EQIPD - User contributions [en]

4.1.3 External Assessment

2026-10-06T09:37:05Z

Leonardo.restivo:

Template:Preamble

2026-10-06T09:20:51Z

Leonardo.restivo:

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Template:Preamble

2026-10-06T09:18:33Z

Leonardo.restivo:

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This template holds the search preamble for a toolbox page: alternative names for
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Place it at the very top of the page, above the first heading.

Parameters:
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Pages using this template are collected in [[:Category:Pages with preamble]].
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Template:Preamble

2026-10-06T09:18:00Z

Leonardo.restivo:

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This template holds the search preamble for a toolbox page: alternative names for
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Place it at the very top of the page, above the first heading.

Parameters:
* '''aliases''' — a bulleted list of other names for the topic
* '''answers''' — a bulleted list of questions, each ending in a question mark

Pages using this template are collected in [[:Category:Pages with preamble]].
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Template:Preamble

2026-10-06T09:15:35Z

Leonardo.restivo:

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This template holds the search preamble for a toolbox page: alternative names for
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Place it at the very top of the page, above the first heading.

Parameters:
* '''aliases''' — a bulleted list of other names for the topic
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Pages using this template are collected in [[:Category:Pages with preamble]].
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Template:Preamble

2026-10-06T09:14:55Z

Leonardo.restivo:

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'''Search terms and questions this page answers'''<br />
<span style="color:#54595d;">Helps people and AI assistants find this page. Not part of the guidance.</span>
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This template holds the search preamble for a toolbox page: alternative names for
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Place it at the very top of the page, above the first heading.

Parameters:
* '''aliases''' — a bulleted list of other names for the topic
* '''answers''' — a bulleted list of questions, each ending in a question mark

Pages using this template are collected in [[:Category:Pages with preamble]].
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Template:Preamble

2026-10-06T09:12:46Z

Leonardo.restivo:

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<span style="color:#54595d;">Search terms for the AI-readable copy of this page. Edited here, read from the markdown version.</span>
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This template holds the search preamble for a toolbox page: alternative names for
the topic, and the questions the page answers.

Place it at the very top of the page, above the first heading.

Parameters:
* '''aliases''' — a bulleted list of other names for the topic
* '''answers''' — a bulleted list of questions, each ending in a question mark

Pages using this template are collected in [[:Category:Pages with preamble]].
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Template:Preamble

2026-10-06T09:11:05Z

Leonardo.restivo:

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'''Search terms and questions this page answers'''<br />
<span style="color:#54595d;">Search terms for the AI-readable copy of this page. Edited here, read from the markdown version.</span>
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; Also known as
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{{{answers|}}}
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This template holds the search preamble for a toolbox page: alternative names for
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Place it at the very top of the page, above the first heading.

Parameters:
* '''aliases''' — a bulleted list of other names for the topic
* '''answers''' — a bulleted list of questions, each ending in a question mark

Pages using this template are collected in [[:Category:Pages with preamble]].
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Template:Preamble

2026-10-06T09:09:22Z

Leonardo.restivo:

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'''Search terms and questions this page answers'''<br />
<span style="color:#54595d;">Metadata to help AI assistants find this page. Not part of the guidance.</span>
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{{{answers|}}}
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This template holds the search preamble for a toolbox page: alternative names for
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Place it at the very top of the page, above the first heading.

Parameters:
* '''aliases''' — a bulleted list of other names for the topic
* '''answers''' — a bulleted list of questions, each ending in a question mark

Pages using this template are collected in [[:Category:Pages with preamble]].
</noinclude>

4.2.1 Installation of solutions, actions and mitigation strategies

2026-10-06T08:31:59Z

Leonardo.restivo:

{{Preamble
| aliases =
* installing solutions
* mitigation strategies
* corrective actions
* action plan
* addressing challenges
| answers =
* What do I do about problems found during a risk or self assessment?
* How are solutions to quality challenges implemented and documented?
* Do we have to address challenges in the priority order given in the Action Plan?
* How often should we check that our solutions still work?
}}

== A. Background & Definitions ==
Researchers may identify issues, needs and challenges via different routes (e.g. [[4.1.1 Risk assessment]], [[4.1.2 Self assessment]], during group meeting discussions,...) that need to be addressed by the research unit to improve the quality of data. These challenges can be listed in a document prepared by the research unit or in the Action Plan when applying the EQIPD Planning Tool. These challenges require solutions to be established and the implementation to be documented.

== B. Guidance & Expectations ==

Installation of solutions, actions and mitigation strategies require continuous efforts by the researchers of a unit for improving the quality of the research data.

Hence, it is expected that:
* Relevant challenges must be addressed with adequate solutions
* The solutions are challenged for their effectiveness and appropriateness on a regular basis (either individually or during the [[4.1.2 Self assessment]])
* If necessary, refinements are implemented
* Implementation and updates are documented

These expectations are supported by EQIPD Tools:
* A list of challenges is provided in the Action Plan and can be addressed according to the prescribed "Importance/Priority", however, researchers do not have to adhere to this priority list if items with lower priority seem to be more important to deal with for a research unit.
* The Toolbox provides information on how to implement solutions
* [[4.1.2 Self assessment]] or [[4.1.3 External assessment]] helps to challenge the implemented solutions
* The Action Plan provides the possibility to document the implementation, updates and comments

'''PLEASE DO NOT FORGET'''
* To periodically assess the solutions

== C. Resources ==
to be added

----

back to [[Toolbox]]

Next item: [[4.2.2 Error and incident management]]

4.3.2.4 Deleting NEEDs

2026-10-06T08:06:02Z

Leonardo.restivo:

{{Preamble
| aliases =
* deleting NEEDs
* removing NEEDs
* outdated NEEDs
| answers =
* How do I delete a NEED that no longer applies?
* What should I do if a NEED is outdated?
* Our funding ended, so how do we mark a NEED as no longer applicable?
}}

== A. Background & Definitions ==
It may occur that NEEDs are outdated or not important for a research unit anymore which can have different reasons (e.g. funding ends, the research unit moves to a different environment, etc.). This might make it neccessary to delete certain NEEDs.

== B. Guidance & Expectations ==
In case a NEED is not required anymore, it is currently not possible to delete this need from the action plan. Instead,
* the research unit shall indicate in the column for comments why this NEED is not applicable anymore.

