CORE--CLINICAL PROTOCOL & DATA MANAGEMENT

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DESCRIPTION (provided by applicant): The Clinical Protocol and Data Management Shared Resource (CPDMSR) is a unifying administrative and educational organization of the San Antonio Cancer Institute that consolidates cancer clinical trials information and functions to meet needs defined by clinical investigators, external regulatory organizations, and individuals needing assistance in obtaining information about and/or referrals to SACI clinical trials. The CPDMSR offers the following services to investigator-members of SACI and to its affiliate institutions: Maintain a centralized library of active and closed cancer clinical trials from all affiliate member institutions of SACI; Publish quarterly a web-based catalog of all active cancer clinical trials for distribution to investigator-members and affiliates; Compile a real-time database of patient accrual to and demographic information for each protocol; Coordinate and perform auditing functions of the SACI including quality assurance audits of institutional studies and data and safety monitoring board (DSMB) meetings; Organize and present educational and training programs in data management, human subject research compliance, investigational drug accountability requirements, and other issues related to the conduct of clinical trials; Maintain a central contact office for external and internal inquiries about SACI cancer clinical trials, patient eligibility for specific studies, and referrals for clinical trial entry; and Assure that all investigators are in full compliance with regulatory issues, including: conflict of interest disclosures, 1572 submissions (for investigational drugs), IRB approvals of protocols, IACUC approvals, and education in human subjects certifications.