Investigator responsibilities and Legal commitments in Drug and Device Clinical Research: The Reality or How to get your PI more involved

Instructor: Charles H Pierce
Product ID: 702063
  • Duration: 80 Min

recorded version

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Training CD

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Read Frequently Asked Questions

This webinar will focus on the principal investigator's role and responsibilities, the legal language of FDA form 1572 or Device equivalent and how you can ensure a celan audit by following GCP.

Why Should You Attend:

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.

This training, by a physician investigator with 20+ years experience, will cover the regulations for both drug and device clinical research in a user friendly way.

Areas Covered in the Seminar:

  • The Investigators key role in the clinical research process.
  • How following GCP helps assure a clean Audit / inspection?
  • The difference between AEs and SAEs and the reporting requirements.
  • What are the main Investigator responsibilities?
  • How is 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?

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

Instructor Profile:

Charles H. Pierce , MD, PhD, FCP, CPI is a consultant in the Clinical Research / Drug-Device Development arena specializing in bringing the message (via webinars, lectures and seminars) of Risk Management through knowledge of 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 has been in the Clinical Research Industry for 20+ years, has been involved in Investigator and staff GCP training, and medical monitoring in both drug and device studies.

Topic Background:

In the FDA form 1572, the Investigator signs an agreement that has 9 statements, 7 of which begin with “I agree”, one with “I have read and understand”, and one with “I will ensure”.

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. To follow the regulations is Good Clinical Practices (GCP) and common sense. To not know and not follow these regulations is folly.

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