Documentation in EQIPD

EQIPD Quality System is lean and does not require excessive documentation.

The following table describes the documentation required to address the EQIPD core requirements.

In some cases, these are stand-alone documents. In others, expected information is typically available in other documents - mandated by the institutional regulations or being part of another process.

Categories​​​	No	Core Requirement	​Toolbox reference	​Implementation of the Core Requirements
				​Stand-alone document	EQIPD expectations
Research team​	1	Process owner must be identified for the Quality System	1.5.2.3​	No	Process Owner should act and be recognized as such by the research unit members.
	2	Communication process must be in place	1.2	Yes	A concise overview of the organisational structure and the communication lines can be described in the Communication plan template provided by EQIPD or in a similar document.
Quality culture	3	The research unit must have defined quality objectives ​	1.1	Yes	The Mission statement template of EQIPD or a similar document can be used to describe quality goals of a research unit. These quality objectives should be known to and shared by all members of a research unit.
	4	All activities must comply with relevant legislation and policies	1.4.2	No	Research unit complies with all applicable national and international legislation and policies and there are no compliance issues.
	5	The research unit must have a procedure to act upon concerns of potential misconduct	4.2.3	No	It is expected that a research unit or its parent organization has a research integrity policy, office and/or officer (or ombudsman) and all research unit members have access to this information.
​​Data integrity	6	Generation, handling and changes to data records must be documented	​2.3.1	Yes	Can be described in the Documentation plan or in a similar document.
	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​		Could be documented in the Documentation plan or in a similar document.
	8	Reported research outcomes must be traceable to experimental data	3.1.2.1		Could be documented in the Documentation plan or in a similar document.
	9	Reported data must disclose all repetitions of a study, an experiment, or a test regardless of the outcome​​	2.4	No	it is expected that the Process Owner conducts spot checks on reported studies to make sure that all repetitions are reported.
​​​Research processes	10	Investigator must declare in advance whether a study is intended to inform a formal knowledge claim	2.1.4	No	This requirement is met by providing corresponding information in the study (experimental) plan, 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	No	Participation in training could be hold available with the training records
	12	Protocols for experimental methods must be available	3.5.2	No	All procedures used in experiments could be hold available in the study/experimental protocol (template)
	13	Adequate handling and storage of samples and materials must be ensured	3.3.3	No	This information could be hold 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	No	Study/experimental protocols could reference or document 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​​	No	Study/experimental protocols could have a dedicated section for risk of bias in experimental processes, see 2.1.1 Study (experimental) plan and for a risk assessment on the level of the research unit, it could be documented in the Risk assessment template
	16	Critical incidents and errors during study conduct must be analyzed and appropriately managed	4.2.2	No	Critical incidents and errors could be documented with the experimental protocol if on experimental level and in a separate Error reporting document for the research unit level
	17	An approach must be in place to monitor the performance of the EQIPD Quality System, and address identified issues​	4.1.2	Yes	This could be documented in the Self assessment template
Sustainability	18	Resources for sustaining the EQIPD Quality System must be available	1.5.5	No	No documentation needed

Back to the EQIPD Quality System​ or Core Requirements.​​​​