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

Standard Declaration form available

No

Standard Declaration form

Use of the online portal OsSC!

National legal framework in place

Yes

Applicable national legal framework/ Reference

Section 10.2 Legislative Decree n. 211

Additional Information

End of the trial shall be declared to the Ministry of Health, the other CAs and the ECs concerned.

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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