Key Terms & Definitions

The translational science and research fields have their own associated language, terms of art, abbreviations, and acronyms. This list of terms is available for reference but is not comprehensive. These are working definitions as understood by UR CTSI staff and faculty, and is not meant to be authoritative.

ACTS

The Association for Clinical and Translational Science supports the CTSA program by representing 5,000+ members working in academia, industry, nonprofit organizations, and the public sector through support for research, education, advocacy for public policy and funding, and mentoring programs.

AI

Artificial intelligence is the use of computers, machines, datasets, and other systems to replicate the cognitive and creative processes of the human mind for complex, higher-order problem solving. AI includes the subdomains of machine learning and deep learning.

CAC

The Community Advisory Council serves in an advisory capacity to the University of Rochester Medical Center, the Center for Community Health & Prevention, and the UR CTSI. The CAC seeks to promote and improve health by combining community expertise with academic knowledge. It brings together individuals from a variety of local community organizations and sectors—such as health and social services agencies, the faith community, and local governments —to provide guidance and collaboration on public health initiatives. The Council helps ensure that programs and strategies are informed by a broad range of community perspectives and practical experience. 

CBPR

Community-Based Participatory Research is a collaborative approach to research that involves community members or recipients of interventions during all phases of the research process and recognizes the unique strengths that each member of the research team brings.

CCHP

The Center for Community Health & Prevention works to create environments that support healthy behaviors through disease prevention, healthy living programs, research, education, and policy.

CER

Community-Engaged Research is a philosophy that supports partnership between community members and researchers to identify needs and develop strategies to address them.

CCOS

The Coordination, Communication, and Operations Support Center fosters collaborative science teams research within the CTSA Program through communications, logistics, collaboration, training, impact analysis, and software and technology support.

Clinical Research

Clinical research is undertaken to produce knowledge to understand, prevent, and treat human diseases and illness, as well as increase health. Clinical research is differentiated through laboratory research by the involvement of research study participants who volunteer to help researchers better understand therapies, technologies, and techniques meant to improve human health.

CQI

Continuous quality improvement is a process that improves practice through ongoing, incremental process, system, and outcome assessment and improvement.

CRC

The UR CTSI’s Clinical Research Center supports URMC researchers engaged in clinical research through the expertise of its highly trained research nursing and nutrition personnel. The CRC offers a facility where clinical research and drug company-sponsored clinical trials may be conducted. The CRC fosters collaboration between investigators, growth opportunities for researchers, and an environment of research study subject care and safety.

CTSA Consortium

The network of 60+ CTSA institutions committed to improving human health by improving and streamlining science processes, training, and clinical research.

Dissemination & Implementation

Dissemination and implementation research focuses on how practices, interventions, and policies are applied in real-world healthcare settings including hospitals, schools, communities.

Dissemination and Implementation Function

The UR CTSI’s dissemination and implementation function promotes and supports collaboration and team science through work with community members and researchers from the University and region to accelerate translational science and improve population health.

Deaf (as in Deaf culture)

Deaf may refer to people who are deaf, hard of hearing, have hearing loss, or who have a related disability. It may also describe people who speak American Sign Language. Deaf culture is the distinct practices, traditions, arts, culture, and history shared by people who are Deaf.

Deep Learning

An artificial intelligence method of computation that recognizes complex patterns in datasets to produce useful insights and predictions.

Digital Health

The FDA categorizes digital health as encompassing mobile health, health information technology, wearable devices, telehealth and telemedicine, and personalized medicine. Digital technology includes apps, software, machine learning, and artificial intelligence that support clinical decisions. Digital health technologies span computers, software, sensors, and other devices that serve as medical devices and products supporting health and medicine, or that support the development and study of medical products.

EHR

Electronic health records are medical charts accessible by computers and other electronic devices, allowing for a centralized and comprehensive source of a patient’s medical information and history. UR Medicine refers to EHR as eRecord (see below).

