Core-005

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The goal of the Hub Research Capacity program of the CCTSI is to support clinical and translational research (CTR) that engages diverse communities in projects conducted by investigators from a broad spectrum of disciplines across the CCTSI affiliated institutions. As outlined in the FOA, this component includes cores focused on Integrating Special Populations (ISP) and Participant and Clinical Interactions (PCI). The ISP core will build on and expand the extensive existing resources and adopt new strategies to engage volunteers in research, with an overarching goal of ensuring appropriate inclusion by age, sex, gender, race, and ethnicity, and from underserved communities. This will be accomplished through the following Specific Aims: Aim 1: ensure that infants, children, and adolescents continue to be an important focus of CTR within the CCTSI by supporting research on both common and rare childhood diseases. Aim 2: evaluate and promote the appropriate inclusion of older adults in CTR and raise awareness of age bias in research. Aim 3: develop a standardized approach for monitoring recruitment success in CTR protocols and strategies to enhance the inclusion of underrepresented minorities. Examples of the approaches to accomplish these aims include: engaging Patient and Advocacy Groups to assist with study design and patient recruitment; supporting research networks focused on improving care for the most vulnerable elderly; and expanding resources, such as tele-technology, to connect with hard-to-reach populations. The PCI core will focus its efforts on improving infrastructure and processes that enhance the safety, efficiency, and merit of CTR. This will be accomplished through the following specific aims: Aim 4: implement OnCore, a Clinical Research Management System, for all CTR protocols that involve more than minimal risk to human subjects to improve tracking and evaluation of benchmarks of success. Aim 5: develop the PCI Management Program, which will provide oversight of centralized research facilities and staff and expand resources to improve the safety, efficiency, and merit of CTR. Aim 6: ensure the high quality and scientific impact of the CTR portfolio through rigorous review of scientific merit, monitoring of protocol benchmarks of success, and tracking of dissemination of results. Examples of the approaches to accomplish these aims include: centralize the management of protocol documents for coordinated reviews by the Scientific Advisory and Review Committee, Colorado Multiple Institutional Review Board, and other entities; expand the pool of centrally-trained and –managed research personnel under a fee-for-service model, including research coordinators, budget specialists, and regulatory specialists; and utilize OnCore to monitor protocol-specific benchmarks of success in participant accrual and retention, compliance to the protocol, and safety. The Hub Research Capacity component of the CCTSI is fully committed to building infrastructure and developing and streamlining processes that will enhance the reach and impact of CTR.