Core G: Clinical Investigation

核心 G：临床研究

• 批准号: 10671344
• 负责人: Maile Ann Young Karris
• 金额: $ 39.64万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-04-01 至 2028-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10671344
• 关键词: AIDS Vaccines; AIDS clinical trial group; Acquired Immunodeficiency Syndrome; Antigens; Basic Science; Behavioral Sciences; Biological; Biological Specimen Banks; Biology; California; Caring; Categories; Clinic; Clinical; Clinical Data; Clinical Investigator; Clinical Research; Clinical Trials Data Monitoring Committees; Collaborations; Communities; Consult; Consultations; Data; Databases; Development; Education; Electronic Health Record; Fostering; Goals; Growth; HIV; HIV vaccine; Health; Immunology; Industry; Infection; Infrastructure; Institution; Institutional Review Boards; International; International AIDS; International Maternal Pediatric Adolescent AIDS Clinical Trials; Investigation; Leadership; Link; Medicine; Mentors; Mentorship; Mission; Monitor; Participant; Performance; Persons; Populations at Risk; Preparation; Process; Psychology; Published Comment; Regulatory Affairs; Research; Research Design; Research Infrastructure; Research Methodology; Research Personnel; Research Priority; Research Training; Risk; Safety; Sampling; Service provision; Services; Social Behavior; Specimen; Strategic Planning; Structure; System; Training; Translational Research; Trauma; Viral; Work; clinical database; clinical investigation; clinical translation; community organizations; falls; health equity; health equity promotion; human subject protection; improved; informal learning; innovation; interest; longitudinal dataset; member; next generation; prevent; programs; recruit; socioenvironmental factor; symposium; translational scientist

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.

核心G：临床研究（CI）项目总结/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HIV 新兴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： 提供咨询，服务，并指导高质量的临床研究的性能必不可少。 这包括访问研究参与者、临床数据库（临床数据单元）和参与者样本 （标本管理股）;在开展和监测临床研究以及提供 临床研究基础设施（研究协调部门和监管部门）。CI核心服务范围广泛 并分为以下几类：获取、临床研究促进和教育， 导师制 CI核心将通过以下具体目标实现我们的CFAR目标： 1.访问：协助基于临床的研究招募，并提供充分表征的数据和生物学 标本，以支持艾滋病毒临床调查和转化研究。 2.临床和转化研究的咨询和促进：提供临床研究设计， 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 下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核心通过核心工作人员协助的基于诊所的招募或 在设计研究招聘战略时提供咨询。获得充分表征的临床数据和 还通过利用CFAR集成临床系统网络（CNICS）来提供生物样本。 临床研究促进可以包括临床研究设计的专家咨询以及提供 临床研究所必需的服务，包括机构审查委员会文件准备、数据安全 监测以及数据库开发和管理服务。 CI核心优先考虑对新兴和国际调查人员的指导和支持，以促进 在我们已建立的艾滋病毒研究人员中开展高影响力和与当地相关的研究。 认识到协作和观点的多样性推动创新，CI核心继续促进 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 和艾滋病毒高危人群。CI核心将继续实施战略规划流程， 不断创新和发展，以满足我们当地艾滋病毒研究界的需求。