Overall Adminstration of Rare Diseases Clinical Research Consortia (RDCRC)

罕见病临床研究联盟（RDCRC）的总体管理

• 批准号: 8916167
• 负责人: Mendel Tuchman
• 金额: $ 25.78万
• 依托单位: CHILDREN'S RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-08-01 至 2019-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8916167
• 关键词: Award; Biometry; Budgets; Child; Child health care; Clinical; Clinical Research; Clinical Sciences; Collaborations; Communication; Communities; Data; Data Quality; Disease; Effectiveness; Ensure; Evaluation; Florida; Foundations; Goals; Guidelines; Health Insurance Portability and Accountability Act; Home environment; Human Development; Industry; Institutes; International; Leadership; Marshal; Medical center; Medicine; Minority; Monitor; Patients; Persons; Pilot Projects; Policies; Principal Investigator; Procedures; Productivity; Rare Diseases; Regulation; Research; Research Design; Resources; Role; Safety; Site; Structure; Training Programs; Training and Education; Translational Research; United States National Institutes of Health; Universities; Woman; college; data management; human subject protection; interest; meetings; operation; programs; symposium; urea cycle; web site

The Urea Cycle Disorders Consortium's Administrative Unit coordinates all UCDC activities and is led by UCDC principal investigator/director, Mark L, Batshaw, MD. Co-principal investigators have spefic roles to ensure that the Consortium operates smoothly. Dr. Mendel Tuchman serves as Administrative Director and Co-PI, leading the the consortium when Dr, Batshaw is unable to do so, assisting Dr. Batshaw with Consortium administration and directing the clinical and pilot projects, Co-Pl Marshall Summar is responsible for industry and international relationships,assists Dr. Batshaw withUCDC administration and with Dr. Brendan Lee co-directs the training program: Co-Pl Cynthia LeMons is the executive director of the National Urea Cycle Disorders Foundation and serves as an advisor to the UCDC leadership, representing patients' interests in major UCDC decisions. She will also direct external communications from the UCDC to the patient community. Dr. Robert McCarter from Biostatistics and Study Design Unit at Children's Medical Center and Dr. Jeffrey Krischer from the Data Management and Coordinating Center at University of South Florida will advise the UCDC leadership on study design and results analysis. In addition to the directors. Dr. Brendan Lee at Baylor College of Medicine directs the training program, project manager Jennifer Seminara is responsible for UCDC operations, and Arlene Gendron assists with administrative duties. The UCDC holds monthly conference calls and one annual in-person meeting: The DMCCs audit program ensures quality data and is supplemented by a monitoring program directed by the UCDC project manager.

尿素循环障碍联盟的行政部门负责协调 UCDC 的所有活动，并由 UCDC 首席研究员/主任 Mark L, Batshaw, MD 领导。联合首席调查员具有特定的职责，以确保联盟顺利运作。 Mendel Tuchman 博士担任行政总监和联合首席研究员，当 Batshaw 博士无法领导该联盟时，协助 Batshaw 博士进行联盟管理并指导临床和试点项目，Co-Pl Marshall Summar 负责行业和国际关系，协助 Batshaw 博士处理 UCDC 行政事务，并与 Brendan Lee 博士共同指导培训计划：Co-Pl Cynthia LeMons 是国家中心的执行董事尿素循环障碍基金会并担任 UCDC 领导层的顾问，代表患者在 UCDC 重大决策中的利益。她还将指导 UCDC 与患者社区的外部沟通。儿童医学中心生物统计和研究设计部门的 Robert McCarter 博士和南佛罗里达大学数据管理和协调中心的 Jeffrey Krischer 博士将就研究设计和结果分析向 UCDC 领导层提供建议。除了董事之外。贝勒医学院的 Brendan Lee 博士指导培训计划，项目经理 Jennifer Seminara 负责 UCDC 运营，Arlene Gendron 协助行政工作。 UCDC 每月举行一次电话会议和一次年度面对面会议：DMCC 审核计划可确保数据质量，并由 UCDC 项目经理指导的监控计划作为补充。