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:
- ClinicalTrials.gov 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