Core Requirements

Revision as of 15:04, 3 September 2020 by Bjoerngerlach (talk | contribs) (Created page with "<div> <table cellspacing="0" class="ms-rteTable-2" style="width: 62%;"> <tbody> <tr class="ms-rteTableEvenRow-2"> <td class="ms-rteTableEvenCol-2...")
(diff) ← Older revision | Latest revision (diff) | Newer revision → (diff)
Jump to: navigation, search
<tbody> </tbody>
Item​ Toolbox item

Research team 1 Process owner must be identified for the Quality System <a href="/sites/EQIPD/EQIPD%20QS/Process%20owner.aspx">​​</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>
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">​</a>
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>
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>
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​.​​​​