== C. Resources ==

tba

----------------
go to [[Toolbox]]

4.3.2.3 Revising NEEDs

2026-10-06T08:05:39Z

Leonardo.restivo:

{{Preamble
| aliases =
* revising NEEDs
* reviewing NEEDs
* updating NEEDs
| answers =
* How often should NEEDs be reviewed?
* When do NEEDs need updating?
* Do we need to review our NEEDs when we get a new funder or move the lab?
}}

== A. Background & Definitions ==
tba

== B. Guidance & Expectations ==
All NEEDs should be carefully checked for their necessity and up-to-dateness and NEEDs should be reviewed:
* on regular time intervalls (e.g. once per year)
* after changes for the RU have occured (e.g. new collaboration partner, new funder, moving the lab)

== C. Resources ==
tba

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

Next item: [[4.3.2.4 Deleting NEEDs]]

[[just a test site]]

4.3.2.2 Creating NEEDs

2026-10-06T08:05:17Z

Leonardo.restivo:

{{Preamble
| aliases =
* creating NEEDs
* creator tool
* defining a new NEED
* challenges and solutions
* challenge priority
| answers =
* How do I use the Creator Tool to create a new NEED?
* How do I turn a funder's requirements into a NEED for research units?
* What is the difference between a challenge and a solution?
* What do the priority levels of a challenge mean?
}}

== A. Background & Definitions ==
NEED: A specific reason for introducing, and maintaining, high quality in the research unit's mission and objectives. NEEDs can be dictated by stakeholders (e.g. funders) or defined by EQIPD. They are identified by the research unit and included in the Planning Tool.

Challenge: An unmet requirement that must be appropriately matched by a specific solution.

Solution: The answer to an identified challenge.

Priority: The challenges are ranked in three categories: "1 - advisable", "2 - strongly recommended", "3 - must have". It will determine the order of the item in the planning tool with priority "3 - must have" at the top.

Planning Tool: A software tool supporting the research unit in order to implement the EQIPD QS.

Creator Tool: A software tool supporting the set-up of a new NEED that has to be followed by the research unit and can be imported into the Action Plan within the Planning Tool.

== B. Guidance & Expectations ==
NEEDs can be created with the Creator Tool, which can be [https://paasp.sharepoint.com/:x:/s/EQIPD/Ec7UcFeom49GvXy43OTrwZABM--RVkHcIfDNLc-xLj7Dlg?e=oOKBbQ downloaded here] (please download the file to enable Macros).

The CREATOR provides guidance for setting-up specific NEEDs and works as follows:
* Opening the Creator Tool requires activated Macros and will directly prompt you to define a name for your NEED. This name will be displayed with every challenge that is set up within this need.
* The Creator Tool displays all EQIPD Core and Confirmatory Requirements in a table to allow judging their importance. Leaving this empty will rate the importance with the lowest priority.
* New CHALLENGES can be set-up with the "ADD NEW CHALLENGE" button which will start a Wizard with 4 tabs:
** 1. Tab – Edit Challenge: A text field gives the possibility to name the new Challenge.
** 2. Tab – Edit Guidance: Free text can be entered to provide guidance on how to tackle this challenge. It is also possible to provide an External link.
** 3. Tab – Edit Importance: With the drop-down menu the importance can be determined.
** 4. Tab – Edit Comment: This free text provides the possibility for additional comments.
* Pressing the "disk-button" will transfer your information into the Excel sheet and finalise the setting up of this Challenge
* The Challenge can be modified by clicking on the row
* It is possible to set-up as many Challenges as needed for a given NEED
* The process is finalised by exporting the NEED with the button "EXPORT NEEDs"
* The resulting Excel file can be shared and imported by the research units who must adhere to this NEED (see more information [[4.3.2.1 Using the Planning Tool]])

'''PLEASE DO NOT FORGET'''
* to take special care that all your Challenges are covered within the NEED
* to provide enough details about each SOLUTION so that they can be easily understood by all members of the researcher unit

== C. Resources ==

Youtube tutorial on using the Creator tool:

{{#ev:youtube|https://www.youtube.com/watch?v=SZwJfJWagl4&t=214s|500}}

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

Next item: [[4.3.2.3 Revising NEEDs]]

4.3.2.1 Using the Planning Tool

2026-10-06T08:04:44Z

Leonardo.restivo:

{{Preamble
| aliases =
* planning tool
* dashboard
* setup wizard
* importing NEEDs
* setting up the quality system with the tool
| answers =
* How do I use the EQIPD Planning Tool?
* What is the Dashboard in the Planning Tool?
* How do I track progress of the quality system implementation?
* How do I add a funder's NEED to our Dashboard?
}}

== A. Background & Definitions ==

The Planning Tool A) provides guidance for setting-up the quality system, B) gives an overview of information connected with it and C) supports the maintenance of the system. The Dashboard within the Planning Tool is the central place to collect relevant information, such as documents established for the quality system, a summary of solutions and dates for the review.

Additionally, it provides the possibility to document the progress of the quality system implementation and has the ability to be expanded with additional NEEDs to match each research unit's specific requirements. These NEEDs created by the organisation or by others (e.g. a funder) can be imported into the existing Dashboard, whereby the challenges will be extended, and the priorities automatically adjusted.

Planning Tool: Software tool supporting the research unit in order to implement the EQIPD QS system in a given institution.

