the unFAIR holds a link to FAIR principles?

[[Bjoern.gerlach]]: This is a very good point, however, in this case, I believe unfair really refers to practices where somebody is unfairly and incorrectly treated. It does not refer to the FAIR principles.

Talk:1.1 Mission

2025-05-14T12:09:11Z

Bjoerngerlach:

I think that some of the "PLEASE DO NOT FORGET" sections show some very important content that -in my opinion- should be highlighted. Would it make sense to have a box (or infobox) dedicated to this type of sections?
you can see an example here below. the draw back is that it is no longer plain text (i.e. it requires formatting) so it less easy to maintain.

[[Bjoerngerlach]]: It makes sense to me, to highlight certain elements. Especially also in the context that [[Harvinder.Virk]] mentioned that it is all very text heavy. Such little things can make it lighter, but indeed require a bit formatting. I am happy to learn and support.

<div style="background-color: #ecfcf4; border: 1px solid #aaa; padding: 0.5em;">
<h3>PLEASE DO NOT FORGET</h3>
To make sure that an <b>incentive and award/reward structure</b> is aligned with the quality objectives (please refer to items 1.3.1-1.3.4 for more information). The following questions serve as examples of how such an alignment can be tested:

<ul>
<li>Do we encourage / support publication of "negative" or "null" results, i.e., findings that are different from those expected?</li>
<li>Do we encourage people to develop and implement risk-mitigating strategies and procedures? Do we recognize these efforts?</li>
<li>Do we encourage people not to rush experiments but to invest time and resources in developing/using robust methods, optimizing experimental set-ups and to conduct experiments properly according to high-quality standards (even if it takes more time than initially allocated)?</li>
<li>Do we review internal processes to make sure that there is no pressure to generate "positive results"? If there is such pressure, do we have processes to mitigate the risks?</li>
<li>When hiring new people, do we consider the quality and rigor of the applicants’ research?</li>
</ul>
</div>

Talk:EQIPD Quality System

2025-05-14T08:39:20Z

Bjoerngerlach: /* General */

On this page we can collect ideas and errors within the entire Wiki.

===New pages needed===
* Sex differences in animal research

===Errors on the pages===

===Dedicated working groups===
====General====
* Checking incorrect items:
** Sara: Section 2
** Björn: Section 1
***Error
** René: Section 3
* Checking missing pages
**Everyone when screening though the website, with René as a contact
* Find mechanisms to keep it up-to-date
**Tbd

====Specific task forces formed already:====
* Quality culture and improvmenent
** Arnoud, Sandrine, Jonathan
* Antibodies and validation
** Harv, Marija
* Creating page on sex differences
** Christina, Vootele

Talk:EQIPD Quality System

2025-05-14T08:37:58Z

Bjoerngerlach: /* General */

On this page we can collect ideas and errors within the entire Wiki.

===New pages needed===
* Sex differences in animal research

===Errors on the pages===

===Dedicated working groups===
====General====
* Checking incorrect items:
** Sara: Section 2
** Björn: Section 1
** René: Section 3
* Checking missing pages
**Everyone when screening though the website, with René as a contact
* Find mechanisms to keep it up-to-date
**Tbd

====Specific task forces formed already:====
* Quality culture and improvmenent
** Arnoud, Sandrine, Jonathan
* Antibodies and validation
** Harv, Marija
* Creating page on sex differences
** Christina, Vootele

Talk:EQIPD Quality System

2025-05-14T08:22:30Z

Bjoerngerlach: /* General */

On this page we can collect ideas and errors within the entire Wiki.

===New pages needed===
* Sex differences in animal research

===Errors on the pages===

===Dedicated working groups===
====General====
* Checking incorrect items:
** Sara
** Björn
** René
* Checking missing pages
**Everyone when screening though the website, with René as a contact
* Find mechanisms to keep it up-to-date
**Tbd

====Specific task forces formed already:====
* Quality culture and improvmenent
** Arnoud, Sandrine, Jonathan
* Antibodies and validation
** Harv, Marija
* Creating page on sex differences
** Christina, Vootele

EQIPD Quality System

2025-05-09T12:46:31Z

Bjoerngerlach:

=General Information=
{{#ev:youtube|https://youtu.be/xLIdxUiaNzo|400|right}}
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.

[[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]]).

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]].

[[FAQ]] section provides more answers to questions about EQIPD Quality System, its implementation and use.

Contact us if you have any questions: [mailto:info@go-eqipd.org info@go-eqipd.org]

=Key principles of the EQIPD QS=

# Engage with autonomy
# Grow through reflection
# Focus on the goal
# Be transparent
# Leave a trace

[[EQIPD principles| More details]]

=Why a quality system?=
Introductory video by Prof Malcolm Macleod to the EQIPD Quality System:
{{#ev:youtube|https://youtu.be/hOaCILTwcU4}}

=Where to start?=
The page '''[[Implementation Strategy]]''' provides a good starting point and answers the questions '''"What is it about?"''' and '''"How to implement it?"'''.

Talk:EQIPD Quality System

2025-05-09T12:27:33Z

Bjoerngerlach:

On this page we can collect ideas and errors within the entire Wiki.

===New pages needed===
* Sex differences in animal research

===Errors on the pages===

===Dedicated working groups===
====General====
* Checking incorrect items:
** Sara, Björn, René
* Checking missing pages
**Everyone when screening though the website, with René as a contact
* Find mechanisms to keep it up-to-date
**Tbd

====Specific task forces formed already:====
* Quality culture and improvmenent
** Arnoud, Sandrine, Jonathan
* Antibodies and validation
** Harv, Marija
* Creating page on sex differences
** Christina, Vootele

Talk:EQIPD Quality System

2025-05-09T12:05:55Z

Bjoerngerlach:

On this page we can collect ideas and errors within the entire Wiki.

