DSM

帝斯曼

• 批准号: 8753117
• 负责人: STEPHEN G EMERSON
• 金额: $ 4.78万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-07-04 至 2019-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8753117
• 关键词: Amendment; Budgets; Cancer Center; Cancer Center Support Grant; Clinical; Clinical Informatics Shared Resource; Clinical Nursing Research; Clinical Protocols; Clinical Research; Clinical Trials; Clinical Trials Network; Complement; Consent; Data; Databases; Development; Diagnostic and Statistical Manual of Mental Disorders; Eligibility Determination; Ensure; Funding; Goals; Information Systems; Institution; Institutional Review Boards; Leadership; Malignant Neoplasms; Modeling; Monitor; Names; Nursing Research; Patients; Phase; Physician Executives; Process; Protocols documentation; Quality Control; Reporting; Research; Research Infrastructure; Research Personnel; Resource Allocation; Resource Sharing; Safety; Security; Services; Supervision; System; TimeLine; Training; Training Support; Training and Education; Translational Research; Update; Work; cancer site; data integrity; data management; design; improved; member; oncology; operation; patient safety; programs

The Clinical Protocol Data Management (CPDM) Office provides infrastructural support for the conduct of clinical research at the HICCC. Its functions include: (1) clinical trial development (from concept to IRB approval), execution, and monitoring; (2) liaising with the HICCC Clinical Informatics Shared Resource (CISR) to ensure the optimal operation of clinical research information systems and databases, and (3) interfacing with regulatory and sponsoring agencies. To successfully accomplish these functions, the CPDM has developed 5 cores overseen by the Director of Clinical Operations and ultimately the Medical Director: Research Nursing, Clinical Research Coordination, Regulatory, Compliance, and Finance. The Research Nursing and Clinical Research (Data Management) cores consist of 8 Research Nurses, 2 Research Nurse Managers, 24 Clinical Research Coordinators (Data Managers), and 2 Clinical Research Coordinator Managers; these cores are responsible for trial assignments, supervision, and training. The Regulatory core consists of 8 Regulatory Research Coordinators and 1 Regulatory Manager; this core is responsible for interfacing with the IRB and maintaining files on each protocol executed by the CPDM (protocol, consents, amendments, annual reviews, etc.). The Compliance core consists of 3 Compliance Coordinators and 1 Compliance Manager; this core is responsible for monitoring investigator-initiated trials(IIT) per our NCI-approved DSMP and managing central registration processes, including eligibility review. The Finance core consists of 1 Finance Manager who is responsible for managing the CPDM operating budget and providing financial oversight of our trial portfolio. The CPDM works very closely with the HICCC Clinical Informatics Shared Resource (CISR), which is responsible for NCI reporting (including CTRP) and Velos support (training, CFR design, interface development, and security/oversight). The CPDM complements the PRMS, while providing investigators with efficient, seamless, and responsible clinical trial oversight for the Cancer Center. The Data and Safety Monitoring Committee (DSMC) Is responsible for data and safety monitoring of ongoing clinical trials. The DSMC prioritizes local investigator-initiated phase I, II, and III clinical trials. The committee will assume responsibility for other interventional trials when it is deemed appropriate by the Protocol Review and Monitoring System Committee (PRMSC), IRB or at the request ofthe PI.

临床方案数据管理 (CPDM) 办公室为开展临床方案数据管理 (CPDM) 提供基础设施支持 HICCC 的临床研究。其职能包括：（1）临床试验开发（从概念到IRB） 批准）、执行和监控； (2) 与 HICCC 临床信息学共享资源联络 (CISR) 确保临床研究信息系统和数据库的最佳运行，以及 (3) 与监管和赞助机构建立联系。 为了成功完成这些职能，CPDM 开发了 5 个核心，由主任监督。 临床操作以及最终的医疗总监：研究护理、临床研究协调、 监管、合规和财务。研究护理和临床研究（数据管理） 核心人员包括 8 名研究护士、2 名研究护士经理、24 名临床研究协调员（数据 经理）和 2 名临床研究协调经理；这些核心负责审判 任务、监督和培训。监管核心由 8 名监管研究协调员组成 1 名监管经理；该核心负责与 IRB 接口并维护每个 IRB 上的文件 CPDM 执行的协议（协议、同意书、修正案、年度审查等）。合规性 核心由3名合规协调员和1名合规经理组成；该核心负责 根据 NCI 批准的 DSMP 监控研究者发起的试验 (IIT) 并管理中央注册 流程，包括资格审查。财务核心由 1 名财务经理组成，负责 用于管理 CPDM 运营预算并为我们的试验组合提供财务监督。 CPDM 与 HICCC 临床信息学共享资源 (CISR) 密切合作，该资源负责 NCI 报告（包括 CTRP）和 Velos 支持（培训、CFR 设计、界面开发和 安全/监督）。 CPDM 补充了 PRMS，同时为研究人员提供了高效、 对癌症中心进行无缝且负责任的临床试验监督。 数据和安全监测委员会 (DSMC) 负责正在进行的数据和安全监测 临床试验。 DSMC 优先考虑当地研究者发起的 I、II 和 III 期临床试验。委员会 当方案审查认为适当时，将承担其他介入试验的责任 监测系统委员会 (PRMSC)、IRB 或应 PI 的要求。