Sponsors, CROs, and Investigator sites are all too aware of the stress of preparing for a health authority inspection. The challenge is that most organizations begin preparing for an inspection when a drug is filed for approval or they receive notification of an inspection. The key to a successful inspection is preparing at the start of the study. Ensuring that your Investigator Site File (ISF) and Trial Master File (TMF) are built in a way that the complete documentation tells the story of the study, will ensure that you are ready come inspection day. The session will also include common GCP violations that are evident in the TMF/ISF and can result in findings.
Donna Dorozinsky, RN, MSN, CCRC, Senior Trainer, Barnett International