CRMO- CLINICAL RESEARCH MANAGEMENT OFFICE

临床研究管理办公室(CRMO)为临床研究的开展提供基础设施 在HICCC的研究。社区关系管理办公室的职能包括： ？通过维持行政和试验管理，促进临床研究的进行 运营， 与生物信息学密切合作，确保临床信息系统的最佳运行 和数据库，以及 ？提供与监管机构和赞助机构的接口。 为了实现这些目标，CRMO有四个办公室，研究护理，数据管理，研究 运营和监管管理以及数据应用。经验丰富的高级管理人员分别领导 四个办事处和前三个办事处的负责人向研究业务署署长报告。这个 研究护理办公室和数据管理办公室负责分配、监督、 以及培训12名研究护士和28名数据经理和临床研究助理 HICCC临床试验。数据管理厅还负责审计合规和质量。 保证。研究、业务和监管管理办公室，有一名主管和一名 7名工作人员，维护提交给CRMO的每个议定书的文件，提交议定书、修正案、年度 评审和向IRB和PRMC提交的药物不良反应报告，并保持开放的最新副本 为调查人员和工作人员提供密码保护的网站上的协议。该办公室还负责 监督CRMO的质量控制和新程序的实施。数据应用程序 该小组向CRMO主任和生物信息学主任共同报告，并处理 信息学，包括临床试验信息学系统VELOS的实施和管理 与CaBIG兼容。CRMO与议定书审查和监测委员会密切合作 (PRMC)，与研究人员和生物统计共享资源，以带来高效、无缝和 负责癌症中心的临床试验管理。CRMO的预计业务预算 是517,204美元，其中我们要求CCSG提供249,084美元。

The Clinical Research Management Office (CRMO) provides infrastructure for the conduct of clinical research at the HICCC. The functions of the CRMO include: ¿ Facilitating the conduct of clinical research by maintaining the administrative and trial management operations, ¿ Working closely with Bioinformatics to ensure the optimal operation of clinical information systems and databases, and ¿ Providing an interface with regulatory and sponsoring agencies. To accomplish these goals, the CRMO has four offices, Research Nursing, Data Management, Research Operations and Regulatory Management, and Data Applications. Experienced senior managers head each of the four offices and the heads of the first three report to the Administrator for Research Operations. The Offices of Research Nursing and of Data Management are responsible for the assignment, supervision, and training of 12 research nurses and 28 data managers and clinical research associates who staff HICCC clinical trials. The Office of Data Management is also responsible for audit compliance and quality assurance. The office of Research Operations and Regulatory Management, with a supervisor and a staff of 7, maintains files on each protocol submitted to the CRMO, submits protocols, amendments, annual reviews and adverse drug reaction reports to the IRB and PRMC and maintains current copies of open protocols on a password protected website for investigators and staff. The office is also responsible for oversight of quality control of the CRMO and implementation of new procedures. The Data Applications Group reports jointly to the Director of the CRMO and to the Director of Bioinformatics and handles the informatics that includes the implementation and management of Velos, a clinical trials informatics system compatible with CaBIG. The CRMO works closely with the Protocol Review and Monitoring Committee (PRMC), with investigators, and with the Biostatistics Shared Resource to bring efficient, seamless and responsible clinical trials management to the Cancer Center. The projected operating budget of the CRMO is $517,204, of which we are requesting $249,084 from the CCSG.