CAEndOfTrial object

End of trial declaration mandatory for

All clinical investigations 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)

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

Applicable national legal framework/ Reference

Art. 37 + 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).

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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