9. Non-conformances and adverse events
In this context, non-conformances and adverse events refer to incidents in relation to the research participants or deviations from the approvals that were granted.
Adverse events must be reported immediately to the person or entity responsible for the research ("forskningsansvarlig"), either through the project manager or directly by the person who discovered the event. Use this form. The person or entity responsible for the research must take steps to resolve the non-conformance in accordance with the procedure. Non-conformance reports and measures taken to resolve the non-conformances must be stored in the folder labelled "non-conformances" and the year under your faculty in NTNU's archival system (ePhorte). If you need help, contact the unit's Head of Records or document centre.
If doubt arises about whether the research project is justifiable and the risk is acceptable, the project must be stopped pending further clarification with the person/entity responsible for research and the regional committee for medical and health research ethics (REK).
The project manager or person/entity responsible for research must report serious incidents as well as adverse and unexpected medical events to the Norwegian Board of Health (Statens helsetilsyn). In the event of death from unnatural causes, the police must be notified immediately.
If research participants have sustained injuries or if complications have arisen because of the research project, the project manager must inform the research participants immediately. At the same time, the research participants must be informed about the possibility of seeking compensation from the Norwegian System of Compensation to Patients (NPE).
Fri, 15 Jun 2012 12:46:15 +0200
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Version 1.0. Date: 1 January 2012