Clinical Research Resources
Data & Safety Monitoring Committee
The Data and Safety Monitoring Committee (DSMC) was formed to ensure data and safety monitoring, as well as protocol compliance, for all institutional cancer protocols. In addition, the DSMC’s oversight extends external cancer protocols not subject to on-site monitoring by any external agency.
The DSMC monitors both institutional and applicable external protocols for the following:
- Accrual level as it pertains to safety
Frequency of DSMC review is typically determined by the protocol’s level of risk as assigned by the Protocol Review Committee (PRC).
The DSMC has the authority to recommend continuation, modification, suspension or termination of protocols based upon its findings. The committee reports its findings and recommendations to the PRC, IRB and the Sylvester’s Associate Director for Clinical and Translational Research. The DSMC also gives notice of any findings and/or recommendations to site disease group chairs and the principal investigator.
The DSMC is a multidisciplinary committee whose chair and members are appointed by the Sylvester’s Associate Director for Clinical and Translational Research. Membership is comprised of groups representing expertise in multiple areas including hematology-oncology, radiation oncology, surgery, biostatistics, nursing and pharmacy. Information on membership and meeting dates may be found in the above-referenced “Meeting Calendar” and “Membership List” links respectively.
Protocol Review Committee
The Protocol Review Committee (PRC) provides initial review of all cancer protocols involving human subjects conducted under the auspices of the University of Miami Sylvester Comprehensive Cancer Center . All cancer protocols must be reviewed and approved by the PRC prior to submission to the University Institutional Review Board (IRB). Without full approval of the PRC, no protocol may have access to any of Sylvester’s shared resources.
The authority and responsibilities of the PRC include:
- Scientific review of all Sylvester protocols.
- Assignment of scientific merit and risk level to all protocols reviewed.
- Monitoring of all cancer protocols for sufficient accrual and scientific progress.
- Review and approval of amendments to active institutional protocols, prior to IRB submission.
Continuation, modification, suspension or termination of active protocols upon recommendation of the Sylvester data and Safety Monitoring Committee or data to support such action.
The PRC is a multidisciplinary committee whose chair and members are appointed by Sylvester’s Associate Director for Clinical and Translational Research. Membership is comprised of experts in multiple areas including, but not limited to hematology-oncology, radiation oncology, surgery, biostatistics, nursing, and pharmacy. Information on membership and meeting dates can be found at the above-referenced “Meeting Calendar” and “Membership List” links respectively.
PRC review provides investigators with valuable feedback including suggestions for improvement of study design, improved study implementation strategies, and opportunities for collaboration with other investigators. The committee works to ensure that all submitted protocols meet the highest standards of clinical research.
CRS Quality Management provides administrative support for the PRC. Please contact CRS at 305-243-4903 for more information. View a complete list of PRC members.
- Stefan Glück, M.D.
- Joseph A. Lucci III, M.D.
CRS Quality Management
1550 N.W. 10th Avenue
Fox Building, Room 503
Miami, FL 33136