Clinical Protocol and Data Management (Core 018)

摘要-临床方案和数据管理(CPDM) 临床方案和数据管理部分包括临床方案办公室(CPO)、 临床数据管理团队和合规委员会(审计、数据和安全监测)。这些 集成组为由进行的癌症临床试验提供集中管理和监督 北卡罗来纳州莱恩伯格综合癌症中心(LCCC)的成员。CPDM提供了全方位的 为研究人员发起的本地和多中心试验(IITs)、行业或 其他受赞助的试验，以及由国家临床试验网络组织和 实验治疗学临床试验网络。CPO集中协议注册、监管 事务、遵从性委员会的工作、临床试验的管理，并促进高效率和有效的培训 为研究人员和及时激活的方案提供支持，以支持所有癌症中心的研究人员 相关学科。调查员发起的方案开发由专门的专家推动，他们 和调查人员在一起。克莱尔·迪斯是CPO的医务主任，并担任礼宾办公室执行主任 委员会，该委员会由疾病特定礼宾办公室疾病组教职员工领导组成。卡丽 李和贾里德·韦斯增加了负责运营和财务的教职员工领导层。 2014年，北卡罗来纳大学所有干预试验的应计费用为1731名患者。治疗干预措施的应计费用 UNC为604名癌症患者。观察性研究纳入4790名受试者，其中572名为辅助研究对象 或北卡罗来纳大学的相关试验。所有类型研究的UNC应计总额为7093名受试者。附属网站 共有450名受试者参加了北卡罗来纳大学的IITS。 CPDM审计研究人员发起的和NCI资助的治疗试验，以验证依从性和 通过其审计小组委员会获取准确的数据。审计小组委员会在每月一次的 审核：审核审核结果。审计结果将直接提交给首席调查员，并带有 将摘要分发给首席调查员和礼宾审查委员会。数据安全与数据安全 监测委员会定期(每季度至每年)审查试验，审查的频率 基于LCCC议定书审查委员会确定的风险和复杂性。 北卡罗来纳大学莱茵伯格分校对少数族裔的健康差距进行研究，并不断寻求新的方法来 优化妇女和少数群体参加试验的收益。温迪·布鲁斯特博士担任少数族裔学院顾问 应计费用。促进少数族裔收益的举措包括配备专门的口译员和修改我们的临床 试验优先顺序核对表，以明确少数群体和女性目标应计项目，这将产生所需的信息 找出计提的障碍。我们还在探索使用EPIC作为监测应计比率的一种方式的选择 癌症部门和个人肿瘤学家，并提醒医生有关试验。

Abstract - Clinical Protocol and Data Management (CPDM) The Clinical Protocol and Data Management component includes the Clinical Protocol Office (CPO), the clinical data management team, and the compliance committees (Audit; Data and Safety Monitoring). These integrated groups provide centralized management and oversight for cancer clinical trials conducted by members of the UNC Lineberger Comprehensive Cancer Center (LCCC). The CPDM delivers a full range of management and quality control services for investigator-initiated local and multi-center trials (IITs), industry or other sponsored trials, as well as those originating in the National Clinical Trials Network groups and the Experimental Therapeutics Clinical Trials Network. The CPO centralizes the protocol registration, regulatory affairs, compliance committee work, management of clinical trials, and facilitates efficient and effective training for research personnel and timely activation of protocols in support of cancer center investigators from all relevant disciplines. Investigator-initiated protocol development is facilitated by dedicated specialists who work with investigators. Claire Dees serves as Medical Director of the CPO and chairs the Protocol Office Executive Committee, which is comprised of the disease-specific Protocol Office Disease Group faculty leaders. Carrie Lee and Jared Weiss provide additional faculty leadership with responsibility for operations and finance. The accrual to all intervention trials at UNC in 2014 was 1731 patients. Accrual to treatment interventions at UNC was 604 cancer patients. Observational studies enrolled 4790 subjects and 572 were accrued to ancillary or correlative trials at UNC. The total UNC accrual to studies of all types was 7093 subjects. Affiliate sites accrued 450 subjects to UNC IITs. The CPDM audits investigator-initiated and NCI-funded therapeutic trials to authenticate compliance and capture of accurate data through its Audit Subcommittee. The Audit Subcommittee meets following the monthly audit to review findings from the audit. Audit findings are addressed directly to the Principal Investigator, with a summary being issued to the Principal Investigator and the Protocol Review Committee. The Data Safety and Monitoring Committee reviews trials on a regular (quarterly to annually) basis, with the frequency of review based on risk and complexity as determined by the LCCC Protocol Review Committee. The UNC Lineberger conducts research on minority health disparities and continually seeks new ways to optimize accrual of women and minorities to trials. Dr. Wendy Brewster serves as Faculty Advisor for Minority Accrual. Initiatives to facilitate minority accrual include a dedicated interpreter and modification of our clinical trial prioritization checklist to specify minority and female target accrual, which will generate information needed to identify obstacles to accrual. We are also exploring options to use Epic as a way to monitor accrual rates by cancer division and the individual oncologist and remind physicians about relevant trials.