Core Requirements

Categories​​​	No	Core Requirement	​Toolbox reference	​EQIPD required stand-alone documents 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	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	-
	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 since they provide guidance. However, there use is not a requirement, the reuiqrement is the documentation and description associated with the Core Requirement.

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