About me
Dr. Grandinetti is the Associate Director for Clinical Policy within the Office of Scientific Investigations’ Division of Clinical Compliance Evaluation and provides leadership and subject matter expertise on policy issues related to GCP, human subject protection, and clinical trial quality. She also serves as an SME in GCP inspections to evaluate data integrity, quality, and safety of human subjects in clinical trials. Before stepping into the position of Associate Director of Clinical Policy, Dr. Grandinetti was a senior reviewer in the DCCE’s Good Clinical Practice Assessment Branch from 2018 to 2024 where she provided regulatory and scientific oversight for CDER-assigned bioresearch monitoring and to FDA field investigators.
