Clinical Research Professionals Lecture
The Johns Hopkins OHSR Compliance Monitoring Program: What to Expect When You’re Being FDA Inspected
FDA inspections can happen to any investigator doing Investigational New Drug (IND) or Investigational Device Exemption (IDE) clinical trials. The Johns Hopkins Office of Human Subjects Research (the IRB) Compliance Monitoring Program is a resource for assisting investigators with preparing for an FDA inspection.
This session will:
• Review the different kinds of inspections.
• Outline strategies to be ready for an FDA review.
• Inform you on what to do if actionable observations are identified.
For questions, please contact Stephanie Swords at [email protected].