Processing IND Safety Reports for CTEP-Sponsored Studies

Purpose: To describe the process to be followed when a Principal Investigator receives an IND Safety Report from the Cancer Therapy Evaluation Program (CTEP). The Food and Drug Administration (FDA) regulations 21 CFR 312.32(c) require sponsors of clinical studies conducted under an IND to notify the FDA and all participating investigators of any serious and unexpected adverse events that are possibly related to the investigational agent. In compliance with these FDA regulations, CTEP will notify its investigators via IND Safety Reports (ISRs).

STEP 1: Receive and Review Sponsor-Generated IND Safety Report

1. Principal Investigator (PI) receives IND Safety Report from CTEP electronically.
   • CTEP does not require a revision to the protocol and/or informed consent documents for IND Safety Reports. If CTEP does require a revision to the protocol and/or consent, this will be outlined in a CTEP IND AE Action Letter that will be sent to the study Principal Investigator. (See SOP #DM-8, Processing Investigational New Drug AE Action Letters for Cancer Therapy Evaluation Program (CTEP)-Sponsored Studies)
2. PI performs assessment of any immediate risk to current subjects and sends safety report to all designated Associate Investigators and Research Nurses
3. PI/Designee should inform currently enrolled patients who would be affected by the report of any potential risks without undue delay, for example, by phone or the next visit.
4. PI/Designee should document the conversation and patient’s willingness to continue on study in medical record.
   • For Multi-Institutional Studies Only:
5. PI/Designee is responsible for sending/forwarding a copy of the IND AE Safety Report to each participating site Principal Investigator for submission to appropriate local IRB.
6. Request that a copy of all IRB submission letter(s) be forwarded to the CCR Principal Investigator/Designee.

STEP 2: Send Safety Report to IRB

1. Create cover memo summarizing the new information to NCI IRB.
2. Attach a copy of the IND Safety Report to the cover memo.
3. Submit both documents to NCI IRB according to current procedures.
4. IRB reviews the safety reports and provides comments as needed.
   • For Multi-Institutional Studies Only:
5. CCR PI/Designee should submit copy of each participating site(s) local IRB submission letter(s) to the NCI IRB.
6. Follow-up with individual institutions if response is not received in a timely manner.

STEP 3: File Documents in Regulatory File/Binder

1. File copy of IND Safety Report and IRB cover memo into protocol-specific regulatory file/binder.
   • For Multi-Institutional Studies Only:
2. CCR Study Coordinator should file the local IRB cover memo from each site in the site’s protocol-specific file/binder.