===New pages needed===
* Sex differences in animal research

===Errors on the pages===

===Dedicated working groups===
* Checking incorrect items:
** Sara, Björn, René
* Checking missing pages
**Everyone when screening though the website, with René as a contact
* Find mechanisms to keep it up-to-date
**Tbd

====Specific task forces formed already:====
* Quality culture and improvmenent
** Arnoud, Sandrine, Jonathan
* Antibodies and validation
** Harv, Marija
* Creating page on sex differences
** Christina, Vootele

Talk:EQIPD Quality System

2025-05-09T12:05:27Z

Bjoerngerlach: /* Dedicated working groups */

On this page we can collect ideas and errors within the entire Wiki.

===New pages needed===
* Sex differences in animal research

===Errors on the pages===

===Dedicated working groups===
* Checking incorrect items:
** Sara, Björn, René
* Checking missing pages
**Everyone when screening though the website, with René as a contact
* Find mechanisms to keep it up-to-date
**Tbd

=Specific task forces formed already:=
* Quality culture and improvmenent
** Arnoud, Sandrine, Jonathan
* Antibodies and validation
** Harv, Marija
* Creating page on sex differences
** Christina, Vootele

Talk:EQIPD Quality System

2025-05-09T12:04:06Z

Bjoerngerlach:

On this page we can collect ideas and errors within the entire Wiki.

===New pages needed===
* Sex differences in animal research

===Errors on the pages===

===Dedicated working groups===
* General task forces
• Checking incorrect items:
o Sara, Björn, René
• Checking missing pages
o Everyone when screening though the website, with René as a contact
• Find mechanisms to keep it up-to-date
o Tbd

Specific task forces formed already:
• Quality culture and improvmenent
o Arnoud, Sandrine, Jonathan
• Antibodies and validation
o Harv, Marija
• Creating page on sex differences
o Christina, Vootele

Talk:EQIPD Quality System

2025-05-09T12:00:12Z

Bjoerngerlach: Created page with "This is the page where we can collect ideas and errors ===New pages needed=== ===Errors on the pages==="

This is the page where we can collect ideas and errors

===New pages needed===

===Errors on the pages===

1.2 Scope

2025-05-01T06:44:22Z

Bjoerngerlach: Removed protection from "1.2 Scope"

== A. Background & Definitions ==
This item refers to one of the Core Requirements (Core Requirement 2 - "Communication process must be in place") and is, therefore, considered as essential.

EQIPD Quality System (QS) can only be implemented in a specific research environment where roles and responsibilities of every team member are clearly defined and there is a clear plan for communication between team members.

Many good initiatives and project proposals are initially well received but later die because there is no follow up.

To avoid that, it is essential to:

define a research unit (lab, territory, organization or part thereof) where EQIPD QS will be applied in order to identify all colleagues who will need to be informed about the new process, colleagues who will need to be actively involved in working on the EQIPD QS implementation;
set up a communication plan / schedule of working meetings;
make sure that the communication plan supports two-way information flow (i.e. also to capture feedback related to performance of the existing and newly introduced practices).

== B. Guidance & Expectations ==
As one of the first steps of implementing the EQIPD QS, research units set up a so called Communication Plan that has four main parts:
# description of a research unit (e.g. a lab, a group or a department which is supervised or managed by a Process Owner)
# identification of those within the research unit who will work together with the Process Owner to implement EQIPD QS and develop various elements that will belong to the QS
# description of all other stakeholders who may be informed about the progress with implementing and maintaining the EQIPD QS:
## within the research unit
## outside the research unit (e.g. colleagues in other research units, support functions, management, collaborators, authorities, public)
# description of how the communication will take place for each of the groups defined above:
## email, intranet, dedicated team meetings (e.g. for those members of the research uinit who are involved in implementiung the QS) and conventional team meetings (e.g. weekly lab meetings)
## intervals of communication and meetings (e.g. weekly, biweekly, per predefined milestones, etc.)
## communication sent by a Process Owner or someone else appointed by the Process Owner

It is also advised that, during the first meeting of the research unit when the intention to implement the EQIPD QS is introduced, the Process Owner discusses with the team relevance of quality for the mission of research unit and identifies what specifically is at stake if proper quality is not maintained. Results of this discussion may be summarized in a form a quality policy or a manifesto or any other form that can be stored and referred to (see section 1.1 Mission for guidance and example of template).

For a more detailed description of Roles and Responsibilites, please refer to section [[1.5.2 Roles and responsibilities of involved personnel and organization]] of the [[Toolbox]].

'''PLEASE DO NOT FORGET'''

To consider adding this subject to a training program for new employees or refresher training (if appropriate)
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)

== C. Resources ==
* Template to create a communicate plan based on the above guidance - [https://paasp.sharepoint.com/:w:/s/EQIPD/ERyfFP_pBytDiEfqCutDAJQBFbaGQEx3G1pyOmDl50o_LQ?e=f5POo0 1.2 Communication Plan.docx]
* Responsibility Assignment Matrix (e.g. Responsible, Accountable, Consulted, and Informed) - [https://en.wikipedia.org/wiki/Responsibility_assignment_matrix#cite_note-slaguide-4 Wikipedia]

----------------
back to [[Toolbox]]

Next item: [[1.3.1 Transparency]]

1.1 Mission

2025-05-01T06:44:05Z

Bjoerngerlach: Removed protection from "1.1 Mission"

== A. Background & Definitions ==
According to the EQIPD Quality System's [[Implementation Strategy]], the first thing that the [[1.5.2.3 Process owner]] does is to prepare a statement explaining why she / he has decided to implement a Quality System. It is expected that questions will be asked, not only by the members of her / his research unit but also by other colleagues, collaborators, advisors and other stakeholders. Thus, the Process Owner should be prepared to provide a compelling rationale to justify the efforts and time that will be invested in the implementation and maintenance of the Quality System.

In EQIPD terms, the mission statement is a concise summary of why quality matters for the research unit. Please visit the [[EQIPD Quality System]] page for information on how EQIPD defines quality and examples of how scientists from different sectors answer the question "why quality matters".

EQIPD emphasizes not the length of the mission statement but its ability to be understood and endorsed by all members of the research unit.

This Toolbox item refers to one of the [[Core Requirements]] (Core Requirement 3 - "The research unit must have defined quality objectives").

