SCIENTIFIC REPORT 2004 - Sylvester Comprehensive Cancer Center

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S H A R E D R E S O U R C E S C L I N I C A L R E S E A R C H S E R V I C E S R E S O U R C E CLINICAL DIRECTOR Joseph A. Lucci, III., M.D. Associate Professor of Obstetrics and Gynecology ASSISTANT DIRECTOR James D. Hanlon, Jr., R.N. Manager PURPOSE The Clinical Research Services Resource provides UM/Sylvester investigators with broad-based support for their clinical research activities to: • Evaluate clinical trial protocol design, scientific merit, and patient care-related issues through the UM/Sylvester Protocol Review Committee. • Provide support services for screening, evaluating, recruiting, tracking, protecting, and maintaining patients on clinical protocols. • Assist investigators with protocol development by providing consultation in protocol design, access to other needed resources, and assistance with reporting requirements and other federal regulations. • Assure compliance with guidelines for investigational drug use and toxicity reporting and maintain quality data management. • Develop a data safety and monitoring board to monitor institutional clinical trials. • Support national cooperative group activities and interact with UM/Sylvester affiliates. • Develop, operate, and maintain a computerized protocol data management system. • Budget clinical trial expenditures and negotiate contracts with clinical trial sponsors. SERVICES 1) Regulatory Office: This office handles all activities involving activation of clinical trials, which include preparing and presenting documents to both the Protocol Review Committee and the University of Miami Internal Review Board, writing informed consents, and distributing active protocols throughout the clinical areas on the medical campus. 2) Informatics Office: This office maintains the database for institutional trials, monitors the charge-back system, provides lists of active clinical trials, and assists with quality control procedures. 3) Budget Office: This office controls the budget for the Clinical Research Services Resource’s personal and office expenditures and negotiates contracts with clinical trial sponsors. 4) Quality Assurance: This office monitors the quality of data management and conducts case auditing to ensure compliance with FDA requirements. It also interacts with the Data Safety and Monitoring Board. 5) Research Pharmacy: The research pharmacy is responsible for investigational drug accountability and inventory, as well as providing drug information for medical, nursing, and pharmacy staff. UM/Sylvester Comprehensive Cancer Center Scientific Report 2004 147
S H A R E D R E S O U R C E S D N A C O R E F A C I L I T Y MANAGER Rudolf K. Werner, Ph.D. Professor of Biochemistry and Molecular Biology PURPOSE The purpose of the DNA Core Facility is to make DNA sequencing services available to UM/Sylvester members in support of their peerreviewed funded research. SERVICES This facility provides cancer center investigators with the following services: 1) DNA Sequencing: The investigator provides purified DNA for analysis and receives a sequence within three to five days. The sequence data are about 98 percent accurate. Some investigators perform their own sequencing reactions and provide the completed reaction mixture for analysis on the instrument. To achieve more uniform DNA quality, the facility also offers, for a small surcharge, DNA purification from a single bacterial colony containing the plasmid to be sequenced. In addition to the sequence analysis of doublestranded DNA, the facility also provides sequencing of polymerase chain reaction (PCR) products. These results are usually superior to those obtained from cloning DNA. 2) Order Coordination: The facility coordinates orders for the synthesis of oligonucleotides from commercial sources. 148 UM/Sylvester Comprehensive Cancer Center Scientific Report 2004
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SCIENTIFIC REPORT 2004 - Sylvester Comprehensive Cancer Center

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