Difference between revisions of "Documentation in EQIPD"

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EQIPD Quality System is lean and does not require excessive documentation.
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The following table describes the documentation required to address the EQIPD [[Core Requirements]].
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In some cases, these are stand-alone documents. In others, expected information is typically available in other documents - mandated by the institutional regulations or being part of another process.
 +
 
{| class="wikitable"
 
{| class="wikitable"
|'''Categories​​​'''  
+
|rowspan="2"|'''Categories​​​'''  
|'''No'''
+
|rowspan="2"|'''No'''
|'''Core Requirement'''
+
|rowspan="2"|'''Core Requirement'''
|​'''Toolbox reference'''
+
|rowspan="2"|​'''Toolbox reference'''
|​'''EQIPD required stand-alone document<sup>*</sup>'''
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|colspan="2"|​'''Implementation of the Core Requirements'''
|'''Required documentation<sup>*</sup>'''
+
|-
 +
|​'''Stand-alone document'''
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|'''EQIPD expectations'''
 
|-
 
|-
 
|rowspan="2"|'''Research team'''​
 
|rowspan="2"|'''Research team'''​
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|Process owner must be identified for the Quality System
 
|Process owner must be identified for the Quality System
 
|[[1.5.2.3 Process owner|1.5.2.3]]​
 
|[[1.5.2.3 Process owner|1.5.2.3]]​
| -
+
|No
| -
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|Process Owner should act and be recognized as such by the research unit members.
 
|-
 
|-
 
|2
 
|2
 
|Communication process must be in place
 
|Communication process must be in place
 
|[[1.2 Scope|1.2]]
 
|[[1.2 Scope|1.2]]
|[https://paasp.sharepoint.com/:w:/s/EQIPD/ERyfFP_pBytDiEfqCutDAJQBFbaGQEx3G1pyOmDl50o_LQ?e=wlkvHJ Communication plan]
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|Yes
| -
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|A concise overview of the organisational structure and the communication lines can be described using the [https://paasp.sharepoint.com/:w:/s/EQIPD/ERyfFP_pBytDiEfqCutDAJQBFbaGQEx3G1pyOmDl50o_LQ?e=wlkvHJ Communication plan template] provided by EQIPD or in a similar document.
 
|-
 
|-
 
|rowspan="3"|'''Quality culture'''
 
|rowspan="3"|'''Quality culture'''
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|The research unit must have defined quality objectives ​
 
|The research unit must have defined quality objectives ​
 
|[[1.1 Mission|1.1]]
 
|[[1.1 Mission|1.1]]
|[https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Mission statement]
+
|Yes
| -
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|The [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Mission statement template] of EQIPD or a similar document can be used to describe quality goals of a research unit. These quality objectives should be known to and shared by all members of a research unit.
 
|-
 
|-
 
|4
 
|4
 
|All activities must comply with relevant legislation and policies
 
|All activities must comply with relevant legislation and policies
 
|[[1.4.2 Adherence to legal and regulatory considerations|1.4.2]]
 
|[[1.4.2 Adherence to legal and regulatory considerations|1.4.2]]
| -
+
|(Yes)
| -
+
|Research unit complies with all applicable national and international legislation and policies and there are no compliance issues. For research units conducting studies using laboratory animals, there must be either a full accreditation by AAALAC (or equivalent) or a standalone description of animal care and use program according to [https://paasp.sharepoint.com/:w:/s/EQIPD/ET18tqgUVfJCsYNYxexlgA8BnwRLEn0k8JcFmeQlTiQMoA?e=zoXuUf the EQIPD checklist]
 +
 
 
|-
 
|-
 
|5
 
|5
 
|The research unit must have a procedure to act upon concerns of potential misconduct
 
|The research unit must have a procedure to act upon concerns of potential misconduct
 
|[[4.2.3 Responsible conduct of research|4.2.3]]
 
|[[4.2.3 Responsible conduct of research|4.2.3]]
| -
+
|No
|It is expected that a formal research integrity policy and ombudsman is in place (e.g. by the parent organization) and that training documentation is available
+
|It is expected that a research unit or its parent organization has a research integrity policy, office and/or officer (or ombudsman) and all research unit members have access to this information.
 
|-
 
|-
 
|rowspan="4"|​​'''Data integrity'''
 
|rowspan="4"|​​'''Data integrity'''
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|Generation, handling and changes to data records must be documented
 
|Generation, handling and changes to data records must be documented
 
|​[[2.3.1 Generation, recording, handling and archiving of raw data|2.3.1]]
 
|​[[2.3.1 Generation, recording, handling and archiving of raw data|2.3.1]]
|rowspan="3"|[https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan]
+
|Yes
|Must be documented with the experimental/study protocol, e.g. identification of the author(s), time of data generation and ensured that data is readable and permanent
+
|Can be described using the [https://paasp.sharepoint.com/:w:/s/EQIPD/EQTANrsKHTVIqtO8LT-ZJIEBEUJVZI6siRLkHfliUD4gdA?e=XlOwMh Documentation plan template] provided by EQIPD or in a similar document.
 
