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The world of clinical and translational research is filled with specific terms (and lots of acronyms) that may need some explanation. We've defined some here that we think will be helpful, or at least interesting. If you have others that you'd like to suggest we share, please contact the Research Concierge with "Glossary" in the subject line.

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• American Recovery Reimbursement Act (ARRA)
  

  See also funding. An economic stimulus package nominally worth $787 billion enacted by Congress in 2009 that includes many measures, one being domestic spending in health care including $8.2 billion to the NIH to support and advance scientific research.

• Bioethics and Regulatory Knowledge
  A core resource of the CTSC focused on assuring responsible research is a primary consideration for every CTSC researcher and activity.
• Biomedical Informatics
  

  A core resource of the CTSC focused on providing and managing the shared IT and informatics resources that make implementation of the entire program possible.

• Biostatistics, Epidemiology, & Research Design (BERD)
  

  A core resource of the CTSC focused on quantitative and statistical analysis in the health sciences.

• Case Center for Reducing Health Disparities
  

  A collaboration of MetroHealth and the CTSC Community Partnership Core Resource, which  works to reduce disparities through research, education, and community partnership. 

• Clinical and Translational Science (CTS)
  

  See also Translational Research. A cyclical system of scientific discoveries about human health, translated into application in a clinical setting, where basic scientists may provide clinicians with tools arising from basic science or clinical researchers may make observations about diseases that stimulate basic investigations.

• Clinical and Translational Science Award (CTSA)
  

  A national initiative of the NIH, now consisting of 46 research institutions, of which the CTSC is a part of.

• Clinical and Translational Science Collaborative (CTSC)
  

  Our organization - a Cleveland-based initiative across Case, UH, Cleveland Clinic, and MetroHealth; we are a part of the CTSA.

• Clinical Research Unit (CRU)
  

  Inpatient and outpatient facilities where researchers and clinical trials participants interact, and which provide staff, resources, and services to the research endeavor. Managed as a Core Resource, the CTSC has CRUs at UH, MetroHealth and the Cleveland Clinic. 

• Community Partnership
  

  A core resource of the CTSC focused on fostering bi-directional understandings between researchers and the community for health promotion, and enhancing research opportunities through collaborations and partnerships among researchers, community residents, and organizations.

• Comparative Effectiveness Research (CER)
  

  An evaluation of the impact of different options available for treating a medical condition – between similar treatments i.e. competing drugs or between different approaches i.e. drug therapy or surgery. The federal government has recently taken a stronger interest in CER that ties effectiveness to cost.

• Conflict of Interest (COI)
  

  A situation which may occur when a researcher or research organization has multiple interests.  The presence of a COI alone does not indicate an impropriety – systematic efforts are made to discovery any COI and defuse it.

• Co-Principal Investigator (Co-PI or Co-I)
  

  See also Principal Investigator.  On multi-site projects, as is the CTSC, more than one individual is responsible for administrative, fiscal, and scientific conduct of the project. The CTSC’s Co-Principal Investigator is Richard Rudick, MD.

• Cultural Competency or Competence
  

  See also Case Center for Reducing Health Disparities:  Being knowledgeable of, respectful of and responsive to the health beliefs, practices, and cultural and linguistic needs of diverse patients; its consistent use is an attribute of successful clinical and translational science.

• Data and Safety Monitoring Board (DSMB) also a Data and Safety Monitoring Plan (DSMP)
  

  A system for the appropriate oversight and monitoring of clinical trials to ensure the safety of participants and the validity and integrity of the data.

• Funding through NIH and its affiliates
  

  The NIH is the principal federal funder of biomedical research; many of their grants have been enhanced through ARRA funding. More than 40,000 funding applications are submitted to the NIH each year, and approvals made through a peer-review process on the basis of scientific and technical merit and in consideration of program goals and available funds. To search a broad array of funding opportunities follow website link. The most popular of the activity categories are the C06, all of the K series, the P series and the R series.

• Health Disparities
  

  Gaps in health and health care quality across racial, ethnic, sexual orientation and socioeconomic groups. The Health Resources and Services Administration defines health disparities as "population-specific differences in the presence of disease, health outcomes, or access to health care." (from Wikipedia) The CTSC seeks to reduce health disparities in northeast Ohio and partners with the Case Center for Reducing Health Disparities.

• Institutional Review Board (IRB)
  

  A committee formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of research subjects.

• Investigational New Drug/Investigational Device Exemption (IND/IDE)
  

  A request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans.

• KL2
  

  See also TL1, Training. Intensive training and mentoring, as well as modest research support, to develop junior faculty members as clinical researchers conducting patient-oriented  research.  The CTSC’s program is one of its greatest strengths with 19 scholars currently enrolled.

• National Center for Research Resources (NCRR)
  

  A part of the NIH, the NCRR provides clinical and translational researchers with the training and tools they need to transform basic discoveries into improved human health.

• National Institutes of Health (NIH)
  

  See also Funding. A part of the U.S. Department of Health and Human Services and the  primary federal agency for conducting and supporting medical research. The NIH is the principal federal funder of biomedical research.

