Core Requirements

<tbody> </tbody>

​​​​​​Categories​​​		Item​	​Toolbox item
​		​	​
Research team ​	1	Process owner must be identified for the Quality System	<a href="/sites/EQIPD/EQIPD%20QS/Process%20owner.aspx">​1.5.2.3​</a>
	2	Communication process must be in place	​<a href="/sites/EQIPD/EQIPD%20QS/Scope.aspx">1.2</a>
​		​	​
​Quality culture ​ ​	3	The research unit must have defined quality objectives	​<a href="/sites/EQIPD/EQIPD%20QS/Mission.aspx" style="text-align: center;">1.1</a>
	4	All activities must comply with relevant legislation and policies	​<a href="/sites/EQIPD/EQIPD%20QS/Adherence%20to%20legal%20and%20regulatory%20considerations.aspx">1.4.2</a>
	5	The research unit must have a procedure to act upon concerns of potential misconduct	​<a href="/sites/EQIPD/EQIPD%20QS/Responsible%20conduct%20of%20research.aspx">4.2.3​</a>
		​	​
​​Data integrity ​ ​ ​	6	Generation, handling and changes to data records must be documented	​<a href="/sites/EQIPD/EQIPD%20QS/Generation,%20recording,%20handling%20and%20archiving%20of%20raw%20data.aspx">2.3.1​</a>
	7	Data storage must be secured at least for as long as required by legal, contractual or other obligations or business needs	​<a href="/sites/EQIPD/EQIPD%20QS/Data%20security.aspx">3.1.3</a>
	8	Reported research outcomes must be traceable to experimental data	<a href="/sites/EQIPD/EQIPD%20QS/Traceability%20of%20data%20and%20any%20person%20having%20impact%20on%20data.aspx">​3.1.2.1</a>
	9	Reported data must disclose all repetitions of a study, an experiment, or a test regardless of the outcome​​	​<a href="/sites/EQIPD/EQIPD%20QS/Reporting.aspx">2.4</a>
		​	​
​​​Research processes ​ ​ ​ ​	10	Investigator must declare in advance whether a study is intended to inform a formal knowledge claim	<a href="/sites/EQIPD/EQIPD%20QS/Purpose%20of%20research.aspx">​2.1.4</a>
	11	All personnel involved in research must have adequate training and competence to perform assigned tasks	​<a href="/sites/EQIPD/EQIPD%20QS/General%20guidance%20on%20training.aspx">3.2.1</a>
	12	Protocols for experimental methods must be available	<a href="/sites/EQIPD/EQIPD%20QS/Protocols%20for%20methods%20and%20assays.aspx">​3.5.2</a>
	13	Adequate handling and storage of samples and materials must be ensured	<a href="/sites/EQIPD/EQIPD%20QS/Management%20of%20research%20materials%20and%20reagents.aspx">​3.3.3</a>
	14	Research equipment and tools must be suitable for intended use and ensure data integrity	<a href="/sites/EQIPD/EQIPD%20QS/Processes%20to%20enable%20computerized%20and%20non-computerized%20systems%20being%20suitable%20for%20intended%20use.aspx">​3.3.2​</a>
		​	​
​Continuous performance ​ ​	15	Risk assessment must be performed to identify factors affecting the generation, processing and reporting of research data	<a href="/sites/EQIPD/EQIPD%20QS/Risk%20assessment.aspx">4.1.1​​</a>
	16	Critical incidents and errors during study conduct must be analyzed and appropriately managed	<a href="/sites/EQIPD/EQIPD%20QS/Error%20and%20incident%20management.aspx">​4.2.2</a>
	17	An approach must be in place to monitor the performance of the EQIPD Quality System, and address identified issues​	​<a href="/sites/EQIPD/EQIPD%20QS/Self%20assessment.aspx">4.1.2</a>
		​	​
Sustainability	18	Resources for sustaining the EQIPD Quality System must be available	​<a href="/sites/EQIPD/EQIPD%20QS/Sustainability.aspx">1.5.5​​</a>

Back to the EQIPD Framework​.​​​​