Protocol Review

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The Protocol Review and Monitoring System provides a centralized framework for initial evaluation and prioritization of more than 160 new studies per year and ongoing monitoring of more than 200 clinical research studies in collaboration with our Institutional Review Board, regulatory agencies, and sponsors. With institutional support, major initiatives were undertaken in key areas during the current grant cycle: 1) Data and Safety Monitonng (DSM): Our Institutional master DSM Plan (DSMP) was written, reviewed, implemented, NCI-approved (JAN-2002), and amended for DCP-CCOP approval (FEB-2004). The DSMP included creation of a local Phase l-ll Protocol Monitoring Committee (Burtness, formerly R. Cohen) to provide oversight for investigator-initiated studies that do not require a full or independent DSMB. 2) Scientific Review: Research Review Committee chair transitioned from the G. Hudes, who still serves as a reviewer, to Schilder, an independent investigator and long-term member of the committee. 3) Quality Assurance: Expansion of the QA program with growth of the Investigator Initiated Program at extramural sites. Continued source documentation for eligibility criteria and 100% internal auditing of protocol eligibility. Integration of expanded QA procedures with the master DSMP. 4) Regulatory Support: Staff resources expanded to manage increased study volume, amendments, safety reports, adverse event reports, HIPAA documentation, sponsor communications, certifications, NCl-CTSU reporting, and global revisions to informed consent documents. 5) Informatics: Enhanced automated reports to support continuing reviews. Specialized database tools for efficient management and distribution of more than 5000 annual safety reports.