Documentation in EQIPD: Difference between revisions

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Created page with "{| class="wikitable" |'''Categories​​​''' |'''No''' |'''Core Requirement''' |​'''Toolbox reference''' |​'''EQIPD provided templates<sup>*</sup>''' |- |rowspan="2"|..."
 
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|'''Core Requirement'''
|'''Core Requirement'''
|​'''Toolbox reference'''
|​'''Toolbox reference'''
|​'''EQIPD provided templates<sup>*</sup>'''
|​'''EQIPD required stand-alone document<sup>*</sup>'''
|'''Required documentation<sup>*</sup>'''
|-
|-
|rowspan="2"|'''Research team'''​
|rowspan="2"|'''Research team'''​
|1
|1
|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 Process owner|1.5.2.3]]​
| -
| -
| -
|-
|-
|2
|2
|Communication process must be in place
|Communication process must be in place
|[[1.2 Scope]]
|[[1.2 Scope|1.2]]
|[https://paasp.sharepoint.com/:w:/s/EQIPD/ERyfFP_pBytDiEfqCutDAJQBFbaGQEx3G1pyOmDl50o_LQ?e=wlkvHJ Communication plan]
|[https://paasp.sharepoint.com/:w:/s/EQIPD/ERyfFP_pBytDiEfqCutDAJQBFbaGQEx3G1pyOmDl50o_LQ?e=wlkvHJ Communication plan]
| -
|-
|-
|rowspan="3"|'''Quality culture'''
|rowspan="3"|'''Quality culture'''
|3
|3
|The research unit must have defined quality objectives ​
|The research unit must have defined quality objectives ​
|[[1.1 Mission]]
|[[1.1 Mission|1.1]]
|[https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Mission statement]
|[https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Mission statement]
| -
|-
|-
|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 Adherence to legal and regulatory considerations|1.4.2]]
| -
| -
| -
|-
|-
|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 Responsible conduct of research|4.2.3]]
| -
| -
| -
|-
|-
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|6
|6
|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 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]
|rowspan="3"|[https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan]
| -
|-
|-
|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 Data security|3.1.3]]​
| -
|-
|-
|8
|8
|Reported research outcomes must be traceable to experimental data
|Reported research outcomes must be traceable to experimental data
|[[3.1.2.1 Traceability of data and any person having impact on data​]]
|[[3.1.2.1 Traceability of data and any person having impact on data|3.1.2.1​]]
| -
|-
|-
|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 Reporting|2.4]]
| -
| -
| -
|-
|-
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|10
|10
|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 Purpose of research|2.1.4]]
| -
| -
| -
|-
|-
|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 General guidance on training|3.2.1]]
| -
| -
| -
|-
|-
|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 Protocols for methods and assays|3.5.2]]
| -
| -
| -
|-
|-
|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 Management of research materials and reagents|3.3.3]]
| -
| -
|-
|-
|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 Processes to enable computerized and non-computerized systems being suitable for intended use|3.3.2]]
| -
| -
|-
|-
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|15
|15
|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 Risk assessment|4.1.1]]​​
| -
| -
| -
|-
|-
|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 Error and incident management|4.2.2]]
| -
| -
| -
|-
|-
|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 Self assessment|4.1.2]]
|[https://paasp.sharepoint.com/:x:/s/EQIPD/EWbE3AdV5jhHglumN_MlrugBQX_KsZQDpJVNYbBJk6svTQ?e=qkW68H Self assessment]
|[https://paasp.sharepoint.com/:x:/s/EQIPD/EWbE3AdV5jhHglumN_MlrugBQX_KsZQDpJVNYbBJk6svTQ?e=qkW68H Self assessment]
| -
|-
|-
|'''Sustainability'''
|'''Sustainability'''
|18
|18
|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 Sustainability|1.5.5]]
| -
| -
| -
|}
|}
<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.
<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.
For information on required documentation within EQIPD please visit: [[Documentation in EQIPD]]


Back to the [[EQIPD Quality System]]​.​​​​
Back to the [[EQIPD Quality System]]​.​​​​

Revision as of 12:52, 30 November 2020

Categories​​​ No Core Requirement ​Toolbox reference ​EQIPD required stand-alone document* Required documentation*
Research team​ 1 Process owner must be identified for the Quality System 1.5.2.3​ - -
2 Communication process must be in place 1.2 Communication plan -
Quality culture 3 The research unit must have defined quality objectives ​ 1.1 Mission statement -
4 All activities must comply with relevant legislation and policies 1.4.2 - -
5 The research unit must have a procedure to act upon concerns of potential misconduct 4.2.3 - -
​​Data integrity 6 Generation, handling and changes to data records must be documented ​2.3.1 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​ -
8 Reported research outcomes must be traceable to experimental data 3.1.2.1​ -
9 Reported data must disclose all repetitions of a study, an experiment, or a test regardless of the outcome​​ 2.4 - -
​​​Research processes 10 Investigator must declare in advance whether a study is intended to inform a formal knowledge claim 2.1.4 - -
11 All personnel involved in research must have adequate training and competence to perform assigned tasks 3.2.1 - -
12 Protocols for experimental methods must be available 3.5.2 - -
13 Adequate handling and storage of samples and materials must be ensured 3.3.3 -
14 Research equipment and tools must be suitable for intended use and ensure data integrity 3.3.2 -
Continuous performance 15 Risk assessment must be performed to identify factors affecting the generation, processing and reporting of research data 4.1.1​​ - -
16 Critical incidents and errors during study conduct must be analyzed and appropriately managed 4.2.2 - -
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 -
Sustainability 18 Resources for sustaining the EQIPD Quality System must be available 1.5.5 - -

*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​.​​​​

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