ECEndOfTrial object

End of trial Declaration mandatory

Yes

Responsible for End of trial Declaration

Sponsor

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

Declaration of the End of Trial Form (cf. Section 4.2.1 of the Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of the trial CT-1)

Applicable national legal framework/ Reference

Art 19 Law 21/2014 (pt)

Additional Information

The final report must be submitted to the EC within 12 month after trial termination.

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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