NIH/NCATS CTSA Grant Application: Submitted May 25th, 2017 Funded: 5/1/2018 – 4/30/2023 Colorado Clinical and Translational Sciences Institute (CCTSI) PRINCIPAL INVESTIGATORS: Ronald J. Sokol, MD CCTSI Director and UL1 Principal Investigator [email protected] UL1 TR002535 Cara C Wilson, MD KL2 Principal Investigator [email protected] KL2 TR002534 Lisa Cicutto, PhD TL1 Principal Investigator [email protected] TL1 TR002533 ADMINISTRATION: Tim Lockie, MS, MBA Administrative Director and Institute Chief Financial Officer [email protected] 720-848-6660 1 Table of Contents Component Name Page Overall 3 A: Administrative Core 18 B: Informatics 32 C: Community and Collaboration 43 D: Translational Endeavors 51 E: Research Methods 60 F: Hub Research Capacity 68 G: Network Capacity 77 H1: Early Life Exposures Program 85 H2: Innovation Ecosystem (PIVOT) 99 I: Institutional Career Development Core (KL2 Program) 108 J: NRSA Training Core (TL1 Program) 139 Facilities and Equipment 171 NOTE: This table of contents is hyperlinked. Click on the description or page number to jump directly to desired section 2 COMPONENT: OVERALL PROJECT SUMMARY/ABSTRACT Funded by NIH in 2008 and 2013, the Colorado Clinical and Translational Sciences Institute (CCTSI) at the University of Colorado Denver (CU-D) has taken impressive steps to transform and improve the biomedical; research and training enterprise in the Colorado region and to accelerate and catalyze the translation of discoveries into improved patient care and public health. The CCTSI, a partnership of CU-D, CU Boulder (CU- B), Colorado State University (CSU), six hospitals and 20 community organizations, has established new infrastructure, streamlined processes and expanded existing resources and services for investigators and stakeholders; tripled the number of training and education programs supporting development of a translational workforce; administratively centralized and expanded the breadth of clinical research capacity and expertise; established system-wide informatics capabilities; promoted team science and interdisciplinary research; established an extensive community engagement program and enhanced research across the lifespan; streamlined processes and reduced start-up times for trials; created an academic home for clinical & translational scientists and trainees; and actively engaged in CTSA network activities. Despite these successes, there remain many challenges to accelerating the translational research process locally and nationally. This application maps our path forward to meet these challenges. Through 2018 CTSA funding, we will develop new methods, innovations, expertise, and procedures to: a) achieve a new level of measurable performance in training translational teams, b) improve efficiency and quality of the full spectrum of translational research, c) facilitate multi-site clinical trials, d) engage regional communities and stakeholders as partners, and e) collaborate and disseminate best practices into the national CTSA consortium to accelerate the translation of discoveries into improved health and patient care. We will accomplish these objectives by embracing the following five Overall Strategic Goals: Goal 1: Develop, educate and sustain a diverse translational science workforce to ensure highest research innovation, quality and safety. Goal 2: Create a translational research environment in which team science and collaboration both locally and nationally are facilitated, supported and valued. Goal 3: Engage local and national communities and stakeholders in all phases of the translational research process. Goal 4: Create novel methodologies and resources to support and integrate research in special populations, including children, the elderly, the underserved and those with rare diseases. Goal 5: Further innovate and streamline our processes and enhance our informatics capacity for research start-up, implementation and oversight to promote quality, efficiency, & safety of our research and our active participation in the national CTSA Trial Innovation Network. Special efforts will be made to enhance diversity in our workforce. Our progress will be monitored by our Evaluation Core and we will make mid-course corrections as needed to achieve these goals and ultimately improve the health of our state and the nation. 3 COMPONENT: OVERALL NARRATIVE The Colorado Clinical and Translational Sciences Institute (CCTSI) is a collaboration between University of Colorado Denver, University of Colorado Boulder, Colorado State University, 6 hospitals and 20 community organizations aimed at translating discoveries into better public health and patient care. Through a variety of programs, the CCTSI will facilitate the performance of high impact research and the training of the next generation of clinical-translational researchers. Emphasis will be placed on accelerating the pace by which research and clinical trials can be conducted while protecting the safety of research participants in order to bring new effective treatments to patients sooner. Ongoing evaluation of our programs will assure that resources are allocated in a cost-effective manner. 