Completion

Publication of Results

For drug trials, results must always be entered into CTIS / EU Clinical Trials Register (EUCTR), depending on whether the trial follows the new or old regulations. See NorCRIN-SOP Completion, Reporting and Archiving section 4.1 / Sluttrapportering til SLV og REK, section 4.2  (old regulations).

For trials that follow the old regulations, it is recommended to apply for an EMA account while working on the EudraCT form. The registration form and results page should be completed in parallel. Expect the process to take about a day to enter a trial. A statistician should be involved in the description of endpoints.

There is a training database available on the EudraCT website.

Guidance, templates, and Q&A in Danish can be found on the GCP Units website.

We have compiled questions related to results registration at OUS in the document " Posting clinical trials and their results on the EU Clinical Trials Register" (PDF, English).

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

Archiving

Archiving of paper documentation at the end of the trial should be avoided as much as possible—all documentation can be stored electronically. See SOP on Closure and Archiving of Clinical Drug Trials (old regulations) / SOP Completion, Reporting and Archiving (new regulations) and SOP Study Files for old/new regulations. It is advisable to create an archiving log to record the date when documents are sent for archiving and the planned date for destruction/deletion.

Oslo University Hospital has an agreement with Iron Mountain for the storage of paper documents. The Patient Archive is responsible for registering boxes and transporting them to storage. The procedure is described in the eHåndboken document: Drug Trials - Practical Solutions for Storing Paper Documentation (in Norwegian).

Deletion and Destruction of Archived Trial Documents

For clinical drug trials, the requirement for storage is at least 15/25 years after the trial has concluded at all sites. Documents must be kept longer if required by other regulations or agreements.

There are specific requirements for archiving periods for trials involving somatic cell therapy, gene therapy, or tissue regenerative treatment. Certain documents, including code lists, must be stored for 30 years in such trials.

The Patient Archive receives notification from Iron Mountain when the registered destruction date is approaching and will contact the responsible investigator/department head to confirm with the sponsor whether destruction can proceed as planned.

For the deletion of electronically stored information, the responsible investigator/department head should send an email to personvern@ous-hf.no indicating which folder should be deleted.