CAEndOfTrial object

End of trial declaration mandatory for

All clinical trials 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

Guidance on End of trial declaration

Section 18 and Annex 8 Decree on GCP

Applicable national legal framework/ Reference

Section 56(5) Act on Pharmaceuticals
Section 18 and Annex 8 Decree on GCP

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
Feedback