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Organizing Your Social Sciences Research Paper

Glossary of research terms.

• Purpose of Guide
• Design Flaws to Avoid
• Independent and Dependent Variables
• Reading Research Effectively
• Narrowing a Topic Idea
• Broadening a Topic Idea
• Extending the Timeliness of a Topic Idea
• Academic Writing Style
• Applying Critical Thinking
• Choosing a Title
• Making an Outline
• Paragraph Development
• Research Process Video Series
• Executive Summary
• The C.A.R.S. Model
• Background Information
• The Research Problem/Question
• Theoretical Framework
• Citation Tracking
• Content Alert Services
• Evaluating Sources
• Primary Sources
• Secondary Sources
• Tiertiary Sources
• Scholarly vs. Popular Publications
• Qualitative Methods
• Quantitative Methods
• Insiderness
• Using Non-Textual Elements
• Limitations of the Study
• Common Grammar Mistakes
• Writing Concisely
• Avoiding Plagiarism
• Footnotes or Endnotes?
• Further Readings
• Generative AI and Writing
• USC Libraries Tutorials and Other Guides
• Bibliography

This glossary is intended to assist you in understanding commonly used terms and concepts when reading, interpreting, and evaluating scholarly research. Also included are common words and phrases defined within the context of how they apply to research in the social and behavioral sciences.

