Difference between revisions of "Core Requirements"

From EQIPD
Jump to: navigation, search
Line 4: Line 4:
 
|'''Core Requirement'''
 
|'''Core Requirement'''
 
|​'''Toolbox reference'''
 
|​'''Toolbox reference'''
|​'''Documents required'''
+
|​'''EQIPD required stand-alone document with links to templates'''
 
|-
 
|-
 
|rowspan="2"|'''Research team'''​
 
|rowspan="2"|'''Research team'''​
Line 15: Line 15:
 
|Communication process must be in place
 
|Communication process must be in place
 
|[[1.2 Scope]]
 
|[[1.2 Scope]]
|Template
+
|[https://paasp.sharepoint.com/:w:/s/EQIPD/ERyfFP_pBytDiEfqCutDAJQBFbaGQEx3G1pyOmDl50o_LQ?e=wlkvHJ|Communication plan]
 
|-
 
|-
 
|rowspan="3"|'''Quality culture'''
 
|rowspan="3"|'''Quality culture'''
Line 21: Line 21:
 
|The research unit must have defined quality objectives ​
 
|The research unit must have defined quality objectives ​
 
|[[1.1 Mission]]
 
|[[1.1 Mission]]
|Template
+
|[https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T|Mission statement]
 
|-
 
|-
 
|4
 
|4
Line 37: Line 37:
 
|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]]
|rowspan="3"|Template:
+
|rowspan="3"|[https://paasp.sharepoint.com/:w:/s/EQIPD/EVUTrgQRuNpKtpHkobdCOq4BhSTw1p3akXGKvI_MRgxYag?e=dJoZ5T|Documentation plan]
Documentation Plan
 
 
|-
 
|-
 
|7
 
|7
Line 57: Line 56:
 
|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]]
|No specific document needed,
+
| -
but document in Study plan
 
 
|-
 
|-
 
|11
 
|11
Line 68: Line 66:
 
|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]]
|No specific document,
+
| -
needed except the protocols
 
 
|-
 
|-
 
|13
 
|13
Line 85: Line 82:
 
|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]]​​
|To be documented with experimental protocol or a risk assessment protocol if performed
+
| -
 
|-
 
|-
 
|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]]
|No specific document needed,
+
| -
but errors should be documented with the experimental protocol
 
 
|-
 
|-
 
|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]]
|Template:  
+
|[https://paasp.sharepoint.com/:x:/s/EQIPD/EWbE3AdV5jhHglumN_MlrugBQX_KsZQDpJVNYbBJk6svTQ?e=qkW68H|Self assessment]
Self assessment available
 
 
|-
 
|-
 
|'''Sustainability'''
 
|'''Sustainability'''

Revision as of 10:04, 27 November 2020

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

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