Clinical and Translational Research Unit (CTRU)

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  The ACRU is primarily used for conducting inpatient and outpatient intensive research studies in adults and is located within ~7,500 SF of dedicated in-patient and outpatient space on the 4th and 5^th floors of Barnard Hospital. This space includes a 12 bed semi–private inpatient unit, a 2 bed and 4 chair/bed outpatient area, waiting room, nurses’ station, Lab Processing/Storage facility, space for body composition analyses housing a dual energy x-ray absorptiometer (iDXA), BOD Pod and Pea Pod, Metabolic Kitchen, and a Conference Room. The ACRU provides research beds, research nursing and technician support, and routine supplies. Skilled nursing staff is needed to provide expert clinical care of study subjects, while ensuring the integrity of study protocol and data collection. ACRU nurses have a range of special skills and knowledge to implement and execute a large number of diverse and complex study protocols. For example, they have been trained to support investigators in specialized procedures, including placing arterial catheters, obtaining tissue biopsies, and performing hyperinsulinemic-euglycemic clamps.
  
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  The CTU is a 5,500 SF outpatient facility located in the CAM. This site is within a 5-minute walk from the ACRU and PCRU. The CTU has 6 exam rooms, a phlebotomy room, a consultation room, 2 long-term procedure rooms, laboratory specimen processing/packaging area, temporary workspaces for investigators and coordinators, and 2 conference rooms for meetings and visits by study monitors. The CTU offers dedicated research space, equipment, and nursing support for low-intensity clinical studies, particularly multi-center clinical trials. These studies include single-center and multi-center clinical trials funded by the NIH, medical and charitable foundations, and industry. However, the CTU space is also used for outpatient studies that require complex sampling procedures, intravenous infusions and pharmacokinetics. The CTU staff is comprised primarily of medical technologists and phlebotomists; a small number of registered nurses provide oversight and nursing support.
  
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  The Pediatric Clinical Research Unit (PCRU) provides space, nursing, and bionutritional support for clinical research projects conducted with children at WUSM. The PCRU provides critical resources to a broad range of clinical and translational studies in infants, children and adolescents (<18 years old). The PCRU has skilled nursing and technical staff to conduct complex, intense or lengthy research procedures (as would be performed in the ACRU) and less intense, single-visit, cross-sectional or longitudinal clinical trials research (as would be performed in the CTU). A suite of 6 private exam rooms, long-term treatment areas, and two cognitive rooms are currently available in the 2,400 SF unit on the 11th floor of SLCH. In addition to research space, the unit provides phlebotomy, research nursing, specimen processing and short term sample storage, and bio-nutrition services. In the most recent grant year, the PCRU provided support for 32 investigators from 6 departments and 7 divisions of the Department of Pediatrics implementing 65 protocols with 1,854 unique research visits totaling 4,564 hours. These visits vary from short 1-2 hour visits for data and/or sample collection and processing to extended visits up to 8-10 hour for complex infusion or pharmacokinetic studies or glucose clamps in children and adolescents. As described in this application, the PCRU will be co-located in early 2017 in the COH, with the ACRU, CTU, and LIRC in purpose-built space. This new space will enhance efficiency of services and use of unit personnel and will help to develop the PCRU, which currently is an exclusively outpatient unit, into a comprehensive research resource for the broadest scope of pediatric investigators.
  
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  The Lifestyle Intervention Research Core (LIRC), established through an NIH CTSA American Recovery and Reinvestment Act of 2009 Administrative Supplement, helps ICTS investigators implement an effective lifestyle intervention program into their research studies. LIRC supports: 1) Specialized nutrition services, including nutrition assessment, education, and counseling; recipe development; nutrient analysis; and development of menus/formulas for diet intervention, 2) Behavioral assessment and therapy for diet and activity lifestyle changes, 3) Training in sensory evaluation techniques and lifestyle behavior-change therapy, and 4) Image processing and analysis services to monitor the effects of lifestyle intervention on body composition.
  
