Termination or end
Here you will find answers to frequently asked questions about termination or end.
Which legal reporting obligations apply in the event of completion or early termination of the clinical investigation?
For clinical investigations initiated before 26.05.2021 and for performance studies initiated before 26.05.2022, the provisions of Section 23a MPG apply. Within 90 days after termination of a clinical investigation, the sponsor must notify the competent higher federal authority (here: BfArM) of the termination of the clinical investigation.
If the clinical investigation is discontinued, this period is reduced to 15 days. The notification must state all reasons for the discontinuation. Receipt of the notification is confirmed by the BfArM.
The sponsor submits the final report to the competent higher federal authority within twelve months of discontinuation or completion of the clinical trial. Receipt of the report is also confirmed by the BfArM.
How should a final report be structured?
It is recommended that the content of the final report be based on Annex D of the standard DIN EN ISO 14155:2020. For performance studies of in vitro diagnostic medical devices, the final report may also be prepared according to Annex D of ISO 20916:2019.