== B. Guidance & Expectations ==

The following steps describe the use of the tool and the import of NEEDs:

===1. Download and extract the EQIPD tools===
either from [[4.3.2.1 Using the Planning Tool#C. Resources|this site]] or [[Implementation Strategy]] as described the following tutorial.
:::{{#ev:youtube|https://youtu.be/abQGnKOGKWI|500|center}}

===2. Setting up the Dashboard with the Wizard===
* Open your planning tool and activate "macros"
* The Wizard will start automatically and give guidance for implementation of the first 6 Core Requirements
* All documents within the Wizard should be read and completed before going to the next step
* Additionally, the wizard asks for information on Animal Care and Use (if applicable) and whether a research unit wants to make a formal knowledge-claim
* After completion of the Wizard, the Dashboard is created, with
** the 6 already implemented Core Requirements, displayed in green
** the 12 additional Core Requirements
** if applicable, 6 EQIPD Requirements for informing a formal knowledge claim
:::{{#ev:youtube|https://youtu.be/y4Milaq3C1w|500|center}}

===3. Getting familiar with the Dashboard===
* After the Dashboard is established, each CHALLENGE should be addressed according to the needs, resources and capabilities of the research unit
* The solutions can be documented in column "D"
* The additional columns "E" to "I" of the Dashboard can be used to document additional information and the progress of implementation and follow-up actions
{{#ev:youtube|https://youtu.be/hJ-l-pZzuOg|500|center}}

===4. The Menubar - Adding NEEDs and support for the assessments===
'''Adding NEEDs with the button "IMPORT NEED"'''
* Click button and a new window will open
* Click on the folder-icon and search for the NEED to be imported
* Click "OK" (the path of the file will be displayed)
* Click on arrow to the right ("Next")
* Confirm import to finalize the process, the NEED will be integrated into the Dashboard

'''Supporting the Assessments'''
* The Planning Tool supports the self- and risk-assessment
* Click on the assessment you would like to perform
* Fill out the template that appeared in a new tab in Excel
* Archive the form via the button on top - this will automatically save a pdf in your Dossier
* Deleting the assessment will automatically close it and bring you back to the Dashboard
{{#ev:youtube|https://youtu.be/rIshWcwr_N8|500|center}}

== C. Resources ==
[[Information on the calculation of the priority ranking]]

[[File:Download img 210329.jpg|170px|link=https://paasp.sharepoint.com/:u:/s/EQIPD/ERWfS3Yuw6NJodMY_iz8A5MBxESAFCjPzWMu-DFd3xUrfw?e=4O5622]] the Planning Tool and the Dossier.

----------------

back to [[Toolbox]]

Next item: [[4.3.2.2 Creating NEEDs]]

4.3.1.3 Revising items

2026-10-06T08:03:39Z

Leonardo.restivo:

{{Preamble
| aliases =
* revising items
* updating the dossier
* reviewing documents
* document review
| answers =
* How often should quality documents be reviewed?
* How do I update an item in the Dossier?
* Which documents should be updated first?
}}

== A. Background & Definitions ==
Dossier: Structured and categorized collection of various quality-related items, such as protocols and training records that are developed and stored by a research unit as solutions to challenges specific to their needs.

== B. Guidance & Expectations ==
Revising and updating is an essential process to keep the system functional.

This should be done
* on regular intervalls defined by the research unit
* as needed, e.g. when an update is neccessary.

Thus, it is recommended that items considered to be most critical should be immeditely updated and a process should be in place to do this on a regular basis.

== C. Resources ==

tba

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

Next item: [[4.3.2 Using the EQIPD applications]]

4.3.1.2 Deleting items

2026-10-06T08:02:22Z

Leonardo.restivo:

{{Preamble
| aliases =
* deleting items
* removing items from the dossier
* retiring documents
* archiving dossier items
| answers =
* How do I remove an item from the Dossier?
* Should outdated quality documents be deleted?
* What should I do with a protocol we no longer use?
}}

== A. Background & Definitions ==
Dossier: Structured and categorized collection of various quality-related items, such as protocols and training records that are developed and stored by a research unit as solutions to challenges specific to their needs.

== B. Guidance & Expectations ==
Folders and documents that are no longer of use should not be deleted per se to protect loss of information and maintain transparency. It is advisable to
* mark the items as not needed anymore
* add a short explanation why the item is not important anymore
* archive the the items in a dedicated space

'''Please do not forget'''
* to make sure that deleting the item will not affect data quality.
* to document for important items why this change was neccessary.

== C. Resources ==
to be added

----

back to [[Toolbox]]

Next item: [[4.3.1.3 Revising items]] in the Dossier

4.2.4 Key performance indicators

2026-10-06T08:01:51Z

Leonardo.restivo:

{{Preamble
| aliases =
* key performance indicators
* KPIs
* quality metrics
* performance metrics
* measuring research quality
| answers =
* What are key performance indicators in EQIPD?
* What metrics could a research unit track to measure research quality?
* Who collects and evaluates the KPIs, and how often?
* How can research quality be quantified?
}}

== A. Background & Definitions ==
Key performance indicators: Specific parameters and quality criteria that are defined in order to measure achievable milestones or to enable performance assessment about areas in a research unit (RU).

== B. Guidance & Expactations ==
The success of research is very complex and difficult to measure; therefore, this topic can only be approached by indirect methods.

Each RU should define key performance indicators depending on the field of research and for specific areas, which are collected and evaluated in a document (LINK) once a year. These can be, for example:
* number of open access publications,
* number of registered reports,
* number/percentage of blinded studies,
* number of studies clearly documented in lab notebook,
* randomization and sample size calculation included,
* number of studies with raw data accessible in a public database,
* the raising of funds,
* the number of doctoral theses completed,
* the number of participants in mandatory training courses,
* the number of EQIPD self assessments per year, etc.

Generating suitable indicators is an ongoing process over many years, in which the process owner, "quality people", researchers and the department heads should be involved. Appropriate metrics must be easy to collect and meaningful.

As a rule, the key performance indicators are collected, checked and evaluated once a year by a dedicated person together with quality professionals, researchers involved in the implementation of the quality system and the process owner. By comparing the key performance indicators over the years, specific trends and information can be read off, so that negative trends can be countered at any time with suitable measures and positive trends can be strenghtened if desired.

'''PLEASE DO NOT FORGET'''

Defining and using suitable key performance indicators can be very tricky. Often, it will only become obvious after using them over a longer period which makes it necessary to review and adjust them periodically.

== C. Resources ==

tbd

----

back to [[Toolbox]]

Next item: [[4.3.1.1 Adding new items]] to the Dossier

4.2.3 Responsible conduct of research

2026-10-06T08:01:20Z

Leonardo.restivo:

{{Preamble
| aliases =
* responsible conduct of research
* research misconduct
* speak up mechanism
* ombudsperson
* integrity concern
* whistleblowing
| answers =
* What should a research unit do about suspected misconduct?
* How do I report a research integrity concern?
* What procedure is required for handling misconduct allegations?
* Which core requirement covers research misconduct?
}}

== A. Background & Definitions ==
This item refers to one of the [[Core Requirements]] (Core Requirement 5 - "The research unit must have a procedure to act upon concerns of potential misconduct") and is, therefore, considered as essential.

