IND/IDE Support
YCCI provides a comprehensive, centralized resource for FDA submission of Investigational New Drug (IND) applications and Investigational Device Exemptions (IDEs), whose staff members have industry experience.
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 they hold an IND, IDE or EUA must submit for review to the YCCI IND/IDE Management Office. The Office must receive IND, IDE, and EUA applications before (or in the case of emergency expanded/compassionate use requests, 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 or 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.
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)
The ideal time to contact the IND/IDE service is before a research protocol is finalized ; consulting with these experts while still in the preparatory phase will ensure that investigators obtain the appropriate data needed for an IND application.
Staff in the IND/IDE Management Office collaborate closely with other YCCI functional groups providing Sponsor support for trials such as: Project Management, Data Management, Monitoring, and Data Safety Monitoring Board, as well as the Yale HRPP.
Services provided by this unit include:
- IND exemption determinations
- Significant Risk vs Non-Significant Risk vs IDE exemption determinations
- Research INDs and Significant Risk IDEs:
- Initial applications
- Protocol amendments
- IND Safety Reports/UADE Reports
- Annual Reports
- Final Reports
- Other document updates
- Clinical Hold Responses
- Pre-IND/Q-Sub feedback
- Expanded Access requests (including emergency, single-patient, and multi-patient)
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