The Tisch Cancer Institute

The level of risk to study participants is assessed as follows:

• High: Research involving greater than minimal risk, which may or may not have direct benefit to the subjects. Risks are high in relation to the anticipated benefits. The Committee conducts reviews every three months while study participants are undergoing study intervention and within the safety follow-up window.
• Moderate: Risks are reasonable in relation to anticipated benefits and the importance of anticipated resulting knowledge. The Committee conducts reviews every six months while study participants are receiving the study intervention and during the safety follow-up window.
• Low: The possibility of harm or discomfort is no more than in daily life or routine physical and psychological exams. The Committee conducts reviews every 12 months while study participants are undergoing study intervention and during the safety follow-up window.
• Exempt. Non-interventional (observational, ancillary, or correlative) trials and survey research do not require Committee review.

The principal investigator and team must submit the following documents to the Committee for review:

1. Protocol-specific data and safety monitoring packet: Prepare this prior to the review date and submit it electronically.
2. Adverse event summary report: Supply a cumulative report and frequency log of adverse events, exporting the summary report from the study’s electronic data capture system.
3. Screening and Enrollment Log: Submit a cumulative report of patients screened for and enrolled in the clinical trial.
4. Deviation Log: Provide a cumulative report of deviations from the protocol.
5. Two-stage design with stopping rules: Supply a summary of progress for clinical trials that have a two-stage design with stopping rules. The Committee will not place a hold on the accrual while it reviews the summary and data, unless otherwise specified in the Institutional Review Board-approved protocol. The principal investigator or designee may continue the study as outlined in the Institutional Review Board-approved protocol as soon as the study statistician approves it.

Following review and presentation by the clinical and biostatistics reviewers, the Committee will make one of the following outcome determinations:

• Approved: The study can continue as planned. We will review it according to the frequency determined by the risk level; researchers need take no additional action.
• Conditionally Approved: The Committee requires clarifications or additional information. The study can continue while the principal investigator provides the information requested, until the Committee is satisfied. When the Committee is satisfied, it will issue a notice of approval.
• Suspended: The Committee has substantial concerns regarding the safety, data integrity, and study conduct and requires that accrual be temporarily suspended until the principal investigator resolves all concerns. Upon resolution, the Committee will issue a notice of approval indicating that all significant concerns have been sufficiently resolved.
• Terminated: The Committee has significant concerns about safety or study conduct and has determined there is greater risk to continue the study than to permanently close it. The Committee communicates this recommendation to the Protocol Review and Monitoring Committee, which shares it with the Institutional Review Board.
• Requires Re-submission: The Committee determines that the submission is incomplete due to unresolved issues or insufficient information. Typically, the principal investigator must re-submit the report for the next available meeting.
• Receives a Final Review. The Committee has determined that the study needs no further review. Reviews stop when all study participants have completed their study procedures and are beyond the time point at which they would be likely to encounter study-related adverse events.