== B. Guidance & Expectations ==
The mission statement may have the following three sections:

'''1. General statement about research data quality'''
* Define what quality means in your environment or context.
* Determine which quality aspects matter the most in your research, and which of them should be addressed in priority.
* State the goal of your research unit or parent organization with regard to research quality.

This statement shall briefly describe your understanding of the term research quality. Since this understanding might vary depending on the context of your organization, you might have a different focus compared to others (e.g., data points being an accurate representation of the population, having implemented measures against bias or providing adequate training).
Depending on your setting, it is advisable to see this as an exercise within a larger group; e.g., within a CRO or a biopharmaceutical company it can be done together with leadership or in academia with all group members, including students.

'''2. What is at stake when research quality is not maintained'''
* Describe the potential consequences of non-compliance or inferior quality for your research unit and/or parent organization.
* Identify and highlight the biggest risks for non-compliance or inferior quality in your environment.
* List specific measures to be taken to address these risks.

The understanding and awareness of the consequences of not maintaining research quality should be known to everyone in the research unit. It should be clear what the impact can be if each team member is not working to generate high-quality research data. This description should point out most, if not all, consequences for the research unit but also for the individual researcher. In this context it is also advisable to identify measures to protect the research unit against the negative impact.

'''3. Quality objectives'''
* Describe what exactly the Quality System shall improve in your research unit and/or parent organization.
* Define the specific, measurable and traceable goals that your research unit and/or parent organization wants to achieve with the EQIPD Quality System.
* Provide indicators for each objective and describe how you will use them.

A description of improvements can be about the research process itself such as experimental design, data analysis and reporting. But it can also be about the supplementary processes such as storage of research materials, the documentation of research data or the archiving thereof. It is important to identify and describe these aspects for which your research unit has the greatest need. Finding measurable goals is difficult but advisable, since they will help assess the effectiveness of the implemented measures over the years.

'''PLEASE DO NOT FORGET'''
* To make sure that an incentive and award/reward structure is aligned with the quality objectives (please refer to items 1.3.1-1.3.4 for more information). The following questions serve as examples of how such an alignment can be tested:
** Do we encourage / support publication of "negative" or "null" results, i.e., findings that are different from those expected?
** Do we recognize / reward high-quality studies irrespective of the outcome ("positive" or "negative/null" results)?
** Do we encourage people to develop and implement risk-mitigating strategies and procedures? Do we recognize these efforts?
** Do we encourage people not to rush experiments but to invest time and resources in developing/using robust methods, optimizing experimental set-ups and to conduct experiments properly according to high-quality standards (even if it takes more time than initially allocated)?
** Do we review internal processes to make sure that there is no pressure to generate "positive results"? If there is such pressure, do we have processes to mitigate the risks?
** When hiring new people, do we consider the quality and rigor of the applicants’ research?

== C. Resources ==
Template to create a Mission Statement based on the above guidance - [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=U3bWIn]

----------------
back to [[Toolbox]]

Next item: [[1.2 Scope]]

Toolbox

2025-05-01T06:43:50Z

Bjoerngerlach: Removed protection from "Toolbox"

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.

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]].

EQIPD has developed a specific terminology that is used to describe the framework and the quality system [[Glossary]].

__NOTOC__

== 1. Objectives ==

'''[[1.1 Mission]]'''

'''[[1.2 Scope]]'''

'''1.3 Quality Culture'''

[[1.3.1 Transparency]]

[[1.3.2 Sources of pressure and bias-producing communication of pressure]]

[[1.3.3 Promotion criteria within a research unit]]

[[1.3.4 Performance criteria and assessment]]

[[1.3.5 Reward system and incentives]]

'''1.4 My Need for Quality'''

[[1.4.1 Research ethics]]

[[1.4.1.1 Research integrity]]

[[1.4.1.2 Data sharing]]

[[1.4.2 Adherence to legal and regulatory considerations]]

[[1.4.2.1 Biosafety]]

[[1.4.2.2 Chemical safety]]

[[1.4.2.3 Radioactivity]]

[[1.4.2.4 Genetically modified organisms]]

[[1.4.2.5 Risks to unborn life]]

[[1.4.2.6 Handling of controlled substances]]

[[1.4.2.7 Animal care and use]]

[[1.4.2.8 Human data protection]]

[[1.4.3 Quality in collaborative research]]

[[1.4.3.1 Industry-academia: Research as service]]

[[1.4.3.2 Industry-academia: Research as collaboration]]

[[1.4.3.3 Academia-academia: Research as service]]

[[1.4.3.4 Academia-academia: Research as collaboration]]

[[1.4.3.5 Expectations from public funders]]

'''1.5 Governance'''

[[1.5.1 Quality policy]]

[[1.5.2 Roles and responsibilities of involved personnel and organization]]

[[1.5.2.1 Organigram]]

[[1.5.2.2 Management]]

[[1.5.2.3 Process owner]]

[[1.5.2.4 Principal investigators and study directors]]

[[1.5.2.5 Research team]]

[[1.5.2.6 Supporting team]]

[[1.5.2.7 Quality professionals]]

[[1.5.3 Management of resources]]

[[1.5.3.1 Personnel]]

[[1.5.3.2 Facilities]]

[[1.5.3.3 Laboratory and experimental equipment used for measurement]]

[[1.5.3.4 Electronic information system]]

[[1.5.3.5 Organization-specific know how]]

[[1.5.3.6 Documentation requirement for sample and material]]

[[1.5.3.7 Retained personnel records]]

[[1.5.4 Prevention of Conflict of Interest]]

[[1.5.4.1 Independence of internal compliance assessment]]

[[1.5.4.2 Internal assessment of the organizations' quality professionals]]

[[1.5.5 Sustainability]]

== 2. Key Processes ==

'''2.1 Experiment Planning'''

[[2.1.1 Study protocol]]

[[2.1.2 Unique study ID]]

[[2.1.3 Appraisal of literature and systematic reviews]]

[[2.1.4 Purpose of research]]

[[2.1.5 Pre-specification]]

[[2.1.6 Sample size and power analysis]]

[[2.1.7 Blinding]]

