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)

90

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

15

Reasons for early termination shall be clearly stated

Yes

Standard Declaration form available

Yes

Standard Declaration form

The standard reporting form to be used is provided on the AEMPS website in section “Aclaraciones sobre la aplicación de la normativa de ensayos clínicos”: Anexo 1D: Notificación del fin del ensayo.

Applicable national legal framework/ Reference

Royal decree 1090/2015
Art 30 Royal Decree 1591/2009

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

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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