Name
Human Subjects Protection (HSP) and Good Clinical Practice (GCP) Myths & Fine Points
Date & Time
Tuesday, October 17, 2023, 2:30 PM - 3:30 PM
Description
Session overview:
- Learn how myths get started
- Review various myths and whether they are true or false
- Discuss how to avoid creating or propagating regulatory myths
- Approximately 2530 hot topics, myths, or fine points related to clinical research administration
- Presented in an entertaining “true or false” or thought-provoking format, with discussions and references for a deeper dive into correct information & answers
- Examples: “When FDA conducts human research it must follow FDA regulations?” “Protocol deviations need to be reported to the IRB” “Consent forms must disclose the procedures being used to maintain confidentiality” “All unanticipated problems involving risk to subjects or others in supported research must be reported to OHRP” etc.
Speakers