Please see Toolbox item [[1.4.1.1 Research integrity]] for background and definitions.

== B. Guidance & Expectations ==
The research unit (or the research organization to which the research unit belongs to) must have a uniform and robust procedure in place to deal with potential research misconduct:
* A central and known to all researchers "speak up" mechanism for research misconduct concerns must be in place.
** This could be an ombudsperson or research integrity officer or an anonymous mailbox or a confidential electronic "hotline" from where concerns are triaged to a dedicated person.
** This could be a person of trust identified in the neighboring research unit or organization and who would be in a position to deal with violations and allegations of misconduct in agreement with the national or institutional guidelines. Please see also the [[FAQ]] section.
* In general, allegations of misconduct are handled by a standing or ad hoc investigation committee taking into account the required expertise and potential conflict of interest.
**The ENRIO handbook on Recommentations for the Investigation of Research Misconduct is a good resource for practical recommendations.

It is advised that the procedure, including the speak-up (anonymous reporting, whistleblower policy) and the investigation mechanism, is described and documented in a single file in the Dossier and the research unit informed about it via Email or in group meetings.

'''PLEASE DO NOT FORGET'''
* Research misconduct is a sensitive topic and has to be handled with maximal care, fairness, and integrity
* To provide training on research integrity and document it
* To make sure that every member of the research unit knows how to report potential misconduct

== C. Resources ==

Essential reading:
* [https://allea.org/code-of-conduct/ The European Code of Conduct for Research Integrity (ALLEA)]
* [https://www.who.int/about/ethics/code-of-conduct-for-responsible-research WHO Code of Conduct for responsible researh]
* [http://eneri.eu/reri-manual/ ENERI Research Integrity & Research Ethics Manual]
* [http://eneri.eu/wp-content/uploads/2019/03/INV-Handbook_ENRIO_web_final.pdf ENRIO Handbook on Recommendations for the Investigation of Research Misconduct]
* [https://www.dfg.de/en/research_funding/principles_dfg_funding/good_scientific_practice/ German Research Foundation]

Training and learning resources:
* [https://www.earma.org/wp-content/uploads/2020/10/EARMA-ERION-Training-Report-2020_v20.10.pdf EARMA Guidance for implementation of ethics and integrity training]
* [https://www.eur.nl/en/about-eur/policy-and-regulations/integrity/research-integrity/dilemma-game Erasmus University dilemma game]
* [https://ukrio.org/publications/case-study-packs/ UKRIO case studies]
* [https://ori.hhs.gov/research-clinic US ORI The research clinic]

Examples and guidance on building institutional policies:
* [https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/415175/bis-15-200-whistleblowing-guidance-for-employers-and-code-of-practice.pdf Whistleblowing: Guidance for employers and code of practice]

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back to [[Toolbox]]

Next item: [[4.2.4 Key performance indicators]]

4.2.2 Error and incident management

2026-10-06T08:00:58Z

Leonardo.restivo:

{{Preamble
| aliases =
* error management
* incident management
* critical incident
* reporting errors
* mistakes during a study
| answers =
* How should errors and incidents be handled?
* What is a critical incident in EQIPD?
* Do I have to document mistakes made during a study?
* Which core requirement covers error management?
}}

== A. Background & Definitions ==
This item refers to one of the [[Core Requirements]] (Core Requirement 16 - "Critical incidents and errors during study conduct must be analyzed and appropriately managed") and is, therefore, considered essential.

Critical Incident: An unexpected deviation from the intention (e.g. study protocol) with a larger or longlasting impact on the experimental outcome or on the research unit (RU).



== B. Guidance & Expectations ==
The EQIPD QS recogizes two levels of error and incident management - mandatory (to meet the EQIPD Core Requirement) and voluntary (for systematic error management).

'''The EQIPD Core Requirement on error and incident reporting'''

Basic reporting of errors and incidents is important to create transparency of the experimental work performed in a research unit. The following is expected:
* Error documentation
** All errors affecting the outcome of experiments must be documented during study conduct within the experimental records
* Impact assessment
** The researcher must assess the incident and decide whether the error has to be communicated (click [https://paasp.sharepoint.com/:p:/s/EQIPD/Ee8vZYriaw1OguV7kUtUXfMBVlZPFBjitJVEvbeL6-ivDA?e=Wa0h5b HERE] for a decision tree)
** This is an informal step and no documentation is required
* Mitigation approach
** Depending on the impact and scope, the mitigation approach must either be developed by the researcher themselves, by the lab supervisor or in a dedicated team. It could also be discussed in a lab meeting if most group members are affected.
** The mitigation approach should be documented (e.g. with a formal template, as a note with the experimental record, as an Email trail in a dedicated mailbox or any other way)
** If applicable, measures should be taken to avoid this error in the future

To fulfill this Core Requirement, it is expected that awareness about the error culture is created (e.g. during lab meetings).

'''Voluntary approaches''' providing a systematic error management

To report and document errors at this level the following approach may be applied:
* Identify a person responsible for collecting errors and incidents
* Report errors via a document (please see below for a template) or electronic tool (e.g. [https://journals.plos.org/plosbiology/article?id=10.1371/journal.pbio.2000705 LabCIRS])
* The person overseeing errors and incidents is informed (anonymously)
* Countermeasures shall be discussed and established to prevent reoccurence
* The error and the countermeasures shall be presented and discussed with the whole team (e.g. during lab meetings)

'''PLEASE DO NOT FORGET'''

* To actively facilitate a positive and transparent error culture. This can be done with short trainings when onboarding new team members or during an annual training. The presentation created by the EQIPD team can provide a starting point ([https://paasp.sharepoint.com/:p:/s/EQIPD/EfltooJlYjhDpLup3PWr_jQBJLyVSbNhz8h9r6AS4oSl2w?e=eBPvV8 LINK]).

'''RISK ASSESSMENT'''
* Admitting and handling errors and incidents is a sensitive topic as it may be perceived as embarrassing and shameful. Hence, special care has to be applied while discussing, documenting and dealing with erros and incidents.

