Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 72

The clinical development pathway which is navigated by a sponsor’s regulatory affairs group is not a silo in terms of conformance with and adherence to GCP. The reach of GCP requirements runs throughout a sponsor’s organization if they are involved and participating in some aspect of a clinical trial activity. Interactions with regulatory authorities via any communication mechanism must be appropriately documented, shared to the extent necessary and available for review as part of the evidence that the overall trial was conducted in conformance with GCP.