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 available

Yes

Standard Declaration form

European "Declaration of the End of Trial Form")/ "Formulário de declaração de fim de EC": provided on the INFARMED website in section Medicamentos Uso Humano> Ensaios Clinicos> Formulários

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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