|-
 
|-
 
|7
 
|7
 
|Data storage must be secured at least for as long as required by legal, contractual or other obligations or business needs
 
|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|3.1.3]]​
 
|[[3.1.3 Data security|3.1.3]]​
| -
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|Yes
 +
|Can be described using the [https://paasp.sharepoint.com/:w:/s/EQIPD/EQTANrsKHTVIqtO8LT-ZJIEBEUJVZI6siRLkHfliUD4gdA?e=XlOwMh Documentation plan template] provided by EQIPD or in a similar document.
 
|-
 
|-
 
|8
 
|8
|Reported research outcomes must be traceable to experimental dat
+
|Reported research outcomes must be traceable to experimental data
|[[3.1.2.1 Traceability of data and any person having impact on data]]
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|[[3.1.2.1 Traceability of data and any person having impact on data​|3.1.2.1]]
|This requires documentation within the study plan and data usage, e.g. an unique study ID
+
|Yes
 +
|Can be described using the [https://paasp.sharepoint.com/:w:/s/EQIPD/EQTANrsKHTVIqtO8LT-ZJIEBEUJVZI6siRLkHfliUD4gdA?e=XlOwMh Documentation plan template] provided by EQIPD or in a similar document.
 
|-
 
|-
 
|9
 
|9
 
|Reported data must disclose all repetitions of a study, an experiment, or a test regardless of the outcome​​
 
|Reported data must disclose all repetitions of a study, an experiment, or a test regardless of the outcome​​
 
|[[2.4 Reporting|2.4]]
 
|[[2.4 Reporting|2.4]]
| -
+
|No
| -
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|it is expected that the Process Owner conducts spot checks on reported studies to make sure that all repetitions are reported.
 
|-
 
|-
 
|rowspan="5"|​​​'''Research processes'''
 
|rowspan="5"|​​​'''Research processes'''
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|Investigator must declare in advance whether a study is intended to inform a formal knowledge claim
 
|Investigator must declare in advance whether a study is intended to inform a formal knowledge claim
 
|[[2.1.4 Purpose of research|2.1.4]]
 
|[[2.1.4 Purpose of research|2.1.4]]
| -
+
|No
|To be documented in the study/experimental protocol, see [[2.1.1 Study (experimental) plan]]
+
|This requirement is most optimally met by providing corresponding information in the study protocol, see [[2.1.1 Study protocol]].
 
|-
 
|-
 
|11
 
|11
 
|All personnel involved in research must have adequate training and competence to perform assigned tasks
 
|All personnel involved in research must have adequate training and competence to perform assigned tasks
 
|[[3.2.1 General guidance on training|3.2.1]]
 
|[[3.2.1 General guidance on training|3.2.1]]
| -
+
|No
|Participation in training must be documented with the training records
+
|For legally required / mandatory training, training records are typically available. For other training, Process Owner decides on whether and what form of documentation should be maintained. EQIPD expects that all research units members are trained on what is considered to be raw data and how to record and handle data. Further, EQIPD expects a training program for new members of the research unit.
 
|-
 
|-
 
|12
 
|12
 
|Protocols for experimental methods must be available
 
|Protocols for experimental methods must be available
 
|[[3.5.2 Protocols for methods and assays|3.5.2]]
 
|[[3.5.2 Protocols for methods and assays|3.5.2]]
| -
+
|No
|All procedures used in experiments must be documented in the protocol
+
|Methods can be described in either standalone protocols or be part of study protocol. ([https://paasp.sharepoint.com/:w:/s/EQIPD/EfUO3B7RFxdHgxQ8JY5hhFoBEDUiPGK4C8n6BBHEprwroA?e=8IezWV template])
 
|-
 
|-
 
|13
 
|13
 
|Adequate handling and storage of samples and materials must be ensured
 
|Adequate handling and storage of samples and materials must be ensured
 
|[[3.3.3 Management of research materials and reagents|3.3.3]]
 
|[[3.3.3 Management of research materials and reagents|3.3.3]]
| -
+
|No
|This information must be available, e.g. as chemical data sheets or within study/experimental protocol
+
|Although there is no requirement to have a standalone document describing the overall process of handling and storage, it is nevertheless in many circumstances to be expected that certain aspects of handling and storage are supported by relevant documentation (e.g. electronic or paper-based system for keeping a control over research chemicals and reagents).
 
