Data and Safety Monitoring Committee (DSMC)

The purpose of the Yale Cancer Center (YCC) Data and Safety Monitoring Committee (DSMC) is to provide ongoing data and safety monitoring for all interventional cancer clinical trials, which include therapeutic, intervention prevention and intervention supportive care studies. The Committee reviews all SAEs, protocol and subject deviations and internal and external audit reports monthly and protocol specific data and safety monitoring reports at the frequency initially determined by the Protocol Review Committee based on trial sponsorship and risk. The DSMC has authority to intervene in the conduct of these studies as necessary to ensure the safety of the participants and to maintain the highest quality in the clinical research performed at YCC. The YCC DSMC is an oversight committee, which is an integral component to both the YCC institutional Data and Safety Monitoring Plan and protocol specific data and safety monitoring for trials conducted at YCC. Guidelines for Submission The Office of Quality Assurance and Monitoring will send notification of DSMC review to the Clinical Research Team (CRT).

Submissions are made electronically to dsmc.ycc.committees@yale.edu.

DSMC Charter

The Quality and Education team will send notification of DSMC review the clinical Research Team (CRT).

Submission are made electronically to dsmc.ycc.committees@yale.edu

• Multicenter Studies
• Investigator Initiated Studies with No External Monitoring
• Externally Monitored Studies