[[2.1.8 Randomisation]]

[[2.1.9 Inclusion and exclusion criteria]]

[[2.1.10 Plausibility check]]

[[2.1.11 Preregistration]]

'''2.2 Study execution'''

[[2.2.1 Use of SOPs for standard experiments]]

[[2.2.2 Use of template for (manual) data recording]]

[[2.2.3 Documentation of the experiment and deviations]]

'''2.3 Data handling'''

[[2.3.1 Generation, recording, handling and archiving of raw data]]

[[2.3.1.1 Converting non-electronic information into an electronic form]]

[[2.3.2 Primary analysis and evaluation of raw data]]

[[2.3.3 Statistical analysis]]

[[2.3.4 Data visualization]]

'''[[2.4 Reporting]]'''

[[2.4.1 Non-public reporting]]

[[2.4.2 Publication]]

== [[3 Support Processes]] ==

'''3.1 Documentation management'''

[[3.1.1 Platform to record data]]

[[3.1.2 Procedures for how and when to record data]]

[[3.1.2.1 Traceability of data and any person having impact on data]]

[[3.1.2.2 Process for witnessing of records]]

[[3.1.3 Data security]]

'''3.2 Education, training and competence'''

[[3.2.1 General guidance on training]]

[[3.2.2 Good Research Practice training]]

[[3.2.3 Implementation of the EQIPD Quality System]]

[[3.2.4 Training on specific methods, tasks and activities]]

'''3.3 Laboratory resources'''

[[3.3.1 Fit-for-purpose working environment]]

[[3.3.2 Processes to enable computerized and non-computerized systems being suitable for intended use]]

[[3.3.3 Management of research materials and reagents]]

'''3.4 Experimental systems'''

[[3.4.1 Animal characteristics, care and use]]

[[3.4.1.1 Ethical evaluation and authorization process of animal use]]

[[3.4.1.2 Animal procurement & identification]]

[[3.4.1.3 Animal housing conditions]]

[[3.4.1.4 Animal environmental conditions]]

[[3.4.1.5 Food, watering and bedding]]

[[3.4.1.6 Sanitation procedure]]

[[3.4.1.7 Frequency and procedure of observation of animals]]

[[3.4.1.8 Animal health and genetic monitoring]]

[[3.4.1.9 Veterinary interventions during the study]]

[[3.4.1.10 Surgical procedures]]

[[3.4.1.11 Animal euthanasia procedures]]

3.4.2 Non-animal test systems

[[3.4.2.1 Cell culturing]]

[[3.4.2.2 Antibody validation]]

[[3.4.2.3 Biological and technical replicates]]

'''3.5 Experimental methods'''

[[3.5.1 Animal and non-animal method and assay qualification]]

[[3.5.2 Protocols for methods and assays]]

[[3.5.3 Minimum reporting guidelines]]

== 4 Continuous Improvement ==

'''4.1 Assessment procedures'''

[[4.1.1 Risk assessment]]

[[4.1.2 Self assessment]]

[[4.1.3 External assessment]]

'''4.2 Prevention and improvement'''

[[4.2.1 Installation of solutions, actions and mitigation strategies]]

[[4.2.2 Error and incident management]]

[[4.2.3 Responsible conduct of research]]

[[4.2.4 Key performance indicators]]

'''4.3 EQIPD framework'''

4.3.1 Updating of EQIPD Dossier

[[4.3.1.1 Adding new items]]

[[4.3.1.2 Deleting items]]

[[4.3.1.3 Revising items]]

[[4.3.2 Using the EQIPD applications]]

[[4.3.2.1 Using the Planning Tool]]

[[4.3.2.2 Creating NEEDs]]

[[4.3.2.3 Revising NEEDs]]

[[4.3.2.4 Deleting NEEDs]]

EQIPD Quality System

2025-05-01T06:43:19Z

Bjoerngerlach: Removed protection from "EQIPD Quality System"

=General Information=
{{#ev:youtube|https://youtu.be/xLIdxUiaNzo|400|right}}
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.

[[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]]).

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]].

[[FAQ]] section provides more answers to questions about EQIPD Quality System, its implementation and use.

Contact us if you have any questions: [mailto:info@paasp.net info@paasp.net]

=Key principles of the EQIPD QS=

# Engage with autonomy
# Grow through reflection
# Focus on the goal
# Be transparent
# Leave a trace

[[EQIPD principles| More details]]

=Why a quality system?=
Introductory video by Prof Malcolm Macleod to the EQIPD Quality System:
{{#ev:youtube|https://youtu.be/hOaCILTwcU4}}

=Where to start?=
The page '''[[Implementation Strategy]]''' provides a good starting point and answers the questions '''"What is it about?"''' and '''"How to implement it?"'''.

3.2.3 Implementation of the EQIPD Quality System

2025-05-01T06:42:49Z

Bjoerngerlach: Removed protection from "3.2.3 Implementation of the EQIPD Quality System"

== Get familiar with the key terms defined by EQIPD ==
{{#ev:youtube|https://youtu.be/bK6emsX5G1Y|400|right}}
=== What means quality? ===
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).

=== Research rigor ===
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.

=== Raw data ===
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:
* 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;
* data directly entered into a computer through an automatic instrument interface, which are the results of primary observations and activities in a study;
* copies of original laboratory records and documentation that are complete and of good quality.

=== Knowledge-claiming research ===
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 protocol) to research that is conducted with the prior intention of informing a knowledge claim.
Examples of research requiring the maximal rigor possible include:
* 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])
*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)
* 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])
* Labor-, resource- and/or time-intensive studies that cannot be easily repeated

=== Must vs. should ===
When reviewing materials provided by EQIPD, please note the use of "must" vs "should".
* "Must" indicates actions that EQIPD considers as imperative and mandatory or as a requirement.
* 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.
* 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.

For more definitions, please see [[Glossary]].

== Take a closer look at the expectations of EQIPD ==
{{#ev:youtube|https://youtu.be/D_Wl6kcs9vU|400|right}}
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.

