Quality Assurance and Safety Monitoring

Overview

Siteman Cancer Center prioritizes the oversight and monitoring of clinical trials to ensure the safety of trial participants and the accuracy and consistency of trial data. Oversight of study-specific data and safety monitoring is the responsibility of the Quality Assurance & Safety Monitoring Committee (QASMC) and the Protocol Review and Monitoring Committee. Every clinical trial conducted at the SCC must include a plan for data and safety monitoring. Specific plans vary based on the degree of risk involved in participation, size and complexity of the trial, study sponsor, nature of the investigational agent, and phase of the trial.

QASMC provides independent management and review of quality assurance audits, unanticipated problem reporting, and interim safety and monitoring reports for investigator-initiated studies (but may provide support for other trials as needed). QASMC reviews trial progress, participant safety, data integrity, and adverse event reporting on an ongoing basis after initial PRMC approval. QASMC findings may prompt PRMC to take action on a particular study.  QASMC meets monthly and membership includes medical oncologists, a surgical oncologist, a radiation oncologist, a biostatistician, and two pharmacists.

Resources

• Institutional Data and Safety Monitoring Plan (PDF)
• Quality Assurance and Safety Monitoring Committee Policies and Procedures
• QASMC Forms
• List of QASMC Members
• Siteman Cancer Center Independent Standing Data Safety Monitoring Board (DSMB) Policies and Procedures
• DSM Report Completion Guidance

Contacts

Chair: Nancy Bartlett, MD

Stephanie L Myles, Associate Director of Clinical Research
[email protected]