Core--Clinical Facility

自从路易斯安那州性病研究中心（LaSTDRC）成立近两年前，新奥尔良的研究人员小组了解到，集中临床资源，包括临床研究设计和管理方面的专业知识，将是一种更有效的方法来招募患者参加临床研究项目。因此，我们建议在本CRC申请中形成临床核心。该核心将执行以下操作：A.从新奥尔良用于STI研究的三个主要临床地点招募患者进入CRC临床方案：1。新奥尔良路易斯安那医学中心（MCLNO）的艾滋病门诊（HOP）诊所。2.新奥尔良性传播疾病（NOSTD）诊所（也称为德尔加多诊所）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）。该诊所由州卫生部的计划生育项目管理，由路易斯安那州区域卫生局负责。 公共卫生区。B。协助项目负责人制定适用于临床环境的方案。C.确保遵循最佳方法从所有临床方案中获取相关行为数据，并协助研究者分析这些数据。D.确保CRC方案的执行方式尽量减少对正常临床操作的干扰，并将研究人员纳入临床工作流程，使研究方案在可能的情况下实际有助于临床的主要使命。E.作为CRC项目负责人与临床管理部门以及对研究所在临床研究中心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.