Agenda Available, Register Now: Clinical Investigator Training Course Nov.12-14, 2019

Agenda Available Clinical Investigator Training Course November 12-14, 2019 | College Park, MD

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This course provides an intermediate-level study of clinical trial principles with in-depth coverage of clinical trial design, issues in safety and efficacy, investigator responsibilities, understanding the investigator brochure, and FDA requirements across centers. FDA speakers: Dr. Robert Temple, CDER Deputy Center Director for Clinical Science and Senior Advisor in the Immediate Office of the Office of New Drugs (OND) Dr. Leonard Sacks, CDER Office of Medical Policy (OMP)

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Topics include: Clinical trial design and analysis, including new trends and key documents such as: protocol, informed consent, investigator’s brochure, health records, and study reports Safety and efficacy requirements Ethical considerations FDA regulatory requirements related to the performance and evaluation of clinical studies Non-clinical, early, and advanced clinical studies Roles and responsibilities of the investigator Rationale for Good Clinical Practice (GCP), FDA regulations and inspections Basic statistical principles