Next, you may want to go through the [https://paasp.sharepoint.com/:b:/s/EQIPD/EWvqq6oej6lEuGj9twOLtYQBK7o77XtOEHrA1UjC5r4PSA?e=4bvKzb self-assessment overview]] in order to check how many [[Core Requirements]] do you already meet and where potential challenges can be encountered.

Once this review is complete, you will be prepared to answer a question - Are most core requirements met?

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]]).

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.

== Implementation guide ==
The following table provides an overview on how to approach the implementation of the quality system. These are suggestions from the EQIPD team to guide you when you start at zero. However, any other approach that might work better for you and leading to the implementation of the 18 [[Core Requirements]] is perfect as well.

{|class="wikitable"
|
|'''Preparation'''
|'''Phase 1'''
|'''Phase 2'''
|'''Phase 3'''
|-
|'''Recommended Action'''
|[[3.2.3 Implementation of the EQIPD Quality System#Get familiar with the key terms defined by EQIPD|Get familiar with EQIPD terminology]]
[[3.2.3 Implementation of the EQIPD Quality System#Take a closer look at the expectations of EQIPD|Take a closer look at EQIPD expectations]]
|
# [[1.5.2.3 Process owner|Define Process Owner]]
# [[1.1 Mission|Set-up Mission Statement]]
# [[1.2 Scope|Set-up Communication Plan]]
# Set-up Documentation (three resources: [[2.3.1 Generation, recording, handling and archiving of raw data|1]] [[3.1.3 Data security|2]] [[3.1.2.1 Traceability of data and any person having impact on data|3]])
# [[3.4.1 Animal characteristics, care and use|Set-up ACU document if applicable]]
# [[2.1.4 Purpose of research|Get familiar with knowledge-claiming research ]]
|[[NEED|Identify additional NEEDS]]
Develop solutions to address CR and NEEDs
|Finalize implementation
[[4.1.2 Self assessment|Check yourself again with Self-assessment]]
|-
|'''Optional Action'''
|[https://paasp.sharepoint.com/:u:/s/EQIPD/ERWfS3Yuw6NJodMY_iz8A5MBxESAFCjPzWMu-DFd3xUrfw?e=4O5622 Download Planning Tool and Dossier]
[[4.3.2.1 Using the Planning Tool|Introduction to the Planning Tool]]
|
# [[4.3.2.1 Using the Planning Tool#2. Setting up the Dashboard with the Wizard|Open Planning Tool and activate Makros to start Wizard]]
# [[4.3.2.1 Using the Planning Tool#2. Setting up the Dashboard with the Wizard|Guided implementation of items above with Wizard]]
|[[4.3.2.1 Using the Planning Tool#3. Getting familiar with the Dashboard|Track your progress on the Dashboard]]
|[[Implementation_Strategy#Assessment by the EQIPD team| Apply for EQIPD certification]]
|}

For more information, please contact the EQIPD team at [mailto:info@eqipd.online info@go-eqipd.oorg].

== Assessment by the EQIPD team ==
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.

----------------
back to [[EQIPD Quality System]]

back to [[Toolbox]]

Item: [[3.2.4 Training on specific methods, tasks and activities]]

Core Requirements

2025-05-01T06:42:03Z

Bjoerngerlach: Removed protection from "Core Requirements"

{| class="wikitable"
|'''Categories'''
|'''No'''
|'''Core Requirement'''
|'''Toolbox reference'''
|'''EQIPD provided templates<sup>*</sup>'''
|-
|rowspan="2"|'''Research team'''
|1
|Process owner for the Quality System must be identified
|[[1.5.2.3 Process owner]]
| -
|-
|2
|Communication process must be in place
|[[1.2 Scope]]
|[https://paasp.sharepoint.com/:w:/s/EQIPD/ERyfFP_pBytDiEfqCutDAJQBFbaGQEx3G1pyOmDl50o_LQ?e=wlkvHJ Communication plan]
|-
|rowspan="3"|'''Quality culture'''
|3
|The research unit must have defined quality objectives
|[[1.1 Mission]]
|[https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Mission statement]
|-
|4
|All activities must comply with relevant legislation and policies
|[[1.4.2 Adherence to legal and regulatory considerations]]
|[https://paasp.sharepoint.com/:w:/s/EQIPD/ET18tqgUVfJCsYNYxexlgA8BnwRLEn0k8JcFmeQlTiQMoA?e=zoXuUf Checklist for preparing an animal care and use program description (for organizations without accreditation by AAALAC or equivalent)]
|-
|5
|The research unit must have a procedure to act upon concerns of potential misconduct
|[[4.2.3 Responsible conduct of research]]
| -
|-
|rowspan="4"|'''Data integrity'''
|6
|Generation, handling and changes to data records must be documented
|[[2.3.1 Generation, recording, handling and archiving of raw data]]
|rowspan="3"|[https://paasp.sharepoint.com/:w:/s/EQIPD/EQTANrsKHTVIqtO8LT-ZJIEBEUJVZI6siRLkHfliUD4gdA?e=GJusMa Documentation plan]
|-
|7
|Data storage must be secured at least for as long as required by legal, contractual or other obligations or business needs
|[[3.1.3 Data security]]
|-
|8
|Reported research outcomes must be traceable to experimental data
|[[3.1.2.1 Traceability of data and any person having impact on data]]
|-
|9
|Reported data must disclose all repetitions of a study, an experiment, or a test regardless of the outcome
|[[2.4 Reporting]]
| -
|-
|rowspan="5"|'''Research processes'''
|10
|Investigator must declare in advance whether a study is intended to inform a formal knowledge claim
|[[2.1.4 Purpose of research]]
|[https://paasp.sharepoint.com/:w:/s/EQIPD/EbuGPqIAiTtKlmRQJ7bSy_0BfmYNqXl-W6Reh3tW5vAIzQ?e=ycqEuG Study protocol]
|-
|11
|All personnel involved in research must have adequate training and competence to perform assigned tasks
|[[3.2.1 General guidance on training]]
| -
|-
|12
|Protocols for experimental methods must be available
|[[3.5.2 Protocols for methods and assays]]
|[https://paasp.sharepoint.com/:w:/s/EQIPD/EfUO3B7RFxdHgxQ8JY5hhFoBEDUiPGK4C8n6BBHEprwroA?e=8IezWV Protocols for experimental methods]
|-
|13
|Adequate handling and storage of samples and materials must be ensured
|[[3.3.3 Management of research materials and reagents]]
| -
|-
|14
|Research equipment and tools must be suitable for intended use and ensure data integrity
|[[3.3.2 Processes to enable computerized and non-computerized systems being suitable for intended use]]
| -
|-
|rowspan="3"|'''Continuous performance'''
|15
|Risk assessment must be performed to identify factors affecting the generation, processing and reporting of research data
|[[4.1.1 Risk assessment]]
|[https://paasp.sharepoint.com/:w:/s/EQIPD/EbuGPqIAiTtKlmRQJ7bSy_0BfmYNqXl-W6Reh3tW5vAIzQ?e=ycqEuG Study protocol] and [https://paasp.sharepoint.com/:x:/s/EQIPD/ETo9OwIvZpNHtepp6IvxylQBjtjhk2AmRnypLCIOrGwMvA?e=n1zy3X Risk assessment template]
|-
|16
|Critical incidents and errors during study conduct must be analyzed and appropriately managed
|[[4.2.2 Error and incident management]]
|[https://paasp.sharepoint.com/:w:/s/EQIPD/EatOAFgLbctEvxRZTuSCdU4Bv8J1I_BitfKl-JJiieOTLA?e=z99RR1 Error reporting template]
|-
|17
|An approach must be in place to monitor the performance of the EQIPD Quality System, and address identified issues
|[[4.1.2 Self assessment]]
|[https://paasp.sharepoint.com/:x:/s/EQIPD/EXjMqJ74JcpLh9x8_UN7EmkBzgAcgODVOTKlDWnAPnIpvw?e=PWwGJY Self assessment]
|-
|'''Sustainability'''
|18
|Resources for sustaining the EQIPD Quality System must be available
|[[1.5.5 Sustainability]]
| -
|}
<sup>*</sup>The provided templates are suggestions which may be used. However, it is not mandatory to use the templates developed by EQIPD. It is up to the research unit to modify them, develop new or use existing documentation.

