Data and Safety Monitoring Committee (DSMC)
The Data and Safety Monitoring Committee (DSMC) is responsible for monitoring and auditing all therapeutic institutional clinical trials for data validity, trial conduct, and adverse event (AE)/serious adverse event (SAE) reporting.
In general, the risk assessment of the study is determined by the phase/type of the trial, which in turn, designates the frequency of monitoring.
Phase 1/Pilot/Gene therapy/Vaccine therapy trials are typically monitored monthly, dependent upon accrual, and beginning within one month of the initiation of enrollment. Additionally, the DSMC must approve any dose escalation decision on a UCSF institutional Phase 1 trial within two business days. The DSMC provides real-time monitoring on all treated subjects on Phase 1/Pilot/Gene therapy/Vaccine therapy institutional trials, and provides auditing on at least twenty percent of the enrolled subjects on Phase 2 and Phase 3 institutional studies. The regulatory files for all studies are audited annually for regulatory compliance. The DSMC also reviews planned interim analyses on institutional trials, evaluates external audit results, and evaluates any safety or study design concerns raised by the PI, Site Committee
, the Protocol Review Committee (PRC)
or the UCSF IRB. In addition, the PRC, the IIRB, or the HDFCCC Deputy Director can request that the DSMC evaluate a certain study, event, Site Committee
, or investigator.
If serious non-compliance is identified during a /auditing visit, the DSMC may request a voluntary hold on accrual while a Corrective Action and Prevention Plan (CAPA) is being formulated by the PI and study team. The DSMC Chair will notify the HDFCCC Deputy Director, UCSF IRB, and the PRC of any audits with an unsatisfactory grade and of the DSMC’s requirements prior to re-opening the trial(s) to accrual.
All clinical trials conducted at the HDFCCC must incorporate the Data and Safety Monitoring Plan (DSMP) templates from the NCI-approved DSMP in the protocol, to include both delineation of responsibilities and a description of the data and safety review process. The Protocol Review Committee (PRC)
will not approve a protocol without the correct incorporated DSMP template. The DSMP templates for various study types are provided below; for questions on plan templates, contact John McAdams (John.McAdams@ucsf.edu
John F. McAdams, MS, CCRP, CDT
Manager, Data and Safety Monitoring Committee
Policies & Procedures developed by the DSMC are located on the ITR Policies page.