INSTITUTIONAL RESOURCES Building on research strengths at the University of Alabama at Birmingham (CCTS Hub), the CCTS continues to engage Institutional Partnerships to create a vibrant scientific environment to improve and accelerate translational research and workforce development. The Institutional Resources herein provide detail on the CCTS facilities and technology, followed by detailed descriptions of CCTS Partners’ resources, starting with the Hub and followed by Partners in alphabetical order. CENTER FOR CLINICAL AND TRANSLATIONAL SCIENCE (CCTS) To speed the translation of research into improved human health, the CCTS and its Partner Network are committed to increasing research capacity, accelerating research processes, developing and supporting excellence in the research workforce and providing creative, innovative approaches to major health and health care delivery challenges. The CCTS offers access to a number of resources and capacities through its co- leadership of the Clinical Trials Initiative as well as the Training Academy and the Research Commons. CCTS Partner Network – In synergy with the resource strengths available at UAB, the CCTS has established Institutional Partnerships to improve and accelerate translational research. The CCTS Partner Network crosses institutional boundaries to improve human health and health care delivery. This innovative partnership is well integrated into the fabric of the CCTS and provides the foundation for addressing health disparities through collaborative research and training efforts. Building on some initial relationships from the Deep South Network for Translational Research, we have significantly expanded to create new and more formal partnerships with regional institutions for mutual benefit. Regional partners are working together to facilitate and promote unique opportunities, including (but not limited to) drug discovery and development, genomics, advanced magnetic resonance imaging, population health and outcomes research. Partners include UAB (Hub), Southern Research, Auburn, South Alabama, HudsonAlpha, LSU, University of Mississippi-Oxford, Pennington, Tulane, UA-Tuscaloosa, Tuskegee). See http://www.uab.edu/ccts/partners . Building on this culture of collaboration, the CCTS has expanded its relationship with other affiliate institutions to advance programmatic synergies (University of Mississippi- Jackson, Jackson State University, Ochsner Health, and Xavier University). Clinical Trials Initiative The mission of the UAB Clinical Trials Initiative is to promote, foster, and enhance high-quality clinical research at the University of Alabama at Birmingham. UAB’s initiative is to provide, support and direct the implementation of cutting-edge human subject research. By promoting clinical research, the effort will help the UAB community meet its mission goals of excellence in patient care, education, research, and community service. The Institution is committed to providing world-class patient care with innovative therapies to treat disease, promote health and wellness, and provide opportunity for patient participation in clinical research. As an academic medical center, it is our responsibility to participate in research that leads to new discoveries and advances the art and science of medicine for future generations. This collaboration provides services to: Last Updated: 05/25/2018 • UAB researchers and research teams, assisting with feasibility assessment, methodologic rigor, study start-up, implementation and reporting. • Patients and the general public, providing opportunities for study participation. • Sponsors, helping them identify UAB investigators for participation in their research. As part of this effort, the CCTS mission addresses four programmatic tasks: 1) performance standards to meet and exceed national standards; 2) educated and knowledgeable workforce; 3) implementation of scientifically reproducible research; and 4) services to support rigorous design and interpretation. Toward these goals, the CCTS Hub has developed a multi-modal implementation strategy overseen by the Clinical Trials Advisory Committee (CTAC) and including guidance in Quality and Efficiency and training via Regulatory Knowledge and Support. Clinical Trials Advisory Committee (CTAC) UAB’s President recently charged the newly-formed Clinical Trials Advisory Committee (CTAC) with the continuous quality improvement toward excellence in clinical trial administration at the Hub. The group meets monthly to refine the expectations in the conduct of trials, consistent with institutional and national objectives. It continually monitors processes to enhance effectiveness and efficiency while upholding the highest standards of transparency, patient safety, ethical conduct and regulatory compliance. The CCTS Director, Dr. Robert Kimberly, chairs the Committee, which reports directly to the President of the University. The director of CCTS Network Capacities, Dr. Jason Nichols, oversees CTAC’s Time to Activation Initiative and represents the Partner Network in the context of multi-site studies. CTAC is transforming the organizational culture at the Hub to support trials through the comprehensive integration of institutional workflows, best practices in performance, education, information technology and data systems, financial management and participant safety in coordination with other research administration offices (sponsored programs, IRB, etc.). Quality and Efficiency The CCTS supports the design and conduct of ethical and scientifically valid clinical trials in an environment predicated on good clinical practice and implemented by a well-trained research workforce. The CCTS works with individual investigators and research teams and with the enterprise to ensure quality and efficiency in scientific investigation involving human subjects. CCTS Institutions have organized tools, expertise and facilities to help investigators succeed at every stage of trial development and implementation: • Pre-Implementation and Study Start-up (e.g., Training & Education in Good Clinical Practice, BERD expertise for study design & methods, informatics assets for feasibility assessments, regulatory support, scientific review of human subjects protocols, guidance for budgeting and contracting, specialized capacity for multi-site investigation). • Study Activation and Implementation (e.g., informatics tools for recruitment & retention, point of care trial notifications, experienced recruiting teams, integrated clinical trial management system (OnCore), state-of-the-art facilities, trained pool of research coordinators) • Analysis, Reporting and Close-out (e.g., CTAC monitoring, ClinicalTrials.Gov assistance, user- friendly data management and archival systems, OnCore tracking, project panels for publications) Pre-Implementation and Study Start-up Training. CCTS Clinical Research Support Program (CRSP) serves a vital role in workforce education by supporting a comprehensive portfolio of complementary programs to introduce and to reinforce skills needed to succeed in translational research, especially as it applies to clinical trials (see RM-RKS). Accessible across the Partner Network, these activities embrace established competencies defined by the national CTSA Consortium and address investigator needs at any stage across the career arc. Study Design. (Described below under Biostatistics, Epidemiology and Research Design (BERD)) BERD engages expert methodologists spanning the Partner Network to support a diverse array of study design and analytic needs in the performance of clinical and translational research. All Last Updated: 05/25/2018 investigator-initiated trials work with biostatisticians to optimize study design, power and analytic strategies early in the development of the study. This collaborative effort also defines the key components (e.g., outcome measures) needed for federal registration and reporting expectations, including clinicaltrials.gov. Feasibility Assessment. (see Informatics, below) Prior to initiating a clinical protocol, a comprehensive feasibility review is conducted by the academic department of the investigator through the Scientific Review Process to determine whether a given trial has the potential to succeed relative to multiple dimensions. This assessment addresses the rigor of science, expertise and availability (effort) of the investigative team and the competitive landscape for duplicative trials. CCTS Informatics has created both self-service and analyst-facilitated query strategies of electronic health record data through i2b2 to assess cohort feasibility. Regulatory. The CCTS CRSP (see Clinical Research Services, below) is available to work with investigators in the establishment and ongoing management of human subjects protocols. In the case of multi-site, interventional, human subjects research, all CCTS Network Partners have formally agreed to use IRB reliance and have joined NCATS’ Streamlined, Multi-site, Accelerated Reliance for Trials (SMART) IRB to harmonize and streamline processes to support the protection of human subjects in research in multi-site research. The CCTS also assists investigators with IND/IDE applications, including protocols related to repurposing existing drugs for new indications, evaluating drugs in new patient populations, new biological-based imaging agents, and gene therapy vectors. Budgeting & Contracting. As each new protocol is submitted to the IRB, it is also assessed for appropriate billing to sponsors. Members of CRSP are available