Core Requirements

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Categories​​​ No Core Requirement Toolbox reference Documents required
Research team 1 Process owner must be identified for the Quality System Process owner -
2 Communication process must be in place 1.2 Scope Template
Quality culture 3 The research unit must have defined quality objectives ​ 1.1 Mission Template
4 All activities must comply with relevant legislation and policies 1.4.2 Adherence to legal and regulatory considerations No specific document needed
5 The research unit must have a procedure to act upon concerns of potential misconduct 4.2.3 Responsible conduct of research No specific document needed
​​Data integrity 6 Generation, handling and changes to data records must be documented 2.3.1 Generation, recording, handling and archiving of raw data Template
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 Template
8 Reported research outcomes must be traceable to experimental data Traceability of data and any person having impact on data​ Template
9 Reported data must disclose all repetitions of a study, an experiment, or a test regardless of the outcome​​ 2.4 Reporting No specific document needed
​​​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 No specific document needed, but document in Study plan
11 All personnel involved in research must have adequate training and competence to perform assigned tasks 3.2.1 General guidance on training No specific document needed
12 Protocols for experimental methods must be available 3.5.2 Protocols for methods and assays No specific document needed except the protocols
13 Adequate handling and storage of samples and materials must be ensured 3.3.3 Management of research materials and reagents No specific document needed
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 No specific document needed
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​​ To be documented with experimental protocol or a risk assessment protocol if performed
16 Critical incidents and errors during study conduct must be analyzed and appropriately managed 4.2.2 Error and incident management No specific document needed, but errors should be documented with the experimental protocol
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 Template Self assessment available
Sustainability 18 Resources for sustaining the EQIPD Quality System must be available 1.5.5 Sustainability No specific document needed

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