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CRMO- CLINICAL RESEARCH MANAGEMENT OFFICE

CRMO-临床研究管理办公室

基本信息

批准号：
8375790
负责人：
Edward P Gelmann
金额：
$ 32.79万
依托单位：
COLUMBIA UNIVERSITY HEALTH SCIENCES
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-07-01 至 2014-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8375790
关键词：
Administrator Adverse event Amendment Bioinformatics Biostatistics Shared Resource Budgets Cancer Center Cancer Center Support Grant Clinical Clinical Data Clinical Research Clinical Research Associate Clinical Trials Clinical Trials Informatics System Communication Conduct Clinical Trials Consent Forms Data Databases Diagnostic and Statistical Manual District of Columbia Documentation Ensure Funding Goals Grant Guidelines Head Herbert Irving Comprehensive Cancer Center Industry Informatics Information Systems Institutional Review Boards Internet Malignant Neoplasms Mediation Medical center Modeling Monitor Nursing Research Office Management Operations Research Peer Review Peer Review Grants Pharmaceutical Preparations Procedures Process Protocols documentation Quality Control Reaction Reporting Research Research Activity Research Infrastructure Research Personnel Research Proposals Resource Sharing Southwest Oncology Group Supervision Training Universities Work data management drug development experience member operation quality assurance web site

项目摘要

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.

临床研究管理办公室（CRMO）为开展临床研究提供基础设施。 HICCC的研究。CRMO的职能包括：通过维持行政和试验管理，促进临床研究的开展操作，与生物信息学密切合作，确保临床信息系统的最佳运行数据库，以及提供与监管和赞助机构的接口。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领导每个四个办公室的负责人和前三个办公室的负责人向研究业务署长报告。的研究护理办公室和数据管理办公室负责分配、监督，培训了12名研究护士和28名数据管理员和临床研究助理， CIMCC临床试验。数据管理办公室还负责审计合规性和质量保证。研究运营和监管管理办公室，有一名主管和一名 7名工作人员，维护提交给CRMO的每份方案的档案，提交方案，修正案，年度审查和药物不良反应报告给IRB和PRMC，为调查人员和工作人员在密码保护的网站上发布了一份协议。该办公室还负责监督CRMO的质量控制和新程序的实施。数据应用该小组共同向CRMO主任和生物信息学主任报告，信息学，包括实施和管理Velos，一个临床试验信息学系统与CaBIG兼容。CRMO与议定书审查和监测委员会密切合作（PRMC），与研究者，并与生物统计共享资源，使高效，无缝，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。