Scientific and Safety Review
The University of Maryland Greenebaum Comprehensive Cancer Center (UMGCCC) governs clinical research through a parent Clinical Research Oversight Committee (CROC), which oversees the function of the Clinical Research Management Office (CRMO), as well as through two under-committees — the Data & Safety Monitoring/Quality Assurance Committee (DSM/QAC) and the Clinical Research Committee (CRC) — that serve as the NCI-required Protocol Review and Monitoring System (PRMS). These committees oversee the conduct of clinical research at UMGCCC.
The CRC is responsible for the scientific review of new protocols. Their review is conducted prior to IRB review and assesses CRMO resources to support study conduct. CRC review includes a consideration of the adequacy of the DSM plan proposed by the principal investigator. The CRC may be asked by the DSM/QAC or the IRB to provide continuing review of protocols about which questions have arisen in relation to new information received and the continuing scientific value of the research question.
The DSM/QAC ensures patient and research subject safety and integrity of research in clinical trials conducted by UMGCCC. The DSM/QAC may refer recommendations to the CRC to permanently close trials in which the demonstrated risks outweigh the potential benefits of the study or where the expected trial outcomes cannot be achieved with further patient enrollment.
The DSM/QAC also:
• Provides ongoing safety review for UMGCCC protocols that lack their own existing DSMB (Reviews occur at least annually.)
• Tracks adverse events for UMGCCC protocols
• Reviews significant findings generated during Internal Monitoring of Investigated Initiated Therapeutic trials and any significant findings generated during auditing (internal or external) of UMGCCC clinical trials
For additional information about the CRC or DSM/QAC process please contact:
Jennifer M. Richards, MS, CIP, CCRP
Director, Clinical Trials and Quality Assurance
University of Maryland Greenebaum Comprehensive Cancer Center
22 S. Greene Street, N9E17
Baltimore, MD 21201