Documentation in EQIPD

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Categories​​​ No Core Requirement Toolbox reference EQIPD provided templates*
Research team 1 Process owner must be identified for the Quality System 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 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 Data security
8 Reported research outcomes must be traceable to experimental data 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 -

*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​.​​​​