== C. Resources ==
Template for documenting errors and critical incidents - [https://paasp.sharepoint.com/:w:/s/EQIPD/EatOAFgLbctEvxRZTuSCdU4Bv8J1I_BitfKl-JJiieOTLA?e=hvjomY 4.2.2 Error Reporting.docx]

Powerpoint presentation for creating awareness about Error management - [https://paasp.sharepoint.com/:p:/s/EQIPD/EfltooJlYjhDpLup3PWr_jQBJLyVSbNhz8h9r6AS4oSl2w?e=eBPvV8 EQIPD training slides on Error Management 200331.pptx]

LabCIRS:
* software [https://github.com/major-s/labcirs]
* publication [https://journals.plos.org/plosbiology/article?id=10.1371/journal.pbio.2000705]

Other publications:
* Errors and error management in biomedical research [https://doi.org/10.5281/zenodo.1406922]

----

back to [[Toolbox]]

Next item: [[4.2.3 Responsible conduct of research]]

4.2.1 Installation of solutions, actions and mitigation strategies

2026-10-06T08:00:22Z

Leonardo.restivo:

{{Preamble
| aliases =
* installing solutions
* mitigation strategies
* corrective actions
* action plan
* addressing challenges
| answers =
* What do I do about problems found during a risk or self assessment?
* How are solutions to quality challenges implemented and documented?
* Do we have to address challenges in the priority order given in the Action Plan?
* How often should we check that our solutions still work?
}}

== A. Background & Definitions ==
Researchers may identify issues, needs and challenges via different routes (e.g. [[4.1.1 Risk assessment]], [[4.1.2 Self assessment]], during group meeting discussions,...) that need to be addressed by the research unit to improve the quality of data. These challenges can be listed in a document prepared by the research unit or in the Action Plan when applying the EQIPD Planning Tool. These challenges require solutions to be established and the implementation to be documented.

== B. Guidance & Expectations ==

Installation of solutions, actions and mitigation strategies require continuous efforts by the researchers of a unit for improving the quality of the research data.

Hence, it is expected that:
* Relevant challenges must be addressed with adequate solutions
* The solutions are challenged for their effectiveness and appropriateness on a regular basis (either individually or during the [[4.1.2 Self assessment]])
* If necessary, refinements are implemented
* Implementation and updates are documented

These expectations are supported by EQIPD Tools:
* A list of challenges is provided in the Action Plan and can be addressed according to the prescribed "Importance/Priority", however, researchers do not have to adhere to this priority list if items with lower priority seem to be more important to deal with for a research unit.
* The Toolbox provides information on how to implement solutions
* [[4.1.2 Self assessment]] or [[4.1.3 External Assessment]] helps to challenge the implemented solutions
* The Action Plan provides the possibility to document the implementation, updates and comments

'''PLEASE DO NOT FORGET'''
* To periodically assess the solutions

== C. Resources ==
to be added

----

back to [[Toolbox]]

Next item: [[4.2.2 Error and incident management]]

4.1.3 External assessment

2026-10-06T07:59:20Z

Leonardo.restivo:

{{Preamble
| aliases =
* external assessment
* external audit
* EQIPD certification
* getting certified
* quality certificate
| answers =
* What is an external assessment in EQIPD?
* How do I get my research unit EQIPD certified?
* Who is qualified to audit a research unit for EQIPD?
* What happens during the certification process?
* How long is an EQIPD certificate valid?
}}

== A. Background & Definitions ==
External Assessment: Evaluation of a research unit performed by an external party to judge whether the EQIPD QS is implemented appropriately

== B. Guidance & Expectations ==
[[File:External Assessment 210906.png|right|400px]]
The External Assessment is performed by partners who are eligible to perform the assessments, meaning that they must have the formal training as auditors.

The aim of the External Assessment is to examine the compliance of structures and procedures of an organization with the EQIPD QS.

The External Assessment is performed with checklists and in two steps, whereas the first is mandatory and the second by chance:
* Remote Assessment
* On-site visits

Examples for a potential assessment:
* Reconstruct data and check critical items (checklist) by selecting a sample and track it back to the methods, equipment and freezer storage
* Validation of a method: who and how to use the SOP => Comparison of the individual steps => description of where problems occurred => compare how to document and evaluate them

The process for the External Assessment is described as follows:
# You can get in contact with EQIPD via Email (info@go-eqipd.org) to initiate your certification
# EQIPD, represented by a partner, will
## Provide you with additional information about the assessment and answer your questions
## Clarify costs, NDA and contracting
## Ask for several relevant documents to be assessed, e.g.:
### Study plans
### SOPs / Method protocols
### Publications
### EQIPD stand-alone documents (more information here: [[Documentation in EQIPD]])
# Remote assessment performed with an in-depth questionnaire focused on the relevant EQIPD core requirements and quality measures + assessment of provided documents
# Random selection of research units for onsite visit
# Provisional assessment report providing feedback and detailing any recommendations to be addressed or implemented (if any) to be shared with you for review
# Final Assessment Report submitted to you
# Award of the Quality Certificate to demonstrate compliance with the EQIPD requirements

'''PLEASE NOTE'''

* The certification will be assigned for 3 years with a short remote assessment after 1 and 2 years.
* You will receive a printed certification and a digital logo

== C. Resources ==
to be added

----

back to [[Toolbox]]

Next item: [[4.2.1 Installation of solutions, actions and mitigation strategies]]

4.1.2 Self assessment

2026-10-06T07:58:34Z

Leonardo.restivo:

{{Preamble
| aliases =
* self assessment
* self-assessment
* compliance check
* checking compliance
* am I compliant
| answers =
* How do I check whether my research unit is compliant?
* How do we know if we meet the EQIPD requirements?
* What is the EQIPD self-assessment?
* Who carries out the self-assessment, and how often?
* Which core requirement covers monitoring the performance of the quality system?
}}

== A. Background & Definitions ==
This item refers to one of the [[Core Requirements]] (Core Requirement 17 - "An approach must be in place to monitor the performance of the EQIPD QS, and address identified issues") and is, therefore, considered as essential.

The self-assessment:
* answers the question whether the RU has everything in place needed for proper performance of the EQIPD Quality System
* sets the basis for internal or external quality checks / accreditation mechanism

Depending on the organization, self-assessments may be supplemented by [[Internal assessment]]s conducted by qualified members outside the RU but within the same organization (e.g., dedicated quality professionals).

