Registration in Publicly Approved Databases

All drug trials requiring application within the EEA must be registered in the Clinical Trials Information System (CTIS) or the EU Clinical Trials Register (EU CTR), depending on whether the trial follows the new or old regulations. All trials with active sites after 30 January 2025 must follow the new regulations.

Other clinical interventional and observational trials should be registered in ClinicalTrials.gov.

If you are unsure whether a study requires registration, refer to the recommendations from the International Committee of Medical Journal Editors (ICMJE).

For Oslo University Hospital, see full requirements in the guideline (Norwegian).  

CTIS

Drug trials following the new regulations must be registered in the Clinical Trials Information System (CTIS). This happens automatically when the application is approved by the Directorate for Medicinal Products (DMP) and the Regional Committees for Medical and Health Research Ethics (REK KULMU).

EU Clinical Trials Register (EU CTR)

Drug trials following the old regulations must be registered in the EU Clinical Trials Register (EU CTR). Sponsors should verify that this has been done. If not, the REK decision must be sent to the Directorate for Medicinal Products (DMP, formerly SLV) with a request for the study to be registered.

Studies with active centres in the European Economic Area (EEA) after 30 January 2025 must be transferred to CTIS. The deadline for the transition application was 16 October 2024.

ClinicalTrials.gov

The process for managing registrations may vary between healthcare institutions, so researchers should familiarise themselves with the procedures applicable at their hospital.

Oslo University Hospital (OUS) has established a shared user account in ClinicalTrials.gov.

For registration or questions about registration, contact the local Protocol Registration System (PRS) administrator to receive a username and password.

The PRS administrator at OUS is the project coordinators in the Department of Research Support for Clinical Studies (CTU).

Contact information for PRS administrator at OUS: ctu@ous-hf.no

Once you have received a username and password for OUS's shared account, you can begin registering your study via the login page. Remember to list the project leader as the Principal Investigator (PI) if it is an investigator-initiated trial based at OUS.

The Principal Investigator (PI) must be listed as the "Responsible Party" to be able to "release" the trial in ClinicalTrials.gov.

Remember to update the trial when there are changes in recruitment status, both per study site and overall. Information must be updated at least every 6 months. The date of the last participant's final visit must be recorded within 30 days.

Publication of Results

Key outcomes must be made publicly available within 12 months after the study's completion by entering them into the primary database where the study was registered.

According to the WHO's interpretation of the Declaration of Helsinki, key findings should be submitted for publication in a peer-reviewed journal and made available via open access. 

For drug trials, results must always be entered into the EU Clinical Trials Register (EU CTR) or CTIS. See NorCRIN SOP:

• Final Reporting to SLV and REK, (Norwegian) section 4.2 (old regulations)
• Ongoing Trial Reports and Notifications, section 4.2 (new regulations).

If the trial is registered in both EU CTR/CTIS and ClinicalTrials.gov, it is recommended to include the following text under the "Detailed Description" in the ClinicalTrials.gov registration module:
"The results are recorded in EU CTR. Reference is EudraCT number xxx / CTIS number xxx."

For all other studies, results should be entered into the results module in ClinicalTrials.gov.

This page was translated from Norwegian using ChatGPT and edited by Ellen Johnsen