For information on required documentation within EQIPD please visit: [[Documentation in EQIPD]]

Back to the [[EQIPD Quality System]].

2.1.1 Study protocol

2025-01-22T10:37:18Z

Bjoerngerlach:

== A. Background & Definitions ==

Within the EQIPD Quality System and the Toolbox, the term "study protocol" refers to a document that is used to describe and summarize information related to a specific study (experiment).

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]].

== B. Guidance & Expectations ==

It is strongly recommended that, for every study (experiment), there is a study protocol prepared prior to the study being conducted.

Each study protocol should identify author(s), date when it was created and a unique ID of the study that it describes.

EQIPD has developed a template (please see below) that outlines the suggested structure and content of a study protocol.

This template is provided as a general guidance and serves only as an example:
# Title of the study
# Study hypothesis
# [[2.1.4 Purpose of research]]
## Indicate whether the research is undertaken with the intention to inform a formal knowledge claim
# Choice of experimental model(s) or method(s)
## Describe how and why specific models and/or methods were chosen (e.g. based on [[2.1.3 Appraisal of literature and systematic reviews]]
## If animal subjects are involved, justify why alternative are not suitable; as well as the selection of species, strain, age, and sex (if applicable)
# Choice of controls
## 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]]
## If a positive control is included, indicate explicitly how the study outcome will be interpreted if positive control fails.
# Measures against risks of bias
## [[2.1.8 Randomisation]] (if selected, a randomisation protocol must be available)
## [[2.1.7 Blinding]] (if selected, a blinding protocol must be available)
## 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.
# Sample size
## Describe methods used to estimate the sample size (such as power analysis).
## For definitions and guidance see section [[2.1.6 Sample size and power analysis]]
## Specify the primary outcome measure that was used to determine the sample size (see [[ARRIVE Essential - Outcome measures]])
## The sample size is the number of experimental units per group (for definition of experimental unit – see [[ARRIVE Essential - Study design]])
## Specify the exact number of experimental units allocated to each group, and the total number in each experiment.
## For definitions and guidance on sample size estimation and power analysis, please follow the link.
# Inclusion and exclusion criteria
## Indicate any [[2.1.9 Inclusion and exclusion criteria]] to be applied
# Animal resources, reagents and materials
## 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)
##If animals are used, provide sufficient details expected for reporting ([[ARRIVE 2.0]])
# Study design overview
## 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).
# Experimental procedures
## 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]])
## 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)
## If more than one method or procedure is used, describe sequence or experimental workflow
## 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]])
### What was done, how it was done and what was used
### When and how often
### Where (including detail of any acclimation periods)
### Why (provide rationale for procedures)
# Data analysis
## Describe the processing of raw data (for definition of raw data – see section [[2.3.1 Generation, recording, handling and archiving of raw data]])
## Describe statistical method(s) to be applied for each analysis ([[2.3.3 Statistical analysis]])
## Describe any methods used to assess whether the data met the assumptions of the statistical approach ([[ARRIVE Essential - Statistical methods]])
# Amendments
## Describe what was changed in the original study protocol, why, when and by whom
## When amending the study protocol, please make sure not to over-write the original version
## Amendments may be saved as documents separate from the original study protocol
# References
## If necessary, include references
# Preregistration
## EQIPD strongly recommends to pre-register study protocol (more information – [[2.1.11 Preregistration]])
## If pre-registered, please indicate the platform used, registration link and other relevant reference information

'''RISK ASSESSMENT'''
* 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)?

== C. Resources ==
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]

Experimental design tools:
* 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/])
* NC3Rs’ Experimental Design Assistant [https://www.nc3rs.org.uk/experimental-design-assistant-eda]

----------------
back to [[Toolbox]]

Next item: [[2.1.2 Unique study ID]]

2.1.4 Purpose of research

2024-10-13T09:52:00Z

Bjoerngerlach: /* B. Guidance & Expectations */

== A. Background & Definitions ==

Several commonly acknowledged risks can bias the research results ([https://doi.org/10.1186/1471-2288-14-43 Hooijmans et al. 2014]).

