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: 8858731
• 负责人: MARK L. BATSHAW
• 金额: $ 17.22万
• 依托单位: CHILDREN'S RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-08-25 至 2019-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8858731
• 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.

尿素周期紊乱联合体的行政单位协调UCDC的所有活动，并由UCDC首席调查员/主任马克·L领导，他来自马里兰州巴特肖。联合主要调查人员具有特殊的作用，以确保财团顺利运作。Mendel Tuchman博士担任行政总监和共同PI，在Batshaw博士无法做到这一点时领导财团，协助Batshaw博士进行财团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，帮助Batshaw博士管理UCDC，并与Brendan Lee博士共同指导培训计划：Co-Pl Cynthia Lemons是国家尿素周期疾病基金会的执行董事，并担任UCDC领导层的顾问，在UCDC的重大决策中代表患者的利益。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。除了导演之外。贝勒医学院的Brendan Lee博士负责培训计划，项目经理Jennifer Seminara负责UCDC的运营，Arlene Gendron协助执行行政职责。UCDC每月召开电话会议和一次年度面对面会议：DMCCS审计计划确保数据质量，并辅之以由UCDC项目经理指导的监测计划。