Clinical Core

临床核心

基本信息

批准号：
7762449
负责人：
Ligia Peralta
金额：
$ 35.36万
依托单位：
UNIVERSITY OF MARYLAND BALTIMORE
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-09-21 至 2014-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7762449
关键词：
Administrative Personnel Adolescent Adult Advisory Committees Age Appointment Behavioral Biohazardous Substance Biological Blood Caring Cervical Childhood Cities Clinic Clinical Clinical Research Clinical Trials Communities Counseling Data Data Quality Development Diagnosis Doctor of Medicine Enrollment Funding Genitourinary system Genome HIV Health Health Insurance Portability and Accountability Act Health education Human Resources Interdisciplinary Study Interview Laboratories Maintenance Maryland Medical Medical Records Medicine Minor Monitor Outreach Research Patients Physicians Population Population Heterogeneity Primary Health Care Principal Investigator Procedures Qualifying Recording of previous events Recruitment Activity Reproductive Health Reproductive Tract Infections Research Research Activity Research Ethics Committees Research Personnel Research Project Grants Research Subjects Risk Sampling Science Screening procedure Secondary Prevention Serum Sister Site Source Specialist Specimen Specimen Handling Supervision Swab System Training Universities Urine Visit Woman Youth base clinical research site cohort computerized cost design experience follow-up health disparity human subject human subject protection implementation research meetings member men outreach research study user-friendly young adult

项目摘要

The purpose of the Clinical Core is to provide biological specimens and behavioral data to Projects 1-3. The Core is hosted by the Division of Adolescent and Young Adult Medicine that has a 38 year history of conducfing research in adolescents and young adults. The Division has extensive experience in the recruitment and retenfion of at risk and HIV infected adolescents and young adults, and adults in clinical trials, with a case load of approximately 3,000 HIV-youths and 150 HIV+ youths (30 of who are in transition to adult care) ages 12-24 in care and over 300 adults in research. The Core is located at the Adolescent and Young Adult Medicine Clinic, a clinical and research center for adolescents and young adults In Balfimore City. The Clinic has recenfiy doubled its space to expand research activities related to RTIs, HIV, and health disparities clinical trials. The P.I. has been independently funded since 1992 to conduct studies in diverse populations and has been the recipient of federally funded collaborative research studies for the last 16 years. The Core research personnel are well trained in human subject protecfion, HIPAA, Good Clinical Pracfice, and handling of biohazard specimens. The team has expertise in the recruitment, retention and protecfion of human subjects, in particular minors. Core research personnel will be responsible for collecting all required biological samples such as genitourinary swabs, endocervical swabs, blood, and behavioral data through the Audio Computerized Assisted Interview (ACASI). Our clinicians will perform the reproductive health examinafions, and provide diagnosis and management. In addifion, the clinical counseling personnel will provide primary and secondary prevention through our prevenfion and health education team. Research personnel will include the Core Director, Study Coordinator, Research Outreach Specialist and Clinician. Additional research and administrative personnel will offer support. The team will conduct weekly research team meefings to assure complefion of project 1, 2 and 3 activities. These meetings will have the participation of principal investigators, laboratory staff, clinical and bidnformafics cores. Human subject protecfion and research appropriateness will be monitored by the IRB, our Division Research Task Force and the Youth Community Advisory Board. Our site characterisfics and long history of successful research Implementafion make us uniquely qualified to conduct projects 1, 2 and 3

临床核心的目的是向项目1-3提供生物标本和行为数据。这核心由青少年和年轻医学部主持，历史38年对青少年和年轻人进行辅导研究。该部门在招募和重述受风险和艾滋病毒感染的青少年和年轻人，以及临床中的成年人试验，大约3,000名HIV-Youth和150名HIV+年轻人的案例负荷（其中30名正在过渡成人护理）12-24岁的护理和300多名成人研究。核心位于青少年，年轻成人医学诊所，巴尔菲莫尔青少年和年轻人的临床和研究中心城市。该诊所恢复了其空间，以扩大与RTI，HIV和Health有关的研究活动差异临床试验。 P.I.自1992年以来一直独立资助，以进行多种多样的研究人口，一直是联邦资助的合作研究的接受者年。核心研究人员对人类受试者，HIPAA，良好的临床培训良好 Pracfice和生物危害标本的处理。团队在招聘，保留和人类受试者，特别是未成年人。核心研究人员将负责收集所有必需的生物样品，例如泌尿生殖签，宫颈拭子，血液和行为数据通过音频计算机辅助访谈（ACASI）。我们的临床医生将执行生殖健康检查，并提供诊断和管理。简而将通过我们的预防和健康教育团队提供初级和次要的预防。研究人员将包括核心主任，研究协调员，研究外展专家和临床医生。其他研究和行政人员将提供支持。团队将每周进行研究团队Meefings确保项目1、2和3活动的组成。这些会议将有主要研究人员，实验室人员，临床和Bidnformafics核心的参与。人类主题我们的部门研究工作组IRB将监控秘密和研究适当性和青年社区顾问委员会。我们的网站性格和成功研究的悠久历史 Impartimafion使我们拥有独特的资格进行项目1、2和3