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.
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.
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
Course Provider
Charles H Pierce,