|-
 
|-
 
|14
 
|14
 
|Research equipment and tools must be suitable for intended use and ensure data integrity
 
|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|3.3.2]]
 
|[[3.3.2 Processes to enable computerized and non-computerized systems being suitable for intended use|3.3.2]]
| -
+
|No
|Study/experimental protocols must show that equipment was fit-for-purpose
+
|It is expected that protocols of experimental methods clearly state whether maintenance or calibration is needed and, if yes, describe the procedure.
 
|-
 
|-
 
|rowspan="3"|'''Continuous performance'''
 
|rowspan="3"|'''Continuous performance'''
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|Risk assessment must be performed to identify factors affecting the generation, processing and reporting of research data
 
|Risk assessment must be performed to identify factors affecting the generation, processing and reporting of research data
 
|[[4.1.1 Risk assessment|4.1.1]]​​
 
|[[4.1.1 Risk assessment|4.1.1]]​​
| -
+
|No
|Study/experimental protocols must have a risk assessment section, see [[2.1.1 Study (experimental) plan]]
+
|Study protocols are expected to have a dedicated section summarizing measures against risks of bias, see [[2.1.1 Study protocol]]. Deviations from practices recommended by EQIPD as well as the risk assessment at the level of the research unit can be handled using the [https://paasp.sharepoint.com/:x:/s/EQIPD/ETo9OwIvZpNHtepp6IvxylQBjtjhk2AmRnypLCIOrGwMvA?e=n1zy3X Risk assessment template].
 
|-
 
|-
 
|16
 
|16
 
|Critical incidents and errors during study conduct must be analyzed and appropriately managed
 
|Critical incidents and errors during study conduct must be analyzed and appropriately managed
 
|[[4.2.2 Error and incident management|4.2.2]]
 
|[[4.2.2 Error and incident management|4.2.2]]
| -
+
|No
|Critical incidents and errors must be documented with the experimental protocol
+
|Critical incidents and errors can be recorded in laboratory notebooks or using [https://paasp.sharepoint.com/:w:/s/EQIPD/EatOAFgLbctEvxRZTuSCdU4Bv8J1I_BitfKl-JJiieOTLA?e=z99RR1 Error reporting template] or using another electronic or paper-based system.
 
|-
 
|-
 
|17
 
|17
 
|An approach must be in place to monitor the performance of the EQIPD Quality System, and address identified issues​
 
|An approach must be in place to monitor the performance of the EQIPD Quality System, and address identified issues​
 
|[[4.1.2 Self assessment|4.1.2]]
 
|[[4.1.2 Self assessment|4.1.2]]
|[https://paasp.sharepoint.com/:x:/s/EQIPD/EWbE3AdV5jhHglumN_MlrugBQX_KsZQDpJVNYbBJk6svTQ?e=qkW68H Self assessment]
+
|No
| -
+
|Evidence for such approach is provided indirectly by the information described in the [https://paasp.sharepoint.com/:x:/s/EQIPD/EXjMqJ74JcpLh9x8_UN7EmkBzgAcgODVOTKlDWnAPnIpvw?e=tYih6H Self assessment template] that is completed at regular intervals (as a minimum, annually).
 
|-
 
|-
 
|'''Sustainability'''
 
|'''Sustainability'''
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|Resources for sustaining the EQIPD Quality System must be available
 
|Resources for sustaining the EQIPD Quality System must be available
 
|[[1.5.5 Sustainability|1.5.5]]
 
|[[1.5.5 Sustainability|1.5.5]]
| -
+
|No
| -
+
|No documentation needed but EQIPD does not accept lack of resources as an argument for not following the best research practices.
 
|}
 
|}
<sup>*</sup>The provided templates are suggestions which may be used. However, their use is not a requirement, the reuiqrement is the documentation and description associated with the Core Requirement.
 
  
Back to the [[EQIPD Quality System]]​.​​​​
+
Research units working with animals must fill out the [https://paasp.sharepoint.com/:w:/s/EQIPD/ET18tqgUVfJCsYNYxexlgA8BnwRLEn0k8JcFmeQlTiQMoA?e=zoXuUf Animal care and use form] unless they are AAALAC certified. Additional information in Toolbox section [[3.4.1 Animal characteristics, care and use]].
 +
 
 +
Additional information about expectations can be found in [https://paasp.sharepoint.com/:b:/s/EQIPD/EWXf1VnZ8ytNr2jl97dGnV0BDJCfEFnO-TH_R71BegJCiQ?e=xcdG5f this] pdf document.
 +
 
 +
Back to the [[EQIPD Quality System]]​ or [[Core Requirements]].​​​​

Latest revision as of 08:49, 6 May 2021

EQIPD Quality System is lean and does not require excessive documentation.

