Data and Safety Monitoring at the Helen Diller Family Comprehensive Cancer Center is overseen by a Data and Safety Monitoring Committee (DSMC), and conducted by a group of monitors and auditors within the Center. The DSMC and monitors are responsible for several activities related to the implementation of the Center's NCI-approved Data and Safety Monitoring Plan (DSMP). Data and Safety and Monitoring functions within the HDFCCC include 1) the conduct of internal audits of protocols;2) evaluation of the results of both internal and external audits of protocols, including those conducted by the NCI Cooperative Groups, other consortia, and CTEP;3) review and approval of any cohort dose escalation decisions on UCSF Institutional Phase I studies;4) review of interim analyses for institutional studies;5) evaluation and addressing of any concerns with regards to safety, or related study design and stopping rules, raised by principal investigators, site committees, the Protocol Review Committee (PRC), or Institutional Review Board (IRB);6) oversight of toxicity and Serious Adverse Events (SAEs) reported by each site committee;7) development and updating of the DSMP and guidelines for its use;8) communication of findings and recommendations with key stakeholders, including the PRC, IRB, and leadership of the Center;and 9) closure of studies for noncompliance or safety issues.
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