Core G: Clinical Investigation

核心G：临床研究(CI)项目摘要/摘要 临床研究(CI)核心的总体目标是支持有效的临床和转化性艾滋病毒 新兴调查人员和国际调查人员进行的调查。CI核心通过以下方式实现这一点 提供高质量临床研究所必需的咨询、服务和指导。 这包括访问研究参与者、临床数据库(临床数据股)和参与者样本。 (标本管理股)；在进行和监测临床研究以及提供 临床研究基础设施(研究协调股和监管股)。CI核心服务产品范围广泛 并分为以下几类：获取途径、促进临床研究和教育以及 师徒关系。 CI核心将通过以下具体目标实现我们的CFAR目标： 1.获取：协助临床研究招募，并提供具有良好特征的数据和生物学 支持艾滋病毒临床研究和翻译研究的标本。 2.临床和转化性研究的咨询和促进：提供临床研究研究设计， 监管、数据安全和监控服务。 3.教育和指导：提供临床研究方法的正式和非正式教育，指导 新一代艾滋病毒临床和翻译研究人员，并支持艾滋病毒研究导师。 CI Core通过由核心员工协助的诊所招聘提供接触研究参与者的途径，或者 在研究招聘战略的设计中进行咨询。获得具有良好特征的临床数据和 生物标本也通过利用CFAR综合临床系统网络(CNICs)提供。 促进临床研究可涉及临床研究设计的专家咨询以及提供 对临床研究至关重要的服务，包括机构审查委员会文件准备、数据安全 监测、数据库开发和管理服务。 CI核心优先为新出现的和国际调查人员提供指导和支持，以促进 在我们现有的艾滋病毒研究人员中表现出高影响力和当地相关性的研究。 认识到协作和多样化观点推动创新，CI核心继续推动 并在专注于艾滋病毒和其他影响艾滋病毒的相关疾病的研究团队之间建立关系 以及有感染艾滋病毒风险的人群。CI核心将继续实施战略规划进程，以促进 不断创新和发展，以满足我们当地艾滋病毒研究界的需求。

Core G: Clinical Investigation (CI) Project Summary/Abstract The overall objective of the Clinical Investigation (CI) Core is to support impactful clinical and translational HIV investigations performed by emerging and international investigators. The CI Core accomplishes this by providing consultation, services, and mentorship essential to the performance of high-quality clinical research. This includes access to research participants, clinical databases (Clinical Data Unit) and participant samples (Specimen Management Unit); expertise in the conducting and monitoring of clinical studies and provision of clinical research infrastructure (Study Coordination Unit and Regulatory Unit). CI Core services offer are broad and fall into the following general categories of access, clinical research facilitation and education and mentorship. The CI Core will meet our CFAR goals through the following specific aims: 1. Access: Assist in clinic-based research recruitment and provide well-characterized data and biological specimens to support HIV clinical investigation and translational research. 2. Consultation and Facilitation of Clinical and Translational Research: Provide clinical research study design, regulatory, and data safety and monitoring services. 3. Education and Mentorship: Provide formal and informal education in clinical research methods, mentor the next generation of HIV clinical and translational investigators, and support HIV research mentors. The CI Core provides access to study participants either via clinic-based recruitment facilitated by core staff or consultation in the design of research recruitment strategies. Access to well-characterized clinical data and biological specimens is also provided by leveraging the CFAR Network of Integrated Clinical Systems (CNICS). Clinical research facilitation can involve expert consultation on clinical study design as well as provision of services essential to clinical research including institutional review board document preparation, data safety monitoring, and database development and management services. The CI Core prioritizes mentorship and support for emerging and international investigators to facilitate the performance of high-impactful and locally relevant research amongst our established HIV researchers. Recognizing that collaboration and a diversity of viewpoints drives innovation, the CI Core continues to foster and build relationships among research teams focused on HIV and on other relevant conditions that impact HIV and populations at risk for HIV. The CI Core will continue to implement strategic planning processes that facilitate continual innovation and growth to meet the needs of our local HIV research community.