Data and Safety Monitoring is a required service provided to Center Investigators. The SKCCC Data and Safety Monitoring Plan (DSMP) outlines all of the steps taken to ensure overall high quality of research data and protection of research participants. The Plan is implemented and coordinated by the Clinical Research Office Quality Assurance Team. The QA team is responsible for 1) auditing and monitoring clinical trials to assure compliance with protocol treatment, measurement of effect, and adherence to regulatory requirements, (auditing is the periodic review of a representative sample of the data from a trial;monitoring is the continuous, ongoing review of the conduct of the trial), 2) supplying data to the Data and Safety Monitoring Committee (DSMC) and ensuring Committee recommendations are followed, 3) coordinating the Data and Safety Monitoring Board (DSMB) and ensuring Board recommendations are followed, 4) providing regulatory guidance to Pis and study staff, 5) developing and implementing Standard Operating Procedures, 6) serving as a liaison with external regulatory agencies, 7) coordinating and implementing the Institution's regulatory changes, and 8) reviewing protocols for completeness, consistency, errors, and acheivability of protocol evaluations in the CRC pre-review Committee. The ultimate responsibility for data and safety monitoring resides with the DSMC. The DSMC is responsible for assuring adherence to study design and patient safety by reviewing internal and external auditing and monitoring reports and reviewing serious adverse events. The DSMC has the ability to close a trial or mandate changes, as well as, make policy recommendations that may improve the quality of data or improve patient safety within the Center. These policy recommendations are submitted to the Clinical Research Operations Committee for possible implementation. In this Core, we are requesting effort only for monitoring related to supporting the DSMC.
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