CORE--CLINICAL PROTOCOL & DATA MANAGEMENT

描述(申请人提供)：临床方案和数据管理 共享资源(CPDMSR)是统一的管理和教育 圣安东尼奥癌症研究所巩固癌症的组织 满足临床需求的临床试验信息和功能 调查人员、外部监管组织和需要 协助获取有关SACI临床的信息和/或转诊至SACI临床 审判。 CPDMSR为SACI和SACI的调查人员提供以下服务 对其附属机构：维护一个集中的活跃和 来自SACI所有附属成员机构的封闭癌症临床试验； 每季度发布一份基于网络的所有活跃癌症临床试验目录 分发给调查员-成员和附属机构；编写实时 每个方案的患者应计和人口统计信息的数据库； 协调和执行SACI的审核职能，包括质量审核 机构研究、数据和安全监测委员会的保证审计 (Dsmb)会议；组织和介绍教育和培训计划 数据管理、人体受试者研究合规性、研究药物 问责制要求以及与以下行为有关的其他问题 临床试验；维护外部和内部的中央联系办公室 关于SACI癌症临床试验的查询，患者是否符合特定条件 临床试验参赛研究和转介；并确保所有 调查人员完全遵守监管问题，包括： 利益冲突披露，1572份意见书(用于调查 药物)、IRB对方案的批准、IACUC的批准和人类教育 科目、证书。

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.