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INFORMATION FOR

IND/IDE Support

YCCI provides a comprehensive, centralized resource for FDA submission of Investigational New Drug (IND) applications and Investigational Device Exemptions (IDEs), with staff members and consultants with Industry experience who provide “soup to nuts” IND/IDE support.

New Policy Regarding IND, IDE or EUA-related protocols

Effective May 1, 2021, a Yale Investigator who intends to conduct an investigation/project that requires an IND, IDE or EUA must submit for review to the YCCI IND/IDE Management Office. The Office must receive IND/IDE/EUA applications either before or contemporaneously with their submission to the FDA and the Yale HRPP for IRB review, as applicable. Submissions of proposals to the HRPP requiring an IND/IDE that have not been previously reviewed or approved by the Office will be routed to the Office by the HRPP prior to IRB review and approval.

Read the full policy here.


To whom does the policy apply?

Investigators at the Yale School of Medicine who hold, or are considering holding with the US Food and Drug Administration (FDA):

  • Investigational New Drug Applications (INDs) including Compassionate use/Expanded access
  • Investigational Device Exemptions (IDEs) including Compassionate use/Expanded access
  • Emergency Use Authorizations (EUA)
For assistance, contact Amy Hummel at the YCCI IND/IDE Management Office for guidance by emailing amy.hummel@yale.edu.
This unit provides guidance on whether an IND is required; answers questions about the submission process; and assists researchers in complying with the regulatory requirements associated with IND and IDE applications. The ideal time to contact the IND/IDE service is before a research study is ready to move into human trials; consulting with these experts while still in the preclinical phase will ensure that investigators obtain the appropriate data needed for an IND application.

In addition to assisting with collecting and compiling documents and submitting applications to the FDA, YCCI can help reduce the administrative burden on investigators by maintaining, managing, and monitoring INDs and IDEs, including those involving external sites; developing data and safety monitoring plans; assisting with the renewal of applications; and writing and submitting annual progress reports.

IND/IDE Office Contact

Amy C. Hummel, MS; Associate Director for IND/IDE Management

IND/IDE Intake Form

For assistance with filling out this form or questions about YCCI services, please contact clinicalresearchresources@yale.edu.