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  The Core Laboratory for Clinical Studies (CLCS) occupies 4400 SF on the 6th floor of the Wohl Clinic Building and 688 SF on the 5th floor of the connected Wohl Hospital Building at WUSM. CLCS, a CLIA certified facility, has a proprietary laboratory information system known as CLAS, the Core Laboratory Access System which is focused on research testing (rather than a typical hospital laboratory) and allows CLCS to adapt to the special requirements of clinical researchers. CLAS runs on a virtual server located in the WUSM Computing Facility. Data are backed up nightly and a policy is in place for data handling during computer downtime. Computer services are HIPAA compliant and part of the WU intranet. Analytical instruments are interfaced directly with CLAS. The CLCS has all common types of clinical chemistry analyzers, including a digital single molecule counting immunoanalyzer and instrumentation for radioimmunoassays and plate based ELISA tests.
  

The Center for Biomedical Informatics (CBMI) provides essential data management/analysis, tools, and comprehensive training resources to promote collaborative studies and facilitate the identification of diagnostic and prognostic biomarkers and the subsequent development of personalized therapies. Along with the BJC Center for Clinical Excellence (CCE) (described separately in Resources), the biomedical informatics within the CBMI is supported through under the direction of the new Institute for Informatics (described separately in Resources).

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  The CBMI handles medical records, clinical studies, biospecimen, and microarray data management services to support clinical and translational research broadly at WU as well as all the primary and processed clinical genomic data for Genomics and Pathology Service. Specific equipment, security, and disaster recovery is described under Equipment.
  

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  CBMI occupies approximately 5,295 SF of modern research biomedical informatics space in the CORTEX Innovation District. This includes 27 cubicles, and 15 offices of which five are capable of being occupied by up to three programmer analysts. In addition, all servers are housed in an environmentally controlled, redundantly powered, redundantly networked, state of the art, monitored and managed data center. There are also four conference rooms where face-to-face, voice, web and video conferences take place. All personnel have workstations and/or laptops with dual monitors and appropriate programming environments (e.g. Eclipse for Java) and software to develop the tools described in this application. 
  
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  The CBMI provides near real-time, point of care recruitment to trials is supported through the Clinical Investigation & Data Exploration Repository (CIDER), which exploits the WUSM/BJH clinical research data warehouse. CIDER contains EHR records on over 5 million patients across 12 hospitals and multiple WUSM clinics. Together with continued involvement with the three Patient-Centered Outcomes Research Institute (PCORI)-funded Clinical Research Data Networks (PEDSNet: A Pediatric Learning Health System, SCILHS-A Scalable Collaborative Infrastructure for a Learning Health System; and the Great Plains Collaborative, described separately in Resources), the CBMI supports application of the Informatics for Integrating Biology & the Bedside (i2b2) (described separately in Resources) platform to allow cohort discovery across institutions.
  

The BJC Center for Clinical Excellence (CCE) was founded in 1995, and provides leadership in quality assessment and health services research throughout BJC. The CCE’s nearly 100 clinicians, epidemiologists, analysts, programmers, industrial engineers, facilitators, project managers, and supporting personnel promote quality improvement and research. The center exists to improve clinical quality and patient safety, contribute to medical education and research, and enhance workforce development. The CCE maintains three core functional areas: (1) Healthcare informatics, (2) Clinical Excellence Consulting, and (3) Transformation Support. CCE manages BJC’s Preventable Harm Initiative, the BJC Excellence in Patient Care Committee, the Infection Prevention and Epidemiology Consortium, the BJC Patient Safety Program, and the Medical Informatics Laboratory (MIL). CCE resources will be used to ensure optimal methods and processes to improve efficiency of research and research training. With the Center for Biomedical Informatics (CBMI), the CCE is supported under the new organizational umbrella of the Institute for Informatics (described separately in Resources).

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  The Medical Informatics Laboratory (MIL) at WUSM and BJC comprises ten computer scientist programmer/analysts, a clinical pharmacist, and its physician director. MIL operates state-of-the-art computing hardware and develops cutting edge clinical software. This group's core competencies include integration of data from disparate sources, automated expert system programming, use of databases for discovery, and automated notification technology. Strong working partnerships exists with BJC pharmacists and BJC’s IS Department. Specific equipment is described under Equipment.
  
