The Data and Safety Monitoring Plan (DSMP) was developed referencing Food and Drug Administration (FDA), National Institutes of Health (NIH), and National Cancer Institute (NCI) guidelines.
The Data and Safety Monitoring Committee (DSMC) oversees monitoring functions investigator initiated clinical trials (IIT) and multisite clinical trials by reviewing study conduct for consistency with Good Clinical Practice (GCP), compliance with federal regulations, and production of high-quality scientific data. The DSMC is comprised of physician investigators, pedestrians, pharmacists, statisticians, regulatory experts, clinical trials monitors, and administrative staff. The DSMC monitored studies are reviewed based on their assigned risk level and, at minimum, will receive annual reviews. The DSMC monitors will routinely assess study conduct, reviewing all study aspects according to the monitoring plan. Such reviews include informed consent documentation, eligibility criteria, protocol compliance, and source document verification for data accuracy. Additionally, query resolution (clarification or correction of inaccurate data), occurrence and reporting of adverse events, test article accountability, and maintenance of essential documentation will be reviewed.
The DSMC committee members are responsible for reviewing the results of all monitoring reports, and when necessary, makes recommendations for Corrective Actions Plans (CAPA). Major deficiencies in protocol conduct and/or non-compliance affecting patient rights, welfare, or safety, will be reported to the DSMC chair who in turn will notify, in writing, the Winship Executive Director and the Institutional Review Board (IRB) of the findings. Reports containing deficient findings could lead to recommendation for suspension of study accrual or all research activities, pending implementation of a CAPA. The DSMC reviews may be routine, re-monitored, preparatory, or for cause. Although the focus of the DSMC is on Investigator-Initiated studies, reviews may also be conducted prior to audits/inspections by the FDA, as in the case of studies using drugs covered by an FDA-approved Investigational New Drug (IND) application or devices covered by an FDA-approved Investigational Device Exemption (IDE) application.