Overview of Clinical Investigator Responsibilities and Inspectional Findings (11/14) REdI 2017

Faranak Jamali provides an overview of clinical investigator responsibilities when conducting clinical studies regulated by the Center for Drug Evaluation and Research (CDER), FDA. He discusses regulatory violations that might occur due to lack of Good Clinical Practice (GCP) compliance, the underlying causes, and the potential corrective actions to prevent future violations. The main message is that clinical studies conducted in accordance with GCP regulatory requirements will be better able to ensure data are reliable and to protect safety of the participating subjects.

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