Core G: Clinical Investigation

点击翻译按钮获取中文摘要

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.