To follow the regulations is Good Clinical Practices (GCP) and common sense. To not know and follow these regulations is folly. 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.
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:
- 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?
- History of the drug/device regulations.
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:- Principal Investigators/Sub-investigators.
- Clinical Research Scientists (PKs, Biostatisticians,& more)
- Safety Nurses.
- Clinical Research Associates (CRAs) and Coordinators (CRCs).
- QA/QC auditors and staff.
- Clinical Research Data managers
Course Provider
Charles H Pierce,