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  The Clinical Data Repository (CDR) was developed by BJC to facilitate integration of data from disparate sources. This repository is used for system-wide patient care, decision support, and research. Most of the data in the repository are acquired from source systems in real time via HL7 interfaces, and incoming data are encoded to standard vocabularies wherever possible. A group within BJC IS maintains a Medical Entity Dictionary that maps inbound facility-specific concepts to an enterprise code. This allows most applications, queries, and reports to work across all facilities with little or no changes. All observations within the CDR are associated with a registration number assigned by the facility where the observation occurred. A separate team in the BJC IS department maintains a Master Patient Index (MPI) database that maps all registration (encounter) numbers to an enterprise-wide patient identifier. The database also stores times associated with each observation. Together with the MPI number, registration number, and facility, the date and time information allows single patients to be tracked across multiple facilities and the sequence of observations within one or more registrations to be analyzed. The repository started with registration, medication, and microbiology data from a single hospital in 1993. Subsequently, new hospitals and data sources were added, as summarized in the table below. Using the MPI as the patient indexing backbone, the CDR has acquired information for 4.6 million persons. The CDR contains over 34.5 million patient encounters and nearly 270 million results, events, and documents. The CDR accepts data from over 140 different BJC Clinical Applications as sources of data with a yearly average of 94 million messages.
  

The Center for Cardiovascular Research (CCR) supports basic research laboratories that focus on understanding the biologic processes that are responsible for cardiovascular disease. A major objective of the CCR is to establish novel interfaces among cardiovascular researchers in diverse scientific disciplines, including molecular and cellular biology, physiology, biophysics, and bioorganic chemistry. Accordingly, the CCR provides a unique research environment for scientists with distinct backgrounds who have common interests in diseases of the heart and vasculature. A key facet is facilitation of interactions between CCR basic scientists and clinical researchers engaged in patient-oriented research. Research faculty, fellows, and students meet twice weekly through highly interactive CCR trainee and faculty (internal and Visiting Professor) seminars

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  The St. Louis region is diverse in its ethnic/racial and socio-economic makeup. African-Americans are the predominant minority group; however, 38.6% of African Americans in St. Louis City live in poverty (U.S. Census Bureau, 2013) and are rarely represented in research. The Research Engagement to Advance Community Health (REACH) (described separately in Resources) initiative focuses on increasing research participation among underrepresented groups by using a “boots on the ground” approach where the CCHPR engages subjects in their own communities – grocery stores, community centers, food pantries, etc. The REACH initiative (and its predecessor, HealthStreet), has been very successful in supporting collaborative research partnerships between community members and university investigators, and more importantly in increasing public trust since its inception in 2009. In addition, there is an active Community Advisory Board that provides consultations on community – university research project design and implementation, and an active PBRN focused on community pediatricians. The CCHPR REACH initiative has dedicated office space (~200 SF) in conjunction with the IPH in the Taylor Avenue Building on the Medical School Campus to house personnel, supplies and secure maintenance of data relating to CCHPR/REACH activities. There is access to a group of 10 multipurpose, state of the art conference rooms that can accommodate 4 - 30 occupants. The bulk of patient engagement occurs in the community by utilizing public spaces. Access to these spaces is gained through our relationships with community partners and stakeholders in an effort to facilitate bidirectional communication in an environment familiar and comfortable to the stakeholder.
  
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  The CCHPR developed and maintains the Community Based Organization (CBO) Database, a tool developed from an earlier ICTS landscape survey on community academic research partnerships to help identify mutual research interests that promote collaborations between research investigators and community based organizations.
  

The Center for Clinical Research Ethics (CCRE), established through a partnership between our CTSA and the Center for Health Care Ethics at SLU, provides a comprehensive consultation network that assists ICTS investigators and programs in addressing clinical research ethics within clinical research protocols and policies. In addition, the faculty provides the Responsible Conduct of Research (RCR) courses and seminars and develops programming responsive to specific needs. The CCRE provides a range of resources including the Program for Ethical and Responsible Conduct in Science and Scholarship (PERCSS), offering ethics workshops and online RCR learning modules as well as didactic course working in ethical and legal issues in clinical research, enabling investigators to critically evaluate ethical and regulatory issues in clinical research. The CCRE maintains a library of research case studies; developed the Interdisciplinary Bioethics Network (IBN) to foster scholarly collaborations and promote clinical bioethics, research ethics and general bioethics; and provides professional development education for investigators who have engaged in wrongdoing or unprofessional behavior through the Professional Integrity (PI) program.