== B. Guidance & Expectations ==
Self-assessment must be conducted by the Process Owner who may involve other members of the RU (or delegate certain tasks).

Defining the scope and content of the self-assessment
* Process Owner should define the scope of the self-assessment (involving the RU members as needed), e.g.
** Are the RU's quality goals and objectives reached?
** Is the RU prepared to seek or maintain a formal EQIPD Quality System certification?
* Together with the RU members, Process Owner should define:
** How often self-assessments are to be conducted (depends on the characteristics of the RU, research that is conducted, and the risks that are likely to be encountered)?
** How often should the [[Spot checks]] on completed studies be conducted? What is the procedure for such spot checks?
** Should any issues be identified, what is the procedure to address these issues? What is the procedure to address the effectiveness of the corrective measures?
* It is up to the Process Owner to decide whether the self-assessment procedure (with/without associated metrics) should be documented and, if yes, in what form

Conducting the self-assessment
* If the EQIPD Planning Tool is used, the integrated self-assessment functionality can facilitate the assessment (see [[4.3.2.1 Using the Planning Tool]]). Between the self assessments, Process Owner (or someone to whom this task is delegated) may record any relevant information on the Dashboard in the Planning Tool (e.g. random spot checks). Having all information and notes in one place will facilitate the completion of the self-assessment
* If the Planning Tool is not used, the Self-assessment form in Resources can be used to support the Self-assessment.
* The solutions developed by the RU to address the EQIPD Core Requirements and beyond (e.g., on the Dashboard) shall be checked for their effectiveness (Process Owner should involve members of the research unit, as needed). If changes are required, these should be implemented and described in the self-assessment
* The self-assessment report may be prepared using the template provided by EQIPD (please see the link below in section C) or the Planning Tool ([[4.3.2.1 Using the Planning Tool]])

[[Internal assessment]]
* Goals and objectives for an internal assessment are typically set by the RU's parent organization
* Internal assessment is performed by a dedicated quality professional or by another trusted and qualified colleague outside the RU but within the same organization
* Internal assessment assures a quality transparency towards the institution and provides additional confidence when preparing for an external assessment

'''PLEASE DO NOT FORGET'''
* To make sure that all members of the RU receive access to and become familiar with the outcome of the self-assessment
* To act upon issues identified during the self-assessment
* To conduct self-assessments and spot checks at regular intervals

'''RISK ASSESSMENT'''
* For an effective self-assessment it is important to be as objective and as unbiased as possible

== C. Resources ==
Template for documenting self-assessments
* Word-file [https://paasp.sharepoint.com/:w:/s/EQIPD/Edt7BSxEZIhBrlg5phtru_oByp-sN2dbMmThT5sRzHlBZg?e=zHPytI 4.1.2 Self assessment.docx]
* Excel-file [https://paasp.sharepoint.com/:x:/s/EQIPD/EXjMqJ74JcpLh9x8_UN7EmkBzgAcgODVOTKlDWnAPnIpvw?e=tYih6H 4.1.2 Self assessment.xlsx]

----

back to [[Toolbox]]

Next item: [[4.1.3 External assessment]]

4 Continuous improvement

2026-10-06T07:57:07Z

Leonardo.restivo:

{{Preamble
| aliases =
* continuous improvement
* improving the quality system
* adapting the quality system
* keeping the quality system up to date
| answers =
* What is continuous improvement in EQIPD?
* How does a research unit keep its quality system up to date over time?
* What should we change in our quality system when new risks or challenges come up?
}}

Process that ensures that new risks and [[challenges]] are appropriately met by adapting the existing quality system (i.e. updating of [[Dossier]]).

Template:Preamble

2026-09-17T14:23:56Z

Leonardo.restivo:

<includeonly><div class="mw-collapsible mw-collapsed" style="display: none; border:1px solid #a2a9b1; background:#f8f9fa; padding:0.5em 0.9em 0.6em; margin:0 0 1em 0; font-size:95%;">
'''Search terms and questions this page answers'''<br />
<span style="color:#54595d;">Metadata to help search engines and AI assistants find this page. Not part of the guidance.</span>
<div class="mw-collapsible-content">
; Also known as
{{{aliases|}}}
; Questions this page answers
{{{answers|}}}
</div>
</div>[[Category:Pages with preamble]]</includeonly><noinclude>
This template holds the search preamble for a toolbox page: alternative names for
the topic, and the questions the page answers.

Place it at the very top of the page, above the first heading.

Parameters:
* '''aliases''' — a bulleted list of other names for the topic
* '''answers''' — a bulleted list of questions, each ending in a question mark

Pages using this template are collected in [[:Category:Pages with preamble]].
</noinclude>

Template:Preamble

2026-09-17T14:22:02Z

Leonardo.restivo:

<includeonly><div class="mw-collapsible mw-collapsed" style="visibility: hidden; border:1px solid #a2a9b1; background:#f8f9fa; padding:0.5em 0.9em 0.6em; margin:0 0 1em 0; font-size:95%;">
'''Search terms and questions this page answers'''<br />
<span style="color:#54595d;">Metadata to help search engines and AI assistants find this page. Not part of the guidance.</span>
<div class="mw-collapsible-content">
; Also known as
{{{aliases|}}}
; Questions this page answers
{{{answers|}}}
</div>
</div>[[Category:Pages with preamble]]</includeonly><noinclude>
This template holds the search preamble for a toolbox page: alternative names for
the topic, and the questions the page answers.

Place it at the very top of the page, above the first heading.

Parameters:
* '''aliases''' — a bulleted list of other names for the topic
* '''answers''' — a bulleted list of questions, each ending in a question mark

Pages using this template are collected in [[:Category:Pages with preamble]].
</noinclude>

Toolbox

2026-09-16T10:14:08Z

Leonardo.restivo:

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]].

'''How EQIPD uses everyday words.''' Several ordinary terms carry a specific meaning here that differs from general usage — among them [[1.5.2.3 Process owner|process owner]], [[1.2 Scope|scope]], quality and [[NEED|NEEDs]]. Where a page defines one of these, it says how the EQIPD meaning differs from the everyday one, so take the definition from the page rather than from the familiar sense of the word. The [[Glossary]] collects the terminology in one place.

