Documentation in EQIPD

The following table describes the documentation required for EQIPD either as stand-alone document or in the context of the research process.

Categories​​​	No	Core Requirement	​Toolbox reference	​Documentation of the Core Requirements
				​Stand-alone document	Expected documentation
Research team​	1	Process owner must be identified for the Quality System	1.5.2.3​	No	No documentation needed, verbal agreement sufficient
	2	Communication process must be in place	1.2	Yes	A brief overview of the organisational structure and the communication lines could be documented in the Communication plan template
Quality culture	3	The research unit must have defined quality objectives ​	1.1	Yes	The Mission statement template could be used to document quality goals of a research unit
	4	All activities must comply with relevant legislation and policies	1.4.2	No	These documents are usually available due to legal reasons and are usually stored at a dedicated place in the research unit or could be hold available in the Dossier in a digital format
	5	The research unit must have a procedure to act upon concerns of potential misconduct	4.2.3	No	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	Yes	Could be documented in the Documentation plan and information about this Core Requirement should be available in 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​		Could be documented in the Documentation plan
	8	Reported research outcomes must be traceable to experimental data	3.1.2.1		Could be documented in the Documentation plan and additional information should be available 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	No	This information could for example be found in presentation as reference to the original experiments
​​​Research processes	10	Investigator must declare in advance whether a study is intended to inform a formal knowledge claim	2.1.4	No	This information could 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	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.​​​​