ECTimelinesEthicalReview object

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

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

Clock-stop possible if complementary information requested

Yes

Applicable national legal framework/ Reference

Single-centre studies: Art. 26 KlinV/ClinO
Multi-centre studies: Art. 27 KlinV/ClinO
Trials involving radiation sources: Art 28 KlinV/ClinO

Additional Information

The lead EC / local EC shall acknowledge receipt of the application within 7 days and notify the applicant (the (coordinating) investigator or sponsor) of any formal deficiencies.
1. Single-centre studies: Local EC informs applicant on its final decision (plus the CA in case of Cat C clinical trials).
2. Multi-centre studies:
the local ECs shall reach a decision on the trial sites within 15 days upon receipt of the application documents and communicate them to the lead EC.
Lead EC informs applicant on its final decision (plus concerned local ECs in case of multi-centre trials as well as the CA in case of Cat C clinical trials).
3. Trials involving radiation sources:
Local EC shall issue a reasoned opinion within 45 calendar days of acknowledgement of receipt of the formally correct application dossier; local EC shall inform the FOPH of its decision.

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