ENACT Network

The Evolve to Next-Gen Accrual to Clinical Trials (ENACT) Network builds upon the CTSA Consortium cohort discovery platform, ACT, to enable investigators and trainees at CTSA hubs to conduct EHR-based research on any disease or condition across the network of over 142M patients. Informatics professionals from across the CTSA Consortium use ENACT as a collaborative platform to develop new tools and improve informatics practices.

eRecord

URMC’s EHR system at Strong Memorial, Highland, and affiliate hospitals. The system (using EPIC software) integrates patient medical history, test results, images, consult notes, and more into an electronic chart.

Expanded Access

Expanded access is a pathway for a patient with a life-threatening condition to gain access to an investigational medical product such as a drug or medical device for treatment outside of a clinical trial setting when no comparable treatment options exist.

FDA

The U.S. Food and Drug Administration is the federal agency responsible for protecting public health through regulation of the production and distribution of food (with the exception of meat, poultry, and some egg products), drugs, vaccines, biological products, and medical devices. It also regulates electronic product radiation, cosmetics and dietary supplements, and tobacco products, and works to speed product innovations.

FQHC

Federally qualified healthcare centers are federally funded, nonprofit centers or clinics that deliver comprehensive primary care services in designated geographic areas. These centers operate under federal standards to ensure access to care, including sliding fee schedules based on income and operational criteria defined by the Health Resources and Services Administration (HRSA).

GR-PBRN

The Greater Rochester Practice-Based Research Network is a collaborative network of primary care clinicians and researchers who have the shared goal of improving patient care and outcomes. GR-PBRN supports research initiatives with all populations where science can translate to better care. The network has 144 member practices from primary care specialties and local health systems.

IDEs

Investigational device exemptions allow devices under investigation to be used in a clinical study setting to collect data on safety and efficacy.

INDs

Investigational new drugs are experimental drugs under study in human clinical trials.

Informatics

Informatics is the overarching field of study that incorporates data science, big data and health information management, and data analytics into one discipline.

Health informatics is the science of how to use data, information, and knowledge to improve human health.

IRB

An institutional review board reviews and monitors biomedical research involving human subjects. The RSRB is the IRB for the University.

K12

The K12 is a mentored career development award that supports early career clinicians and is actively linked to another research project or projects. The K12 offered by UR CTSI provides two years of support for the early career development of multidisciplinary clinical and translational scientists at URMC. This program supersedes the KL2.

Learning Health System

The Agency for Healthcare Research and Quality (AHRQ) defines a learning health system as a health system in which internal data and experience are systematically integrated with external evidence, and that knowledge is put into practice. As a result, patients get higher quality, safer, more efficient care, and health care delivery organizations become better places to work.

Machine Learning

A subset of AI featuring the development and use of statistical algorithms meant to simulate human thinking to interpret data, specifically through learned actions not explicitly programmed.

NCATS

The National Center for Advancing Translational Sciences’ mission is to turn research observations into health solutions through translational science, resulting in more treatments for all people more quickly. It is part of the NIH.

NCDHR

The National Center for Deaf Health Research’s mission is to “promote health and prevent disease with populations of Deaf sign language users and people with hearing loss through community-based participatory research.”

NIH

The National Institutes of Health is the U.S.’s largest medical research agency, dedicated to making important research discoveries that improve human health. It is part of the U.S. Department of Health and Human Services.

OCR

The Office of Clinical Research provides tools and services to help University of Rochester Medical Center faculty and staff with the administration of clinical trials. By streamlining research processes, OCR empowers clinical research teams to conduct more high-impact trials that advance clinical discovery and expand options and opportunities for patients and community members.

OnCore

URMC’s clinical trial management system that allows researchers to manage protocols, track participant visits, and manage project finances.

ORIT

The Office of Research IT provides guidance, infrastructure, and other technology support for researchers. ORIT falls under University IT.

