ECMultiCenterStudiesEthicalReview object
Ethical approval (favourable opinion) required from
Lead EC (authorised to issue a single opinion)
Submission of application required to
Lead EC + All concerned local ECs for site-specific assessment
Additional Information
Submission to all reference ECs of the participating clinical sites is required.
The single opinion (“Parere Unico”) is provided by the ethics committee of the Italian facility where the coordinating investigator is located (lead EC). The trial may not begin at any site until the said opinion has been issued. The other local ECs involved in the trial may send its comments to the (lead) Ethics Committee of the coordinating centre.
