ECTimelinesEthicalReview object

General timespan for single-centre studies (max nr days)

15

General timespan for multi-centre studies (max nr days)

15

Timespan counted from

Confirmation of formal completeness

Applicable national legal framework/ Reference

Regulation on Clinical Trials of Medicinal and Biological Products 2014

Additional Information

The sponsor is granted a single opportunity to resubmit amendments upon request of the Ministry

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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