CAEndOfTrial object

End of trial declaration mandatory for

All clinical investigations requiring authorisation by CA

Responsible for End of trial declaration

Sponsor
Legal representative domiciled in the respective country

Regular Termination - Declaration timespan (max nr days)

Early/premature Termination - Declaration timespan (max nr days)

Reasons for early termination shall be clearly stated

Yes

Standard Declaration form available

Yes

Standard Declaration form

A standard notification form and cover letter sample are posted on the Ministry’s website.

National legal framework in place

Yes

Applicable national legal framework/ Reference

Regulation On Medical Device Clinical Trials 2014

Additional Information

If the clinical trial was terminated early, its grounds will also be stated and an information letter regarding the measures for maintenance of the treatment of the volunteers enrolled into the study will also be attached. In cases where early termination was due to safety reasons, the Agency shall inform the situation to the European Union Commission through the agency of the Ministry of Economy or electronically.
In cases where early termination was due to safety reasons, the Agency shall inform the situation to the European Union Commission through the agency of the Ministry of Economy or electronically.

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395