Documentation in EQIPD

UNDER CONSTRUCTION

not finalised yet

Categories​​​	No	Core Requirement	​Toolbox reference	​Documentation of the Core Requirements	​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 to be documented in a Risk 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 or in a separate Error reporting document
	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​.​​​​