ECTimelinesEthicalReview object

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

60

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

60

Clock-stop possible if complementary information requested

Yes

Timespan counted from

Confirmation of formal completeness

National legal framework in place

Yes

Applicable national legal framework/ Reference

Art 18 Circular 7/2004
Royal Decree 1090/2015

Additional Information

Formal evaluation of application dossier for both mono-centre and multicentre trials: The REC(s) has/have 10 days to validate the application documentation and to notify the sponsor on the decision.

There are different submission deadlines for each of the RECs. The corresponding meeting schedules are provided on the MSSSI website in section "Calendario de los CEIC's".

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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