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  The Informed Consent Enhancement Core (ICEC) aims to enhance the quality of the informed consent process by providing education, resources, and consultation services to investigators and research staff that facilitate the use of best practices. Issues with the informed consent process are the most common concerns that require investigators to revise protocols, thus, creating delays in study approval. Hence, the ICEC also aims to reduce regulatory burden on investigators and increase the efficiency of IRB review by helping investigators to develop consent processes that respect participants and satisfy IRB requirements for complex clinical trials. The ICEC will focus its efforts to help expedite clinical trials that are neither exempted nor expedited—that is, on greater than minimal risk studies that require IRB full board review.
  
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  The PSI Lab resources will provide survey and assessment services (SAS) focused on regulatory and ethical issues. Assessment will take place across the lifespan of the change process in the immediate and mid-term, and it will continue throughout the long-term. Metrics will be defined across each change dimension—people, process, and technology. SAS faculty have specific expertise related to organizational psychology, psychological assessment, and the conduct of Delphi consensus panel surveys, and will advise on the content and process for assessment related to people at the internal and external levels and work to align assessments across the TIU. SAS will offer the following services: 1) Delphi consensus panel surveys of diverse stakeholder groups to establish a consensus on priorities for the TIU’s regulatory and clinical research ethics services; 2) Quality assurance surveys among users of TIU’s regulatory and clinical ethics services; and 3) Consultation on matters of clinical research ethics to other programs within the TIU that are engaged in establishing TIU goals or providing quality assurance services for the TIU.
  

The Center for Diabetes Translation Research (WU-CDTR) aims to eliminate disparities in Type 2 diabetes by translating evidence-based interventions to high-risk populations. The NIH-funded research center is a collaboration between the WU George Warren Brown School of Social Work (Brown School) and WUSM and was formed to address health literacy and health communication; dissemination and implementation; health economics and health policy; and community-based participatory research and cultural competency. The WU-CDTR is a regional and national resource to investigators committed to translating interventions that have demonstrated efficacy into healthcare settings, communities, and populations at-risk. The WU-CDTR supports studies around two interacting scientific themes: the root causes of diabetes and disparities; and the prevention of obesity as a major contributing cause of Type 2 diabetes. WU-CDTR provides access to core services in support of real-world translation research and funds a pilot and feasibility program and enrichment program to support team science and transformative diabetes research.

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  The Scalable Collaborative Infrastructure for a Learning Health System (SCILHS) supports an open data platform across 13 healthcare centers, including BJC, as established through collaboration with the Department of Biomedical Informatics at Harvard Medical School. Supported by PCORI, this CDRN facilitates clinical research by sharing EHR data between academic medical centers using Informatics for Integrating Biology and Bedside (i2b2). SCILHS provides support for the development and establishment of an i2b2 instance at WUSM and BJC to build two local network nodes. The deployment of i2b2 for both pediatric and adult clinical data will provide the ICTS researchers with the necessary discovery tools to identify patient cohorts for clinical research studies. This network covers a broad array of populations, including underserved, rural, urban, rare disorders, children, geriatric, minority, disabled, and other vulnerable groups.
  
