Data and Safety Monitoring

$38,880P30FY2009CANIH

Virginia Commonwealth University, Richmond VA

Investigators

Linked publications & trials

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Abstract

The NCI requires that all clinical trials and all clinical research involving risk to subjects have a written data and safety monitoring (DSM) plan. The Cancer Center has had an approved plan since the previous CCSG competitive renewal in 2002. For research involving more than minimal risk, a DSM plan has three elements: 1) A study team (ST) 2) Either an Independent Physician Monitor (IPM) or a Data and Safety Monitoring Board (DSMB) 3) A Monitoring Committee (MC). The study teams hold regular meetings to review study conduct, including data quality and subject safety. _ Independent Physician Monitors (IPM) and the DSMB provide an independent assessment of study events in terms of subject safety and, in certain situations, scientific goals (for example, early stopping rules and/or interim analyses). Independent Physician Monitors interact directly with Study Teams as well as review MC reports. Independent Physician Monitor and DSMB reports are forwarded to investigators, the PRMS, and the IRB. Independent Physician Monitors and DSMB have no independent authority to alter research conduct. Monitoring Committee(s) (MC) monitor the scientific integrity and timeliness of the pursuit of a protocol, including regulatory compliance, patient eligibility, protocol compliance, data management processes, adverse event reporting procedures, and accrual. MCs report their findings to investigators, Independent Monitors and DSMB, and to PRMS. MCs have no independent authority to alter research conduct. The PRMS reviews protocols, proposed informed consent forms, and amendments. The PRMS also reviews reports received from investigators, MC, Independent Physician Monitors, and DSMB. The PRMS assesses the information received from all these sources in an ongoing process that focuses on scientific merit, ncluding subject safety, and scientific progress. The PRMS has the authority to suspend, modify, or terminate protocol conduct.

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