== Start here ==

* [[EQIPD]] — the framework, who it is for, and where it came from.
* [[EQIPD Quality System]] — what a quality system is in this context, and what it is for.
* [[Core Requirements]] — the 18 mandatory requirements. Every toolbox item below refers to one of them.
* [[3.2.3 Implementation of the EQIPD Quality System|Implementation Strategy]] — what a research unit should do first, and in what order.
* [[EQIPD principles]] — the reasoning the requirements rest on.
* [[Glossary]] — definitions of EQIPD terminology.
* [[NEED|NEEDs]] — the unit of work a research unit records and tracks.
* [[FAQ|Frequently asked questions]] — common questions, answered.

__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]]

Toolbox

2026-09-16T10:11:21Z

Leonardo.restivo:

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]].

== Start here ==

* [[EQIPD]] — the framework, who it is for, and where it came from.
* [[EQIPD Quality System]] — what a quality system is in this context, and what it is for.
* [[Core Requirements]] — the 18 mandatory requirements. Every toolbox item below refers to one of them.
* [[3.2.3 Implementation of the EQIPD Quality System|Implementation Strategy]] — what a research unit should do first, and in what order.
* [[EQIPD principles]] — the reasoning the requirements rest on.
* [[Glossary]] — definitions of EQIPD terminology.
* [[NEED|NEEDs]] — the unit of work a research unit records and tracks.
* [[FAQ|Frequently asked questions]] — common questions, answered.

__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]]

4.1.1 Risk assessment

2026-09-16T08:14:25Z

Leonardo.restivo:

{{Preamble
| aliases =
* risk assessment
* identifying risks
* risks to data quality
* risk
| answers =
* What is risk assessment in EQIPD?
* How do I identify risks to my research data?
* What counts as harm in the EQIPD risk framework?
* Which core requirement covers risk assessment?
}}

== A. Background & Definitions ==
This item refers to one of the [[Core Requirements]] (Core Requirement 15 - "Risk assessment must be performed to identify factors affecting the generation, processing and reporting of research data") and is, therefore, considered as essential.

Risk is the combination of the probability of occurrence of harm, and the severity of that harm. In the context of EQIPD Quality System, harm is defined as research data not being fit for purpose, research data being biased and/or inadequate data integrity.

Risk assessment is the process of identifying all risks to and from an activity or situation and assessing the potential impact on the research enviroment.

For any research unit using EQIPD Quality System, there are three main areas of risk assessment:
* alterations from strongly recommended practices (i.e. situations when EQIPD language included „should“ and the research unit provided a declaration on why it does not or cannot apply to them)
* key / support processes that are inherently associated with risks endangering the validity of results (e.g. risk of unblinding; emergency access to blinding codes; see also [[2.1.10 Plausibility check]])
* changes in the environment of the research unit (new hires / key people leaving; facility changes, etc.)

== B. Guidance & Expectations ==
EQIPD expects risk assessment to be conducted at three levels:
{| class="wikitable"
! scope="col"|
! scope="col"|'''By whom'''
! scope="col"|'''When / how often'''
! scope="col"|'''To be documented?'''
! scope="col"|'''Use of EQIPD tools'''
|-
! scope="col"|'''Alterations from strongly recommended practices'''
|Process Owner
|At least as part of [[4.1.2 Self assessment]]
(Process Owner may decide to conduct assessments more frequently)
|Yes, as part of a [[4.1.2 Self assessment]] protocol
|If EQIPD Planning Tool is used, alterations from the recommended practices can be marked or highlighted in the corresponding Risk Assessment column in the Action Plan.
|-
! scope="col"|'''Inherent risks of key / support processes'''
|Team member with the primary responsibility over design and execution of a particular study
|For each planned / conducted study
|Yes, as part of a [[2.1.1 Study protocol]] that should have a dedicated section or box for risk assessment summary
|Certain Toolbox items are marked with a warning sign and a "please do not forget" text in order to suggest processes that may require attention
|-
! scope="col"|'''Changes in the environment'''
|Process Owner (alone or with the team)
|Ad hoc
|Optional (to be decided by the Process Owner - see below for a template, can be easily done with Planning Tool current version[https://paasp.sharepoint.com/:u:/s/EQIPD/Eaq198yQK_xAvr24inTL1PoBDL6N7qanY62awbTLTHNN-Q?e=5DyhXi])
|Corresponding Toolbox items may be consulted for any specific guidance or references to useful resources; If EQIPD Planning Tool is used, new solutions and changes to existing solutions can be recorded
|}

Optionally, risk assessment can be conducted more often by the process owner or a dedicated person on a broader level than what is suggested above. When doing so, the following questions can be used for guidance:
* What can go wrong and have a negative impact on the research data or unit?
* How likely is it to happen?
* What are the potential consequences?
* How tolerable is the identified risk?

Outcome of such risk assessment can be documented (e.g. using the template provided below) and and store in Dossier folder 4.1.1. A case study can be found [[Risk Management Case Studies]]

'''DO NOT FORGET'''
* To justify acceptance of risk based on both probability and severity of harm

== C. Resources ==
SYRCLE Risk of Bias [https://bmcmedresmethodol.biomedcentral.com/articles/10.1186/1471-2288-14-43]

The following techniques provide a more detailed framework and can be used if resources allow it:
* SWOT analysis [https://en.wikipedia.org/wiki/SWOT_analysis]
* FMEA [https://en.wikipedia.org/wiki/Failure_mode_and_effects_analysis]

ICH Q9 Quality Management
* FDA [https://www.fda.gov/media/71543/download]
* EMA [https://www.ema.europa.eu/en/ich-q9-quality-risk-management]

Template for optional risk assessment - [https://paasp.sharepoint.com/:w:/s/EQIPD/EfSJLIZdbOFOlKneuiRrf5MBeTug7VsZoWHsETvI3pY_mg?e=GXBsdk 4.1.1 Risk Management.docx]

----

back to [[Toolbox]]

Next item: [[4.1.2 Self assessment]]

Template:Preamble

2026-09-16T08:11:58Z

Leonardo.restivo: Created page with "<includeonly><div class="mw-collapsible mw-collapsed" style="border:1px solid #a2a9b1; background:#f8f9fa; padding:0.5em 0.9em 0.6em; margin:0 0 1em 0; font-size:95%;"> '''Sea..."