The following table describes the documentation required to address the EQIPD Core Requirements.

In some cases, these are stand-alone documents. In others, expected information is typically available in other documents - mandated by the institutional regulations or being part of another process.

Categories​​​ No Core Requirement Toolbox reference Implementation of the Core Requirements
Stand-alone document EQIPD expectations
Research team 1 Process owner must be identified for the Quality System 1.5.2.3 No Process Owner should act and be recognized as such by the research unit members.
2 Communication process must be in place 1.2 Yes A concise overview of the organisational structure and the communication lines can be described using the Communication plan template provided by EQIPD or in a similar document.
Quality culture 3 The research unit must have defined quality objectives ​ 1.1 Yes The Mission statement template of EQIPD or a similar document can be used to describe quality goals of a research unit. These quality objectives should be known to and shared by all members of a research unit.
4 All activities must comply with relevant legislation and policies 1.4.2 (Yes) Research unit complies with all applicable national and international legislation and policies and there are no compliance issues. For research units conducting studies using laboratory animals, there must be either a full accreditation by AAALAC (or equivalent) or a standalone description of animal care and use program according to the EQIPD checklist
5 The research unit must have a procedure to act upon concerns of potential misconduct 4.2.3 No It is expected that a research unit or its parent organization has a research integrity policy, office and/or officer (or ombudsman) and all research unit members have access to this information.
​​Data integrity 6 Generation, handling and changes to data records must be documented 2.3.1 Yes Can be described using the Documentation plan template provided by EQIPD or in a similar document.
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 Yes Can be described using the Documentation plan template provided by EQIPD or in a similar document.
8 Reported research outcomes must be traceable to experimental data 3.1.2.1 Yes Can be described using the Documentation plan template provided by EQIPD or in a similar document.
9 Reported data must disclose all repetitions of a study, an experiment, or a test regardless of the outcome​​ 2.4 No it is expected that the Process Owner conducts spot checks on reported studies to make sure that all repetitions are reported.
​​​Research processes 10 Investigator must declare in advance whether a study is intended to inform a formal knowledge claim 2.1.4 No This requirement is most optimally met by providing corresponding information in the study protocol, see 2.1.1 Study protocol.
11 All personnel involved in research must have adequate training and competence to perform assigned tasks 3.2.1 No For legally required / mandatory training, training records are typically available. For other training, Process Owner decides on whether and what form of documentation should be maintained. EQIPD expects that all research units members are trained on what is considered to be raw data and how to record and handle data. Further, EQIPD expects a training program for new members of the research unit.
12 Protocols for experimental methods must be available 3.5.2 No Methods can be described in either standalone protocols or be part of study protocol. (template)
13 Adequate handling and storage of samples and materials must be ensured 3.3.3 No Although there is no requirement to have a standalone document describing the overall process of handling and storage, it is nevertheless in many circumstances to be expected that certain aspects of handling and storage are supported by relevant documentation (e.g. electronic or paper-based system for keeping a control over research chemicals and reagents).
14 Research equipment and tools must be suitable for intended use and ensure data integrity 3.3.2 No It is expected that protocols of experimental methods clearly state whether maintenance or calibration is needed and, if yes, describe the procedure.
Continuous performance 15 Risk assessment must be performed to identify factors affecting the generation, processing and reporting of research data 4.1.1​​ No Study protocols are expected to have a dedicated section summarizing measures against risks of bias, see 2.1.1 Study protocol. Deviations from practices recommended by EQIPD as well as the risk assessment at the level of the research unit can be handled using the Risk assessment template.
16 Critical incidents and errors during study conduct must be analyzed and appropriately managed 4.2.2 No Critical incidents and errors can be recorded in laboratory notebooks or using Error reporting template or using another electronic or paper-based system.
17 An approach must be in place to monitor the performance of the EQIPD Quality System, and address identified issues​ 4.1.2 No Evidence for such approach is provided indirectly by the information described in the Self assessment template that is completed at regular intervals (as a minimum, annually).
Sustainability 18 Resources for sustaining the EQIPD Quality System must be available 1.5.5 No No documentation needed but EQIPD does not accept lack of resources as an argument for not following the best research practices.

Research units working with animals must fill out the Animal care and use form unless they are AAALAC certified. Additional information in Toolbox section 3.4.1 Animal characteristics, care and use.

Additional information about expectations can be found in this pdf document.

Back to the EQIPD Quality System​ or Core Requirements.​​​​