• Partner Institutions
  

  The CTSC consists of four research intensive partner institutions: Case School of Medicine, University Hospitals, Cleveland Clinic, and MetroHealth. 
  
  

• Pilot Funding
  

  Start up or seed money funding for research and a Core Resource of the CTSC.  A core group of research administrators implement a peer-reviewed pilot funding program designed to stimulate new translational research, new researchers, and additional funding. See current CTSC opportunities at our website.

• Practice Based Research Networks (PBRN or PBRNs)
  

  A network of ambulatory practices devoted principally to the care of patients and that engage in research; a Core Resource of the CTSC focused on developing capacity for generating and applying new knowledge at the patient’s front line. 

• Principal Investigator (PI)
  

  See also Co-Principal Investigator. The lead scientist for a research project; in the context of federal funding the PI is the person who takes direct responsibility for completion of a funded project, directing the research and reporting directly to the funding agency. The CTSC’s Principal Investigator is Pamela Davis, MD, PhD.

• Program Evaluation & Reporting
  

  A Core Resource of the CTSC which evaluates how well the CTSC is achieving its goals – both across the researcher community overall and also within each core resource; they help assure the program meets professional evaluation standards of utility, feasibility, propriety, and accuracy as well as adhering to five principles: systematic inquiry, competence, integrity/honesty, respect for people, and responsibility for general and public welfare. 

• Proteomics
  

  The large-scale study of proteins, particularly their structures and functions. After genomics, proteomics is often considered the next step in the study of biological systems. It is much more complicated than genomics mostly because while an organism's genome is more or less constant, the proteome differs from cell to cell and from time to time. (from Wikipedia).

• Research Subject Advocate (RSA) also Research Subject Advocacy Program (RSA)
  

  Individuals or program that support and ensure the safety of people participating in clinical research.  In addition to serving as an advocate for participants, the RSA assists researchers to create a compliant Data and Safety Monitoring Plan and obtain Informed Consent. 

• Strategic Goals Guiding the CTSA Consortium
  

  A national research agenda of five goals: 1. Build national clinical and translational research capability. 2. Provide training and improve career development of clinical and translational scientists. 3. Enhance consortium-wide collaborations. 4. Improve the health of our communities and the nation. 5. Advance T1 translational research to move basic laboratory discoveries and knowledge into clinical testing.

• T0
  

  Pre-clinical or “bench” research such as animal models, human blood or cell lines, development of questionnaires, computational models, and human physiological studies, all directed at mechanisms and presentations of human disease.

• T0 - T1 - T2 - T3 - T4
  

  See also Translational Research.  At the CTSC translational research as a multidisciplinary collaboration accelerates application of findings across five levels of human research. The power of translational research is that it is an iterative process, allowing room for the returning to a prior translational stage to respond to treatment strategy barriers or address the underlying mechanisms.

• T1
  

  Translates discoveries made at the bench to first testing in humans, typically case studies, phase 1 and 2 clinical trials that take place at the patient bedside in an academic medical center.

• T2
  

  Second phase of the translation process, builds on the clinical efficacy work conducted in T1, and translates results from early clinical studies to controlled observation studies and phase 3 clinical trials for bedside patient care and health decision making.

• T3
  

  Third phase of the translation process, builds on the clinical efficacy work conducted in T2, and translates T2 research into clinical practice.

• T4
  

  Fourth phase of the translation process, builds on the results of T3, helps identify the best approach to reach clinicians and patients nationwide so that they not only understand the new treatment but will start to use it.

• TL2
  

  See also KL2 and Training. A Clinical and Translational Scientist Training Program (CTSTP) through which  researchers obtaining the Medical Doctorate, Doctorate in Dental Sciences or Doctorate in Nursing at Case can enter a combined program leading to the Ph.D. degree in engineering, epidemiology, biostatistics, and ultimately in clinical research as well.

• Training, Education and Career Development
  

  See also KL2 and TL2.  A core resource of the CTSC focused on preparing clinical research scholars to be future leaders of the nation’s clinical research enterprise. There are currently three components: Formal training in the KL2 and TL2 programs, and a broad array of sessions aimed at the entire research community better understanding one another’s disciplines, terminology, and approach to research or patients.   

• Translational Methodologies Research (TMR)
  

  Research focused on developing new methodologies and statistical analysis tools that solve problems lacking off-the-shelf solutions, are applicable to future research, and can accelerate movement along the ‘discovery pathway’ from laboratory to improved human health – and a Core Resource of the CTSC. 

• Translational Research
  

  See also T0 and Clinical and Translational Research. Translational research transforms scientific discoveries found in the laboratory, or through clinical and population studies, into interventions or treatments that will reduce morbidity and mortality from disease as well as provide prevention programs to improve the health of the general population.  It includes two interrelated processes: bench and preclinical studies that inform and shape studies and trials in humans, and studies and trials in humans that leads to adoption of best practices in clinical practice and in the community including prevention and treatment strategies.

• Translational Technology Resources (TTR)
  

  Core resource of the CTSC focused on providing researchers tools to characterize clinical populations, understand clinical research interventions, and discover molecular mechanisms underlying disease. Visit our website for a listing of available services.