Completion

For drug trials, results should always be entered in the EU Clinical Trials Register (EUCTR), see NorCRIN SOP Final Reporting to SLV and REK, section 4.2.

It is recommended to apply for an EMA account at the same time as working with the EudraCT form. The registration form and the results page should be filled in in parallel. Expect approx. one day's work to post a trial. Statisticians should be involved in describing endpoints.

Tutorials on posting results in EudraCT can be found on the EudraCT website, as well as a training database.

Guidance, templates and Q&A in Danish are available at GCP-enhederne.

We have collected questions we have received in connection with result registration at OUS here: Posting clinical trials and their results on the EU Clinical Trials Register.

If the trial is registered in both EUCTR 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".

Archiving of paper documentation at the end of the trial should be avoided if possible. All study documentation can be stored electronically, see SOP Avslutning og arkivering av kliniske legemiddelstudier (Completion and Filing of Clinical Drug Trials) and SOP Study Files. We recommend creating an archive log for recording of dates when documents are sent for archiving and scheduled date for shredding / deletion.

For clinical drug trials, the requirement for document retention is at least 15 years after completion of the trial at all sites. Documents must be kept longer if required by other regulations or agreements.