We are running a phase 3 MRCT trial, to ensure a better compliance to study inclusion criteria, the sponsor required that for every patient that are to be enrolled, there is an "eligibility verification procedure" by sponsor's medical monitor, and this will be done through EDC data review and may have some query emails. Only after the approval of the sponsor, the investigator could proceed to randomize the trial subjects.

This procedure has been challenged by some investigators, viewing as an interference of their medical judgment and some of them will not agree to do so. The investigator thinks the sponsor's medical monitor could only advise on trial related medical questions but not make decision for them, this procedure could possibly violate GCP. However, in that case, the sponsor is asking to document as "major PD".

We searched carefully of guidance and GCP guidelines, but still could not find an ideal solution: who is correct on this? This procedure was designed with protocol compliance intention, but could it violate GCP?