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（稽查;数据和安全性监查）。这些 综合小组为癌症临床试验提供集中管理和监督， Lineberger综合癌症中心（LCCC）CPDM提供全方位的 为制药商发起的本地和多中心试验（IIT）、行业或 其他申办的试验，以及来自国家临床试验网络组和 实验治疗药物临床试验网络。CPO集中方案注册、监管 事务，合规委员会的工作，临床试验的管理，并促进高效和有效的培训 为研究人员和及时激活协议，以支持癌症中心的研究人员从所有 相关学科。研究者发起的方案制定由专门的专家推动， 和调查员。Claire Dees担任CPO的医学总监，并担任礼宾办公室执行主席 该委员会由特定疾病礼宾办公室疾病组的教员领导人组成。嘉莉 李和贾里德韦斯提供额外的教师领导与运营和财务责任。 2014年，所有干预试验的累积人数为1731例患者。治疗干预的累积 604名癌症患者。观察性研究入组了4790例受试者，572例入组辅助研究 或相关试验。所有类型研究的总入组人数为7093例受试者。关联公司 将450名受试者纳入研究。 CPDM审核制药商发起和NCI资助的治疗试验，以验证合规性， 通过其审计小组委员会收集准确的数据。审计小组委员会在每月 审核，以审查审核结果。稽查结果直接提交给主要研究者， 向主要研究者和方案审查委员会发布总结。资料及安全 监测委员会定期（每季度至每年）审查审判，审查频率 基于LCCC方案审查委员会确定的风险和复杂性。 Lineberger基金会对少数民族的健康差异进行研究，并不断寻求新的方法， 尽量增加妇女和少数族裔接受审判的人数。温迪布鲁斯特担任少数民族学院顾问 应计。促进少数族裔应计费用的举措包括专门的口译员和修改我们的临床 试验优先次序清单，以指定少数族裔和女性目标累积，这将产生所需信息 找出妨碍应计利润的障碍。我们还在探索使用Epic作为监控应计费率的方法， 癌症部门和个体肿瘤学家，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.