Documentation in EQIPD

Categories​​​	No	Core Requirement	​Toolbox reference	​EQIPD required stand-alone document*	Required documentation
Research team​	1	Process owner must be identified for the Quality System	1.5.2.3​	-	-
	2	Communication process must be in place	1.2	Communication plan	-
Quality culture	3	The research unit must have defined quality objectives ​	1.1	Mission statement	-
	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	-	It is expected that a formal research integrity policy and ombudsman is in place (e.g. by the parent organization) and that training documentation is available
​​Data integrity	6	Generation, handling and changes to data records must be documented	​2.3.1	Documentation plan	Must be documented with the experimental/study protocol, e.g. identification of the author(s), time of data generation and ensured that data is readable and permanent
	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		Must be documented within the study plan and along the data usage chain, e.g. an unique study ID
	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	-	Must be documented in the study/experimental protocol, see 2.1.1 Study (experimental) plan
	11	All personnel involved in research must have adequate training and competence to perform assigned tasks	3.2.1	-	Participation in training must be documented with the training records
	12	Protocols for experimental methods must be available	3.5.2	-	All procedures used in experiments must be documented in the protocol (template)
	13	Adequate handling and storage of samples and materials must be ensured	3.3.3	-	This information must be available, e.g. as chemical data sheets or within study/experimental protocol
	14	Research equipment and tools must be suitable for intended use and ensure data integrity	3.3.2	-	Study/experimental protocols must show that equipment was fit-for-purpose, e.g. by using reference substances
Continuous performance	15	Risk assessment must be performed to identify factors affecting the generation, processing and reporting of research data	4.1.1​​	-	Study/experimental protocols must have a risk assessment section, see 2.1.1 Study (experimental) plan or Risk assessment template or Self assessment template
	16	Critical incidents and errors during study conduct must be analyzed and appropriately managed	4.2.2	-	Critical incidents and errors must 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	-
Sustainability	18	Resources for sustaining the EQIPD Quality System must be available	1.5.5	-	-

^*The provided templates are suggestions which may be used. However, their use is not a requirement, the requirement is the documentation and description associated with the Core Requirement which can have any format suitable for the research unit.

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