• Acculturation -- refers to the process of adapting to another culture, particularly in reference to blending in with the majority population [e.g., an immigrant adopting American customs]. However, acculturation also implies that both cultures add something to one another, but still remain distinct groups unto themselves.
• Accuracy -- a term used in survey research to refer to the match between the target population and the sample.
• Affective Measures -- procedures or devices used to obtain quantified descriptions of an individual's feelings, emotional states, or dispositions.
• Aggregate -- a total created from smaller units. For instance, the population of a county is an aggregate of the populations of the cities, rural areas, etc. that comprise the county. As a verb, it refers to total data from smaller units into a large unit.
• Anonymity -- a research condition in which no one, including the researcher, knows the identities of research participants.
• Baseline -- a control measurement carried out before an experimental treatment.
• Behaviorism -- school of psychological thought concerned with the observable, tangible, objective facts of behavior, rather than with subjective phenomena such as thoughts, emotions, or impulses. Contemporary behaviorism also emphasizes the study of mental states such as feelings and fantasies to the extent that they can be directly observed and measured.
• Beliefs -- ideas, doctrines, tenets, etc. that are accepted as true on grounds which are not immediately susceptible to rigorous proof.
• Benchmarking -- systematically measuring and comparing the operations and outcomes of organizations, systems, processes, etc., against agreed upon "best-in-class" frames of reference.
• Bias -- a loss of balance and accuracy in the use of research methods. It can appear in research via the sampling frame, random sampling, or non-response. It can also occur at other stages in research, such as while interviewing, in the design of questions, or in the way data are analyzed and presented. Bias means that the research findings will not be representative of, or generalizable to, a wider population.
• Case Study -- the collection and presentation of detailed information about a particular participant or small group, frequently including data derived from the subjects themselves.
• Causal Hypothesis -- a statement hypothesizing that the independent variable affects the dependent variable in some way.
• Causal Relationship -- the relationship established that shows that an independent variable, and nothing else, causes a change in a dependent variable. It also establishes how much of a change is shown in the dependent variable.
• Causality -- the relation between cause and effect.
• Central Tendency -- any way of describing or characterizing typical, average, or common values in some distribution.
• Chi-square Analysis -- a common non-parametric statistical test which compares an expected proportion or ratio to an actual proportion or ratio.
• Claim -- a statement, similar to a hypothesis, which is made in response to the research question and that is affirmed with evidence based on research.
• Classification -- ordering of related phenomena into categories, groups, or systems according to characteristics or attributes.
• Cluster Analysis -- a method of statistical analysis where data that share a common trait are grouped together. The data is collected in a way that allows the data collector to group data according to certain characteristics.
• Cohort Analysis -- group by group analytic treatment of individuals having a statistical factor in common to each group. Group members share a particular characteristic [e.g., born in a given year] or a common experience [e.g., entering a college at a given time].
• Confidentiality -- a research condition in which no one except the researcher(s) knows the identities of the participants in a study. It refers to the treatment of information that a participant has disclosed to the researcher in a relationship of trust and with the expectation that it will not be revealed to others in ways that violate the original consent agreement, unless permission is granted by the participant.
• Confirmability Objectivity -- the findings of the study could be confirmed by another person conducting the same study.
• Construct -- refers to any of the following: something that exists theoretically but is not directly observable; a concept developed [constructed] for describing relations among phenomena or for other research purposes; or, a theoretical definition in which concepts are defined in terms of other concepts. For example, intelligence cannot be directly observed or measured; it is a construct.
• Construct Validity -- seeks an agreement between a theoretical concept and a specific measuring device, such as observation.
• Constructivism -- the idea that reality is socially constructed. It is the view that reality cannot be understood outside of the way humans interact and that the idea that knowledge is constructed, not discovered. Constructivists believe that learning is more active and self-directed than either behaviorism or cognitive theory would postulate.
• Content Analysis -- the systematic, objective, and quantitative description of the manifest or latent content of print or nonprint communications.
• Context Sensitivity -- awareness by a qualitative researcher of factors such as values and beliefs that influence cultural behaviors.
• Control Group -- the group in an experimental design that receives either no treatment or a different treatment from the experimental group. This group can thus be compared to the experimental group.
• Controlled Experiment -- an experimental design with two or more randomly selected groups [an experimental group and control group] in which the researcher controls or introduces the independent variable and measures the dependent variable at least two times [pre- and post-test measurements].
• Correlation -- a common statistical analysis, usually abbreviated as r, that measures the degree of relationship between pairs of interval variables in a sample. The range of correlation is from -1.00 to zero to +1.00. Also, a non-cause and effect relationship between two variables.
• Covariate -- a product of the correlation of two related variables times their standard deviations. Used in true experiments to measure the difference of treatment between them.
• Credibility -- a researcher's ability to demonstrate that the object of a study is accurately identified and described based on the way in which the study was conducted.
• Critical Theory -- an evaluative approach to social science research, associated with Germany's neo-Marxist “Frankfurt School,” that aims to criticize as well as analyze society, opposing the political orthodoxy of modern communism. Its goal is to promote human emancipatory forces and to expose ideas and systems that impede them.
• Data -- factual information [as measurements or statistics] used as a basis for reasoning, discussion, or calculation.
• Data Mining -- the process of analyzing data from different perspectives and summarizing it into useful information, often to discover patterns and/or systematic relationships among variables.
• Data Quality -- this is the degree to which the collected data [results of measurement or observation] meet the standards of quality to be considered valid [trustworthy] and  reliable [dependable].
• Deductive -- a form of reasoning in which conclusions are formulated about particulars from general or universal premises.
• Dependability -- being able to account for changes in the design of the study and the changing conditions surrounding what was studied.
• Dependent Variable -- a variable that varies due, at least in part, to the impact of the independent variable. In other words, its value “depends” on the value of the independent variable. For example, in the variables “gender” and “academic major,” academic major is the dependent variable, meaning that your major cannot determine whether you are male or female, but your gender might indirectly lead you to favor one major over another.
• Deviation -- the distance between the mean and a particular data point in a given distribution.
• Discourse Community -- a community of scholars and researchers in a given field who respond to and communicate to each other through published articles in the community's journals and presentations at conventions. All members of the discourse community adhere to certain conventions for the presentation of their theories and research.
• Discrete Variable -- a variable that is measured solely in whole units, such as, gender and number of siblings.
• Distribution -- the range of values of a particular variable.
• Effect Size -- the amount of change in a dependent variable that can be attributed to manipulations of the independent variable. A large effect size exists when the value of the dependent variable is strongly influenced by the independent variable. It is the mean difference on a variable between experimental and control groups divided by the standard deviation on that variable of the pooled groups or of the control group alone.
• Emancipatory Research -- research is conducted on and with people from marginalized groups or communities. It is led by a researcher or research team who is either an indigenous or external insider; is interpreted within intellectual frameworks of that group; and, is conducted largely for the purpose of empowering members of that community and improving services for them. It also engages members of the community as co-constructors or validators of knowledge.
• Empirical Research -- the process of developing systematized knowledge gained from observations that are formulated to support insights and generalizations about the phenomena being researched.
• Epistemology -- concerns knowledge construction; asks what constitutes knowledge and how knowledge is validated.
• Ethnography -- method to study groups and/or cultures over a period of time. The goal of this type of research is to comprehend the particular group/culture through immersion into the culture or group. Research is completed through various methods but, since the researcher is immersed within the group for an extended period of time, more detailed information is usually collected during the research.
• Expectancy Effect -- any unconscious or conscious cues that convey to the participant in a study how the researcher wants them to respond. Expecting someone to behave in a particular way has been shown to promote the expected behavior. Expectancy effects can be minimized by using standardized interactions with subjects, automated data-gathering methods, and double blind protocols.
• External Validity -- the extent to which the results of a study are generalizable or transferable.
• Factor Analysis -- a statistical test that explores relationships among data. The test explores which variables in a data set are most related to each other. In a carefully constructed survey, for example, factor analysis can yield information on patterns of responses, not simply data on a single response. Larger tendencies may then be interpreted, indicating behavior trends rather than simply responses to specific questions.
• Field Studies -- academic or other investigative studies undertaken in a natural setting, rather than in laboratories, classrooms, or other structured environments.
• Focus Groups -- small, roundtable discussion groups charged with examining specific topics or problems, including possible options or solutions. Focus groups usually consist of 4-12 participants, guided by moderators to keep the discussion flowing and to collect and report the results.
• Framework -- the structure and support that may be used as both the launching point and the on-going guidelines for investigating a research problem.
• Generalizability -- the extent to which research findings and conclusions conducted on a specific study to groups or situations can be applied to the population at large.
• Grey Literature -- research produced by organizations outside of commercial and academic publishing that publish materials, such as, working papers, research reports, and briefing papers.
• Grounded Theory -- practice of developing other theories that emerge from observing a group. Theories are grounded in the group's observable experiences, but researchers add their own insight into why those experiences exist.
• Group Behavior -- behaviors of a group as a whole, as well as the behavior of an individual as influenced by his or her membership in a group.
• Hypothesis -- a tentative explanation based on theory to predict a causal relationship between variables.
• Independent Variable -- the conditions of an experiment that are systematically manipulated by the researcher. A variable that is not impacted by the dependent variable, and that itself impacts the dependent variable. In the earlier example of "gender" and "academic major," (see Dependent Variable) gender is the independent variable.
• Individualism -- a theory or policy having primary regard for the liberty, rights, or independent actions of individuals.
• Inductive -- a form of reasoning in which a generalized conclusion is formulated from particular instances.
• Inductive Analysis -- a form of analysis based on inductive reasoning; a researcher using inductive analysis starts with answers, but formulates questions throughout the research process.
• Insiderness -- a concept in qualitative research that refers to the degree to which a researcher has access to and an understanding of persons, places, or things within a group or community based on being a member of that group or community.
• Internal Consistency -- the extent to which all questions or items assess the same characteristic, skill, or quality.
• Internal Validity -- the rigor with which the study was conducted [e.g., the study's design, the care taken to conduct measurements, and decisions concerning what was and was not measured]. It is also the extent to which the designers of a study have taken into account alternative explanations for any causal relationships they explore. In studies that do not explore causal relationships, only the first of these definitions should be considered when assessing internal validity.
• Life History -- a record of an event/events in a respondent's life told [written down, but increasingly audio or video recorded] by the respondent from his/her own perspective in his/her own words. A life history is different from a "research story" in that it covers a longer time span, perhaps a complete life, or a significant period in a life.
• Margin of Error -- the permittable or acceptable deviation from the target or a specific value. The allowance for slight error or miscalculation or changing circumstances in a study.
• Measurement -- process of obtaining a numerical description of the extent to which persons, organizations, or things possess specified characteristics.
• Meta-Analysis -- an analysis combining the results of several studies that address a set of related hypotheses.
• Methodology -- a theory or analysis of how research does and should proceed.
• Methods -- systematic approaches to the conduct of an operation or process. It includes steps of procedure, application of techniques, systems of reasoning or analysis, and the modes of inquiry employed by a discipline.
• Mixed-Methods -- a research approach that uses two or more methods from both the quantitative and qualitative research categories. It is also referred to as blended methods, combined methods, or methodological triangulation.
• Modeling -- the creation of a physical or computer analogy to understand a particular phenomenon. Modeling helps in estimating the relative magnitude of various factors involved in a phenomenon. A successful model can be shown to account for unexpected behavior that has been observed, to predict certain behaviors, which can then be tested experimentally, and to demonstrate that a given theory cannot account for certain phenomenon.
• Models -- representations of objects, principles, processes, or ideas often used for imitation or emulation.
• Naturalistic Observation -- observation of behaviors and events in natural settings without experimental manipulation or other forms of interference.
• Norm -- the norm in statistics is the average or usual performance. For example, students usually complete their high school graduation requirements when they are 18 years old. Even though some students graduate when they are younger or older, the norm is that any given student will graduate when he or she is 18 years old.
• Null Hypothesis -- the proposition, to be tested statistically, that the experimental intervention has "no effect," meaning that the treatment and control groups will not differ as a result of the intervention. Investigators usually hope that the data will demonstrate some effect from the intervention, thus allowing the investigator to reject the null hypothesis.
• Ontology -- a discipline of philosophy that explores the science of what is, the kinds and structures of objects, properties, events, processes, and relations in every area of reality.
• Panel Study -- a longitudinal study in which a group of individuals is interviewed at intervals over a period of time.
• Participant -- individuals whose physiological and/or behavioral characteristics and responses are the object of study in a research project.
• Peer-Review -- the process in which the author of a book, article, or other type of publication submits his or her work to experts in the field for critical evaluation, usually prior to publication. This is standard procedure in publishing scholarly research.
• Phenomenology -- a qualitative research approach concerned with understanding certain group behaviors from that group's point of view.
• Philosophy -- critical examination of the grounds for fundamental beliefs and analysis of the basic concepts, doctrines, or practices that express such beliefs.
• Phonology -- the study of the ways in which speech sounds form systems and patterns in language.
• Policy -- governing principles that serve as guidelines or rules for decision making and action in a given area.
• Policy Analysis -- systematic study of the nature, rationale, cost, impact, effectiveness, implications, etc., of existing or alternative policies, using the theories and methodologies of relevant social science disciplines.
• Population -- the target group under investigation. The population is the entire set under consideration. Samples are drawn from populations.
• Position Papers -- statements of official or organizational viewpoints, often recommending a particular course of action or response to a situation.
• Positivism -- a doctrine in the philosophy of science, positivism argues that science can only deal with observable entities known directly to experience. The positivist aims to construct general laws, or theories, which express relationships between phenomena. Observation and experiment is used to show whether the phenomena fit the theory.
• Predictive Measurement -- use of tests, inventories, or other measures to determine or estimate future events, conditions, outcomes, or trends.
• Principal Investigator -- the scientist or scholar with primary responsibility for the design and conduct of a research project.
• Probability -- the chance that a phenomenon will occur randomly. As a statistical measure, it is shown as p [the "p" factor].
• Questionnaire -- structured sets of questions on specified subjects that are used to gather information, attitudes, or opinions.
• Random Sampling -- a process used in research to draw a sample of a population strictly by chance, yielding no discernible pattern beyond chance. Random sampling can be accomplished by first numbering the population, then selecting the sample according to a table of random numbers or using a random-number computer generator. The sample is said to be random because there is no regular or discernible pattern or order. Random sample selection is used under the assumption that sufficiently large samples assigned randomly will exhibit a distribution comparable to that of the population from which the sample is drawn. The random assignment of participants increases the probability that differences observed between participant groups are the result of the experimental intervention.
• Reliability -- the degree to which a measure yields consistent results. If the measuring instrument [e.g., survey] is reliable, then administering it to similar groups would yield similar results. Reliability is a prerequisite for validity. An unreliable indicator cannot produce trustworthy results.
• Representative Sample -- sample in which the participants closely match the characteristics of the population, and thus, all segments of the population are represented in the sample. A representative sample allows results to be generalized from the sample to the population.
• Rigor -- degree to which research methods are scrupulously and meticulously carried out in order to recognize important influences occurring in an experimental study.
• Sample -- the population researched in a particular study. Usually, attempts are made to select a "sample population" that is considered representative of groups of people to whom results will be generalized or transferred. In studies that use inferential statistics to analyze results or which are designed to be generalizable, sample size is critical, generally the larger the number in the sample, the higher the likelihood of a representative distribution of the population.
• Sampling Error -- the degree to which the results from the sample deviate from those that would be obtained from the entire population, because of random error in the selection of respondent and the corresponding reduction in reliability.
• Saturation -- a situation in which data analysis begins to reveal repetition and redundancy and when new data tend to confirm existing findings rather than expand upon them.
• Semantics -- the relationship between symbols and meaning in a linguistic system. Also, the cuing system that connects what is written in the text to what is stored in the reader's prior knowledge.
• Social Theories -- theories about the structure, organization, and functioning of human societies.
• Sociolinguistics -- the study of language in society and, more specifically, the study of language varieties, their functions, and their speakers.
• Standard Deviation -- a measure of variation that indicates the typical distance between the scores of a distribution and the mean; it is determined by taking the square root of the average of the squared deviations in a given distribution. It can be used to indicate the proportion of data within certain ranges of scale values when the distribution conforms closely to the normal curve.
• Statistical Analysis -- application of statistical processes and theory to the compilation, presentation, discussion, and interpretation of numerical data.
• Statistical Bias -- characteristics of an experimental or sampling design, or the mathematical treatment of data, that systematically affects the results of a study so as to produce incorrect, unjustified, or inappropriate inferences or conclusions.
• Statistical Significance -- the probability that the difference between the outcomes of the control and experimental group are great enough that it is unlikely due solely to chance. The probability that the null hypothesis can be rejected at a predetermined significance level [0.05 or 0.01].
• Statistical Tests -- researchers use statistical tests to make quantitative decisions about whether a study's data indicate a significant effect from the intervention and allow the researcher to reject the null hypothesis. That is, statistical tests show whether the differences between the outcomes of the control and experimental groups are great enough to be statistically significant. If differences are found to be statistically significant, it means that the probability [likelihood] that these differences occurred solely due to chance is relatively low. Most researchers agree that a significance value of .05 or less [i.e., there is a 95% probability that the differences are real] sufficiently determines significance.
• Subcultures -- ethnic, regional, economic, or social groups exhibiting characteristic patterns of behavior sufficient to distinguish them from the larger society to which they belong.
• Testing -- the act of gathering and processing information about individuals' ability, skill, understanding, or knowledge under controlled conditions.
• Theory -- a general explanation about a specific behavior or set of events that is based on known principles and serves to organize related events in a meaningful way. A theory is not as specific as a hypothesis.
• Treatment -- the stimulus given to a dependent variable.
• Trend Samples -- method of sampling different groups of people at different points in time from the same population.
• Triangulation -- a multi-method or pluralistic approach, using different methods in order to focus on the research topic from different viewpoints and to produce a multi-faceted set of data. Also used to check the validity of findings from any one method.
• Unit of Analysis -- the basic observable entity or phenomenon being analyzed by a study and for which data are collected in the form of variables.
• Validity -- the degree to which a study accurately reflects or assesses the specific concept that the researcher is attempting to measure. A method can be reliable, consistently measuring the same thing, but not valid.
• Variable -- any characteristic or trait that can vary from one person to another [race, gender, academic major] or for one person over time [age, political beliefs].
• Weighted Scores -- scores in which the components are modified by different multipliers to reflect their relative importance.
• White Paper -- an authoritative report that often states the position or philosophy about a social, political, or other subject, or a general explanation of an architecture, framework, or product technology written by a group of researchers. A white paper seeks to contain unbiased information and analysis regarding a business or policy problem that the researchers may be facing.

