CORE--PROTOCOL-SPECIFIC RESEARCH SUPPORT

核心——特定于协议的研究支持

• 批准号: 6203208
• 负责人: Charles A Coltman
• 金额: $ 13.16万
• 依托单位: CTRC RESEARCH FOUNDATION
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-08-01 至 2000-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6203208
• 关键词: biomedical facility; cancer information system; cancer registry /resource; data management; health science research support; human data

Description: (Excerpted from Application) The Protocol Specific Research Support has the following objectives: 1) To assist in reviewing protocol eligibility for assignment of these resources in support of appropriate institutional pilot clinical protocols approved by the Protocol Review and Monitoring System of the Cancer Center; 2) To establish research nurse/data management for approved pilot clinical protocols requiring such support, to include coordination or data collection, liaison activities for both patients and referring physicians, patient follow-up, and collaboration with the physician-investigator in assuring compliance with all protocol requirements. 3) To create, as necessary, data collection records for assigned clinical protocols and quality control mechanisms for all such records; 4) To serve as central repository for all data records for approved cancer center protocols and provide a format for the audit of records by sponsoring organizations; 5) To maintain a roster of all patients on assigned studies (including appropriate demographic data such as race, gender, age, city of origin, etc.) and an ongoing patient tracing system for assurance of long-term patient follow-up; to submit patient accrual data as required for inclusion in the centralized SACI protocol data base; 6) To create educational programs about clinical investigations protocols supported by the Cancer Center for the purpose of training new research nurses/data managers and for the education of other cancer center personnel about the principles underlying clinical cancer research; and 7) To serve as a back-up for the Patient Referral Coordinator of the Clinical Investigators Shared Resource at times with the Coordinator may be absent from her duties. The principal role of this cancer center resource will be the support of innovate institutional research studies approved by the PRMS. This support includes data collection and management of approved institutional pilot studies, patient-subject evaluation liaison, and other responsibilities. The Senior Research Nurse many also participate in broader functions for other peer-reviewed clinical trials of this cancer center, including the development of educational programs and assistance in research data quality control and audit preparation.

描述：（摘自申请）方案特定研究 支持有以下目标：1）协助审查方案 是否有资格分配这些资源， 经方案审查批准的机构试点临床方案， 癌症中心的监测系统; 2）建立研究 护士/数据管理，用于批准的试点临床方案， 支助，包括协调或数据收集、联络活动 对于患者和转诊医生，患者随访，以及 与医生-研究者合作，确保遵守 所有协议要求。3)根据需要创建数据收集 指定临床方案和质量控制机制的记录， 所有此类记录; 4）作为所有数据记录的中央存储库 获得批准的癌症中心方案，并提供审核 赞助组织的记录; 5）维护所有人的名册 分配研究中的患者（包括适当的人口统计学数据， 种族、性别、年龄、原籍城市等）和正在进行的病人追踪 确保长期病人随访的系统;提交病人 纳入集中SACI方案所需的应计数据 6）建立临床研究教育项目 由癌症中心支持的协议，用于培训新的 研究护士/数据管理员和其他癌症中心的教育 向有关人员讲解癌症临床研究的基本原则;及7） 作为临床医疗中心病人转介协调员的后备人员。 研究者有时与协调员共享资源可能缺席 从她的职责中。 这个癌症中心资源的主要作用将是支持 创新由PRMS批准的机构研究。这种支持 包括数据收集和经批准的机构试点的管理 研究、患者-受试者评价联络和其他职责。 高级研究护士也可以参与更广泛的功能， 该癌症中心的其他同行评审临床试验，包括 制定教育方案和协助提供研究数据 质量控制和审计准备。