ECEndOfTrial object

End of trial Declaration mandatory

Yes

Responsible for End of trial Declaration

Sponsor
Principal Investigator

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

Applicable national legal framework/ Reference

Section 12 & 13 GCP-V

Additional Information

The duties of the PI and the sponsor regarding the completion of the trial can be found in section 12 subsection 2-3 and section 13 subsections 8-10 GCP-V.

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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