Difference between revisions of "Core Requirements"
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Revision as of 12:43, 30 November 2020
|Categories||No||Core Requirement||Toolbox reference||EQIPD provided templates*|
|Research team||1||Process owner must be identified for the Quality System||22.214.171.124 Process owner||-|
|2||Communication process must be in place||1.2 Scope||Communication plan|
|Quality culture||3||The research unit must have defined quality objectives ||1.1 Mission||Mission statement|
|4||All activities must comply with relevant legislation and policies||1.4.2 Adherence to legal and regulatory considerations||-|
|5||The research unit must have a procedure to act upon concerns of potential misconduct||4.2.3 Responsible conduct of research||-|
|Data integrity||6||Generation, handling and changes to data records must be documented||2.3.1 Generation, recording, handling and archiving of raw data||Documentation plan|
|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 Data security|
|8||Reported research outcomes must be traceable to experimental data||126.96.36.199 Traceability of data and any person having impact on data|
|9||Reported data must disclose all repetitions of a study, an experiment, or a test regardless of the outcome||2.4 Reporting||-|
|Research processes||10||Investigator must declare in advance whether a study is intended to inform a formal knowledge claim||2.1.4 Purpose of research||-|
|11||All personnel involved in research must have adequate training and competence to perform assigned tasks||3.2.1 General guidance on training||-|
|12||Protocols for experimental methods must be available||3.5.2 Protocols for methods and assays||-|
|13||Adequate handling and storage of samples and materials must be ensured||3.3.3 Management of research materials and reagents||-|
|14||Research equipment and tools must be suitable for intended use and ensure data integrity||3.3.2 Processes to enable computerized and non-computerized systems being suitable for intended use||-|
|Continuous performance||15||Risk assessment must be performed to identify factors affecting the generation, processing and reporting of research data||4.1.1 Risk assessment||-|
|16||Critical incidents and errors during study conduct must be analyzed and appropriately managed||4.2.2 Error and incident management||-|
|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||Self assessment|
|Sustainability||18||Resources for sustaining the EQIPD Quality System must be available||1.5.5 Sustainability||-|
*The provided templates are suggestions which may be used. However, their use is not a requirement, the reuiqrement is the documentation and description associated with the Core Requirement.
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