PBRN

A practice-based research network is a group of collaborative practices that work with researchers to address clinical and organizational challenges in primary care. See GR-PBRN.

Phases of Translational Research

Scientific translation happens along a nonlinear spectrum, with each stage building upon and informing the others:

T0 - Basic Science: Preclinical and animal studies that happen at "the bench" to define molecular mechanisms and drug targets

T1 – Translation to Humans: Clinical trials that assess the safety of a drug, device, or intervention

T2 – Translation to Patients: Clinical trials that test the efficacy of a drug, device, or intervention

T3 – Translation to Clinical Practice: Clinical trials and outcomes research that test long-term impact and cost-effectiveness of a drug, device or intervention that is already on the market

T4 – Translation to Populations: Public health research that tests a drug, device, or intervention's benefit to society

Population Health

Population health refers to the health outcomes of groups of people, includes the distribution of such outcomes within the group, and the factors that influence those outcomes.

RDIA

The Research Data Integration and Analytics group is a team of experienced data engineers, data managers, and statisticians that provides integrated research study and experimental data management as part of UR CTSI’s Informatics branch.

REDCap

REDCap is a secure web application for building and managing online surveys and databases.

Regulatory Science

According to the FDA, “regulatory science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products.”

Research Help Desk

A closely monitored and responsive email account (researchhelp@urmc.rochester.edu) dedicated to answering questions about research.

ResearchMatch.org

Funded by NIH, ResearchMatch.org connects people interested in health research with investigators conducting studies.

RESIN

The Rochester Early-Stage Investigator Network works across departments and centers to optimize and support training for early-stage investigators from across the translational spectrum.

RDW

The research data warehouse, or clinical research data warehouse, is a specialized repository that stores and manages clinical and healthcare data for research purposes.

RocHealthData

RocHealthData is an interactive mapping and reporting tool website of nationally representative health-related data mapped locally by census track/zip code.

RSRB

The Research Subjects Review Board reviews human biomedical research that is conducted or supported by the University.

RWD

Real world data are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. 

RWE

Real world evidence is the clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of RWD.

SERDA

The Secure Environment for Research Data Analytics platform offers analytical tools, secure data storage, and data backup for University researchers.

SCORE

Study Coordinators Organization for Research & Education Regulatory Support provides support and networking opportunities to clinical research coordinators and staff working in academic settings.

SRB

The Saunders Research Building is home to the UR CTSI offices, among other URMC groups, centers, and departments.

StudyPages

StudyPages is a platform providing increased transparency for clinical research, allowing potential study participants to find and volunteer for studies. The platform automates recruitment and retention of study participants, including communications, allowing investigators and their teams to focus more on the research rather than administration.

Team Science

A collaborative research effort between investigators who come from different specialties and fields, allowing them to address more complex, interdisciplinary challenges.

TEAMSS

Transforming Expanded Access to Maximize Support and Study is an expanded access program led by the University of Michigan of which UR CTSI is a part.

TIN

The Trial Innovation Network is a collaborative initiative composed of the CTSA Program Hubs, Trial Innovation Centers, and the Recruitment Innovation Center that innovatively addresses critical roadblocks in clinical research and accelerates the translation of novel interventions into life-saving therapies.

T32

A grant provided through the NIH CTSA Program for pre-doctoral translational science researchers. 

Translational Biomedical Science Program

An interdisciplinary PhD program offered by UR CTSI.

Translational Research

Research that takes scientific discovery and develops applications, specifically in healthcare contexts.

Translational Science Day

UR CTSI’s annual celebration of translational science and research occurring in and around URMC.

Translational Science

According to NCATS, “translational science is the field that generates scientific and operational innovations that overcome longstanding challenges along the translational research pipeline. These include scientific, operational, financial, and administrative innovations that transform the way that research is done, making it faster, more efficient, and more impactful.”

UNYTE

The UNYTE Translational Research Network assists faculty and trainees from participating institutions across upstate New York in increasing the quality and quantity of translational research.