Register Now: Clinical Investigator Training Course Nov 12-14, 2019 - Drug Information Update

Clinical Investigator Training Course November 12-14, 2019 | 10th Anniversary Register Now

About this Course This course provides a 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. Upon completion, attendees should understand pre-clinical research, clinical trials, and FDA submissions for licensure of medical products.    Full Agenda Topics Covered 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