Difference between revisions of "Documentation in EQIPD"

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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
−
| -
+
|No documentation needed, verbal agreement sufficient
 
|-
 
|-
 
|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]
+
|Yes
−
| -
+
|A brief overview of the organisation and communication plan could be documented in the [https://paasp.sharepoint.com/:w:/s/EQIPD/ERyfFP_pBytDiEfqCutDAJQBFbaGQEx3G1pyOmDl50o_LQ?e=wlkvHJ Communication plan template]
 
|-
 
|-
 
|rowspan="3"|'''Quality culture'''
 
|rowspan="3"|'''Quality culture'''
Line 35: Line 35:
 
|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
−
| -
+
|The [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Mission statement] template could be used to document these mission.
 
|-
 
|-
 
|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]]
−
| -
+
|No
−
| -
+
|These documents usually must be available for legal purposes and are usually stored at t dedicated space in the research unit or could be hold available in the Dossier.
 
|-
 
|-
 
|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 formal research integrity policy and ombudsman is in place (e.g. by the parent organization) and that training documentation is available
 
|-
 
|-
Line 54: Line 54:
 
|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]
+
|rowspan="3"|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
+
|Could be documented in the [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan] and information should be available in the experimental/study protocol, e.g. identification of the author(s), time of data generation and ensured that data is readable and permanent
 
|-
 
|-
 
|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]]​
−
| -
+
|Could be documented in the [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan]
 
|-
 
|-
 
|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]]
 
|[[3.1.2.1 Traceability of data and any person having impact on data​|3.1.2.1]]
−
|Must be documented within the study plan and along the data usage chain, e.g. an unique study ID
+
|Could be documented in the [https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T Documentation plan] and additional information should be available within the study plan and along the data usage chain, e.g. an unique study ID
 
|-
 
|-
 
|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
−
| -
+
|This information could for example be found in presentation as reference to the different experiments
 
|-
 
|-
 
|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
−
|Must be documented in the study/experimental protocol, see [[2.1.1 Study (experimental) plan]]
+
|This information could be documented in the study/experimental protocol, see [[2.1.1 Study (experimental) plan]]
 
|-
 
|-
 
|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
+
|Participation in training could be hold available with the training records
 
|-
 
|-
 
|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 ([https://paasp.sharepoint.com/:w:/s/EQIPD/EfUO3B7RFxdHgxQ8JY5hhFoBEDUiPGK4C8n6BBHEprwroA?e=8IezWV template])
+
|All procedures used in experiments could be hold available in the study/experimental protocol ([https://paasp.sharepoint.com/:w:/s/EQIPD/EfUO3B7RFxdHgxQ8JY5hhFoBEDUiPGK4C8n6BBHEprwroA?e=8IezWV template])
 
|-
 
|-
 
|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
+
|This information could be hold available, e.g. as chemical data sheets or within study/experimental protocol
 
|-
 
|-
 
|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, e.g. by using reference substances
+
|Study/experimental protocols could reference or document that equipment was fit-for-purpose, e.g. by using reference substances
 
|-
 
|-
 
|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]] or to be documented in a [https://paasp.sharepoint.com/:x:/s/EQIPD/ETo9OwIvZpNHtepp6IvxylQBjtjhk2AmRnypLCIOrGwMvA?e=n1zy3X Risk assessment template]
+
|Study/experimental protocols could have a dedicated section for risk of bias in experimental processes, see [[2.1.1 Study (experimental) plan]] and for a risk assessment on the level of the research unit, it could be documented in the [https://paasp.sharepoint.com/:x:/s/EQIPD/ETo9OwIvZpNHtepp6IvxylQBjtjhk2AmRnypLCIOrGwMvA?e=n1zy3X Risk assessment template]
 
|-
 
|-
 
|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 or in a separate [https://paasp.sharepoint.com/:w:/s/EQIPD/EatOAFgLbctEvxRZTuSCdU4Bv8J1I_BitfKl-JJiieOTLA?e=z99RR1 Error reporting document]
+
|Critical incidents and errors could be documented with the experimental protocol if on experimental level and in a separate [https://paasp.sharepoint.com/:w:/s/EQIPD/EatOAFgLbctEvxRZTuSCdU4Bv8J1I_BitfKl-JJiieOTLA?e=z99RR1 Error reporting document] for the research unit level
 
