Conduct

For clinical drug trials, serious, unexpected, adverse events that may be related to the trial drug (suspected unexpected serious adverse reactions, SUSARs) should only be sent to the Norwegian Medicines Agency (NoMA/SLV), not to the ethics committee (REK). See SOP Rapportering av uønskede medisinske hendelser og bivirkninger (Reporting of Adverse Events and Side Effects).

A link to SLV's website for reporting requirements in clinical trials can be found here (in Norwegian).

Other serious, adverse and unexpected events involving research participants must be registered in Achilles, OUS' deviation reporting system, as a "Patient Event". Nonconformities related to the use of health information or human biological material in research shall be registered in the deviation reporting system as "Other nonconformities and improvement measures". The PI, trial staff and other personnel are obliged to provide the authorities with information on matters that may endanger the safety of the research participants.

Changes to the protocol and other project changes must follow the SOP Protokolltillegg og endringer etter studiestart (Protocol Amendments and Changes after Trial Start).

Correspondence with authorities and ethics committees, including submissions and approvals/decisions, should be sent to godkjenning@ous-hf.no.

For clinical studies that affect patient treatment, the Principal Investigator (PI), or National Coordinating Investigator (NC) for multicenter studies, is responsible for reporting how many new patients were included for each study site the previous year. Reporting must be carried out each spring via a web form. Prior to this, the PI/NC will receive an email with a personal link to the web form. See Registration and Reporting.