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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

临床核心的目的是为项目 1-3 提供生物样本和行为数据。这 Core 由青少年和青少年医学部主办，该部门拥有 38 年的历史对青少年和年轻人进行研究。该部门在以下方面拥有丰富的经验在临床中招募和保留高危人群和艾滋病毒感染者以及成年人试验的病例数约为 3,000 名艾滋病毒青年和 150 名艾滋病毒+青年（其中 30 名处于过渡期）到成人护理）12-24 岁的人接受护理，300 多名成年人接受研究。核心位于青少年和青年医学诊所，巴尔菲摩青少年和年轻人的临床和研究中心城市。该诊所最近将其空间扩大了一倍，以扩大与 RTI、艾滋病毒和健康相关的研究活动临床试验的差异。 P.I.自1992年以来一直独立资助开展不同领域的研究人群，并且在过去 16 年中一直是联邦资助的合作研究的接受者年。核心研究人员在人体保护、HIPAA、Good Clinical 方面接受过良好的培训生物危害标本的实践和处理。该团队在招聘、保留和保留方面拥有专业知识保护人类主体，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本，例如泌尿生殖拭子、宫颈内拭子、血液和行为数据通过音频计算机辅助访谈 (ACASI)。我们的临床医生将进行生殖健康检查，并提供诊断和管理。此外，临床咨询人员将通过我们的预防和健康教育团队提供初级和二级预防。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。其他研究和管理人员将提供支持。该团队将每周进行研究团队会议以确保完成项目 1、2 和 3 活动。这些会议将有主要研究人员、实验室工作人员、临床和双信息学核心人员的参与。人类主体保护和研究的适当性将由我们部门研究工作组 IRB 进行监督和青年社区咨询委员会。我们的场地特点和成功研究的悠久历史实施使我们有资格开展项目 1、2 和 3