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Data and Safety Monitoring

Data and Safety Monitoring (DSM)

The Data and Safety Monitoring Committee (DSMC) is responsible for monitoring and auditing all therapeutic investigator-initiated* clinical trials for data validity, trial conduct, and serious adverse event (SAE) reporting.

The risk assessment of the study is determined by the phase of the trial, which in turn, designates the frequency of monitoring.

Phase 1 studies are typically monitored monthly, dependent upon accrual, and beginning within one month of the initiation of enrollment.  The DSMC must approve any dose escalation decision on a UCSF investigator-initiated* Phase 1 trial (approved within two business days).   The DSMC monitors all treated subjects on Phase 1 trials, and at least twenty percent of the enrolled subjects on Phase 2 and Phase 3 studies.  The regulatory files for all studies are monitored annually for regulatory compliance.  The DSMC also reviews planned interim analyses on investigator-initiated* trials, evaluates external audit results, and evaluates any safety or study design concerns raised by a PI, Program/Disease Site Committee, the Protocol Review Committee (PRC) or the UCSF IRB, otherwise known as the Committee on Human Research (CHR).  In addition, the PRC, the CHR, or the ITR Director can request that the DSMC evaluate a certain study, event, Program/Disease Site Committee, or investigator.

If serious non-compliance is identified during a monitoring visit, the DSMC may request a voluntary hold on accrual while a Corrective Action and Prevention Plan (CAPA) is being formulated.  If there is serious or repeated non-compliance to Good Clinical Practices (GCPs)or there is an increased risk to subject safety, the DSMC may recommend that the CHR mandate closure.  The DSMC Chair will notify the CHR 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 have a satisfactory Data Safety Monitoring Plan (DSMP) that is summarized 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 DSMP embedded.  The DSMC plan templates for various study types are provided below; for questions on plan templates, contact John McAdams (mcadamsj@cc.ucsf.edu.

 Contact Information:

John F. McAdams, M.S., C.C.R.C.
Manager, Data and Safety Monitoring Committee
P: 415.353-7746 / F: 415.353.9721
Email: mcadamsj@cc.ucsf.edu

Good Clinical Practice (GCP) Website

DSMP with Templates for Protocol

Policies & Procedures developed by the DSMC are located on the ITR Policies page.

 

*  Can include studies written by an investigator at another institution.