University Sponsor and Sponsor-Investigator IND/IDE and FDA Pre-Submission Requirements

IND regulations can be found in 21 CFR 312, and IDE regulations can be found in 21 CFR 812. If you have questions or need help interpreting these regulations, please reach out to either CTSI’s Regulatory Hub or HRPP’s MedReg. There is practical information about investigator responsibilities in ICH GCP E6, Section 4; and sponsor responsibilities in ICH GCP E6 Section 5.

IRB and/or FDA makes the final risk level determination. A non-significant risk determination assessment is made by the HRPP MedReg ancillary review for IRB review and final determination (unless the FDA has already made the final determination). The CRSC Feasibility Review can give you a good idea if your study meets these criteria prior to submission, or you can request a consultation with HRPP’s MedReg.

The FDA definitions for these product types can be found at Drugs@FDA Glossary of Terms.

Consultations about the content of your FDA application are available from the CTSI Regulatory Hub. One hour of free consultation time with regulatory experts may also be available by request to HRPP’s MedReg.

CTSI’s Regulatory Hub can help decide whether an FDA submission is needed for your study. For cancer research, the Masonic Cancer Center’s CTO can assist you. Complicated studies may be escalated to HRPP’s MedReg for consultation.

FDA submission support is available from CTSI’s Regulatory Hub. Please note that FDA submissions for the Masonic Cancer Center are handled by the cancer center’s Clinical Trials Office. You can also seek support from private Contract Research Organizations or Consultants if your budget permits.

CTSI’s Regulatory Hub can help request a meeting with the FDA and can submit questions and information in advance of your FDA meetings. For cancer research, the Masonic Cancer Center can assist you. Investigators are responsible for their own scheduling, agendas, and meeting minutes.

CTSI’s regulatory specialists can help you with your IRB submissions. Some departments already have specialized regulatory support to which you may be redirected if applicable.

CTSI’s internal monitors can help guide investigator-initiated studies through preparation for an FDA audit.

To submit document to the IND/IDE Central File Form Submission, email your documents to: [email protected]

For each new protocol, whether Non-Significant risk IDE, Significant Risk IDE or IND or an FDA pre-submission, Sponsors and Sponsor-investigators must submit the following to the University’s IND/IDE Central File (Central File Online Submission Portal), as applicable:

• IND/IDE exemption or determinations requests
• IND/IDE pre-submission and application
• Safety reports
• Amendments
• Communications, including transcriptions of calls with the FDA
• Annual report(s)