Adverse Medical Events

The project manager is obliged to submit a written notification to the regulatory authorities regarding serious and adverse unexpected medical events that are believed to be related to the research. The project manager and all project staff also have an independent responsibility to inform the regulatory authority (Helsetilsynet - The Norwegian Board of Health Supervision) about any issues that may pose a risk to the safety of research participants. In the event of an unnatural death, the police must be notified immediately.

The project manager must also promptly inform the research participants if they have sustained harm or if complications have arisen as a result of the research project, including informing the participant of their right to seek compensation from Norwegian Patient Injury Compensation (NPE).

OUS has a guideline on reporting of adverse events and non-conformity in research.

For drug trials, there are specific procedures for reporting adverse events; see Clinical Trials - Drugs and Medical Devices.