Elliot, Mark, Fairweather, Ian, Olsen, Wendy Kay, and Pampaka, Maria. A Dictionary of Social Research Methods. Oxford, UK: Oxford University Press, 2016; Free Social Science Dictionary. Socialsciencedictionary.com [2008]. Glossary. Institutional Review Board. Colorado College; Glossary of Key Terms. Writing@CSU. Colorado State University; Glossary A-Z. Education.com; Glossary of Research Terms. Research Mindedness Virtual Learning Resource. Centre for Human Servive Technology. University of Southampton; Miller, Robert L. and Brewer, John D. The A-Z of Social Research: A Dictionary of Key Social Science Research Concepts London: SAGE, 2003; Jupp, Victor. The SAGE Dictionary of Social and Cultural Research Methods . London: Sage, 2006.

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Multidisciplinary Methods for Exploring Organizations

Bias :  a lack of balance and accuracy in the use of research methods. It can appear at any phase of research, from deciding on a sampling frame, sampling, to data collection and analysis.  Bias also arises in the identity of the researcher through assumptions and ideas related to his or her own culture that may influence data collection and analysis.  Bias interfere with the extent to which results are valid and accurate, whether or not the research is reliable, and the potential for results to be representative of, or generalizable to, a wider population.   Click here to access a brief article from the National Institutes of Health on research bias. 

Case Study :  the collection and presentation of in-depth information about a specific individual, group, or community.  Often these data represent the subjective experiences of an individual or group.   Click here to access more information on the case study approach to research.  

Causality :  the relation between cause and effect.  Causality is the agency that links one process or event (the cause) with another process, state, or event (the effect).  The first of these is normally understood to be at least partly responsible for the occurrence of the second, thus the second is dependent upon the first.  Causality is an abstraction based upon experience that is used to show and explain how change happens in the world.  Below is a very useful video explaining causality and how it relates to research.

Cultural Relativism : the idea that cultures are value-neutral.  This means that rather than various cultures being a better or worse ways of organizing behavior, they are simply different.  In anthropology, this idea has been used to make sense out of behaviors and values that seem alien or morally wrong to an outside observer; it has also been used to raise awareness of the potential for bias by an observer.  The concept has been debated in anthropology and has raised concern that it inherently leads to moral relativism.   Most modern anthropologists use the idea of cultural relativism as a way to bracket off one’s own cultural assumptions and biases to the extent possible.  Here is a brief article on cultural relativism by anthropologist Clifford Geertz.

Data :  factual information, collected through systematic methods, that is used as a basis for reasoning and analysis of a phenomenon.

Deductive Reasoning:   a type of reasoning in which conclusions are formulated about particulars from general or universal premises.  Here’s Monty Python’s take on deductive reasoning.

Dependent Variable:  a variable that varies due, at least in part, to the impact of the independent variable. In other words, its value “depends” on the value of the independent variable. For example, in the variables “gender” and “academic major,” academic major is the dependent variable, meaning that your major cannot determine whether you are male or female, but your gender might indirectly lead you to favor one major over another.  Check out the video under the entry for independent variables  for more information on the difference between dependent and independent variables.

Emic : an approach to the study or description of a language or culture that focuses on its internal elements and logic and their functioning rather than in terms of any existing external scheme.  The term can also refer to the native explanation for a behavior or cultural pattern.  The video below will help you to understand the differences between emic and etic perspectives as they are understood by cultural anthropologists.

Etic : an approach to the study or description of a language or culture that is general, nonstructural, and objective in its perspective.  It is typically explanations for behavior from the perspective of the scientist/researcher observing a culture or language.

Epistemology:   theory of knowledge that questions how we know things, how knowledge is constructed, and what constitutes valid knowledge.  Here is a very detailed definition/discussion of   epistemology from the Stanford online dictionary of philosophy.

Ethnography:  method for studying study groups and/or cultures over an extended period of time using a variety of qualitative (and sometimes quantitative) research techniques. Ethnography employs participant observation, which is intended to allow researchers to understand a group through immersion into its lifestyles.  This allows for a detailed, in-depth, understanding of human experience.  Check out the TEDx video below for a nice discussion of the use of ethnography in business.

Field Studies : research studies carried out in natural settings, rather than in laboratories, classrooms, or other structured environments.

Focus Groups :  small, roundtable discussion groups charged with examining or discussing topics or problems associated with a research project.  In some cases, these may also involve discussion of solutions to identified problems.   Focus groups usually consist of 4-12 participants and are guided by moderators to keep the discussion moving and collect data.  Here is more on focus group research from the Robert Wood Johnson Foundation.

Grounded Theory:  an approach to research in which theories emerge from observing a group rather than being brought to the context of observation. Theories are grounded in the group’s observable experiences and interpretations, but researchers add their own insight into why those experiences exist.  Click here to access the website Grounded Theory Online .

Hypothesis : a tentative explanation or educated guess based on theory or observation that is used to predict a causal relationship between variables.  Click here to review some examples of hypotheses .

Independent Variable:   the conditions or variables of an experiment that are systematically manipulated by the researcher or a variable that is not impacted by the dependent variable, but that itself impacts the dependent variable.  Check out the video below for more information on the difference between dependent and independent variables.

Inductive Reasoning:  a type of reasoning in which a generalized conclusion is formulated generated based on particular instances.  Below is a video on the difference between inductive and deductive approaches to reasoning.

Naturalistic Observation:   observation of behaviors and events in natural settings rather than in experimental contexts that involve manipulation of variables or other types of interference.

Ontology:   a discipline of philosophy that explores the science of what is, the kinds and structures of objects, properties, events, processes, and relations in every area of reality.  Click here for a detailed discussion of logic and ontology from the Stanford online dictionary of philosophy.

Organization :  For the purposes of MMEO, and organization is an institutionalized structure that is formed for a specific purpose.  Examples of organizations are businesses, academic institutions, religious institutions, or government institutions.

Participant observation :  a form of qualitative research that involves participating in the activities of the people being observed as a way of developing an experience-near understanding of their behaviors and ideas.

Phenomenology:  a qualitative research approach that focuses on meaning expressed by individuals through their lived experience of a particular idea, concept, or event.  This link will take you to more information on phenomenology .

Probability :  the likelihood that a phenomenon will occur randomly. As a statistical measure, it is represented as p.

Qualitative research:  a systematic approach to creating knowledge about how people interpret their surroundings, construct meaning, and interpret the meanings they construct. Qualitative research relies upon subtle and complex techniques of observation, recording data, and writing to develop an interpretive framework for analyzing and explaining why people do what they do and think what they think.

Quantitative research:  Quantitative research focuses on identifying objective measurements of phenomena such as human behavior.  In human subjects research it makes use of statistical, mathematical, and numerical analysis of empirical data collected using instruments such as questionnaires or through analyzing and manipulating pre-existing statistical data using computational techniques. Quantitative research uses numerical data to draw general conclusions across groups of people as a way of explaining particular behaviors or phenomena.  This link to a site as USC will give you more details on quantitative research .

Questionnaire :  structured groups of questions used to gather information, attitudes, or opinions.  Questionnaires can be either quantitative, including forced-choice questions, or qualitative, including open-ended questions.

Random Sampling : a process used in research to draw a sample of a population that does not reflect any pattern or order beyond chance.

Reliability : the extent to which a research method yields consistent results.  If the observational or measurement instrument is reliable, then administering it to similar groups should yield similar results. Reliability is a prerequisite for validity. If a data collection approach is unreliable, then cannot produce trustworthy results.

Rigor:   degree to which research methods are carefully designed and carried out.

Sample :  any population researched in a study. In many studies, researchers often try to select a “sample population” that is believed to be representative of the behaviors or other qualities (race, ethnicity, gender) of people for whom results will be generalized.  This video will help you understand different types of sampling and the goals in sampling.

Sampling Error : the degree to which the results from the sample deviate from those that would be obtained from the entire population.  This can be a result of random error in the selection of participants and any corresponding reduction in reliability that arises as a result of that error.

Standard Deviation : a measure  used to quantify how much variation or dispersion there is in a set of data values.  A low standard deviation means that the data points tend to be close to the mean; a high standard deviation means the data points are spread out over a wider range of values and further from the mean.

Statistical Analysis :  application of statistical methods and theory to the collection, presentation, and interpretation of numerical data.

Statistical Significance:  in any experiment or observation that involves using a sample from a population, statistical significance refers to the likelihood that a behavior or set of behaviors is due to chance.  The probability that the null hypothesis can be rejected at a predetermined significance level [0.05 or 0.01].

Theory:   a general explanation about a specific behavior or set of events that is based on known principles and serves to organize related events in a meaningful way. A theory is not as specific as a hypothesis.

Triangulation:   a multi-method or pluralistic approach to research that uses a variety of methods to collect data from different viewpoints.  This produces a complex and multi-faceted data set that helps in checking the validity of findings.

Unit of Analysis:   the thing being observed, analyzed, and for which data are collected in the form of variables.

Validity — the degree to which a study accurately represents and assesses the specific phenomenon a researcher wants to measure.  This brief video will help you to understand the difference between validity and reliability in research.

Variable:  any characteristic or trait that can vary from person to person.  Race, gender, education level, hair color, age, political beliefs, religion are all examples of variables.  This link will take you to a website that provides more detail on variables.

Glossary of Key Research Terms

This glossary provides definitions of many of the terms used in the guides to conducting qualitative and quantitative research. The definitions were developed by members of the research methods seminar (E600) taught by Mike Palmquist in the 1990s and 2000s.

Citation Information

Members of the Research Methods Seminar (E600) taught by Mike Palmquist in the 1990s and 2000s. (1994-2024). Glossary of Key Terms. The WAC Clearinghouse. Colorado State University. Available at https://wac.colostate.edu/repository/writing/guides/.

Copyright Information

Copyright © 1994-2024 Colorado State University and/or this site's authors, developers, and contributors . Some material displayed on this site is used with permission.

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General Research Glossary

A-110 .  “Uniform Administrative Requirements for Grants and Agreements with Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations,” an OMB circular covering the award of grants and contracts, post-award requirements, and property standards.

A-133 .  “Audits of States, Local Governments, and Non-Profit Organizations,” an OMB circular setting standards for obtaining consistency and uniformity among federal agencies for the audit of recipients of federal awards.