There are modes of research that can tolerate a certain level of uncertainty, and while not leading to a formal knowledge claim, such work is an essential part of the research process. It may be used to generate hypotheses, to provide evidence to give the investigator greater confidence that an emerging hypothesis is valid, or to “screen” compounds for potential effects prior to more formal testing.

There are also modes of research where researchers want to minimize the risks of failing due to inadequate control of the risks of bias.

For every study, EQIPD recommends scientists to apply protection against risks of bias and to be transparent about the protective measures applied.

EQIPD requires that the maximal rigor possible is applied (and exceptions explained / documented in the study protocol) to research that is conducted with the prior intention of informing a knowledge claim ([[Glossary]]). This will usually (but not always) involve some form of null hypothesis statistical testing or formal Bayesian analysis. Hypotheses are articulated in advance of data collection, with pre-specified criteria defining the primary outcome measure and the statistical test to be used. Depending on the purpose for which the knowledge claim will be used, different research strategies are appropriate. A single well conducted preclinical study may be considered sufficient to convince others that the phenomena are real enough to justify their attention, but may not be sufficient to justify major research investment such as a clinical study.

Examples of research requiring the maximal rigor possible include:
* 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])
* 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)
* 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])
* Labor-, resource- and/or time-intensive studies that cannot be easily repeated

== B. Guidance & Expectations ==
One of the [[Core Requirements]] of the EQIPD Quality System is that investigators must assert in advance whether a study will be conducted to inform a formal knowledge claim. This statement should be recorded in the [[2.1.1 Study protocol]] (see below for a template).

If uncertain about your study being knowledge-claiming or not, please check [[FAQ]] page or contact the EQIPD Expert Team for an advice.

Efforts to minimize the risks of bias ([https://doi.org/10.1186/1471-2288-14-43 Hooijmans et al. 2014]) should be applied to all studies that aim to inform a knowledge claim (table inspired by [https://doi.org/10.1161/STROKEAHA.116.013244 Dirnagl 2016]):

{| class="wikitable"
|
|'''Research NOT informing a formal knowledge claim'''
|'''Research informing a formal knowledge claim (i.e. research requiring maximal rigor)*'''
|-
|'''[[2.1.1 Study protocol|Study protocol]]'''
|should be defined and documented before starting the experiments
|must be defined and documented before starting the experiments
|-
|'''Study hypothesis'''
|advised to define
|must be pre-specified
|-
|'''[[2.1.7 Blinding|Blinding]]'''
|advised to implement
|should be implemented, exceptions must be justified and documented
|-
|'''[[2.1.8 Randomisation|Randomisation]]'''
|advised to implement
|should be implemented, exceptions must be justified and documented
|-
|'''[[2.1.6 Sample size and power analysis|Sample size and power analysis]]'''
|advised to define and document before starting the experiments
|must be defined and documented before starting the experiments (e.g. included in the study protocol)
|-
|'''[[2.3.3 Statistical analysis|Data analysis]]'''
|advised to define and document before starting the experiments
|must be defined and documented before starting the experiments (e.g. as a formal statistical analysis plan and/or included in the study protocol)
|-
|'''[[2.1.9 Inclusion and exclusion criteria|Inclusion and exclusion criteria]]'''
|advised to define and document before starting the experiments
|must be defined and documented before starting the experiments (e.g. included in the study protocol)
|-
|'''Deviations from study protocol'''
|advised to document
|must be documented
|-
|'''[[2.1.11 Preregistration|Preregistration]]'''
|no
|should be implemented
|}

* * Please refer to [[Glossary]] for explanation on the EQIPD use of the verbs "must" and "should"

'''PLEASE DO NOT FORGET'''

To consider adding this subject to a training program for new employees or refresher training (if appropriate)

== C. Resources ==
Template to create a study protocol based on the above guidance - [https://paasp.sharepoint.com/:w:/s/EQIPD/EbuGPqIAiTtKlmRQJ7bSy_0BfmYNqXl-W6Reh3tW5vAIzQ?e=CkXHXv 2.1.1 Study protocol.docx], [https://paasp.sharepoint.com/:w:/s/EQIPD/EXmh9e3w78ZLqPjOd1WNdaQBpt4FZ0mTctaQCRTM8NisMw?e=UJrcmw 2.1.1 Study protocol with macro.docm]

Literature:
* Hooijmans CR, Rovers MM, de Vries RBM, Leenaars M, Ritskes-Hoitinga M, Langendam MW (2014) SYRCLE’s risk of bias tool for animal studies. BMC Medical Research Methodology 14:43 [https://bmcmedresmethodol.biomedcentral.com/articles/10.1186/1471-2288-14-43]
* Kimmelman J, Mogil JS, Dirnagl U (2014) Distinguishing between exploratory and confirmatory preclinical research will improve translation. PLoS Biol 12(5):e1001863 [https://doi.org/10.1371/journal.pbio.1001863]
* Nosek BA, Errington TM (2020) What is replication? PLoS Biol 18(3): e3000691 [https://doi.org/10.1371/journal.pbio.3000691]
* Dirnagl U (2016) Thomas Willis Lecture: Is Translational Stroke Research Broken, and if So, How Can We Fix It? Stroke 47(8):2148-53 [https://doi.org/10.1161/STROKEAHA.116.013244]

----------------
back to [[Toolbox]]

Next item: [[2.1.5 Pre-specification]]

2.1.4 Purpose of research

2024-10-13T09:51:11Z

Bjoerngerlach: /* B. Guidance & Expectations */

== A. Background & Definitions ==

Several commonly acknowledged risks can bias the research results ([https://doi.org/10.1186/1471-2288-14-43 Hooijmans et al. 2014]).

There are modes of research that can tolerate a certain level of uncertainty, and while not leading to a formal knowledge claim, such work is an essential part of the research process. It may be used to generate hypotheses, to provide evidence to give the investigator greater confidence that an emerging hypothesis is valid, or to “screen” compounds for potential effects prior to more formal testing.

