ECEndOfTrial object

End of trial Declaration mandatory

Yes

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

There is no standard form available for investigations of MD

Applicable national legal framework/ Reference

Art 27 Circular 7/2004 & Royal Decree 1090/2015

Additional Information

In case of premature trial termination, the notification must include the study data obtained so far as well as the reasons for early study termination and the measures taken relating to the study participants,

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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