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What happens when the Sponsor of a Clinical Research study does not follow their Responsibilities?

Duration :

Course Description:

With the increasing surveillance / auditing by the investigative wing of the FDA / OHRP it behooves Physician and dentist Investigators to become familiar and knowledgeable regarding their responsibilities. To ‘think’ you know the rules of Clinical Research is not enough these days.

Why should you Attend?

This Webinar will familiarize the PI and other investigators in a friendly Peer to peer manor of the current regulations that govern our activities and why not knowing the rules is an open invitation to be embarrassed when there is an FDA audit. When the PI signs the FDA form 1572 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 talk, by a certified physician investigator, will go over the regulations. In the FDA form 1572, the Investigator signs an agreement that has 9 statements, 7 of which begin with “I agree”. 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.

Areas Covered:

  • 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 Conduct of a study?

  • What is the legal language of the FDA form 1572 ?

  • Why is Financial Disclosure information important?

    Learning Objectives:

  • Define the extent of the Responsibility of the PI in studies involving human subjects

  • Compare and contrast the responsibility of the other players in the drug and device development industry

  • Explain the continued reference to the PI throughout the FDA regulations

  • Evaluate what the regulatory bodies look for in Audits / inspections
  • 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. Basically all persons involved in the conduct of Clinical Research studies will benefit.

    Registration Options

    Avail 12 months unlimited access for a single user.

    Material shipped within 15 days post webinar completion & get life time access for unlimited participants.

    Speaker Details

    Dr. Charles Pierce

    Dr. Charles Pierce

    Clinical Research

    Dr. Charles Pierce has served as a family physician (7 years as an ER doc) and 23+ years in the medical research industry (7 years as a Principal Investigator). Charles has an experienced based knowledge of the Clinical Research part of Drug Development. Charles is a Fellow and Life Member of the American Academy of Family Physicians and Emeritus fellow of the American College of Clinical Pharmacology (ACCP) of which he was a Regent

    Refund Policy

    Participants/Registrants for our live events, may cancel up to 72 hours prior to the start of the live session and ComplyArena will issue a letter of credit to be used towards any of ComplyArena's future events. The letter of credit will be valid for 12 months.

    ComplyArena will process refund in cases where the event has been cancelled and is not rescheduled within 90 days from the original scheduled date of the webinar. In case if a live webinar is cancelled, participants/registrants may choose between recorded version of the course or a refund. Refunds will not be processed to participants who do not show up for the webinar. A webinar may be cancelled due to unavoidable circumstances, participants will be notified 24 hours before the scheduled start of the event. Contact us via email: or call +1-888-222-5917 (Toll Free).