CAEndOfTrial object

End of trial declaration mandatory for

All clinical trials 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)

15

Standard Declaration form available

Yes

Standard Declaration form

The standard End of trial declaration form (Form 3) to be used is available (in Serbian and Cyrillic script only) on the ALIMS website in section Regulativa » Humani Lekovi » Obrasci (Obrasci vezani za klinička ispitivanja lekova » Obaveštenje o završetku kliničkog ispitivanja).

Applicable national legal framework/ Reference

Art 92 Law on MP & MD 2010

Additional Information

Final report shall be submitted to the Agency within one year.

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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