Data Integrity from International Perspectives (2of11) GCP Data Integrity Workshop

CDER’s Director of Division of Clinical Compliance Evaluation Ni A. Khin, M.D. defines good clinical practice (GCP), data quality, data integrity and data reliability from global clinical trial perspectives. She describes types of GCP inspections.

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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.

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