4 COMPONENT: OVERALL SPECIFIC AIMS Funded by NIH in 2008 and 2013, the Colorado Clinical and Translational Sciences Institute (CCTSI) at the University of Colorado Denver (CU-D) has taken impressive steps to transform and improve the biomedical; research and training enterprise in the Colorado region and to accelerate and catalyze the translation of discoveries into improved patient care and public health. The CCTSI, a partnership of CU-D, CU Boulder (CU- B), Colorado State University (CSU), six hospitals and 20 community organizations, has established new infrastructure, streamlined processes and expanded existing resources and services for investigators and stakeholders; tripled the number of training and education programs supporting development of a translational workforce; administratively centralized and expanded the breadth of clinical research capacity and expertise; established system-wide informatics capabilities; promoted team science and interdisciplinary research; established an extensive community engagement program and enhanced research across the lifespan; streamlined processes and reduced start-up times for trials; created an academic home for clinical & translational scientists and trainees; and actively engaged in CTSA network activities. Despite these successes, there remain many challenges to accelerating the translational research process locally and nationally. This application maps our path forward to meet these challenges. Through 2018 CTSA funding, we will develop new methods, innovations, expertise, and procedures to: a) achieve a new level of measurable performance in training translational teams, b) improve efficiency and quality of the full spectrum of translational research, c) facilitate multi-site clinical trials, d) engage regional communities and stakeholders as partners, and e) collaborate and disseminate best practices into the national CTSA consortium to accelerate the translation of discoveries into improved health and patient care. We will accomplish these objectives by embracing the following five Overall Strategic Goals: Goal 1: Develop, educate and sustain a diverse translational science workforce to ensure highest research innovation, quality and safety Goal 2: Create a translational research environment in which team science and collaboration both locally and nationally are facilitated, supported and valued Goal 3: Engage local and national communities and stakeholders in all phases of the translational research process Goal 4: Create novel methodologies and resources to support and integrate research in special populations, including children, the elderly, the underserved and those with rare diseases. Goal 5: Further innovate and streamline our processes and enhance our informatics capacity for research start-up, implementation and oversight to promote quality, efficiency, & safety of our research and our active participation in the national CTSA Trial Innovation Network. Common Abbreviations used in this Application AMC Anschutz Medical Campus ACCORDs Adult and Child Consortium for Health Outcomes TIC Trial Innovation Center Research and Delivery Science BERD Biostatistics, Epidemiology and Research CTR Clinical and Translational Research QPIP Quality and Process Improvement Design Program CBC Colorado Biostatistics Consortium CTRC Clinical Translational Research Center REDCap Research Electronic Data Capture CCTSI Colorado Clinical & Translational Sciences CTRE Clinical and Translational Research Environment RKS Regulatory Knowledge and Support Institute Program CE&R Community Engagement & Research CU-B University of Colorado at Boulder SARC Scientific Advisory & Review Committee CHCO Children’s Hospital Colorado CU-D University of Colorado Denver SOD School of Dentistry CLSC Clinical Sciences Graduate Program DH Denver Health & Hospital Authority SOM School of Medicine CMH Child and Maternal Health Research DVAMC Denver Veterans Affairs Medical Center SOP School of Pharmacy and Pharmaceutical Sciences CO-Mentor Colorado Mentoring Training EMR Electronic Medical Record TEC The Evaluation Center COMIRB Colorado Multiple Institutional Review Board KL2 Mentored Career Development Program TL1 Pre-doctoral Research Training Program CON College of Nursing KP Kaiser Permanente UCH University of Colorado Hospital CO-Pilot Colorado Translational Pilot Grant