Principal Investigator responsibility in Research Involving Human Subjects: The International Conference on Harmonization (ICH) view

When the PI signs the FDA form 1572 (for IND studies) or the "Statement of the Investigator (for IDE studies), she / he is signing a legally binding document committing themselves to follow all of the appropriate regulations. The responsibilities are clearly described / outlined in The ICH GCP Guidelines of E6 (4.1 to 4.13). These 13 areas are described and discussed. Additionally, 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. To follow the regulations of Good Clinical Practices (GCP) and common sense. To not know and follow these regulations is folly.

Areas Covered in the seminar:

• The Investigators role in the clinical research process.
• The difference between AEs and SAEs and the reporting requirements of the investigator.
• Why the investigator maintains a list of staff signatures.
• Why the investigator files the signed and dated protocol.
• Why the investigator is responsible for the IC process.
• What is the legal language of the FDA form 1572 or Device equivalent.
• Why is Financial Disclosure information important.
• What is the history of the drug / device regulations.

Who will benefit:

This webinar will provide invaluable assistance to investigators and their staff in the regulatory / legal responsibilities and also the ethical considerations in pharmaceutical product (Drug or device) research involving human subjects. Those benefiting the most would be:

• Principal Investigators / Sub-investigators.
• Clinical Research Scientists (PKs, Biostatisticians).
• Safety Nurses.
• Clinical Research Associates (CRAs) and Coordinators (CRCs).
• QA / QC auditors and staff.
• Clinical Research Data managers

Instructor Profile

Charles H. Pierce, MD, PhD, FCP (Fellow of the American College of Clinical Pharmacology), CPI (Certified Physician Investigator) is a consultant in the Clinical Research / Drug-Device Development arena specializing in bringing the message of the GCP Regulations 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 serves as an advisor to several clinical research organizations, sits on University and industry based boards, and is VP of Medical Affairs for Harrison Clinical Research GmbH, a global CRO headquartered in Munich. He has been active in the Clinical Research Industry for 19 years including 7 years as the PI of a large CRO, has authored a "Manual for Investigators", and has been involved in developing Phase I & IIa Clinical Pharmacology Units, Investigator and staff GCP training, and medical monitoring in both drug and device studies.

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