Clinical Protocol and Data Management

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The Clinical Protocol and Data Management Shared Resource (known at Stanford as the "Cancer Clinical Trials Office" or CCTO) provides administrative, research, and educational services to Cancer Center investigators conducting clinical trials. The goals of the Clinical Protocol and Data Management Shared Resource are to: (1) Facilitate clinical trials and translational research by providing administrative support to all Cancer Center investigators; (2) Enhance and facilitate data collection and reporting of clinical cancer research; (3) Provide programs to contribute to quality assurance of performance and the ongoing education of Cancer Center Clinical Research Personnel; (4) Coordinate outreach efforts in the community (Northern California) to increase clinical trials awareness and accrual; and (5) Promote interdisciplinary collaborations and translational medical research. Prior to 2003, Stanford did not have an institutionally supported Cancer Clinical Trials Office. With the decision to apply for NCI-designation as a Cancer Center, the School of Medicine and Stanford Hospital committed funding to the development of a centralized Cancer Clinical Trials Office. The Facility Director was hired in June 2003. The funding for Fiscal Year 2004 was $750,000 allowing the hiring of a core staff of 6 FTE's. In Fiscal Year 2005, Lucile Packard Children's Hospital added its support to this effort. Funding from the three institutional sources totaled $1,400,000 allowing growth to 14 FTE's by August 2005. A small expansion is underway for FY 2006 with funding of $1,600,000 allowing growth to 15.5 FTE's. The CCTO organization has grown to meet the centralization, standardization, and reporting requirements of NCI-designation and the service needs of the clinical research staff. Each year services and usage have expanded. We will continue to adjust staffing and service offerings as needed to meet the priorities of the Cancer Center. PERFORMANCE SITE(S) (organization, city, state) Stanford UniverScientific Goals The mission of the Clinical Protocol and Data Management Shared Resource is to: 1. Facilitate clinical trials and translational research by providing centralized administrative support to all Cancer Center investigators. 2. Centralize and standardize data collection and reporting of clinical cancer research. 3. Provide programs to contribute to quality assurance of performance and the ongoing education of Cancer Center Clinical Research Personnel. 4. Coordinate outreach efforts in the community (Northern California) to increase clinical trials awareness and accrual. 5. Promote Interdisciplinary collaborations and translational medical research. The CCTO provides a centralized resource that assists clinical researchers with administrative services in order to facilitate protocol processing thus allowing the researcher to focus on scientific research needs and patient care. Programs of the Clinical Protocol and Data Management Shared Resource serve to increase awareness and accrual to clinical trials as well as to centralize and standardize the quality and efficiencies of conducting clinical trials in compliance with the regulatory, documentation, and oversight requirements. In this document the Protocol and Data Management Shared Resource will be referred to as the Cancer Clinical Trials Office (CCTO).sity, Stanford, CA PHS 398/2590 (Rev. 09/04) Page 847