CORE--PROTOCOL AND DATA MANAGEMENT OFFICE

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The Protocol and Data Management Office (PDMO) of the University of Chicago Cancer Research Center (UCCRC) is a shared resource that provides expertise for protocol and data management of cancer-related research projects. This resource provides cancer center members with broad-based support for their clinical research activities. The services are essential for the collection of high quality data necessary for a successful trial. Since the last submission of the Cancer Center Support Grant, the facility has been reorganized to separate the biostatistical component from the protocol and data management component. The office has been renamed as the Protocol and Data Management Office. Dr. Everett Vokes remains director of this facility. Dr. John Bailar was appointed director of the Biostatistics Facility. The specific aims of the Protocol and Data Management Office are: 1. To facilitate and coordinate protocol design, development, and implementation; 2. To facilitate review and approval of the protocol by the Institutional Review Board, and the UCCRC Clinical Trials Review Committee (CTRC). To maintain all correspondence with both committees and assure compliance with federal guidelines for investigational drug use and toxicity reporting; 3. To provide for central patient registration, and randomization (when applicable) on all protocols, and to implement effective procedures for receipt and storage of the data collected; 4. To provide quality assurance and timely and accurate interim reporting of the accumulating data as required by the protocol and the sponsoring agencies; 5. To develop, operate and maintain an automated computer database and network communication system that will satisfy the scientific and administrative needs of the facility; 6. To develop and provide central maintenance for the design, content, operations, and security of the study database; 7. To monitor patient accrual and assure timely closure of over- or under-accruing studies with the input of the CTRC and the Biostatistics Facility, and 8. To provide training and education of new personnel in data management requirements, protocol elements and clinical trials monitoring.