The Regulatory Affairs division of the Office of Research Compliance provides a variety of services to support FDA regulated research. The following services are available:
- Clinical Research Monitoring Services – Fee-for service monitoring is available for investigators that hold an Investigational New Drug (IND) application or Investigational Device Exemption (IDE) with the FDA. Services are offered for single or multi-site studies and fees are structured based on proposed number of sites and subjects enrolled.
- IND/IDE Services and Resources
Regulatory Affairs Team
AVP, Research Compliance & Privacy Officer: Emmelyn Kim, MA, MPH, CCRA, CHRC
Director, Research Regulatory Affairs: Ji-Eun Kim, RPh, PhD
Clinical Research Monitor: Sharon Hochman, MA