HIV/AIDS Clinical Trials Unit

艾滋病毒/艾滋病临床试验单位

• 批准号: 8119162
• 负责人: John A Bartlett
• 金额: $ 1.28万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-08-09 至 2011-08-08
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8119162
• 关键词: AIDS clinical trial group; AIDS/HIV problem; Academic Medical Centers; Accountability; Address; Adult; Area; Child; Clinical Management; Clinical Research; Clinical Trials Unit; Communication; Communities; Creativeness; Ensure; Environment; Foundations; Funding; Leadership; Life; Medical center; Mothers; Persons; Prevention; Procedures; Recording of previous events; Research; Research Personnel; Role; Southeastern United States; Structure; Tanzania; Translational Research; Work; clinical research site; high standard; operation; pediatric AIDS

Composite The Duke University Medical Center (DUMC) Clinical Trials Unit (CTU) proposes to address the key scientific areas of translational research and optimization of clinical management in children and adults, and prevention of mother to child transmission.The CTU and its affiliated Clinical Research Sites (CRS's) bring scientific leadership, a rich history of successful collaborative clinical research within networks, a strong and efficient organizational foundation for the conduct of rigorous clinical research, and access to growing numbers of underserved persons living with HIV/AIDS (PLWHA) in the US Southeast and Tanzania. The scientific leadership of the CTU and CRS investigators is reflected in their past participation in the Adult and Pediatric AIDS Clinical Trials Groups (ACTG's), and the expanding portfolio of NIH-funded research at DUMC and the Kilimanjaro Christian Medical Centre (KCMC). The three CRS's included in the CTU proposal each bring unique value and are highly motivated to perform the proposed work, and together they will constitute a formidable research enterprise. Their interactions will be guided by an administrative structure which supports a dynamic intellectual environment to enhance scientific creativity, clear roles and responsibilities for investigators and staff, facile and regular communications, harmonized standard operating procedures across CRS's which emphasize CTU accountability through quality management, and a strong commitment to serve the community of PLWHA. The clarity of CTU and CRS organization and operations will ensure that it operates efficiently to perform clinical research at the highest standard, with the ability to rapidly respond to evolving opportunities.

复合 杜克大学医学中心（DUMC）临床试验部门（CTU）建议解决关键问题 科学领域的转化研究和优化临床管理的儿童和 CTU及其附属的临床研究机构， 研究中心（CRS）带来了科学领导力，成功合作临床研究的丰富历史 在网络内，为开展严格的临床研究奠定了强大而有效的组织基础。 艾滋病毒/艾滋病感染者（PLWHA）人数不断增加， 美国东南部和坦桑尼亚。CTU和CRS调查员的科学领导力 反映在他们过去参与成人和儿童艾滋病临床试验组（ACTG），以及 在DUMC和基利曼哈罗基督教医学中心，NIH资助的研究项目不断扩大 （KCMC）。CTU提案中包含的三个CRS均带来独特的价值，并受到高度评价 激励执行拟议的工作，他们将共同构成一个强大的研究 企业.它们的互动将由一个支持动态的 知识环境，以提高科学创造力，明确角色和责任， 调查员和工作人员，方便和定期的通信，统一的标准业务 通过质量管理强调CTU责任的CRS程序，以及 坚定地致力于为艾滋病毒/艾滋病感染者社区服务。CTU和CRS组织的清晰度以及 业务将确保其有效运作，以最高标准进行临床研究， 能够快速应对不断变化的机遇。