> FDA may inspect study records, for example, to assess investigator compliance with the study protocol and the validity of the data reported by the sponsor ht

> FDA may inspect study records, for example, to assess investigator compliance with the study protocol and the validity of the data reported by the sponsor https://www.fda.gov/regulatory-information/search-fda-guidance-documents/informed-consent#confidentiality https://www.fda.gov/regulatory-information/search-fda-guidan... https://www.fda.gov/media/75185/download https://www.fda.gov/media/75185/download