Clinical Protocol and Data Management Core

临床方案和数据管理 项目摘要 莫菲特癌症中心（MCC）的临床方案和数据管理（CPDM）功能包括1）试验设计， 开发和执行; 2）监督安全和合规性; 3）确保数据质量和 4）适当增加妇女和少数民族的人数。约190人的合作团队 CPDM专业人员为所有类型的临床试验提供集中管理和支持，包括 制药商发起（IIT）、行业或其他制药商发起的实验性治疗药物临床试验 网络（ET-CTN）和国家临床试验网络（NCTN）。CPDM为会员提供的支持包括： 方案制定;预算制定和合同签订;法规和IND/IDE管理;方案 激活;患者入组;研究相关患者护理协调;研究药物给药和护理 服务;相关科学（药代动力学/药效学）样品协调;数据收集和 报告;通过方案监测委员会监测IIT研究和数据以及安全性监测 (PMC)和数据安全与监测委员会（DSM）;审计准备和协调;少数民族外联 和导航，用于临床试验的招募;临床试验管理系统（CTMS，OnCore）管理 工作人员工作量管理;工作人员教育和培训。 在审查期间（2011 -2015财年），CPDM团队成功地积累和协调了 共有11，851例患者参加了临床干预性试验（治疗、预防和支持性治疗），包括 附属网站的应计费用。 CPDM通过及时监控以下内容，为成员提供集中的安全和合规性监督 制药商发起的干预性试验、PMC的协调以及MCC的公司合规性稽查 临床研究试验、政策和流程。PMC将监控和审计结果用于 全面审查。 MCC制定并保持了积极的努力，为妇女、少数民族、 通过文化和语言相关的护理、教育和内部培训， 和社区外展。教师进行少数民族健康差距的研究，告知这些 方案和服务。此外，临床科学ACD和多样性和社区副总裁 关系共同领导一个多学科的少数民族临床研究委员会，以解决有关的问题， MCC的少数应计权益。在这些努力中，儿童权利委员会的资源得到了密切的整合。

Clinical Protocol & Data Management PROJECT SUMMARY Clinical Protocol & Data Management (CPDM) functions at Moffitt Cancer Center (MCC) include 1) trial design, development, and conduct; 2) oversight of safety and compliance; 3) ensuring data quality and education of personnel; and 4) appropriate accrual of women and minorities. A collaborative team of approximately 190 CPDM professionals provides centralized management and support of all types of clinical trials, including investigator-initiated (IITs), industry or other sponsor-initiated, Experimental Therapeutics Clinical Trials Network (ET-CTN), and National Clinical Trials Network (NCTN). CPDM support for members includes: protocol development; budget development and contracting; regulatory and IND/IDE management; protocol activation; patient enrollment; coordination of study-related patient care; research drug administration and care services; correlative science (pharmacokinetics/pharmacodynamics) sample coordination; data collection and reporting; monitoring of IIT studies and data and safety monitoring through the Protocol Monitoring Committee (PMC) and Data Safety & Monitoring (DSM) Committee; audit preparation and coordination; minority outreach and navigation for accrual to clinical trials; clinical trials management system (CTMS, OnCore) administration and reporting; staff workload management; and staff education and training. During the review period (FY2011-2015), the CPDM team successfully accrued and coordinated a combined total of 11,851 patients to clinical interventional trials (therapeutic, prevention, and supportive care), including accrual at affiliate sites. CPDM provides centralized safety and compliance oversight to members through timely monitoring of investigator-initiated interventional trials, coordination of the PMC, and corporate compliance audits of MCC clinical research trials, policies, and processes. Results of monitoring and audits are utilized by the PMC for comprehensive review. MCC has developed and maintains proactive efforts to provide programs and services to women, minorities, and other underserved populations through culturally and linguistically relevant care, education, and internal and community outreach. Faculty members conduct research on minority health disparities, informing these programs and services. In addition, the ACD for Clinical Science and the VP of Diversity and Community Relations co-lead a multi-disciplinary Minority Clinical Research Committee to address issues related to minority accrual at MCC. CPDM resources are closely integrated in these efforts.