Core Requirements

Categories​​​	No	Core Requirement	​Toolbox reference	​Documents required
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	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	-
	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	Template: 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	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	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	-
	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	-
	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​​	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	-

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