Clinical Investigation Core

临床调查核心的主要目标是促进CFAR调查人员的能力 启动或扩大需要接触艾滋病毒-1感染者的艾滋病毒/艾滋病研究项目，临床 样本和/或数据，并指导初级和其他新的临床和社会调查人员 行为艾滋病毒相关研究。核心将为CFAR成员提供访问强大的数据库的权限 来自参与临床研究的患者和其他人的人口统计学、临床和实验室数据 学习。对这些数据库的查询可以提供对以前收集的数据的访问，并促进快速 获得符合新研究资格标准的受试者。临床环境包括艾滋病 流行病学与人口健康学部物质学部研究计划 虐待，艾滋病中心传染病诊所，青少年艾滋病方案，以及一个新的社会和 包括预防干预研究中心在内的行为部分。核心也将 在研究设计方面提供帮助，包括样本选择、功率计算和 使用适当的分析方法。核心开发了一个集中式的、人性化的、高效的 门户，提供跨临床护理和临床研究站点的数据访问，以促进临床 研究，并鼓励临床和实验室研究人员之间的互动，以促进翻译 研究。高级调查人员指导初级和新调查人员的指导会议将继续进行。 最后，核心将促进新的国际研究倡议。具体目标是：1)促进 检索和共享目前在不同数据系统中可用的临床数据；2)协助确定 为新的研究项目提供个人和/或他们的标本；3)加快通知潜在的人类 新的和正在进行的研究项目的主题，并促进潜在研究对象之间的互动 和研究人员；4)协助临床、社会科学和基础研究人员实现严谨的研究 通过提供样本选择、研究和研究方面的专业知识，设计和验证研究结果的有效性和概括性 设计、功率计算和适当的分析方法；5)指导初级和新手调查人员 艾滋病毒相关研究的所有方面，包括研究设计、受试者登记、IRB要求、 与基础科学家合作，准备和重新提交资助申请，以及提交和 发表研究结果；6)提高调查人员进行研究的能力 社会和行为因素，并将社会科学研究纳入现有或新的临床研究， 通过最先进的社会和行为科学咨询和支持服务；7) 扩大与艾滋病毒有关的国际研究；以及8)教育临床医生有关艾滋病毒的最新发展 研究以激发对未解决的重要临床研究问题的调查兴趣。

The primary objectives of the Clinical Investigation Core are to facilitate the ability of CFAR investigators to initiate or expand HIV/AIDS research projects that require access to HIV-1 -infected individuals, clinical specimens and/or or data, and to mentor junior and other new investigators in both clinical and social and behavioral HIV-related research. The Core will provide CFAR members with access to robust databases with demographic, clinical, and laboratory data from among patients and others enrolled in clinical research studies. Queries to these databases can provide access to previously collected data and facilitate rapid access to subjects who meet eligibility criteria for new studies. The clinical settings include the AIDS Research Program of the Department of Epidemiology and Population Health, the Division of Substance Abuse, the AIDS Center Infectious Diseases Clinic, the Adolescent AIDS Program, and a new Social and Behavioral Component that includes the Prevention Intervention Research Center. The Core also will provide assistance in study design, including recommendations for sample selection, power calculations and the use of appropriate analytical methods. The Core has developed a centralized, user-friendly, efficient gateway to provide access to data across clinical care and clinical research sites, to facilitate clinical research, and to stimulate interactions among clinical and laboratory investigators to promote translational research. Mentoring sessions at which senior investigators mentor junior and new investigators will continue. Finally, the Core will facilitate new international research initiatives. The Specific Aims are: 1) To facilitate the retrieval and sharing of clinical data currently available in disparate data systems; 2) To assist in identifying individuals and/or their specimens for new research projects; 3) To expedite informing potential human subjects of new and ongoing research projects and facilitate interactions between potential research subjects and investigators; 4) To assist clinical, social science, and basic researchers in achieving rigor of study design and validity and generalizability of study results by providing expertise in sample selection, study design, power calculations, and appropriate analytical methods; 5) To mentor junior and new investigators in all aspects of HIV-related research, including study design, subject enrollment, IRB requirements, collaboration with basic scientists, preparation and resubmission of grant applications, and presentation and publication of research findings; 6) To increase the capacity of investigators to perform studies involving social and behavioral elements, and to build social science studies into existing or new clinical research, through state-of-the-art consultation and support services in the social and behavioral sciences; 7) To expand international HIV-related research; and 8) To educate clinicians about the latest developments in HIV research to stimulate interest in investigating important unresolved clinical research questions.