Clinical Protocol and Data Management Core

临床方案和数据管理核心

• 批准号: 10115681
• 负责人: Hatem H Soliman
• 金额: $ 23.75万
• 依托单位: H. LEE MOFFITT CANCER CTR & RES INST
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-02-18 至 2022-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10115681
• 关键词: Accountability; Address; Adherence; Adverse event; Budgets; Cancer Center; Cancer Center Support Grant; Caring; Clinic; Clinical; Clinical Cancer Center; Clinical Data; Clinical Investigator; Clinical Protocols; Clinical Research; Clinical Sciences; Clinical Trials; Clinical Trials Network; Communication; Community Outreach; Community Relations; Conduct Clinical Trials; Consent; Contracts; Data; Data Collection; Data Management Resources; Data Reporting; Development; Development Plans; Drug Kinetics; Education; Education and Outreach; Educational Curriculum; Educational workshop; Eligibility Determination; Ensure; Faculty; Goals; Human Resources; Individual; Industry; Informed Consent; Institutional support resources; Insurance; Intervention Trial; Investigational Therapies; Lead; Linguistics; Link; Minority; Monitor; National Clinical Trials Network; Patient Care; Patients; Performance; Pharmaceutical Preparations; Pharmacodynamics; Physicians; Policies; Positioning Attribute; Preparation; Prevention; Procedures; Process; Protocols documentation; Reporting; Research; Research Personnel; Resources; Safety; Sampling; Science; Services; Site; Staff Work Load; Structure; Supportive care; System; Therapeutic; Time; Training; Training and Education; Translational Research; Transportation; Underserved Population; Update; Woman; Work; Workload; base; care systems; data management; data quality; flexibility; health disparity; high standard; innovation; meetings; member; minority health; multidisciplinary; outreach; participant enrollment; point of care; programs; protocol development; quality assurance; research study; trend; trial design

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.

临床方案与数据管理 项目总结 莫菲特癌症中心(MCC)的临床方案和数据管理(CPDM)职能包括1)试验设计， 开发和实施；2)监督安全和合规；3)确保数据质量和教育 人员；以及4)妇女和少数群体的适当应计利润。由大约190人组成的协作团队 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 研究人员发起(IITs)、行业或其他赞助商发起的实验治疗学临床试验 网络(ET-CTN)和国家临床试验网络(NCTN)。针对成员的CPDM支持包括： 协议制定；预算制定和订约；监管和IND/IDE管理；协议 激活；患者登记；与研究相关的患者护理的协调；研究用药管理和护理 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；通过礼宾监测委员会监测机构间通信技术研究和数据以及安全监测 (PMC)和数据安全与监测(DSM)委员会；审计准备和协调；少数群体外联 和临床试验收益导航；临床试验管理系统(CTMS，OnCore)管理 工作人员管理和报告；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小组成功地积累并协调了一项合并 共有11,851名患者参加临床干预试验(治疗、预防和支持性护理)，包括 关联网站的应计费用。 CPDM通过及时监控以下各项，为成员提供集中的安全和合规监督 调查员发起的干预性试验、PMC的协调以及MCC的公司合规审计 临床研究试验、政策和流程。监测和审计的结果由项目管理委员会用于 全面审查。 MCC制定并保持了积极主动的努力，向妇女、少数族裔、 和其他服务不足的人群，通过文化和语言相关的护理、教育和内部 和社区外展。教职员工对少数族裔的健康差距进行研究，告知这些 程序和服务。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族裔临床研究委员会，以解决与 在MCC的少数应计利润。CPDM资源在这些努力中紧密结合在一起。