There are also modes of research where researchers want to minimize the risks of failing due to inadequate control of the risks of bias.

For every study, EQIPD recommends scientists to apply protection against risks of bias and to be transparent about the protective measures applied.

EQIPD requires that the maximal rigor possible is applied (and exceptions explained / documented in the study protocol) to research that is conducted with the prior intention of informing a knowledge claim ([[Glossary]]). This will usually (but not always) involve some form of null hypothesis statistical testing or formal Bayesian analysis. Hypotheses are articulated in advance of data collection, with pre-specified criteria defining the primary outcome measure and the statistical test to be used. Depending on the purpose for which the knowledge claim will be used, different research strategies are appropriate. A single well conducted preclinical study may be considered sufficient to convince others that the phenomena are real enough to justify their attention, but may not be sufficient to justify major research investment such as a clinical study.

Examples of research requiring the maximal rigor possible include:
* 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])
* 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)
* 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])
* Labor-, resource- and/or time-intensive studies that cannot be easily repeated

== B. Guidance & Expectations ==
One of the [[Core Requirements]] of the EQIPD Quality System is that investigators must assert in advance whether a study will be conducted to inform a formal knowledge claim. This statement should be recorded in the [[2.1.1 Study protocol]] (see below for a template).

If uncertain about your study being knowledge-claiming or not, please check [[FAQ]] page or contact the EQIPD Expert Team for an advice.

Efforts to minimize the risks of bias ([https://doi.org/10.1186/1471-2288-14-43 Hooijmans et al. 2014]) should be applied to all studies that aim to inform a knowledge claim (table inspired by [https://doi.org/10.1161/STROKEAHA.116.013244 Dirnagl 2016]):

{| class="wikitable"
|
|'''Research NOT informing a formal knowledge claim'''
|'''Research informing a formal knowledge claim (i.e. research requiring maximal rigor)*'''
|-
|'''[[2.1.1 Study protocol|Study protocol]]'''
|should be defined and documented before starting the experiments
|must be defined and documented before starting the experiments
|-
|'''Study hypothesis'''
|advised to define
|must be pre-specified
|-
|'''[[2.1.7 Blinding|Blinding]]'''
|advised to implement
|should be implemented, exceptions must be justified and documented
|-
|'''[[2.1.8 Randomisation|Randomisation]]'''
|advised to implement
|should be implemented, exceptions must be justified and documented
|-
|'''[[2.1.6 Sample size and power analysis|Sample size and power analysis]]'''
|advised to define and document before starting the experiments
|must be defined and documented before starting the experiments (e.g. included in the study protocol)
|-
|'''[[2.3.3 Statistical analysis|Data analysis]]'''
|advised to define and document before starting the experiments
|must be defined and documented before starting the experiments (e.g. as a formal statistical analysis plan and/or included in the study protocol)
|-
|'''[[2.1.9 Inclusion and exclusion criteria|Inclusion and exclusion criteria]]'''
|advised to define and document before starting the experiments
|must be defined and documented before starting the experiments (e.g. included in the study protocol)
|-
|'''Deviations from study protocol'''
|advised to document
|must be documented
|-
|'''[[2.1.11 Preregistration|Preregistration]]'''
|no
|should be implemented
|}

* Please refer to [[Glossary]] for explanation on the EQIPD use of the verbs "must" and "should"

'''PLEASE DO NOT FORGET'''

To consider adding this subject to a training program for new employees or refresher training (if appropriate)

== C. Resources ==
Template to create a study protocol based on the above guidance - [https://paasp.sharepoint.com/:w:/s/EQIPD/EbuGPqIAiTtKlmRQJ7bSy_0BfmYNqXl-W6Reh3tW5vAIzQ?e=CkXHXv 2.1.1 Study protocol.docx], [https://paasp.sharepoint.com/:w:/s/EQIPD/EXmh9e3w78ZLqPjOd1WNdaQBpt4FZ0mTctaQCRTM8NisMw?e=UJrcmw 2.1.1 Study protocol with macro.docm]

Literature:
* Hooijmans CR, Rovers MM, de Vries RBM, Leenaars M, Ritskes-Hoitinga M, Langendam MW (2014) SYRCLE’s risk of bias tool for animal studies. BMC Medical Research Methodology 14:43 [https://bmcmedresmethodol.biomedcentral.com/articles/10.1186/1471-2288-14-43]
* Kimmelman J, Mogil JS, Dirnagl U (2014) Distinguishing between exploratory and confirmatory preclinical research will improve translation. PLoS Biol 12(5):e1001863 [https://doi.org/10.1371/journal.pbio.1001863]
* Nosek BA, Errington TM (2020) What is replication? PLoS Biol 18(3): e3000691 [https://doi.org/10.1371/journal.pbio.3000691]
* Dirnagl U (2016) Thomas Willis Lecture: Is Translational Stroke Research Broken, and if So, How Can We Fix It? Stroke 47(8):2148-53 [https://doi.org/10.1161/STROKEAHA.116.013244]

----------------
back to [[Toolbox]]

Next item: [[2.1.5 Pre-specification]]

2.1.4 Purpose of research

2024-10-13T09:50:54Z

Bjoerngerlach: /* B. Guidance & Expectations */

Sex as a biological variable

2024-08-28T14:41:08Z

Bjoerngerlach:

== A. Background & Definitions ==

tba

== B. Guidance & Expectations ==

tba

'''PLEASE DO NOT FORGET'''

== C. Resources ==

tba

----------------
back to [[Toolbox]]

back to [[Abbreviations]]

Sex as a biological variable

2024-08-28T14:40:51Z

Bjoerngerlach: Created page with "== A. Background & Definitions == tba == B. Guidance & Expectations == tba '''PLEASE DO NOT FORGET''' == C. Resources ==..."

== A. Background & Definitions ==

tba

== B. Guidance & Expectations ==

tba

'''PLEASE DO NOT FORGET'''

== C. Resources ==

----------------
back to [[Toolbox]]

back to [[Abbreviations]]