Welcome to the Department of Operations, Compliance and Monitoring (DOCM) new website!
DOCM
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Clinical Trials Scientific Review and Monitoring Committee (CTSRMC)
Overview of the CTSRMC. The Abramson Cancer Center (ACC) established a comprehensive Protocol Review and Monitoring System (PRMS) in 1992 known as the Clinical Trials Scientific Review and Monitoring Committee (CTSRMC). The Committee's focus is scientific merit, priorities, and progress of cancer relevant protocols conducted within the University of Pennsylvania and Children's Hospital of Philadelphia (CHOP). Presented below is an overview of the PRMS as administered by the CTSRMC.
Overview of the Data and Safety Monitoring Committee (DSMC)
Overview of the DSMC. n response to the NCI requirement for Cancer Centers to develop Data and Safety Monitoring programs, the ACC established a comprehensive Quality Control (QC), Quality Assurance (QA), Regulatory Affairs (RA) and Pharmacovigilance (PV) system for all cancer based human subject research that has been in place since September 2001. These responsibilities are met through the Data and Safety Monitoring Committee (DSMC) which oversees study monitoring and auditing, safety reviews, and the development of study monitoring plans, as well adherence to the Cancer Center's NCI approved institutional Data and Safety Monitoring Plan. For pediatric cancer studies, the DSMC has a sub-committee, the Clinical Research Quality Assurance committee (CRQA), based in the Children's Hospital of Philadelphia (CHOP). This sub-committee is directed by the DSMC and mirrors the activities, policies and procedures of the adult committee.
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https://docm.med.upenn.edu/
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