The Clinical Research Steering Committee (CRSC) reviews all Yale Cancer Clinical Study protocol concepts after approval by their disease team and before full scientific review by the Protocol Review Committee (PRC). The study concept and the use of YCC-supported centralized resources such as data management and research nursing are considered during this review.
The CRSC is also responsible for reviewing protocol accrual and scientific progress of Cancer Clinical studies at least twice annually. These reviews are conducted within the context of the entire Disease Team (DT) portfolio. Disease Team leaders or their designee(s) are required to present the portfolio, discuss progress and accrual (as well as rationales for continuing existing studies, as needed), and the DT’s plans for the future. This provides an opportunity for the SC to recommend closures, make suggestions for collaboration with other DT’s or recommendations for expanding the portfolio with new studies.
To submit a new study to the CRSC:
- The form must include the signature of the PI and disease team leader. **In the event of a vacancy in Disease Unit leadership, the signature of the section chief or department chair is required.
- While not required for this initial concept review, please submit an electronic version of the protocol if it is ready.