CORE--PROTOCOL-SPECIFIC RESEARCH SUPPORT

描述：(摘自应用程序)协议特定研究 支持的目标如下：1)协助审查协议 分配这些资源的资格，以支持适当的 议定书审查和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 针对经批准的试点临床方案的护士/数据管理 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 与医生兼研究人员合作，确保遵守 所有协议要求。3)根据需要创建数据收集 指定的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，并提供了一种审计格式 赞助组织的记录；5)维持一份所有 接受指定研究的患者(包括适当的人口统计数据 如种族、性别、年龄、出生地等)以及正在进行的病人追踪 保证患者长期随访的制度；提交患者 列入中央SACI议定书所需的应计数据 数据库；6)创建有关临床研究的教育计划 由癌症中心支持的方案，用于培训新的 研究护士/数据管理人员和其他癌症中心的教育 人员对癌症临床研究的基本原理的了解；以及7) 作为临床部病人转诊协调员的后备 有时与协调员共享资源的调查员可能缺席 逃避她的职责。 该癌症中心资源的主要作用将是支持 创新PRMS批准的院校研究。这一支持 包括已批准的机构试点的数据收集和管理 研究、患者-受试者评估联络和其他职责。 高级研究护士也参与了更广泛的职能 该癌症中心的其他同行评议临床试验，包括 制定教育方案并协助提供研究数据 质量控制和审核准备。

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.