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.
Learning Objectives/Benefits (for those needing CME credits)
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:
- Dr. David Lim
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...
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