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Phyllis Carello, BS, CCRC, CTRC Research Study Coordinator Manager

Phyllis Carello, BS, CCRC, CTRC Research Study Coordinator Manager 2025

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The document outlines essential regulatory and source documents necessary for conducting clinical research, emphasizing the importance of maintaining adequate case histories as per FDA requirements. It covers topics such as source documents, case report forms, regulatory files, financial documentation, and quality assurance practices. The document also highlights the significance of proper record-keeping, compliance with Good Clinical Practices (GCP), and the auditing process to ensure participant safety and data integrity in clinical trials.

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