DSM

临床方案数据管理办公室（CPDM）为开展以下工作提供基础设施支持： 临床研究中心。其职能包括：（1）临床试验开发（从概念到IRB 批准）、执行和监测;（2）与CIMCC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） 与监管机构和赞助机构进行沟通。 为了成功地完成这些功能，CPDM开发了5个核心，由 临床运营和最终医学总监：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名临床研究协调员经理;这些核心负责试验 分配、监督和培训。监管核心由8名监管研究协调员组成 和1名法规经理;该核心负责与IRB对接并维护每个 CPDM执行的方案（方案、同意书、修正案、年度审查等）。遵约 核心由3名合规协调员和1名合规经理组成;该核心负责 根据我们的NCI批准的DSMP监测药物启动的试验（IIT）并管理中心注册 程序，包括资格审查。财务核心由1名财务经理组成， 负责管理CPDM运营预算并对我们的试验组合进行财务监督。CPDM 与CISR临床信息共享资源（CISR）密切合作，CISR负责 NCI报告（包括CTRP）和Velos支持（培训、CFR设计、接口开发和 安全/监督）。CPDM补充了PRMS，同时为调查人员提供了高效， 为癌症中心提供无缝和负责任的临床试验监督。 数据和安全性监查委员会（DSMC）负责正在进行的数据和安全性监查 临床试验DSMC优先考虑当地制药商发起的I、II和III期临床试验。委员会 在方案审查认为适当时，将承担其他干预性试验的责任 和监查系统委员会（PRMSC）、IRB或PI要求。

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.