CORE--CLINICAL PROTOCOL & DATA MANAGEMENT

核心——临床方案

• 批准号: 6651729
• 负责人: GEOFFREY R WEISS
• 金额: $ 25.41万
• 依托单位: CTRC RESEARCH FOUNDATION
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-08-26 至 2003-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6651729
• 关键词: biomedical facility; cancer registry /resource; clinical research; clinical trials; data management; health care referral /consultation; human subject; information systems; neoplasm /cancer therapy; patient /disease registry

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.

描述（由申请人提供）：临床方案和数据管理 共享资源（CPDMSR）是一个统一的行政和教育 圣安东尼奥癌症研究所的一个组织， 临床试验信息和功能，以满足临床 研究者、外部监管机构和个人需要 协助获得有关SACI临床的信息和/或转诊 审判 CPDMSR为SACI的会员提供以下服务， 对其附属机构：维护一个集中的活跃和 SACI所有附属成员机构的已关闭癌症临床试验; 每季度发布一份所有正在进行的癌症临床试验的网络目录， 分发给经销商成员和分支机构;编制实时 每个方案的患者招募和人口统计学信息数据库; 协调和执行SACI的审计职能，包括质量 机构研究和数据的保证审计以及安全监测委员会 （DSMB）会议;组织和提供教育和培训计划， 数据管理，人类受试者研究依从性，研究药物 问责要求以及与开展 临床试验;维持外部和内部的中央联络办公室 关于SACI癌症临床试验的查询，患者是否符合特定的 研究和临床试验进入转介;并确保所有 研究者完全遵守监管问题，包括： 利益冲突披露，1572份提交（用于调查 药物），IRB批准的方案，IACUC批准，以及人类教育 科目认证。