Registration in ClinicalTrials.gov and EU CTR

All prospective clinical trials conducted at Oslo University Hospital HF (OUS) must be registered in a publicly available, approved database before the project can start, i.e. before the inclusion of the first patient.

Most external funding sources demand registration of projects when allocating grants. It is also a prerequisite for publishing results.

All drug trials subject to application within the EEA area must be registered in the EU Clinical Trials Register (EU CTR). This is done by the Norwegian Medicines Agency (SLV), which uploads information from the EudraCT form when the study has been approved by both REK and SLV. The PI must verify that the trial has been registered in the EU CTR. Notify SLV in the event of deviations.

Other clinical intervention and observational studies should be registered in ClinicalTrials.gov.

If in doubt as to whether the study should be registered or not, see recommendations from the International Committee of Medical Journal Editors (ICMJE).