Data and Safety Monitoring

Mayo Clinic Rochester, Rochester MN

Investigators

Linked publications, trials & patents

Abstract

The Mayo Clinic Cancer Center (MCCC) oversees clinical trial conduct and participant safety of cancer clinical trials conducted at Mayo Clinic through the center's Data and Safety Monitoring (DSM) system. Data and safety monitoring is required for all types of clinical trials (pilot and phase l - lll ) . Monitoring of studies is proportionate to the risk associated with each study. Per NIH policy, a Data and Safety Monitoring Board (DSMB) is established for multi-site clinical trials involving interventions that entail potential risks to participants. The DSM system is in place and provides oversight of clinical research conducted through the MCCC. The process of oversight has been developed to ensure patient safety while promoting research with a high level of quality and integrity. The system is constructed in a manner that promotes ongoing review of each of the components. This permits timely changes in procedures and policies as the regulatory environment changes. It also provides a mechanism to identify internal areas of inconsistency, promoting modifications to the MCCC procedures to address these issues. DSM activities are accomplished through the center's Data and Safety Monitoring Board (DSMB) and Data and Safety Monitoring Committee (DSMC). The Data and Safety Monitoring Committee (DSMC) operates as a component of the DSM system and provides oversight related to the review of changes for investigator brochures, deviation reporting, and the review of adverse events across studies that require changes to the informed consent form. As opposed to the DSMB focus on elements of safety of individual trials, the DSMC is an added value service to investigators in that adverse events across studies for any given agent and investigator brochure (IB) changes that would mandate consent form or protocol procedure changes are identified and addressed to ensure consistency, standardization, and efficiencies. The Data and Safety Monitoring Board (DSMB) operates as a component of the DSM system and is structured to serve all pilot, phase I, II, and III interventional trials for which a DSMB does not exist and for which Mayo is the data center.