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'''Search terms and questions this page answers'''<br />
<span style="color:#54595d;">Metadata to help search engines and AI assistants find this page. Not part of the guidance.</span>
<div class="mw-collapsible-content">
; Also known as
{{{aliases|}}}
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</div>[[Category:Pages with preamble]]</includeonly><noinclude>
This template holds the search preamble for a toolbox page: alternative names for
the topic, and the questions the page answers.

Place it at the very top of the page, above the first heading.

Parameters:
* '''aliases''' — a bulleted list of other names for the topic
* '''answers''' — a bulleted list of questions, each ending in a question mark

Pages using this template are collected in [[:Category:Pages with preamble]].
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Examples of implementing a unique study ID

2021-04-29T07:51:49Z

Leonardo.restivo:

==From INBC of University of Heidelberg==
[https://orcid.org/0000-0002-7663-1031 Claudia Pitzer], the core facility head of the [http://www.medizinische-fakultaet-hd.uni-heidelberg.de/Home.111344.0.html Interdisciplinary Neurobehavioral Core], uses this explanation in a document handed out to the user:

File naming: in order that each data is unique and retrievable we suggest that you adhere to the following file naming convention: [date YYMMDD]-[the first letter of your first name together with your last name]-[free text]. If your surname is long you may use only the first 6 letters of it.

::: e.g. '''201108-cpitzer-catwalk with mice zQ98'''

==From Neuro-Behavioral-Analysis Unit, Department of Fundamental Neuroscience, University of Lausanne==
[https://orcid.org/0000-0002-3709-5504 Leonardo Restivo], the core facility head of the [http://neurobau.com Neuro-BAU], uses this nomenclature to store metadata at his core facility.[[File:LRestivo_StudyID_210428.jpg|frame|]]

This system is only used to store metadata(project id, project info, experimental protocols) but it is not used for raw data.
The experimental record ID is generated as follows:

Initials of the PI + Acronym of the department + Institution acronym + Sequential integer

Example:
Leonardo Restivo, Department of Fundamental Neuroscience (swap letters in french acronym), University of Lausanne, project one

::: e.g. '''LR_DNF_UNIL_1'''

This id is part of a simple two-table database (it has its unique own row_id see image):
The `code-name` field contains a friendly name (e.g. "gut microbiota and spatial orientation") for the project. This name is used to communicate with the lab working on the project.
Each experiment belonging to this project inherits the project id. Every experiment has its own unique id (which is a unique auto-incrementing integer) + friendly name (e.g. "water maze")
The `experiment` table has a field named `data`. This is a link to a text-markdown file that logs the experimental protocol and any change to it.

==From Behavioral and Physiological Phenotyping Unit of Weizmann Institute of Science==
[https://orcid.org/0000-0003-0441-8757 Michael Tsoory], the core facility head at [http://www.weizmann.ac.il/vet/advanced-services/behavior-and-physiology/about Weizman Institute], describes the procudure for users as follows:

''“The PI must communicate the IACUC Approval number to the CF and to the person(s) undertaking the Studies and Experiments. This number must be incorporated into the unique study-experiment ID by whomever assumes responsibility on maintaining the Experimental Records”.''

Here at the WIS, the IACUC# is the first and most important requirement; a PI CANNOT purchase lab animals without it (it is a “must fill in field” in the procurement system) NOR ask for a breeding procedure (similar “must fill in field in electronic form).

Therefore a record keeping system may apply the below noted suggestion:

For example, '''IACUC Approval 12340221-1 (IA)'' includes 3 studies (3 Study Protocols: SP1, SP2, SP3), one of which ('''SP2''') is assessing the relevance of gene X to learning and memory. So SP2 includes assessing wt and KO mice in the 1) Y-maze; 2) NOR; 3) MWM; as well as some anxiety tests 4) Acoustic Startle Response; 5) Dark-Light Transfer test; and basic motor assessments 6) home-cage locomotion; 7) Open-Filed. All together 7 '''Experimental Procedures (EP)'''.

The Experimental Records will be filed in a '''FOLDER named: IA12340221-1'''
* '''PLANS''', experimental designs, planed experimental procedures, and everything else that has to do with planning etc. (like calculations of Ns), will filed in folders named SP with subfolders for every experiment EP.,
* All data generated in these studies will be filed a '''RAW DATA''' folder; a DATA folder will have subfolders of SP and subsequent EP.
* All analyses of data generated in these studies will be filed an '''ANALYSES''' folder
(we may want to include additional folders for “conclusions”, “publications”)

'''IA12340221-1'''
:'''PLANS'''
::SP1
::SP2
:::EP1
:::EP2
:::…
:::EP7
:'''RAW DATA'''
::SP1
::SP2
:::EP1
:::EP2
:::…
:::EP7
:'''ANALYSES
::SP1
::SP2
:::EP1
:::EP2
:::…
:::EP7
 
The data generated in this MWM experiment will be

e.g. '''IA12340221-1/DATA/SP2/EP3'''

The files in that folder can take a name comprised of the DATE and initials of the person performing the test “John Doe”: JD_YYMMDD.
 
Moreover, in the data sheet I STRONGLY recommend that the IACUC#, SP# and EP# would appear in the columns next to the mouse#, DOB, SEX and Genotype columns (in the Noldus Ethovision these columns may be added already in the “trial list” stage and would be automated included in all output/export files):

{|class="wikitable"
!colspan="7"|Identifiers
!colspan="4"|Latency to reach platform
|-
|IACUC#
|SP#
|EP#
|M#
|DOB
|SEX
|Genotype
|Day1 Trail1
|Day1 Trail2
|…..
|Day5 Trail4
|-
|12340221-1
|2
|3
|666
|YYMMDD
|F
|wt
|90
|90
| 
|25
|-
|12340221-1
|2
|3
|667
|YYMMDD
|m
|vKO
|90
|v87
| 
|34
|-
|v12340221-1
|2
|3
|668
|YYMMDD
|F
|KO
|90
|90
| 
|18
|-
|12340221-1
|2
|3
|669
|YYMMDD
|m
|wt
|90
|78
| 
|27
|} 