A-21 .  “Cost Principles for Educational Institutions,” an OMB circular describing financial management procedures relevant to federal agreements with academic institutions and represent the “Cost Accounting Standards” for federal awards.

AAALAC .  American Association for the Accreditation of Lab Animal Care :  an organization that accredits research animal facilities.

Advance spending .  Authorization to expend funds on a project prior to receipt of the sponsor’s notice of award, e.g., to hire staff and purchase materials required to perform the scope of work.

Agency .  Synonym for “sponsor.”

Allowable costs .  Costs that may be charged to a grant, such as salaries and equipment, that meet the requirements of being reasonable, allocable to the project, and treated consistently at the institution, and not excluded by Circular A-21.

Audit .  A formal examination of an organization’s or individual’s accounts, financial situation, or compliance with applicable terms, laws, and regulations.

Authorized signature .  Signature of the person authorized to commit funds and facilities on grants and contracts.

AUTM .  Association of University Technology Managers .  Its mission is “to promote, support and improve academic technology transfer worldwide and demonstrate its benefits globally through education, advocacy, networking and communication.”

Award .  Funds provided by a sponsor to support a particular project.

Bequest .  An award given with few or no conditions specified, for instance to establish an endowment or to provide direct support for existing programs.

Broad Agency Announcement (BAA) .  An announcement describing a federal agency’s general research interest, soliciting proposals, and specifying the criteria for selecting proposals.

Budget .  The detailed estimate of the expenditures to be made under a project’s scope of work.

Budget category .  A section of the budget that includes a defined type of expenditure (e.g., salaries, fringe benefits, travel, patient costs).

Budget justification .  A description of the individual cost elements that together comprise the budget and the estimation methods used in costing the project.

Budget period .  The interval of time into which the project period is divided for budgetary and funding purposes:  generally one year.

CAS .  See Cost Accounting Standards

CDC .  Centers for Disease Control and Prevention (DHHS)

CFDA .  Catalog of Federal Domestic Assistance , a listing of all programs available to state and local governments, organizations, individuals, etc.

CFR .  Code of Federal Regulations:  general and permanent rules established by the Executive branch of the Federal Government.

Change order .  A written order signed by the contracting officer, modifying contract clauses or scope of work without the consent of the contractor.

Classified research .   Research sponsored by the federal government involving restrictions on the distribution or publication of the research findings or results following completion.

Close-out .  Completion of internal procedures and sponsor requirements to terminate or complete a research project.

Cognizant audit agency .  The federal office that is designated to perform audits for sponsored projects at a university (at UVA, the Department of Health and Human Services [DHHS]).

COGR .   Council on Governmental Relations , an association of colleges and universities that advise the government on the impact of its regulations on their business practices.

Competing proposal .  A proposal (1) submitted for the first time, (2) that was unfunded but is being re-submitted, or (3) for an ongoing project after the term of the original award expired.

Compliances and certifications .  Federal and state rules and requirements concerning the responsible handling of research involving human subjects, vertebrate animal care, and hazardous substances, as well as other legal issues (such as conflict of interest, drug-free workplace, etc.). Administrative officers of an institution must regularly certify, by their signature, compliance with these rules and regulations; individual investigators must comply with institutional requirements and must sign to that effect on the proposal cover sheet.

Confidentiality agreement .  A legal agreement preventing one or both party from disclosing confidential information belonging to the other party.  Also called a nondisclosure agreement.

Conflict of commitment .  Any situation in which non-university activities are sufficiently demanding of time and attention that they interfere with assigned duties or with responsibilities to students or the university.

Conflict of interest .  Situations in which employees use their positions for purposes that are, or give the appearance of being, motivated by a desire for private gain for themselves or others, such as those with whom they have family, business or other ties.

Consideration .  Anything of value that changes hands between the parties of contract.

Consortium agreement .  A document formalizing the terms and conditions under which a group of collaborative investigators (i.e., a consortium) at different institutions collaborate on a project.

Consultant .  An individual whose expertise is required by the PI to perform the research project. Consultant may be a paid or unpaid.

Continuation project (non-competing) .  A subsequent award on a project after the previous budget period has expired, on multi-year projects.  These do not compete with other proposals:  rather, satisfactory progress is assessed in determining whether to provide the next period’s funding.

Contract .  Agreement to provide services that primarily benefit the sponsor. For an award to be considered a contract, it normally must contain all of the following: detailed financial and legal requirements; specific statement of work to be performed; deliverables and/or reports required by the sponsor; accounting procedures to be followed; legally binding contract clauses.

Contract/grant officer .  A sponsor’s designee who is responsible for the business management aspects of an award.  In general, this individual works with the project (scientific) officer.

Cooperative Agreement .  An award involving greater agency involvement than a grant, during proposal preparation or in carrying out the scope of work.

Co-Principal Investigator (Co-PI) .  An investigator sharing responsibility for the direction of a research program. PHS/NIH does not recognize the concept of co-principal investigator, but does recognize multiple-PI projects.

Copyright .  A government grant of exclusivity in reproduction and sale of creative (e.g., literary, artistic, computer programs) inventions.

Cost Accounting Standards (CAS) .  Federally mandated accounting standards intended to ensure uniformity in budgeting and spending funds.

Cost-reimbursement contract/grant.   A contract or grant for which the sponsor reimburses the actual allowable costs incurred during the conduct of the work.

Cost-sharing.   University and nonfederal sponsor resources provided in support of sponsored programs; includes contributed effort and matching funds.  Cost-sharing contributions must meet the following criteria:  verifiability in University records; contributions are allowable, allocable, reasonable, and necessary to accomplish the scope of work; shared costs are not also used for other projects; and shared costs are identifiable in the proposal budget or justification.

Cover sheet .  The first page of a proposal, often in a format supplied by an agency, showing summary data on the proposal and PI, plus all required compliance check-offs

CRADA or CRDA.   Cooperative Research and Development Agreement.  A document allowing government investigators to collaborate with non-government scientists on common research projects.

CSR.   Center for Scientific Review (National Institutes of Health).  

DARPA.  Defense Advanced Research Projects Agency , the central R&D arm of the Department of Defense.

Data.  Recorded information, regardless of form or characteristic, describing the design or resulting from a scientific project.

Defense Acquisition Regulations (DAR) .  The regulations governing research projects sponsored by the Department of Defense.

Deficit.   Expenditures exceeding available funds.

Deliverable .  Items to be delivered to the sponsor, generally as required by contracts.  These might include technical reports, reagents, computer programs, etc.

DFARS.   Defense Federal Acquisition Regulation Supplement

DHHS.   Department of Health and Human Services

Direct costs.   Costs that are identified specifically with a sponsored project, such as salaries/fringe benefits, supplies, equipment, etc.

DOD.   Department of Defense (includes Air Force, Army, ARPA, and Navy)

Donation.   Transfer of equipment, money, goods, services, and property, much like a gift except often with more specific intent than the latter.

DRG .  Division of Research Grants (National Institutes of Health)

EDISON .   Interagency Extramural Invention Information Management System (for reporting of inventions created under federal funding)

Effort .  The amount of time (usually a percent of total professional effort) that individual expends on a project.

Effort report .   Periodic report of the time (as a percent of total) expended by an employee on sponsored projects and other professional activities.  The employee must sign the effort report, as required by law.

Effort, contributed .  Effort expended on a sponsored project that the sponsor does not compensate for; a form of cost sharing.

Encumbrance.   Funds set aside for a projected expense prior to their actual expenditure.

Endowment.   An income-generating fund usually provided as a gift in order to generate long-term support for faculty positions or research activities.

Equipment .  Property having a useful life of more than one year and an acquisition cost of more than $5,000 per unit on federal grants (exclusive of taxes and shipping).

Equipment, general purpose .  Equipment that can be utilized for activities other than the specific scope of work supported by a grant or contract (e.g., office equipment and furniture, computers, and photocopiers).

Equipment, government-furnished ,  Equipment provided to the university by the federal government or a government contractor; title may or may not remain with the government.

Equipment, special purpose .  Equipment that can be utilized only for research, medical, scientific, or technical activities.

Expanded authorities .  A policy of some federal granting agencies, which delegate prior approval authorities to awardees.

Expiration date.   The end of the performance period for a sponsored award.

Extension.   A delay of the expiration date by the sponsor to the awardee in order to complete the scope of work.  These generally are no-cost (no additional funds provided by the sponsor).

Facilities and Administrative (F&A) costs .  Also referred to as indirect costs, overhead, or administrative costs. These are incurred to conduct normal business activities of the organization receiving support that cannot be readily identified or directly charged to a particular project or activity (e.g., library, depreciation of facilities, heat).

Federal Acquisition Regulations (FAR) .  The policies and procedures for acquisition by federal executive agencies.

FDA .  Food and Drug Administration

FDP .  A cooperative effort among several 10 federal agencies to reduce the administrative burdens associated with research grants and contracts.

Federal Commons .  An on-line grants management system offering grants processing to awardees.  Includes funding opportunities, proposal submission, and award management modules.

Fellowship .  An award directly to an individual rather than an institution.

FIC .  Fogarty International Center (NIH)

Final report.   The technical or financial report required by the sponsor to complete a research project.

Fiscal Year (FY) .  The period for which annual accounts are kept (UVA:  July 1 through June 30; federal government:  October 1 through September 30).

Fixed-price contract/grant.   A contract or grant for which payment is based on a predetermined price, regardless of actual costs.

FOIA .  Freedom of Information Act

Fringe benefits .  Employee benefits paid by the employer. (e.g., FICA, workers’ compensation, medical insurance).  UVA has a negotiated fringe benefits rate with the federal government.

Funding cycle .  Periodic deadlines and review and award dates, which may occur either cyclically or throughout the year.

GCP .  Good Clinical Practices.

Gift .  Awards given with no restrictions specified. Gifts allow the recipient can manage their use, are not associated with deliverables, and are not overseen by the donor.

GLP .  Good Laboratory Practices.

GMP .  Good Manufacturing Practices.

Goldenrod .  UVA’s internal proposal routing form documenting PI assurances and institutional approval.

