ECEndOfTrial object

End of trial Declaration mandatory

Yes

Responsible for End of trial Declaration

Sponsor
Investigator

Regular Termination - Declaration timespan (max nr days)

90

Timespan counted from

Last patient - last visit in the respective country

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

15

Reasons for early termination shall be clearly stated

Yes

Standard Declaration form available

Yes

Standard Declaration form

Standard notification form (in Danish) available and downloadable on the website of the National Research EC in Section: Reporting of adverse reactions, completion of trials, etc.

Submission format: electronically using digital signature

Applicable national legal framework/ Reference

Section 31(1&2) of the Committee Act

Additional Information

The investigator and the sponsor must jointly notify the EC.

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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