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  PEDSnet is a community of patients, families, clinicians, scientists, and health system leaders who are building a national, pediatric learning health system dedicated to discovering and implementing new ways of providing the best care and ensuring the best outcomes for children. It is producing reusable and expandable governance, logistical, informatics, regulatory, scientific, and training resources, organized as a Pediatric Research Commons that will help the pediatric patient-centered outcome research process become faster and more efficient. PEDSnet has created connections with disease-specific Patient-Powered Research Networks (PPRNs), CTSAs, health plans, and other national pediatric research initiatives with the intent of forming a sustainable pediatric clinical research infrastructure and is implementing a flexible dual data architecture that incorporates two widely used data models and national terminology standards to support multi-institutional data integration, cohort discovery, and advanced analytics that enable rapid learning. A consortium consisting of PEDSnet includes eight academic medical centers (Boston Children’s Hospital, Children’s Hospital of Philadelphia, Cincinnati Children’s Hospital Medical Center, Children’s Hospital Colorado, Nationwide Children’s Hospital, Nemours Children’s Health System, Seattle Children’s Hospital and SLCH), existing disease-specific networks (inflammatory bowel disease, hypoplastic left heart syndrome, childhood obesity, and two national data partners (ExpressScripts and IMS Health) forms the initial partners in the National Pediatric Learning Health System (NPLHS). Areas of expansion are the development of new relationships with pediatric PPRNs, NIH-funded centers for translational research, CDRNs, HealthCore (BC/BS health plan data), and with local health plan partners of PEDSnet sites.
  
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  The Greater Plains Collaborative (GPC) is a network of 12 leading medical centers in 8 states, including MU, who have implemented i2b2 as the common platform for developing a federated PCORI CDRN. The goal is to improve healthcare delivery through ongoing learning, adoption of evidence-based practices, and active research dissemination. Now in Phase II, the GPC will offer broadened network leadership and productive partnerships across CDRNs and five patient-powered research networks. Enhanced data resources to support observational/interventional research will be created by adding record linkage and duplication analysis capabilities with new data partners, and deploying free text note de-identification and processing to support advanced computable phenotyping at a vast scale across PCORNet data warehouses. This network serves a broad array of populations, including underserved, rural, urban, rare disorders, children, geriatric, minority, disabled, and other vulnerable groups.
  

The Center for Genome Sciences & Systems Biology (CGS_SB) studies the role of genes in human health, including the influence of the millions of microbes that live in and on humans. The CGS_SB also fosters development and application of new analytic methods for studying the disease families embraced by BioMed 21. The CGS_SB strives to develop new ways to address global health problems, including childhood malnutrition, obesity and antibiotic resistance; to discover new technologies for understanding how genetic variations impact health worldwide; and to create innovative programs to prepare the next generation of scientists.

The Center for Regenerative Medicine aims to advance regenerative medicine through excellence in education and collaborative research. Housed in state-of-the art facilities in the 4515 McKinley Scott Research building, the Center embraces a broad understanding of regenerative medicine, including embryonic and adult tissue stem cells, cell reprogramming, cell and tissue engineering, and development, degeneration, and aging. The Center aims to facilitate and enhance research in regenerative medicine, as well as educate the public on the vast potential that regenerative medicine holds for human health. Four working groups including 1) Development and Regenerative Biology; 2) Developmental and regenerative biology in aging; 3) Chromatin and Epigenetics and 4) Stem cell, provide seminars and training. Just-In-Time awards to use core resources, seed grants, and graduate fellowships are available. Joint challenge funding opportunities, such as the hPSC Kidney Organoid Challenge supported by the Center and the Division of Nephrology, are open to faculty and postdoctoral fellows.

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  McDonnell Pediatric Cancer Center: focuses on the etiology and treatment of pediatric cancers.
  
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  Center for Metabolism and Immunity: focuses on musculoskeletal, kidney and gastrointestinal disorders including the microbiome, disorders of metabolism and diseases related to the immune system.
  
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  Center for Pediatric Pulmonary Disease: focuses on the biology of the pulmonary system and genetic and acquired causes of pediatric lung disease.
  
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  Congenital Heart Disease Center: focuses on the environmental and genetic etiology of congenital heart and vascular disease, related birth defects, and other heart disorders.
  

The Clinical Genomics Research Unit is a full service state-of-the art research facility with CLIA and CAP accreditation, equipped with modern imaging stations, laboratory information system, chromosomal microarray facility and automated metaphase scanning. The Unit, located in a 2^nd floor suite in the CORTEX Innovation District, provides support for clinical trials/studies for which a CLIA/CAP environment is required as well as conventional metaphase karyotyping and a comprehensive menu of molecular cytogenetic methods (FISH, Chromosomal Microarrays) for human and mouse tissues.