DATA SAFETY AND MONITORING BOARDS

University Of Texas Hlth Science Center, San Antonio TX

Investigators

Linked publications & trials

Abstract

To ensure the highest level of pafient safety and research quality, the Data Safety and Monitoring Committee (DSMC) is charged with the responsibility for monitoring, reviewing, and taking administrative acfion as needed on all acfive studies within the Cancer Center. All studies are monitored until every pafient has completed treatment and follow-up on study. The DSMC oversees all aspects of research data validity and integrity, ensures regulatory compliance, and protects the safety of participants in all Cancer Center clinical studies. The P30 Office of Research Administrafion (ORA) is a Cancer Center shared resource that provides support to the DSMC. The Quality Assurance Division of the ORA is responsible for conducfing quality assurance (QA) audits which focus on verifying data accuracy, pafient eligibility, and protocol compliance. The ORA collects research-related information and produces reports for DSMC action, and ensures that DSMC-mandated corrective actions are completed. The Chair of the DSMC reports to Dr. Giles, the P30 Deputy Director. Oversight and monitoring activifies conducted by ORA staff and supervised by the DSMC include: Monitoring the safety of study participants in all studies Reviewing eligibility of study participants Ensuring protocol compliance Verifying the completeness of participant information as well as data accuracy and validity Verifying adherence to the Cancer Center Data and Safety Monitoring Plan (DSMP) Ensuring corrective acfion and adherence to QA reports and findings Assuring compliance with adverse events (AE) reporting requirements Reviewing of AE trends Verifying that studies that require a DSMB have one in place Ensuring that the terminafion and suspension of studies are appropriately reported Assigning a Priority of Audit Level Score (PALS) Reviewing efficacy rates and ensuring that stopping rules are enforced