The UC Davis Cancer Center has established a Data and Safety Monitoring Plan (DSMP) that ensures patient safety, protocol adherance, and the quality of data for all cancer-related trials being carried out by UCD investigators, including those carried out in the VA Mather and Cancer Care Network. The DSMP is undertaken by the Data and Safety Monitoring Committee (DSMC) and the Quality Assurance Committee (QAC). A study-specific Data and Safety Monitoring Board (DSMB) may also be assigned to certain trials deemed by the Scientific Review Committee as being of higher risk to patients. The primary responsibility of the DSMC Is to review all serious adverse events (SAEs). It also monitors the overall progress and safety ofthe trial (e.g., QAC input and, where applicable, dose escalations). The DSMC (and DSMB) have the authority to close or suspend trials on the basis of safety concerns, the recognition of early attainment of study objectives, indication of futility, or inadequate performance. Regular quality assurance audits (QAAs) verify that enrolled patients are eligible, adequately screened, and treated according to protocol. Every month, 2 or 3 trials are selected at random to be audited by the Quality Assurance Board (QAB). The QAC discusses the QAA results, assigns an overall score, and informs the PI of any action required. The DSMP delineates the communication systems that are in place that ensure feedback of critical information, especially that related to SAEs, across all key stakeholders. This includes having a centralized system for multicenter trials for the collection and reporting of AEs to each participating PI. The DSMC notifies the IRB if a trial is terminated or suspended and DSMC minutes are circulated to the IRB.

Public Health Relevance

In clinical trials, the safety of patients is paramount. The DSMP ensures patient safety by having systems in place that review all SAEs, verify that patients are being treated according to protocol, monitor the quality of the data, ensure that all key stakeholders are notified of SAEs and trial terminations/suspensions, and provide oversight to the overall progress and safety of the trial.

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