CAEndOfTrial object

End of trial declaration mandatory for

All clinical investigations requiring authorisation by CA

Regular Termination - Declaration timespan (max nr days)

30

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

15

Standard Declaration form available

No

Applicable national legal framework/ Reference

Art 18 Decree No 33/2009

Additional Information

Final Report (two copies) of the Study should attached to the notification!
The acceptance of the EC is also necessary for the Final Report (Final Report is submitted to the EC via HRTC).

If the study cannot be finish until the planned ending date of the study indicated in the study plan, the applicants should notify the HRTC!

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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