Reporting at the Conclusion of a Trial

The person responsible for the trial and the sponsor must jointly notify the committee within 90 days after the completion of the project (committee law § 31, para. 1). The project is considered completed when the last trial subject has finished.

The report of the project's conclusion can be done by submitting a form. Skemaet kan indsendes elektronisk til den regionale komité ved anvendelse af digital signatur.

If the project is terminated earlier than planned, the committee must be informed within 15 days from the date the decision to terminate the project was made. The termination must be justified. The committee may require the trial responsible or the sponsor to provide a reasoned statement.

Reporting/Publication of Data on the EU Clinical Trials Register

The committee normally requires that the final report or publication be submitted to the committee (committee law § 28, para. 2). If the results of the trial or the final report are published on a website, such as, the sponsor and trial responsible can inform the committee system by sending a link to the trial on the respective website (however, this does not apply to phase 1 trials, which the committees do not have access to on these sites).

Definition of Trial Conclusion:

A trial is considered completed at the last visit of the last trial subject, or at a later date as set out in the protocol.

For trials not involving medicinal products, including biobank trials or health data trials, it is also considered that a trial is completed when the researcher has finished collecting all the information for the project, i.e., the trial participants have completed the trial, and/or analyses of biological material and collection of registry data, etc., have been carried out.

Projects involving the collection of biological material, including biobank projects, must have an approval that extends beyond the actual patient inclusion and visits or collection of material, e.g., if trial-related procedures are to be carried out afterward, such as disclosure of or access to patient records in connection with the compilation of results or follow-up.

Last updated 01-02-2024

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