Governing law .  UVA, as a Virginia state agency, cannot accept a contract governed by the laws of another state or other jurisdiction:  contracts must be governed by the laws of the Commonwealth of Virginia or silent on the governing law.

Grant .  A type of financial assistance awarded to an organization for the conduct of research or other program as specified in an approved proposal. A grant, as opposed to a cooperative agreement, is used whenever the agency anticipates no substantial programmatic involvement during the performance of the activities.

Grant/Contract Officer.   A sponsor’s designee who is responsible for the business management aspects of an award.  In general, this individual works with the project (scientific) officer.

Grantee .  The recipient of a grant.

GSA .  General Services Administration

IACUC (Animal Care and Use Committee) .  An institutional  committee that reviews and approves the use of animal subjects in all research projects. It also oversees institutional animal facilities.

IBC .  Institutional Biosafety Committee

IDC.   Indirect Costs (= F&A costs)

Incremental funding.   A method of funding contracts that by the agency provides specific spending limits below the total estimated cost of the project. These interim limits may be exceeded at the contractor’s own risk.

Indemnification .  An agreement to hold harmless the other party in a contract, from legal actions or claims for damages. State agencies such as UVA cannot indemnify other parties, but can offer insurance clauses.

Indirect cost rate .  The rate established by negotiation with the cognizant federal agency (DHHS for UVA) on the basis of the institution’s projected costs for the year and distributed as prescribed in OMB Circular A-21.  Various rates exist for sponsored research, service, other projects, and on- vs. off-site activities.

Indirect costs .  Also referred to as facilities and administrative costs, overhead, or administrative costs. These are incurred to conduct normal business activities of the organization receiving support that cannot be readily identified or directly charged to a particular project or activity (e.g., library, depreciation of facilities, heating).

In-kind .  Contributions other than money, such as equipment, materials, or services of recognized value.

Institutional Authorized Official .  An individuals authorized by the Board of Regents to sign grants, contracts, and agreements on behalf of The University of Virginia.

Intellectual property (IP) .  Creations of the mind that include inventions, know-how, copyrightable works, or creative or artistic works. Intellectual property may be protected legally via patents, copyrights, and so on, or protected as trade secrets.

Invention .  A process, machine, manufacture, composition of matter, or design, or any new or useful improvement thereof, and any variety of plant which is or may be patentable under the laws of the United States or any other country.

Investigator-initiated proposal.   A submitted proposal that is not in response to an RFP or RFA.

Intergovernmental Personnel Agreement (IPA) .  A mechanism by which state employees may be assigned to work for a federal agency, or vice-versa, while remaining on the payroll of the “home” agency. Often used for a temporary assignment of a faculty member to a federal agency, with the faculty retaining his/her university benefits.

IRB .  Institutional Review Board (charged with ethical review and oversight of human subjects research).

Key personnel.   The personnel considered to be of primary importance to the successful conduct of a research project. The term usually refers to doctoral-level contributors, but may also include other individuals with specialized expertise.  In contracts, replacement of key personnel may require approval of the funding agency.

Letter of intent .  A document advising a funding agency that an application will be submitted in response to a specific solicitation. These letters often are used to guide the creation of a peer review committee.

Limitation of cost (LOC) .  A mandatory clause for cost-reimbursement type contracts stating that the sponsor is not obligated to reimburse the contractor for costs in excess of the stated amount. Similarly, the contractor is not obligated to continue performance once expenses reach the stated amount.

Line item budget .  A budget that lists the cost of individual project personnel and itemizes the costs for all other budgeted categories such as travel, supplies, equipment, etc. Also known as a detailed budget.

Lobbying certification .  An assurance that no federal funds have been used to influence federal officials in the award of a grant or contract.

Matching funds .  Funds obligated by the institution that are required by the granting or contracting agency.

Matching grant.   A grant requiring that a portion of the cost be obtained from other sources.

Materials transfer agreement .  A legally binding document in which one party releases a proprietary reagent, organism, or other item to another party for the purposes of research. It defines the field of use by the recipient and describes the intellectual property rights of sending and receiving parties.

Misconduct in science.   Fabrication, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting research. It does not include honest error or honest differences in interpretations or judgments of data.

Modification .  A document changing an existing award, such as approvals to carry over funds among project periods, changes in funding levels or in key personnel, etc.

Modified Total Direct Costs (MTDC) .  For federal awards, these are a subset of direct costs, normally excluding equipment, patient care, space rental, alterations and renovations, and subcontract costs in excess of the first $25,000.  These are the base on which F&A (indirect) costs are calculated.

NACUBO .  National Association of College and University Business Officers

NASA .  National Aeronautics and Space Administration

NCI .  National Cancer Institute (NIH)

NCRR .   National Center for Research Resources (NIH)

NCURA .  National Council of University Research Administrators

NEI .  National Eye Institute (NIH)

New award .  A grant, cooperative agreement, or contract that had not previously been awarded.

New proposal .  Proposals that are submitted to a particular sponsor for the first time.

NHGRI .  National Human Genome Research Institute (NIH)

NHLBI .  National Heart, Lung, and Blood Institute (NIH)

NIA .  National Institute on Aging (NIH)

NIAAA .  National Institute on Alcohol Abuse and Alcoholism (NIH)

NIAID .  National Institute of Allergy and Infectious Diseases (NIH)

NIAMS .  National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIH)

NICHD .  National Institute of Child Health and Human Development (NIH)

NIDA .  National Institute on Drug Abuse (NIH)

NIDCD .  National Institute on Deafness and other Communication Disorders (NIH)

NIDDK .  National Institute of Diabetes and Digestive and Kidney Diseases (NIH)

NIDR .  National Institute of Dental Research (NIH)

NIEHS .  National Institute of Environmental Health Sciences (NIH)

NIGMS .  National Institute of General Medical Sciences (NIH)

NIH .  National Institutes of Health

NIMH .  National Institute of Mental Health (NIH)

NINDS .  National Institute of Neurological Disorders and Stroke (NIH)

NINR .  National Institute for Nursing Research (NIH)

NLM .  National Library of Medicine

No-cost extension .  An extension of the period of performance beyond the expiration data to accomplish the scope of work.  By definition, no additional costs are provided.

Non-competing continuation .  A report on project progress that requests continuation funding for the next portion of the project period.

Non-compliance .  Failure to adhere to applicable regulations, policies, procedures or special conditions related to the conduct of research. These might include unapproved changes in project work scope, use of animals without IACUC approval, and breaches of clinical protocol methodology.

Nondisclosure agreement .  A legal agreement preventing one or both party from disclosing confidential information belonging to the other party.  Also called a confidentiality agreement.

Notice of grant award .  Also called “Notice of award.”  The legally binding document that serves as a notification to the recipient that a grant or cooperative agreement has been made.  The document lists or references the terms of the award and obligates sponsor funds.

NSF .  National Science Foundation

Off-campus .  Sponsored activities, less than 50% of which are conducted on university property or which charge rent to the project as a direct cost.

OHRP .  Office for Human Research Protections (DHHS).  This unit oversees DHHS Regulations for the Protection of Human Subjects (45 CFR 46), and offers guidance on ethical issues in biomedical and behavioral research.

OMB .  Office of Management and Budget.  OMB establishes government grants management policies and guidelines through circulars and common rules.

OMB circulars .  See A-21, A-110, and A-133 above.

On-campus (also on-site) .  Sponsored activities conducted on university property.  In general, when over 50% of such activity takes place within the University, the on-campus F&A rate will be applied to the project.

ONR .  Office of Naval Research

ORI .  Office of Research Integrity (in DHHS).  This office promotes research integrity in projects supported by the PHS, monitors institutional investigations of research misconduct, and facilitates the responsible conduct of research (RCR) through educational, preventive, and regulatory activities.

Patent .  A government grant of the right to stop others from making, using, offering for sale, or selling an invention.

Patent infringement .  Violation of the rights covered by a patent.

Patent prosecution .   Filing of a patent application and the subsequent actions required in order to obtain a granted patent and the maintenance thereof after the award.

Peer review .  A process by which committees of researchers from several institutions review and recommend applications to the funding agency.

Per diem .  A daily allowance paid to personnel working on a sponsored project to cover meals and lodging while traveling.

PHS .  Public Health Service

PHS 2590 .  Application for Continuation of a PHS Grant (National Institutes of Health )

PHS 398 .  Application Form for a PHS Grant (NIH, in the process of being replaced by the SF 424).

PRDA .  Program Research and Development Announcement:  a competitive solicitation for research, development, and related projects in a specified area of interest.

Pre-proposal .  A preliminary proposal of a research project and its estimated budget.  Successful PIs are asked by the sponsor to submit full proposals.

Principal Investigator (PI) .  The individual responsible for the conduct of research or other activity described in a proposal for an award.  The PI has primary responsibility for technical compliance, completion of programmatic work, and fiscal stewardship of sponsor funds.

Prior approval .  The requirement for written sponsor permission for changes in the scope of work, key personnel, use of funds for a project, etc., beyond the original proposal/approval.

Priority score .  A numerical value representing the rating given a proposal by a review committee. Grants are ordered on the basis of their priority scores in order for funding decisions to be made.

Program Announcement.   Notification of a research opportunity that will be available for several years.  Renewed in 3 years at NIH.

Program income .  Gross income earned by the recipient for activities supported by an award.

Program/Project Officer.   A sponsor’s technical officially overseeing an award.  This person works with the Principal Investigator of the awardee and with the sponsor’s grant/contract officer in overseeing the project.

Progress report.   A periodic summary of research progress required by the sponsor.

Project period .  The total time for which support of a project has been approved by the sponsor.

Proposal.   An application for funding including the technical description of the project, personnel, available resources, and funds requested.

Proprietary research .  Sponsored research involving restrictions placed by the sponsor on the distribution or publication of the research findings.

Rebudget .  The movement of funds from one budget category to another.  May require approval of the sponsor’s grant/contract officer.

Regulations .  The contractual rules and procedures governing sponsored research projects.

Renewal .  A competitively reviewed grant and cooperative agreement proposal requesting additional funds extending the scope of work and project period.

