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
The application of MD studies (with randomization) has to be submitted to and approved by all local RECs of the participating sites (Art 18 & 19 Circular 7/2004).
For observational studies with no randomization, the protocol has to be submitted to all participating EC (for the evaluation of local issues), but it is only required the approval from one EC.
