This Webinar will provide invaluable assistance to investigators and staff with regulatory/ legal responsibilities. It also delves into the complex ethical considerations in pharmaceutical product (drug or device) research involving human subjects.
It must be understood that when the Principal Investigator (PI) signs FDA form 1572 (for IND studies) or the ‘Statement of the Investigator’ (for IDE studies), she or he is signing a legally binding document with a commitment to follow all appropriate regulations.
Named in the 1572 is 21 CFR 50 (Protection of Human Subjects), 21 CFR 56 (Institutional Review Boards), and 21 CFR 312 (Investigational New Drug Application/IND). For Device studies, 21 CFR 812 (Investigational Device Exemptions/IDE) is added in place of 21 CFR 312. Additional responsibilities are clearly outlined in The GCP Guidelines of E6 (4) and the Compliance Program Guidance Manual (CPGM) 7348.811. Good Clinical Practice demands a diligent adherence to these regulations.
Areas Covered in the seminar:
Who will benefit:
For investigators and staff involved in regulatory or legal responsibilities, this Webinar has a wealth of information and guidance. The ethical considerations in research involving human subjects are clearly complex, requiring the astute and practical perspective that this Webinar provides. Individuals who will receive maximum benefit include:
Charles H. Pierce, MD, PhD, FCP, CPI is a consultant specializing in bringing the message of GCP and Investigator Responsibility to the entire investigative team to help them understand the regulations as well as the ethics of research involving human subjects. Dr. Pierce has been in the Clinical Research Industry for 18 years, has authored a "Manual for Investigators", and has been involved in developing Phase I & IIa Clinical Pharmacology Units, Investigator GCP training, and medical monitoring in both drug and device studies.
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