Core Requirements

Categories​​​	No	Item	​Toolbox reference
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
Quality culture	3	The research unit must have defined quality objectives ​	1.1
	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​
	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
Sustainability	18	Resources for sustaining the EQIPD Quality System must be available	1.5.5​​

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