I am currently developing a GCP framework for a small pharma company who have a lot of investigator led studies ongoing. This is the first time I've actually worked so closely on investigator led studies (ILS) and my question is, just how much involvement should the pharma company have with these ongoing ILS. Wold the MHRA expect to see the MAH include ILS in their GCP framework which is currently being developed to support the clinical development plan for the MAH sponsored studies? Any tips you can provide will be greatly appreciated!