ECEndOfTrial object

End of trial Declaration mandatory

Yes

Responsible for End of trial Declaration

Investigator

Regular Termination - Declaration timespan (max nr days)

90

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

2 (interruption for safety reasons) / 15 (for other reasons)

Reasons for early termination shall be clearly stated

Yes

Standard Declaration form

A standard trial termination form to be used for declaration to the EC is available on the Swissethics website in section: Templates.

Applicable national legal framework/ Reference

Art 37 + Art. 38 KlinV/ClinO

Additional Information

A fundamental definition for the end of the trial should be explicitly mentioned in the trial protocol. It is usually the date of the final visit by the final trial participant: LPLV (last patient, last visit).

Multi-centre trials: In case of an interruption or premature termination of at one of the trial site, the coordinating investigator informs the responsible EC 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
Feedback