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IND/IDE Consultation

The Dartmouth GCP and Regulatory Program is a resource for Dartmouth faculty researchers regarding Investigational New Drug (IND) applications and Investigational Device Exemptions (IDEs).

Objectives

  • To ensure that all Dartmouth faculty members who need to file either an IND or IDE do so accurately and in a manner that will not detract from their clinical research.
  • To provide on-going regulatory assistance to the Sponsor-Investigator of the clinical investigation.
  • To offer monitoring services to faculty researchers to confirm compliance with applicable research policies at Dartmouth.

The IND/IDE Consultation Service provides guidance regarding

  • Applicability of an IND or IDE.
  • Submission of an IND or IDE application to the FDA.
  • Maintenance of an IND or IDE, including submission of IND or IDE amendments, annual reports, and a safety report to the FDA.
  • Preparation for and regulatory support during FDA inspections of investigator-initiated clinical trials.
  • Updates regarding new guidance documents, inspection trends, inspection actions, and new regulatory actions taken by the FDA as they relate to clinical trials.

Contact Us

Michele Issokson Sbrega, MS, CCRP
IND/IDE Specialist
Dartmouth Clinical Trials Office
Phone: (603) 650-3411
Email: cto@hitchcock.org

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