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).
Registration routines may vary between hospitals, so it is important for researchers to familiarize themselves with their local procedures. OUS has established a joint user account in ClinicalTrials.gov. If you need username and password or have questions regarding how to register, contact the local Protocol Registration System (PRS).
PRS administrator at OUS is Administrative Advisor Gunn Ellingsen at Regional Research Support Services:
Email: gunn.ellingsen@ous-hf.no
Tel: +47 23 06 60 13
Once you have received your username and password for the OUS user account, you can start registration via the login page. Remember to list the project manager/principal investigator for the study as Principle Investigator (PI) for researcher-initiated studies where OUS is sponsor.
Principal Investigator (PI) should be listed as "Responsible Party" in order to "release" the study in ClinicalTrials.gov.
Remember to update the study in ClinicalTrials when there are changes in recruitment status, both per study center and overall. The information should be updated at least every 6 months. The date of the last study participant's last visit must be registered within 30 days.
Publication of results
WHO's interpretation of the Helsinki Declaration's requirements for publication of results is that main findings must be sought published in a peer-reviewed journal and via open access. In addition, key outcomes shall be made publicly available within 12 months of the end of the study by reporting in the primary database where the study was registered. Phase 1 studies are exempt from reporting obligations.
For drug trials, results should always be entered in the EU Clinical Trials Register (EU CTR), see NorCRIN SOP Final Reporting to SLV and REK, section 4.2. If a trial is already registered in both EU CTR and ClinicalTrials.gov, it is recommended to enter the following text under "Detailed Description" in the registration module in ClinicalTrials.gov: "The results are recorded in EUCTR. Reference is EudraCT number xxx".
For all other trials, the results should be recorded in the results module in ClinicalTrials.gov.