The Legal Role of the Investigator in Subject Safety, Data Integrity and Study Audits in Drug and Device Clinical Research Will Surprise You!

Event Information
Product Format
Prerecorded Event
Presenter(s)
Charles H Pierce, MD, PhD, FCP, CPI
Length
90 minutes
Product Description

Get Current Knowledge for PIs and Other Investigators on FDA Regulations That Govern Clinical Research Activities

Do you know what constitutes an “Adverse Event” – from the FDA point of view?  Bet you will be surprised. Do you know that in the Form FDA 1572, the PI “Agrees” (by signature) to follow 7 of the 9 listed sentences? Do you know what it is that the PI “agrees” on the 1572 to have “read and understand”? You need to know all these rules and more to avoid being embarrassed during an FDA audit.

When Prinicipal Investigators sign the FDA form 1572 or the "Statement of the Investigator (for IDE studies), they commit themselves to follow all the appropriate regulations by signing a document that is legally binding. Therefore, the subject safety as well as data integrity becomes the responsibility of the PI. It has become necessary for physician and dentist investigators to be knowledgeable and familiar regarding their responsibilities with the investigative wing of the FDA /OHRP increasing the auditing/surveillance.

In this webinar, our expert speaker, Charles H. Pierce, MD, PhD, FCP, CPI, will acquaint the PI and other investigators of the current FDA regulations that govern clinical research activities. You will understand why it’s Good Clinical Practice (GCP) and common sense to follow the regulations.

Session Topics:

  • FDA form 1572
    • 21 CFR 50 (Protection of Human Subjects)
    • 21 CFR 56 (Institutional Review Boards)
    • 21 CFR 50 (Protection of Human Subjects)
    • 21 CFR 312 (Investigational New Drug Application/IND)
    • Replacing 21 CFR 812 (Investigational Device Exemptions/IDE)in place of 21 CFR 312
  • GCP Guidelines of E6 (4)
  • Compliance Program Guidance Manual (CPGM) 7348.811

Session Highlights:

  • Key role of the Investigators in the clinical research process.
  • How you can assure a clean Audit/inspection by following GCP?
  • AEs and SAEs: Difference between them and their reporting requirements
  • Responsibilities of the main Investigator
  • Responsibility of the investigator for the Conduct of a study
  • Know the legal language of the FDA form 1572
  • How important is Financial Disclosure information?
  • How Important it is to avoid the error of non-inclusion in safety testing?

Learning Objectives/Benefits (for those needing CME credits)

  • Learn the extent of PI’s Responsibility in studies where human subjects are involved.
  • Gain an understanding to summarize the PI’s responsibility for a study.
  • Defend the primacy of the Research Protocol and explain why the PI is responsible for following it to the letter.
  • Get to compare and contrast the responsibility of other players in the drug and device development industry.
  • Understand the continued reference to the PI in FDA regulations.
  • Analyze what the regulatory bodies look for in audits/inspections.

Who should attend?

This webinar is intended for all personnel conducting clinical studies who have an interest in the safety of the study participants. In addition, this webinar will provide invaluable assistance to industry study sponsors of pharmaceutical product research involving human subjects. Those specifically benefiting would be:

  • Principal Investigators and sub investigators
  • Safety Nurses
  • Clinical Research Associates (CRAs) and Coordinators (CRCs)
  • Recruiting staff
  • QA / QC auditors and staff
  • All Pharmaceutical and Biotech companies
  • All Contract Research Organizations
  • All serious Clinical Research Sites
  • All University Research groups

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About Our Speaker

Charles H Pierce

Charles H. Pierce, MD, PhD, FCP, CPI


From an original Master’s thesis (Pharmacology) in 1961 (Minnesota) through a Doctorate in Surgery-Pharmacology in 1974 (Saskatchewan) and continuing throughout 45+ years in the practice of clinical medicine as a family physician (7 years as an ER doc) and 25+ years in the medical research industry (7 years as a Principal...   More Info
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