Sponsor-Investigator Services (IND/IDE) 

Sponsor-Investigator Services (IND/IDE) Sponsor-Investigator Handbook – NEW!

A reference tool for Sponsor-Investigators and study teams who seek to initiate FDA regulated research, which involve an investigational drug or device. The Sponsor-Investigator Handbook provides guidance on federal regulations and Good Clinical Practice (GCP). D-H policies/procedures/resources are highlighted throughout, demonstrating how institutional requirements are designed to meet internationally recognized guidelines, facilitating implementation of Good Clinical Practice across all clinical trials conducted at D-H.

FDA Regulatory Affairs – Sponsor-Investigator Support

  • · Please email Andrea Volz, Research Regulatory Affairs Specialist – IND/IDE, to request support.

The ORO is committed to maintaining centralized, standardized processes that aim to create high-quality, compliant FDA regulatory submissions – explicitly designed to support Dartmouth-Hitchcock Sponsor-Investigators of IND/IDE clinical trials.

This service line is led by the Research Regulatory Affairs Specialist – IND/IDE, whose key responsibilities include:

  • Consult and support Dartmouth-Hitchcock Sponsor-Investigators who are seeking guidance in determining if an IND or IDE is required for a clinical trial they are initiating (i.e. sponsoring) – this includes, but is not limited to, preparation of:
    • Q-Submissions – a mechanism by which sponsors can directly request feedback from FDA regarding regulatory applications (i.e., IDE, Premarket Applications (PMA), Humanitarian Device Exemption (HDE) applications, Evaluation of Automatic Class III Designations (De Novo requests), Premarket Notification (510(k)) Submissions, etc.)
    • Act in collaboration with Dartmouth-Hitchcock Sponsor-Investigators to liaise with the FDA for those investigators seeking to file an IND exemption request. This includes, but is not limited to, preparation and submission of:
      • Initial exemption request
        • Subsequent IND application, if required
    • Act in collaboration with Dartmouth-Hitchcock Sponsor-Investigators to liaise with the FDA for IND/IDE clinical trials. This includes, but is not limited to, preparation and submission of:
      • Initial Application
      • Response to FDA Request for Information
      • IND Protocol Amendments
      • IDE Supplements/Reports
      • Safety Reports
      • IND Information Amendments
      • Annual Reports/Progress Reports
      • Sponsor Transfers
      • Final Report & Withdrawal
    • Acting as the FDA liaison for Dartmouth-Hitchcock sponsors of Expanded Access Programs
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