Notification of the study termination and final report

 

The conclusion of a clinical investigation coincides with the last visit of the last participant, unless the clinical investigation plan provides for another time that determines its end.

The sponsor notifies the Member States concerned when a clinical investigation comes to an end or in case of temporary interruption or early termination.

If you prematurely terminate or temporarily interrupt a clinical investigation for safety reasons, you must notify the Member States within 24 hours. In addition to these cases, you have a maximum of 15 days to communicate the conclusion or temporary interruption, provided that safety-related aspects are not involved.

 

Results

The clinical investigation process is only considered complete after receipt of the clinical investigation report, which must be accompanied by a summary, written in terms easily understandable to the intended user (which are made public). You have 12 months to submit the report or 3 months in case of interruption or early termination.

You can find more details about the clinical research summary and report in Chapter III, Annex XV of the MDR and European guidelines published by the MDCG such as 2023/C 163/06 - Commission Guidance on the content and structure of the clinical research report summary.