Email IND and IDE Support for:

  • Guidance to determine whether there is a requirement for the submission of an IND or IDE application 
  • Assistance with IND and IDE submissions to FDA
  • Requests for Non-Emergent Expanded Access
  • Assistance with completing the Application to Conduct a Multi-Center Clinical Trial under a University-based IND or IDE

Email Clinical Trial Registration and Transparency for questions regarding:

  • submissions
  • Public posting of study documents (e.g., Protocol, Statistical Analysis Plan, Informed Consent Document)
  • Disclosure of plans to share de-identified Individual Participant Data with other researchers

Email Education and Compliance Support for:

  • Monitoring Services
  • Questions about Good Clinical Practices
  • Request a Good Clinical Practice Presentations
  • New Investigator Education