CAEndOfTrial object

End of trial declaration mandatory for

All clinical investigations requiring authorisation by CA

Responsible for End of trial declaration

Sponsor

Regular Termination - Declaration timespan (max nr days)

15

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

15

Reasons for early termination shall be clearly stated

Yes

Standard Declaration form available

Yes

National legal framework in place

Yes

Applicable national legal framework/ Reference

Royal Decree 1090/2015

Additional Information

In case of premature trial termination, the notification must include the study data obtained until the study termination as well as the reasons for this and the measures taken relating to the study participants.
Additionally the promotor will send to the CA a copy of the summary of the Clinical Trial results. This information will be sent (maximum timeframe) after 1 year of the anticipated trial ending.

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
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