Representations and certifications (Reps & Certs) .  Statements of policies, practices, and commitments (e.g., conflict of interest, misconduct in science, debarment/suspension, delinquent federal debt, drug-free workplace, assurances on lobbying) which must be signed as part of some proposals, and especially for federal contract proposals.

Request for Applications (RFA) .  Focused programmatic announcement of a grant opportunity, for a topic of specific interest to a sponsor.  Usually a one-time solicitation, as opposed to a program announcement.

Request for Proposal (RFP) .  Announcement of a contract opportunity that specifies the anticipated area of research, methods to be used, deliverables, and characteristics of allowable applicants (e.g., small business concerns).

Research .  Systematic investigation aimed at the discovery, interpretation, or revision of facts or accepted theories or to make practical applications with the help of such knowledge.

Research, applied .  The systemic, intensive study directed toward producing results that are applicable to a particular problem.

Research, basic .  A systemic, intensive study designed to increase the body of knowledge in a particular field, rather than to develop specific, practical applications.

Responsible conduct of research .  As described by the DHHS Office of Research Integrity, this is comprised of the following components:  honest in conveying information and keeping commitments; accuracy and precision in reporting findings; using resources wisely; avoiding improper bias.

Revised proposal .  A modified request for funding for a project that previously was not funded by the sponsor.

SBIR .  Small Business Innovative Research

Scope of work .  The description of the work to be performed on a research project.

SF 424 .    Standard Form 424 (R&R).

Site visit .  An agency-initiated review of a proposed project conducted at the applicant’s institution.

Small Business Innovative Research (SBIR) .  A program under which a federal agency provides funds to small businesses.

Small Business Technology Transfer (STTR) .  A federal program providing funds to small businesses that are “teamed” with research institutions.

Sole source acquisition .  A procurement that does not provide full and open competition, but rather because one source is available.

Sponsor .  The organization or agency funding research project.

Sponsored project .  A research, training, or service activity supported by an external agency by means of a grant or contract.

Sponsored research .  Research supported by outside sources that is conducted by University employees using any University space or facilities.

SRA .  Society of Research Administrators

Stipend .  A payment made to an individual under a fellowship or training grant in accordance with pre-established levels to provide for the individual’s living expenses during the period of training.  Such individuals are not University employees but are covered by University policies and regulations.

Subcontract, subgrant, or subagreement .  A contract issued under a prime contract, agreement, purchase order, or grant for the procurement of services or program-related tasks over $10,000.  Subcontracts must be consistent with the terms and conditions of the master award, transferring a portion of the research or substantive effort of the prime award to another institution or organization.

Supplemental proposal .  A request to the sponsor for additional funds for an existing project:  may result, for example, from increased costs or changes in project design.

Task order .  A contractual document authorizing work and appropriating funds in a supplement to an existing contract or master agreement.

Teaming agreement .  An agreement between two or more parties to participate in a research teaching activity.

Terms of award .  Requirements imposed by the sponsor on the recipient by policy, statute, or regulations.

Total Direct Costs (TDC) .  The total of all direct costs of a project.

Total project costs .  Also known as total costs.  The allowable direct and indirect costs to carry out an approved project.

Unallowable costs .  Specific expenditures that cannot be charged, directly or indirectly, to federally sponsored agreements.

Unrestricted funds .  Monies with no requirements as to their use or disposition.  Gifts represent such funds.

Unsolicited proposal .  Proposals submitted to a sponsor that are not in response to an RFP or RFA. (See also Investigator-Initiated Proposal.

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Pocket Glossary for Commonly Used Research Terms

• Michael J. Holosko - University of Georgia, USA
• Bruce A. Thyer - Florida State University, USA, North-West University, Vaal Triangle Campus, Republic of South Africa
• Description

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• The Glossary of Research Terms chapter contains definitions and descriptions of over 1500 research terms. It is the heart of the glossary, features crisp and clear statements as to the meaning of each entry.
• Commonly Used Statistical Terms: A dedicated chapter offers a brief synopsis of commonly used statistical terms, ranging from the alpha coefficient to the Z-test. Questions related to the meaning of a statistical term will likely be found here.
• Commonly Used Acronyms, Symbols, Abbreviations and Terms Found in Research and Evaluation Studies are organized into categories so readers can easily find them: for example, research and evaluation studies, statistics, Internet, and U.S. federal government.
• Core Disciplinary Journals in Selected Social and Behavioral Science chapter lists the most highly ranked journals in over a dozen social and behavioral sciences and professional disciplines, as determined by their impact factors published by the Journal Citation Reports database. URLs are also provided to each journal so that the reader can locate each journal's individual webpage.

Sample Materials & Chapters

Chapter Two: Commonly Used Acronyms, Symbols, Abbreviations, and Terms Found in

Chapter Three: Commonly Used Statistical Terms

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Research 101 Glossary of Terms

Doctors and scientists use a lot of language that can be hard for the average person to understand. This "jargon" helps them communicate effectively with one another, but it can make learning about research difficult.

When we talk about health research, we sometimes need to use these terms to be as specific and transparent as possible.

So, to help, we've put together this list of common research terms and their definitions.

Common Health Research Terms

You can refer back to this page anytime you need to, and we'll update it to reflect new topics we post about.

Aggregate data

Data from a group of individuals that is combined into a summary format, for example, in tables or graphs. When data is aggregated (combined), individuals cannot be identified by their data. 

Clinical Research

Clinical research is a type of health science which aims to produce knowledge that is valuable for understanding human disease, preventing and treating illness, and promoting health.  

Coded study data

Data from a study which does not contain personally identifiable information (PII), for example, name, address, date of birth, social security number, etc. The PII is replaced by a code (usually a string of random letters and numbers) so no one can know who the participant is just from looking at the dataset. The participant’s corresponding personal information is kept separate to protect their identity as much as possible.

A group of individuals who share a common characteristic or group of characteristics who are observed in a study. For example, the feature they may have in common could be a health diagnosis or a treatment assignment.

Sometimes, this term can also be used to refer to a group that a study participant is assigned to, such as a “study branch”, "study group", or “study arm”. 

• In a study on diabetes, researchers may observe a set of traits patients diagnosed with diabetes who are on insulin (cohort 1) and who are not on insulin (cohort 2)
• In a study on how social media affects people of different ages, researchers might  observe symptoms in people age 10-15 (cohort 1), 16-20 (cohort 2), and 21-25 (cohort 3)

Confidentiality

Confidentiality refers to how an individual’s personal data is protected by people or groups granted permission to process it. It refers to how a person’s information is treated once it has been shared. Maintaining confidentiality is an important way to protect privacy and build trust.

Control group

The control group in a randomized controlled trial does not receive an “experimental treatment”, or the treatment that is being tested. Instead, they may receive no treatment, or another treatment that gets compared to the treatment being tested. The purpose of the control group is to compare research results between the group that receives the treatment and the group that doesn’t. 

For example, in a study that wants to learn whether a pain medication is helpful, one group would get the pain medication and the other group wouldn’t. The group that does not receive the pain medication is known as the control group. The data from these two groups could then be compared to learn more about whether the pain medication (the treatment or drug) is helpful.

De-identification

A process used to remove any personally identifying information (or PII) from data collected during a study. This is used to protect the identity of participants in a research study.

De-identified data

Data that is not linked to any personally identifying information (or PII), which means that it cannot be linked back to a specific person. 

Decentralized trial

A research trial that is not conducted at a physical location or “site” (also referred to sometimes as a “siteless” trial). Instead of having participants come to a location to complete study activities, they are able to participate from where they are (i.e. online, using home care, telemedicine visits, etc.)

Eligibility criteria

Criteria for who can or cannot participate in a research study, as defined by the researchers. These criteria must be met by all participants. Eligibility criteria are put in place to make sure that the researchers are able to get meaningful data to answer the study’s research questions, and/or protect people who may experience negative effects from a study. Eligibility criteria are different for any study.

For example, a study researching a birth control pill in females may exclude males. That same study may exclude females with heart conditions for their safety, if the birth control being tested is known to cause heart problems.

Eligibility screening

Questions or activities used to determine (or “screen”) if a person is eligible to participate in a study. This often occurs in the form of a survey, but could include other activities such as interviews or medical assessments.

The process of entering into a research study or trial. This can include a variety of steps, including agreeing to participate in a study by signing the informed consent form.

Exclusion criteria

Any criteria that would make a person ineligible to participate in a study. Exclusion criteria are created by the researchers to make sure the study results are meaningful and to protect potential participants from study activities that could be harmful to them. 

For example, a study may exclude participants who take a blood pressure medication, if there is reason to believe that people taking that type of medication could be harmed by the study. 

Good Clinical Practice

Good Clinical Practice (GCP) is an international guide for how to conduct ethical and good quality research. GCP applies to every aspect of a study, from start to finish. The purpose of this guide is to protect the rights and safety of study participants, as well as ensure the integrity and quality of study data.

Health research

Research that aims to learn about human health. This type of research can help us learn about, prevent, and treat health conditions. Also sometimes referred to as clinical research. 

HIPAA stands for the Health Insurance Portability and Accountability Act of 1996. It is a U.S. federal law that created guidelines to protect patients' PHI (personal health information). For more details on how HIPAA applies to research, click here . 

Inclusion criteria

Criteria that a person must meet to be eligible to participate in a study. 

For example, a study that is researching a blood pressure medication may require individuals to have high blood pressure. 

Informed consent

A process by which a person voluntarily confirms that they are willing to participate in a particular study. During this process, the person is given detailed information about the study so that they can make an informed decision about whether they want to participate. If a person decides to participate in a study, their consent is documented on an Informed Consent Form.

Informed Consent Form (ICF)

A form used to explain and document a person’s willingness to participate in a specific study. The form provides any important information a person needs to be able to decide whether participating in the study is right for them. For example, the form will include information on the purpose of the study, who is conducting the study, and any risks.

Interventional Research

Studies which are designed to understand the effects of treatment or preventive measures on a condition. This can also be described as “experimental research.” 

For example, a researcher may want to understand if an anxiety medication can also be used to treat chronic pain. In such a study, the researcher may give the anxiety medication to individuals with chronic pain, to see if the medication affects them. 

