Reporting at the Conclusion of a Trial

The trial responsible and 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. The form can be submitted electronically to the regional committee using a digital signature.

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 www.clinicaltrialsregister.eu, 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.