Lead EC (authorised to issue a single opinion)
Lead EC + All concerned local ECs for site-specific assessment
The formal opinion should be issued by one of the ECs with full accreditation status (see Circular ).
The situation in the hierarchy (Academic Hospital ECs authorised to issue a single opinion > Non- Academic Hospital ECs authorised to issue a single opinion > Hospital ECs not authorised to issue a single opinion) will guide the sponsor in his choice of the leading EC (LEC) to issue the single opinion for the multi-centre research project.
The LEC reviews the experiment and issues a single opinion on the trial protocol considering all the aspects of the trial. The other “non-leading” ECs (n-LEC) send remarks to the LEC on the following aspects of the trial: suitability of investigator, suitability of facilities, Informed consent form.