Core--Clinical Facility

核心--临床设施

• 批准号: 7979782
• 负责人: Stephanie N Taylor
• 金额: $ 15.04万
• 依托单位: LSU HEALTH SCIENCES CENTER
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-01 至 2010-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7979782
• 关键词: Ambulatory Care Facilities; Behavioral; Behavioral Sciences; Cities; Clinic; Clinical; Clinical Protocols; Clinical Research; Clinical Trials Data Monitoring Committees; Data; Data Analyses; Enrollment; Family Planning; Family Planning Programs; HIV; Health; Hospitals; Learning; Local Microbicides; Louisiana; Medical center; Methods; Mission; Operative Surgical Procedures; Outpatients; Patients; Protocols documentation; Public Health; Research; Research Design; Research Personnel; Research Project Grants; Resources; Sexually Transmitted Diseases; Site; Women' s Health; Work; clinical research site; experience; meetings

Since the founding of Louisiana STD Research Center (LaSTDRC) nearly two years ago the New Orleans group of investigators learned that centralization of clinical resources including expertise in clinical study design and administration would be a more efficient approach to patient enrollment in clinical research projects. Thus, we are proposing to form a Clinical Core in this CRC application. This core will do the following: A. Enroll patients into CRC clinical protocols from the three primary clinical sites used for STI research in New Orleans: 1. The HIV Outpatient (HOP) Clinic of the Medical Center of Louisiana in New Orleans (MCLNO). 2. The New Orleans Sexually Transmitted Disease (NOSTD) clinic (also known as the Delgado Clinic) which is a component of the city's health department. 3. The Orleans Parish Family Planning (FP) clinic (also known as the Women's Health Clinic). This clinic is administered through the family planning program of the state health department and is the responsibility of Louisiana's Regional Public Health District. B. Assist project leaders in developing protocols that are suitable for the clinical setting in which they are to be carried out. C. Insure that optimal methods are followed to obtain relevant behavioral data from all clinical protocols and assist investigators in the analyses of these data. D. Insure that CRC protocols are carried out in such a way as to interfere the least with normal clinic operations and integrate research personnel into the clinic work flow in such a way that the research protocol actually contributes to the clinics primary mission when possible. E. Act as liaison between CRC project leaders and clinic administration as well as with the public health department or hospital that has ultimate responsibility for the clinic sites where research will be conducted. F. Organize data safety monitoring board (DSMB) meetings as needed.

自大约两年前的路易斯安那州立大学（Lastdrc）成立以来，新奥尔良 一组研究人员了解到，临床资源的集中化，包括临床研究专业知识 设计和管理将是一种更有效的临床研究患者入学方法 项目。因此，我们建议在此CRC应用中形成临床核心。这个核心将做 以下：A。从用于STI的三个主要临床部位的CRC临床方案中注册患者 新奥尔良的研究：1。路易斯安那州医疗中心的HIV门诊（HOP）诊所 奥尔良（麦克尔诺）。 2。新奥尔良性传播疾病（NOSTD）诊所（也称为 Delgado Clinic）是该市卫生部门的组成部分。 3。奥尔良教区家庭 计划（FP）诊所（也称为妇女健康诊所）。该诊所通过 州卫生部门的计划生育计划，是路易斯安那州地区的责任 公共卫生区。 B.协助项目领导者制定适合临床的协议 将其进行的设置。 C.确保遵循最佳方法以获得相关 来自所有临床方案的行为数据，并协助研究人员对这些数据进行分析。 D.确保 CRC方案的执行方式最少干扰正常的诊所操作和 将研究人员整合到诊所工作流程中，以使研究方案实际上 尽可能为诊所的主要任务做出贡献。 E.充当CRC项目负责人与 诊所管理以及具有最终责任的公共卫生部门或医院 对于将进行研究的诊所地点。 F.组织数据安全监控委员会（DSMB） 根据需要的会议。