CORE--PROTOCOL MANAGEMENT OFFICE

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The Protocol Management Facility participates at all levels in the activation and conduct of cancer treatment and prevention trials, including scientific and technical review, compliance with regulatory guidelines, patient registration and treatment, data management, reporting to outside sponsors, preparation of pharmacokinetic and genomic samples, and ongoing communication with principal investigators and statisticians. 147 investigators have utilized this facility during the last grant period, including 79 with peer-reviewed funding, together representing 11 Programs that span all three Divisions. With institutional support, major initiatives were undertaken in six key areas during the current grant cycle: 1) Data and Safety Monitoring: Implementation of our NCI-approved institutional master Data and Safety Monitoring Plan. A Phase l-ll Protocol Monitoring Committee was established for oversight of investigator-initiated studies not requiring a full DSMB. 2) Scientific Review: Research Review Committee chair transitioned from the Facility Director (M. Bookman) to an independent investigator (G. Hudes). Scientific Review Coordinator role established to facilitate overall review process. 3) Quality Assurance: Improved source documentation for eligibility criteria and 100% internal auditing of protocol eligibility. 4) Regulatory Support: Staff resources expanded to manage increased study volume, amendments, safety reports, adverse event reports, HIPAA documentation, sponsor communications, certifications, NCI-CTSU reporting, and global revisions to informed consent documents. 5) Informatics: Remote on-demand printing of customized patient registration packets. Generation of all protocol chemotherapy orders, including nursing documentation of drug delivery. Revision of automated reports for continuing review. Database tools for management of safety reports. 6) Centralized Research Operations: Expanded phase I program, including the protocol support laboratory. Construction of a new 17,000 square foot ambulatory care clinical research pavilion. Future initiatives include additional expansion to support the phase I program, integration of chemotherapy orders with institutional information systems, and coordination with NCI caBIG project.