CORE--CLINICAL PROTOCOL OFFICE

核心——临床方案办公室

基本信息

批准号：
7751856
负责人：
MARK A SOCINSKI
金额：
$ 69.29万
依托单位：
UNIV OF NORTH CAROLINA CHAPEL HILL
依托单位国家：
美国
项目类别：
财政年份：
资助国家：
美国
起止时间：
至
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/7751856
关键词：
Bortezomib Cancer Center Cancer Patient Clinical Clinical Protocols Clinical Research Clinical Trials Communities Complex Contracts Critiques Data Storage and Retrieval Databases Development Doctor of Medicine Education Ensure Epidermal Growth Factor Receptor Faculty Family Grant Health Personnel Incidence Malignant Neoplasms Minority Mission Morbidity - disease rate North Carolina Patient Care Patients Pharmacologic Substance Phase Phase III Clinical Trials Policies Preparation Protocol Compliance Protocols documentation Quality Control Randomized Regulation Reporting Research Research Infrastructure Resource Allocation Resource Sharing Resources Science Services System Training Translational Research UNC Lineberger Comprehensive Cancer Center anticancer research data acquisition innovation mortality novel novel therapeutics oncology outreach patient population protocol development

项目摘要

The Clinical Protocol Office (CPO) is the coordinating center for all UNC Lineberger Comprehensive Cancer Center sponsored local and multi-center trials and the majority of Cooperative Group and pharmaceutical company supported cancer research. The CPO consists of 30 professionals responsible for assisting in protocol development, contract acquisition and management, regulatory oversight and compliance, 9reparation and submission of INDs for novel studies and novel compounds, internal and external study tudits and quality control, and data acquisition and preparation, and management. Since the last critique, the CPO has implemented the ProTrack database, an effective and reliable data storage and retrieval system for managing clinical trials. This database facilitates the timely and accurate submission of numerous INDs to the FDA, as well as expansion of capacity for managing novel institutional and multi-center studies. At the urging of external advisors, the Center has also added a Protocol Office Executive Committee that provides oversight, advice, and direction for policy, study prioritization, and resource allocation. These improvements plus continued staff expansion have enabled the CPO to support increasinly complex, innovative studies such as the Phase I bortezomib (LCCC 9804), a GSK sponsored EGFR trials, and multi-center, Phase III studies such as LCCC 9719. Mark Socinski, MD is the CPO Faculty Director; Joy Ostroff, RN, BBSN, OCN, is the Facility Director. The CPO reports to Dr. Richard Goldberg, Associate Director for Clinical Research. The majority of the proposed increase provides infrastructure to support increased quality (including audit), growing demands for regulation and oversight, and accrual outreach, particularly to minorities.

临床方案办公室 (CPO) 是北卡罗来纳大学莱恩伯格综合癌症中心赞助的所有本地和多中心试验的协调中心，大多数合作组织和制药公司支持癌症研究。 CPO 由 30 名专业人员组成，负责协助方案开发、合同获取和管理、监管监督和合规、新研究和新化合物的 IND 9 准备和提交、内部和外部研究和质量控制以及数据采集和准备，和管理。自上次批评以来，CPO 实施了 ProTrack 数据库，这是一个用于管理临床试验的有效且可靠的数据存储和检索系统。该数据库有助于及时、准确地向 FDA 提交大量 IND，并扩大管理新颖机构和多中心研究的能力。在外部顾问的敦促下，该中心还增设了礼宾办公室执行委员会，为政策、研究优先顺序和资源分配提供监督、建议和指导。这些改进加上持续的人员扩张，使 CPO 能够支持日益复杂的创新研究，例如 I 期硼替佐米 (LCCC 9804)、GSK 赞助的 EGFR 试验以及多中心 III 期研究例如 LCCC 9719。Mark Socinski，医学博士是 CPO 教员主任； Joy Ostroff，注册护士、BBSN、OCN，是设施总监。 CPO 向临床研究副总监 Richard Goldberg 博士汇报。拟议增加的大部分资金提供基础设施，以支持提高质量（包括审计）、不断增长的监管和监督需求以及权责发生制外展（特别是针对少数群体）。