All clinical trials must have a written Data and Safety Monitoring (DSM) plan. Many clinical trials activated at the Virginia Commonwealth University (VCU) Massey Cancer Center (MCC) are multicenter trials and have a DSM plan that has been previously approved by an appropriate authority external to VCU. Although not required by NCI CCSG guidelines or NCI/NIH policy, the MCC default DSM plan for clinical trials is a DSMB. DSMBs evaluate ongoing trials for data integrity and subject safety. DSMB recommendations are reported to investigators and the IRB. If a DSMB identifies problems so serious as to raise doubts about the meaningfulness of the results of a trial, it also reports its findings to the Protocol Review and Monitoring Committee (PRMC). Although DSMBs make recommendations, the DSMB function is an advisory function. In addition to the DSMB, a DSM plan generally contains two other components: the Study Team and an Audit Committee (AC). The Study Team is the group primarily responsible for study conduct. In most cases, the study team consists of the Investigator(s), Study Biostatistician, a Research Nurse, a Clinical Research Associate, and a Regulatory Expert. Study teams meet regularly as appropriate for an individual study. ACs audit trials for regulatory compliance, protocol compliance, and data quality. AC findings are reported to the investigator and the trial DSMB. Although the AC may make recommendations, the AC function is a fact finding function.

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