Institutional Review Board (IRB)

A group which independently reviews any research involving people. This group is made up of at least five members with different scientific and non-scientific backgrounds (for example, researchers, doctors, nurses, scientists, psychologists, patients, etc.)  The role of the IRB is to ensure that participants' rights and welfare are protected and that studies are carried out in an ethical manner.

Observational Research

Studies which are designed to observe what happens to a group of participants. Unlike interventional research, observational research does not try to introduce a treatment or product, but instead observes how participants behave naturally.

For example, a researcher may want to observe how depression affects the average number of steps a person walks per day. 

Participant

A person who enrolls (or takes part) in a research study after signing an informed consent form and completing any other study-required enrollment activities.

Person-Generated Health Data

Health-related data that is created, recorded, or gathered by individuals (or by family members or caregivers). Sources of PGHD include wearable devices or phones, electronic surveys, apps, or any other interactions with technology that generate personal data about health. 

Personally identifiable information (PII)

Personally identifiable information (PII) is any form of sensitive data that can be used to identify a person (for example, name or social security number). A study that collects PII is required to protect that data.

Privacy refers to a person’s right to limit access or processing of their personal information by other people or groups. This can include controlling what, how much, and when personal information is shared with others

Principal Investigator

The person(s) who leads and takes overall responsibility for a research study. Typically, this is a medical doctor or someone with a doctorate degree in a health field. The Principal Investigator (PI) makes sure that the research follows good scientific and ethical practices and that it can answer the research questions being asked (often, being asked by a study sponsor). The PI also oversees the research support staff.

Protected Health Information (PHI)

Protected Health Information (PHI) refers to personal health-related information that is shared between individuals or organizations who provide treatment, payment, and operations in healthcare. For example, this can include Medical Record Numbers, hospital bills, lab reports, etc. 

It’s important to note that PHI is different from PII. PII is an umbrella term for any information that can be traced to an individual’s identity, while PHI refers specifically to identifiable health information possessed by HIPAA covered entities. 

Protected group

Groups of people who are provided additional protections in health research based on federal regulations. In some cases, individuals in these groups may not be able to legally consent to participating in research by themselves and may require consent to be given by a caregiver or legally authorized representative. 

Examples of protected groups include children, pregnant women, and prisoners. 

Randomized Controlled Trial (RCT)

A study in which researchers randomly assign participants to different groups (also called arms or cohorts). The goal is to minimize bias and then compare the study results between the groups.

For example, a study may randomly assign participants to take either a new medication or a sugar tablet every day. The researchers will then use the data from participants to learn if the medication made a difference for the group that received it.

Real-world evidence

Clinical evidence that is generated from real-world data about the use, risks, and/or benefits of a medication, product, or treatment. 

Real-world data

Data about the use, risks, and/or benefits of a medication, product, or treatment that come from a variety of sources. For example, real-world data can come from clinical sources like electronic health records, claims and billing activities, product and disease registries. Or it can come from everyday sources like health apps and fitness trackers. 

The process of using scientific methods to collect, analyze, and interpret data collected from studies to contribute to knowledge about a topic. 

Research site

A location where research is conducted. This can include hospitals, universities, private medical practices, research institutes, and more. 

A sponsor may be an individual or pharmaceutical company, governmental agency, academic institution, private organization, or other group that initiates, oversees, and/or is financially responsible for the research. 

For example, a pharmaceutical company may initiate research to learn if the drug they make works, and pay another independent organization to actually conduct the study. 

Where research methods are used to collect, analyze, and interpret data collected from participants to contribute to knowledge about a topic. 

Information collected during a research study. It can include demographic information (race, age, education level), health information, descriptions of the participant’s progress, and other relevant information.

The process of exiting a research study or trial. All research studies are voluntary, which means that participants are free to stop participating at any time for any reason.

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Participants belong to a large community of people who help researchers learn more about important health conditions and treatments. Because they devote their time, data, and effort to research that can improve health care for all, it’s important that participants receive value in return for their contributions. 

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In 2018, Evidation launched the DiSCover Program, a study designed to help us gain a better understanding of what it’s like to live with this condition. More than 10,000 members participated in the program over the course of a year. 

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Glossary in a Dissertation – A Comprehensive Guide

Published by Owen Ingram at August 26th, 2021 , Revised On September 20, 2023

A list of glossary contains all those terms used in your dissertation, but the meanings of which may not be evident to the readers. Here is all you need to know about the glossary in a dissertation.

Basically, any term you use in your dissertation that you know, without a doubt, is not going to be common knowledge to readers outside of your field, is included in a list called glossary. And since every field has its unique, technical jargon, a glossary list can contain many terms some readers might not have even heard of before.

A typical glossary in a dissertation may look something like this:

Do you Even Need Glossary in your Dissertation to Begin with?

You may or may not be required to have a separate list of glossaries in your  dissertation . The decision whether to have a list of glossaries in a dissertation depends on whether it will improve the readability of your paper.

For example , if you are  writing a dissertation  for an engineering degree and have used several technical terms that readers—especially laymen—may not be familiar with, \ it is advised to add a glossary in a dissertation.

Listing Terms in a Glossary

A recommended practice of adding a glossary in a dissertation is to sort the terms alphabetically and provide a definition or explanations for each of those terms. Having the terms listed in alphabetical order will help the readers to easily locate the information they are interested in.

Location of a Glossary List in a Dissertation

The glossary list is generally placed at the beginning of the dissertation paper, just after the  list of tables and figures or the list of abbreviations.  However, if your paper does not have a list of abbreviations or a list of tables and figures, you can place the glossary right after the  table of contents .

This gives readers the opportunity to understand the meanings of key terms they are not familiar with even before they start to read the main content of the paper.

However, if you haven’t used a lot of technical terms in your dissertation, you can choose to provide an explanation and meanings of the few terms that you have used in the form of footnotes .

Difference Between Abbreviations and Glossary

It is important not to confuse the glossary in the dissertation with the abbreviations, which are put in the list of abbreviations.

A list of abbreviations contains all the terms that have abbreviations. For instance, if you have used terms like NASA , UNICEF , UNESCO , UN , NIH , etc., such terms along with what they stand for will come under the list of abbreviations.

Note, however, that only their full forms, and not their meanings, are mentioned in that list. That is what’s mentioned in a glossary list, though: meanings. Definitions of terms, terms that were used in the dissertation. The terms themselves aren’t abbreviation.

For instance, in a linguistics’ dissertation, you might end up creating a glossary list containing terms like phenomenology, code-switching, diglossia, etc. Notice how these are complete terms , not abbreviations.

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Example of a Glossary in Dissertation

If you haven’t created a list of glossaries before then you will find the below example of a glossary in a dissertation particularly useful:

Other Lists you can have in your Dissertation

You might also want to have a list of tables and figures as well as a list of abbreviations in your dissertation particularly if you are writing a master’s or PhD dissertation. However, make sure to keep the following order:

• Table of contents
• Lists of figures and tables
• List of abbreviations

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FAQs About Glossary in a Dissertation

What is a glossary.

It’s a list of special terms—single words, phrases, etc.—that are not commonly known to the ‘average’ reader or to a reader who isn’t an expert in that field.

What is included in a glossary?

Ideally, words are included in a glossary. However, in some cases—depending on the topic— abbreviations , phrases etc. might also be mentioned within the list of glossary in a dissertation. Sometimes, it might also include a brief definition of how to pronounce a certain word/phrase.

What is the best way to create a glossary?

Keep in mind two things while creating a glossary list: keep the language of the definition simple so that every kind of reader can understand it. That’s why a glossary is given, to begin with, to simplify technical jargon and inform laymen. Secondly, arrange the terms inside it alphabetically.

How many times can I include the same term in a glossary list?

No matter how many times a word or a phrase appears in your dissertation , include it and define it only once in your glossary. There should be no duplicate entries in a glossary list.

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Analysis : an examination of the topic you are studying. 

Baseline data : Recording the initial situation or condition before an intervention.

Bias : A loss of balance and accuracy in the use of research methods. It can appear in research via the sampling frame, random sampling, or non-response. It can also occur at other stages in research, such as while interviewing, in the design of questions, or in the way data are analyzed and presented. Bias means that the research findings will not be representative of, or generalizable to, a wider population (USC, 2018).

Blinding : Also known as masking, it is the process of not telling participants or researchers what treatment or intervention the participants are being given.  The purpose of this process is to prevent study participants and researchers from influencing the results (NIH, 2017).  

Capacity building : The development and strengthening of human and institutional resources (WHO, 2006).

Case Studies : Studies subject (the topic or research participant that is the focus of the study) in depth and can include qualitative and quantitative data.

Causation/Causality: The relationship between cause and effect (USC, 2018).

Clinical Study : A research study involving human volunteers (aka participants) that serves to add medical knowledge

Collaboration : The act of working together.  Can be individuals, communities, organizations, etc.

Community : Defined by who we are, our social connections or characteristics.

Community Engagement : A way in working so that everyone can participate and act to make change and address issues that affect the well-being of the community of focus.  It involves a partnership with individuals who identify within the community, with a special interest, or are in a similar situation. 

Correlation : Relationship of association.

Correlational/Descriptive Studies : Says issues or situations are related but cannot say one thing causes another.

Cost-Effective : The effectiveness or usefulness in relation to the cost (Perrin, 2016).

Data Analysis : The process of systematically applying statistical and/or logical methods to describe and illustrate, condense, and recap, and evaluate data. (ORI, n.d.)

Data collection : The process of gathering and measuring information on variables of interest in a systematic way that allows one to answer research questions, test hypotheses, and evaluate outcomes (ORI, n.d.).

Data Management : Describes the organization, storage, preservation, and sharing of data collected and used in a research project (University of Pittsburgh, 2018).

Data Reporting : The process of preparing and distributing research findings to the scientific community (ORI, n.d.).

Data : Observations that have been collected (Triola & Triola, 2006).

Dependent Variable (DV) : The variable that depends on other factors being measured (USC, 2018)

Efficacy : How well something works; the ability to produce intended result. 

Eligibility Criteria : The key characteristics or requirements participants must meet.