|-
 
|-
 
|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]
+
|Yes
−
| -
+
|This could be documented in the [https://paasp.sharepoint.com/:x:/s/EQIPD/EWbE3AdV5jhHglumN_MlrugBQX_KsZQDpJVNYbBJk6svTQ?e=qkW68H Self assessment template]
 
|-
 
|-
 
|'''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
 
|}
 
|}
 
<sup>*</sup>The provided templates are suggestions which may be used. However, their use is not a requirement, the requirement is the documentation and description associated with the Core Requirement which can have any format suitable for the research unit.
 
<sup>*</sup>The provided templates are suggestions which may be used. However, their use is not a requirement, the requirement is the documentation and description associated with the Core Requirement which can have any format suitable for the research unit.
  
 
Back to the [[EQIPD Quality System]]​.​​​​
 
Back to the [[EQIPD Quality System]]​.​​​​

Revision as of 13:05, 2 December 2020



UNDER CONSTRUCTION

not finalised yet

Categories​​​ No Core Requirement ​Toolbox reference ​Documentation of the Core Requirements
​Stand-alone document Expected documentation
Research team​ 1 Process owner must be identified for the Quality System 1.5.2.3​ No No documentation needed, verbal agreement sufficient
2 Communication process must be in place 1.2 Yes A brief overview of the organisation and communication plan could be documented in the Communication plan template
Quality culture 3 The research unit must have defined quality objectives ​ 1.1 Yes The Mission statement template could be used to document these mission.
4 All activities must comply with relevant legislation and policies 1.4.2 No These documents usually must be available for legal purposes and are usually stored at t dedicated space in the research unit or could be hold available in the Dossier.
5 The research unit must have a procedure to act upon concerns of potential misconduct 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
​​Data integrity 6 Generation, handling and changes to data records must be documented ​2.3.1 Yes Could be documented in the Documentation plan and information should be available in the experimental/study protocol, e.g. identification of the author(s), time of data generation and ensured that data is readable and permanent
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​ Could be documented in the Documentation plan
8 Reported research outcomes must be traceable to experimental data 3.1.2.1 Could be documented in the Documentation plan and additional information should be available within the study plan and along the data usage chain, e.g. an unique study ID
9 Reported data must disclose all repetitions of a study, an experiment, or a test regardless of the outcome​​ 2.4 No This information could for example be found in presentation as reference to the different experiments
​​​Research processes 10 Investigator must declare in advance whether a study is intended to inform a formal knowledge claim 2.1.4 No This information could be documented in the study/experimental protocol, see 2.1.1 Study (experimental) plan
11 All personnel involved in research must have adequate training and competence to perform assigned tasks 3.2.1 No Participation in training could be hold available with the training records
12 Protocols for experimental methods must be available 3.5.2 No All procedures used in experiments could be hold available in the study/experimental protocol (template)
13 Adequate handling and storage of samples and materials must be ensured 3.3.3 No This information could be hold available, e.g. as chemical data sheets or within study/experimental protocol
14 Research equipment and tools must be suitable for intended use and ensure data integrity 3.3.2 No Study/experimental protocols could reference or document that equipment was fit-for-purpose, e.g. by using reference substances
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/experimental protocols could have a dedicated section for risk of bias in experimental processes, see 2.1.1 Study (experimental) plan and for a risk assessment on the level of the research unit, it could be documented in the 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 could be documented with the experimental protocol if on experimental level and in a separate Error reporting document for the research unit level
17 An approach must be in place to monitor the performance of the EQIPD Quality System, and address identified issues​ 4.1.2 Yes This could be documented in the Self assessment template
Sustainability 18 Resources for sustaining the EQIPD Quality System must be available 1.5.5 No No documentation needed

*The provided templates are suggestions which may be used. However, their use is not a requirement, the requirement is the documentation and description associated with the Core Requirement which can have any format suitable for the research unit.

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

Retrieved from "http://eqipd-toolbox.paasp.net/index.php?title=Documentation_in_EQIPD&oldid=714"