Core--Clinical Facility

点击翻译按钮获取中文摘要

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.