Another scenario: There are 4 sites as part of a multi-centre study, and the lead site has chosen PICF pathway 2 and submitted the Master PICF + their site-specific clauses. All other sites have submitted their site-specific clauses prior to EC approval. EC has queries about Site 2 and Site 3’s site specific clauses document. Does this hold up the initial EC approval letter for the Lead Site and Site 4?
No. It only holds up the site/s in question. Suppose it is something minor that could be dealt with swiftly. In that case, we will encourage our team to rectify the issue so approval for all sites can occur on the same day. If it appears that is not likely, sites 1 & 4 would be approved. Then, sites 2&3 would be approved when they have resolved their issues. Sites 2&3 are then provided with any approval letters that have been issued for the other sites if there are documents on there that are relevant to them (e.g. protocol, IB, Master PICF).