ECMultiCenterStudiesEthicalReview object

Ethical approval (favourable opinion) required from

All local ECs of participating sites

Submission of application required to

All local ECs of participating sites

Additional Information

There is no central EC for the evaluation of multi-centre trials (MCT). MCT must be submitted for approval to the local ECs of the trial sites where the clinical trials are being performed. The Local ECs assess the clinical trial and issue their opinion on the applications independently. There is no single opinion procedure! ( Art 42 Rulebook Application 2011).

Multi-centre clinical trials are conducted in accordance with the provisions pursuant to Art 93 of the Law on MP & MD 2010 .
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For ECRIN research: Lead EC will be Serbian Medical Society Ethic Committee (SMS EC), for application submission. The final decision will be given from SMS EC after local EC approval.

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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