Difference between revisions of "Documentation in EQIPD"

From EQIPD
Jump to: navigation, search
(Created page with "{| class="wikitable" |'''Categories​​​''' |'''No''' |'''Core Requirement''' |​'''Toolbox reference''' |​'''EQIPD provided templates<sup>*</sup>''' |- |rowspan="2"|...")
 
Line 4: Line 4:
 
|'''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]]
 +
| -
 
| -
 
| -
 
|-
 
|-
Line 36: Line 42:
 
|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]]
 +
| -
 
| -
 
| -
 
|-
 
|-
Line 55: Line 65:
 
|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]]
 
| -
 
| -
 
|-
 
|-
Line 81: Line 94:
 
|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​.​​​​

Retrieved from "http://eqipd-toolbox.paasp.net/index.php?title=Documentation_in_EQIPD&oldid=683"