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.

尿素周期障碍联盟的行政部门协调所有UCDC活动，并由UCDC首席研究员/主任Mark L，Mark L，Batshaw，医学博士领导。联合主管研究人员具有弱势作用，以确保财团运作顺利。 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国家尿素周期障碍基金会，并担任UCDC领导层的顾问，代表了患者在重大UCDC决策中的利益。她还将指导从UCDC到患者社区的外部通信。来自Biostatistics和研究设计部门的Robert McCarter博士在儿童医疗中心和南佛罗里达大学数据管理和协调中心的Jeffrey Krischer博士将向UCDC领导力提供有关研究设计和结果分析的建议。除了董事。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，而Arlene Gendron协助担任行政职责。 UCDC举行月度电话会议和一次年度面对面会议：DMCCS审计计划确保了质量数据，并由UCDC项目经理指导的监视计划补充。