Core--Clinical Facility

自从路易斯安那州性病研究中心(LaSTDRC)在近两年前成立以来，新奥尔良的研究小组了解到，集中临床资源，包括临床研究设计和管理方面的专业知识，将是临床研究项目中患者登记的更有效的方法。因此，我们建议在这项CRC申请中形成一个临床核心。该核心将做以下工作：a.从新奥尔良用于STI研究的三个主要临床站点招募患者参加CRC临床方案：1.新奥尔良路易斯安那医学中心(MCLNO)的艾滋病毒门诊(HOP)诊所。2.新奥尔良性传播疾病(NOSTD)诊所(也称为Delgado诊所)，它是该市卫生部门的一个组成部分。3.奥尔良教区计划生育诊所(也称为妇女健康诊所)。该诊所是通过州卫生局的计划生育计划管理的，由路易斯安那州地区负责 公共卫生区。协助项目负责人制定适合临床环境的方案。确保遵循最佳方法从所有临床方案中获得相关的行为数据，并协助调查人员分析这些数据。D.确保CRC协议的执行方式对正常临床操作的干扰最小，并将研究人员整合到临床工作流程中，使研究协议在可能的情况下真正为诊所的主要任务做出贡献。E.作为儿童权利中心项目领导人与诊所管理部门以及对将进行研究的诊所地点负有最终责任的公共卫生部门或医院之间的联络人。F.根据需要组织数据安全监测委员会(DSMB)会议。

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.