ViSE Seminar Series: Investigational Device Exemptions: What Level of Oversight is Required for Your Human Subjects Device Research? SC 5326, Thursday April 25, 11:50. Lunch provided.
ViSE Seminar Series: Investigational Device Exemptions: What Level of Oversight is Required for Your Human Subjects Device Research?
SC 5326, Thursday April 25, 11:50. Lunch provided.
Speaker:
Presented by Barbara Gibson, Regulatory Affairs Officer; Vanderbilt Human Research Protection Program
Location: Stevenson Center 5326; Time: 11:50 (lunch), noon (seminar start)
Abstract:
An overview of FDA and IRB oversight of clinical research studies of devices in humans will be provided, including the purpose of an IDE, determining when an IDE is needed, and IRB and FDA considerations.