The overall goal of the Clinical Trials Office (CTO) is to provide central management, research support and oversight functions for coordinating, facilitating and conducting human research and reporting results in conjunction with members of the Yale Cancer Center (YCC). The CTO provides a broad range of management and quality control functions, including trial activation and monitoring, centralized protocol document directory, a centralized database of protocol-specific data, data and safety reporting, and assistance with complex regulatory issues. The CTO further provides high quality services involving assistance with patient enrollment, screening, obtaining informed consent and safety reporting. Specific objectives are to: 1. Facilitate timely institutional approval and implementation of clinical trials and translational research; 2. Ensure the research team is adequately trained, qualified and prepared to support each trial; 3. Maintain a centralized web-based repository of all protocol specific documents and consents; 4. Provide clinical assistance and facilitate the conduct of clinical trials (institutional and multi-center) via centralized clinical trial operations, including but not limited to enrollment and verification of patient eligibility, scheduling of appropriate tests, treatments, and assessment; 5. Verify trial data and provide electronic data capture and data management; 6. Insure that all reports, including reports of serious adverse events and unanticipated problems, are , submitted in accordance with institutional and federal regulatory guidelines to appropriate regulatory bodies, including local and central IRBs and sponsors;and 7. Insure protocol compliance with all institutional policies and agreements, state and federal regulations, data accuracy and data integrity through a system of monitoring and quality assurance that is consistent with the YCC Data and Safety Monitoring Plan (DSMP). 8. Carry out the research priorities and functions as determined by the YCC leadership and PRMS committees. The activity and usage of the CTO parallels the growth of the center. As the number of YCC investigators has increased with the number of oncology faculty, the usage of the CTO has increased. For example, in the year (2005) preceding the previous grant submission, 143 patients had been enrolled onto therapeutic trials. In the five years preceding this grant submission 1531 patients have been enrolled onto therapeutic trials, with 471 accrued in the most recent fiscal year (FY12). A number of efficiencies have allowed CTO to maintain quality services and increase in the number of staff. With the rapid expansion of staff to meet the demands, the CTO provides high quality services to the YCC investigators, allowing protocol compliance and conduct consistent with excellence in clinical research.
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