Research Resources / Office of Research Operations

Sponsor-Investigator Services

SYNERGY’s Sponsor-Investigator Services (IND/IDE) supports investigators navigating FDA requirements for IND- and IDE-regulated research, from submission through ongoing study oversight.

Sponsor-Investigator Handbook

Overview

The Sponsor-Investigator Handbook is a real time reference tool designed to assist investigators and study teams conducting Sponsor-Investigator initiated trials with INDs or IDEs. The Handbook provides guidance on federal regulations, recently updated Good Clinical Practice (ICH E6 (R3) GCP), and D-H specific policies, procedures, and resources.

Highlights

  • Overview of the Sponsor-Investigator role
  • Investigational Drug studies (INDs) guidance
  • Investigational Devices studies (IDEs) guidance
  • Good Clinical Practice overview
  • ORO resources and tools

FDA Regulatory Affairs – Sponsor-Investigator Support

The ORO is committed to maintaining standardized processes that aim to create high-quality, compliant FDA regulatory submissions explicitly designed to support Dartmouth-Hitchcock Sponsor-Investigators of clinical trials regulated by an Investigational New Drug (IND) or Investigational Drug Exemption (IDE).

This service line is led by the Research Regulatory Affairs Specialist – IND/IDE whose key responsibilities are consulting with and supporting Dartmouth-Hitchcock Sponsor-Investigators who are seeking guidance for the appropriate regulatory pathway for a clinical trial they are initiating.

Contact Andréa M. Volz, Research Regulatory Affairs Specialist – IND/IDE, to request support.

Regulatory Support Services

The Research Regulatory Affairs Specialist – IND/IDE support services include:

  • Prepare pre-IND submissions – a formal meeting request (virtual or written feedback only) to ask FDA specific questions about the design of a clinical trial involving an investigational drug.
  • Prepare submissions through the Q-Submission Program
    • Pre-IDE – a formal meeting request (virtual or emailed response) to ask FDA specific questions about the design of a clinical trial involving an investigational device
    • Risk Determination – a formal submission to provide rationale for the sponsor’s determination of the risk level or exemption status of a device used in a trial, and request FDA’s written confirmation of that decision
  • Serve as a liaison to FDA to obtain written determination regarding whether a drug trial can be exempt from IND regulations. This includes preparation and submission of an IND exemption request on behalf of Sponsor-Investigators.
  • Serve as a liaison to FDA for the submission of applications and reports required for INDs and IDEs. This includes preparation and submission on behalf of Sponsor-Investigators for:
    • Initial IND/IDE Applications
    • Response to FDA Requests for Information
    • IND Protocol Amendments
    • IDE Supplements and Reports
    • IND/IDE Safety Reports
    • IND Information Amendments
    • IND/IDE Annual Reports/Progress Reports
    • IND/IDE Sponsor Transfers
    • IND/IDE Final Reports and Withdrawals 
  • Serve as a liaison to FDA for Dartmouth-Hitchcock sponsor/treating physicians for use of drugs and devices in Expanded Access Programs.