Investigator Resources

Data and Safety Monitoring Plan

Wilmot’s Data and Safety Monitoring Plan provides oversight for all clinical research trials conducted at Wilmot Cancer Institute and its regional locations. It includes guidance for clinical trial monitoring; verification of data validity and integrity; and the oversight of participant safety.

Protocol Review and Monitoring System

The Protocol Review and Monitoring System’s functions are accomplished by rigorous review in a two-stage process conducted by:

• Disease Working Groups, where initial assessment of value, fit, and prioritization within the existing portfolio of studies is performed, as well as an assessment of each study’s operational and accrual feasibility.
• The Protocol Review and Monitoring Committee, a multidisciplinary committee responsible for scientific peer review of all cancer-related clinical research protocols at Wilmot Cancer Institute. It provides a mechanism for assuring robust internal oversight for the scientific merit and progress of all cancer-related clinical trials at Wilmot.

Deepak Sahasrabudhe, M.D. (Hematology/Oncology)
Committee Chair

Richard Moore, M.D. (Gynecologic Oncology)
Committee Vice Chair

Wilmot’s Protocol Review and Monitoring Committee oversees and provides independent, peer review of the scientific merit, priority, and progress of all cancer studies involving human subjects conducted at the University of Rochester. The Protocol Review and Monitoring Committee specific aims are to:

• Assess value, fit, and prioritization with existing disease-based research portfolios;
• Conduct thorough reviews to ensure cancer research studies are scientifically and statistically sound, appropriately designed and prioritized to avoid competing studies, feasible for completion, and have an adequate data and safety monitoring plan in place based on the risk level of the study;
• Monitor scientific progress and relevance;
• Recommend closure of studies in response to inadequate accrual, changing priorities, or developing scientific concerns that are deemed significant enough to interfere with the reliability of the study outcome.

Data and Safety Monitoring Committee

For investigator-initiated studies, Wilmot has established a Data and Safety Monitoring Committee, a multidisciplinary group that performs risk-based monitoring to ensure the highest levels of patient safety.

The specific aims of the Data and Safety Monitoring Committee are to:

• Set the standards and procedures for all risk-based safety monitoring for institutionally developed interventional trials.
• Ensure adequate and objective real-time monitoring of patient safety and data integrity through the review of safety reports, trial progress reports, and internal quality assurance audits.

Barbara Asselin, M.D. (Pediatrics)
Committee Chair