Equitable/Equity : The fair distribution of health determinants, outcomes, and resources within and between segments of the population (Healthy People 2020).

Ethics : A system of moral principles and values applied to all aspects of evaluation and research that involve contact with human subjects (Perrin, 2016).

Evaluability Assessment : The process of assessing a program for the evaluation process.

Evaluation instrument: Survey questionnaire designed to collect evaluation data.

Evaluation : Process to determine if goals and objectives of research and/or program were met and guidelines were followed (Perrin, 2016). 

Evidence : The facts, information, or data that supports research question or study.  

Evidence-based methods or practices : Also known as “best practices”, the process of using current, best evidence in one’s practice.

Experiment : Examines the differences between randomly assigned groups (randomization) and can show causation. 

External Validity : Extent to which results of a study can be generalized to other settings, people, & over time.

  Hypothesis : A proposed explanation for why something occurs. It is like an educated guess (Triola & Triola, 2006).

Immediate outcome : Benefits or results to participants by the end of a program.

Independent Variables (IV): The variable that you control and is not affected by the other variables you are trying to measure (USC, 2018)

Informed Consent : Ongoing process to assure human subjects continue to understand their involvement is voluntary.  It reflects the individual’s right to respect and autonomy (Perrin, 2016). 

Inputs : The invested resources volunteers, time, money, equipment, etc.

Institutional Review Board (IRB) : Committee that serves to formally approve, monitor, and review every type of research and evaluation with human subjects to protect the rights and welfare of the participants.

Internal Validity : How well the research design has been done.  It is measuring what was intended to be measured.

Intervention : In research, it is typically what is altered or changed to produce a desired effect or outcome.  It can be a program, a policy, behavior, treatment, and more. 

Investigation : Looking into or studying a subject or topic. 

Investigator : Researcher who oversees patient care during the study.

Logic model : Graphic depiction of a program from the planning phase through the evaluation.  A way to communicate the big picture (Perrin, 2016).

Long-term outcomes : Benefits or results that participants get a long time (after six months) after completing a program. Long-term outcomes are similar to impact.

Methods : Systematic approaches to the conduct of an operation or process. It includes steps of procedure, application of techniques, systems of reasoning or analysis, and the modes of inquiry employed by a discipline (USC, 2018).

Naturalistic Observation- Collects information by observing people, do not interfere with them, make a record of events.

Neighborhood :  It is an area between natural/manufactured boundaries.  Can be determined by physical, administrative, or psychological boundaries.

Objective:   To be unbiased, something that can be observed by anyone and can be verified

Outcomes : Results, changes or benefits that come from a program.

Outcomes : The results, changes, or benefits of a program.  They can be short medium or long.  Should be measurable and phrased in terms of change visual improvements, financial gains, connections, etc.

Outputs : Tangible materials or activities delivered educational pamphlets, volunteer hours, meetings, etc.

Participant Rights : The protections that are guaranteed to all participants involved in a research study.

Populations : The complete collection of all elements (Triola & Triola, 2006).

Primary Data : Data collected for the very first time (Goodman and Thompson Sanders, 2018).

Program impact : Condition or situation improvement as a result of a program.

Program input : Resources allocated for a program.

Program output : Educational materials and activities developed and delivered.

Public Health Surveillance Data : Data that tracks disease and health conditions.

Public Participation : Is based on the assumption that those who are affected by a decision have a right to be involved in the decision-making process and requires two-way communication and collaborative problem solving.

Qualitative : Observations or data collection that typically cannot be expressed numerically. 

Quantitative : Approaches used to create numerical data to answer evaluation questions. It is data that uses numbers.

Quasi-Experiment : It examines the differences between assigned groups but does not use randomization.

Reliability : The consistency and quality of a measure.  Commonly known as “repeatability”. 

Research : The investigation into and study of materials and sources in order to establish facts and reach new conclusions.  It is a process to learn new information (ORI, n.d.).

Sampling : The process of choosing participants for research (ORI, n.d.).

Scientific Method : A process or series of steps used to observe the world around you and create a hypothesis about relationships in the world (ORI, n.d.). 

Secondary Data : Data that has already been gathered (Goodman and Thompson Sanders, 2018)

Stakeholder : An individual who may be involved in, interested in, or affected by a program.

Subjective: Relies on a point of view, feelings/emotions, or personal experience 

Summative Evaluation : A comprehensive or cumulative evaluation that is conducted and made public to provide program decision makers and potential consumers with judgments about that program’s worth via important criteria. 

Survey Data: Collection of information on specific behaviors, experiences, events. Relies on questionnaires and interviews.

Systematic : Following a specific process or method of steps.

Systematic Procedures : The process of research that involves specific, ordered steps to reduce error and increase ability of replication. 

Validity : When a measure to captures the intended construct.  It describes whether findings truly represent what you are claiming to measure. 

Variables : Any characteristic or trait that can vary (USC, 2018).

Vulnerable Populations : Populations that when involved in research require special protections and regulations, a higher level of scrutiny, and limitations on research subject due to issues of informed consent (Salazar, Crosby, & DiClemente, 2015).

• Goodman, M. & Thompson Sanders, V. (Eds.). (2018). Public Health Research Methods for Partnerships and Practice . New York, NY: Routledge.
• Healthy People 2020.  (2014). Disparities. Retrieved from https://www.healthypeople.gov/2020/ about/foundation-health-measures/Disparities
• National Institute of Health. (2017).  NIH Clinical Trials and You: The Basics.  Retrieved from https://www.nih.gov/health-information/nih-clinical-research-trials-you/basics
• Office of Research Integrity. (n.d.).  Retrieved from https://ori.hhs.gov/
• Perrin, K.M. (2016). Essential of Planning and Evaluation for Public Health . Burlington, MA: Jones & Bartlett Learning. 
• Salazar, L., Crosby, R., &DiClemente, J. (2015). Research Methods in Health Promotion . San Francisco, CA: Jossey-Bass.
• Triola, M.M. & Triola, M.F. (2006). Biostatistics for the Biological and Health Sciences . Boston, MA: Pearson Education.
• University of Pittsburgh. (2018). Research Data Management @ Pitt.  Retrieved from https://pitt.libguides.com/managedata
• University of Southern California. (2018). Glossary of Research Terms.  Retrieved from http://libguides.usc.edu/writingguide/researchglossary
• University of Southern California. (2018). Organizing Your Social Science Research Paper: Independent and Dependent Variables. Retrieved from http://libguides.usc.edu/writingguide/variables
• World Health Organization. (2006).  Retrieved from http://www.who.int/tobacco/control/capacity_building/background/en/

For information on more research terms, please review this glossary from the University of Southern California. 

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• What is a Glossary? | Definition, Templates, & Examples

What Is a Glossary? | Definition, Templates, & Examples

Published on 26 May 2022 by Tegan George . Revised on 25 October 2022.

A glossary is a collection of words pertaining to a specific topic. In your thesis or dissertation, it’s a list of all terms you used that may not immediately be obvious to your reader.

Your glossary only needs to include terms that your reader may not be familiar with, and it’s intended to enhance their understanding of your work. Glossaries are not mandatory, but if you use a lot of technical or field-specific terms, it may improve readability to add one.

If you do choose to include a glossary, it should go at the beginning of your document, just after the table of contents and (if applicable) list of tables and figures or list of abbreviations . It’s helpful to place your glossary at the beginning, so your readers can familiarise themselves with key terms prior to reading your work. Remember that glossaries are always in alphabetical order.

To help you get started, download our glossary template in the format of your choice below.

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Example of a glossary

Citing sources for your glossary, additional lists to include in your dissertation, frequently asked questions about glossaries.

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Glossaries and definitions often fall into the category of common knowledge , meaning that they don’t necessarily have to be cited.

However, it’s always better to be safe than sorry when it comes to citing your sources , in order to avoid accidental plagiarism .

If you’d prefer to cite just in case, you can follow guidance for citing dictionary entries in MLA or APA Style for citations in your glossary. Remember that direct quotes should always be accompanied by a citation.

In addition to the glossary, you can also include a list of tables and figures and a list of abbreviations in your thesis or dissertation if you choose.

Include your lists in the following order:

• List of figures and tables
• List of abbreviations

A glossary is a collection of words pertaining to a specific topic. In your thesis or dissertation, it’s a list of all terms you used that may not immediately be obvious to your reader. Your glossary only needs to include terms that your reader may not be familiar with, and is intended to enhance their understanding of your work.

Definitional terms often fall into the category of common knowledge , meaning that they don’t necessarily have to be cited. This guidance can apply to your thesis or dissertation glossary as well.

However, if you’d prefer to cite your sources , you can follow guidance for citing dictionary entries in MLA or APA style for your glossary.

A glossary is a collection of words pertaining to a specific topic. In your thesis or dissertation, it’s a list of all terms you used that may not immediately be obvious to your reader. In contrast, an index is a list of the contents of your work organised by page number.

Glossaries are not mandatory, but if you use a lot of technical or field-specific terms, it may improve readability to add one to your thesis or dissertation. Your educational institution may also require them, so be sure to check their specific guidelines.

A glossary is a collection of words pertaining to a specific topic. In your thesis or dissertation, it’s a list of all terms you used that may not immediately be obvious to your reader. In contrast, dictionaries are more general collections of words.

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Child Care and Early Education Research Connections

The research glossary defines terms used in conducting social science and policy research, for example those describing methods, measurements, statistical procedures, and other aspects of research; the child care glossary defines terms used to describe aspects of child care and early education practice and policy.

Welcome to the SOM Clinical Research Glossary

Quickly look up the meaning of words, acronyms, or abbreviations commonly used in clinical research:

• Narrow your search by typing the word you are looking for in the search box. Clear the search box to start a new search.
• Use the alphabet bar for quick filtering of words by first letter or select a word category to explore words that are related. Remove the letter or word filters by clicking the respective ALL button.

Return to the glossary index page after each word search using the « Back to Glossary Index link.

• Adverse Drug Reaction (ADR)
• Adverse Event (AE)
• Adverse Reaction (AR)
• Age of majority
• AIR (Activities Interests and Relationships)
• ALCOA (Attributable, Legible, Contemporaneous, Original, Accurate)
• ALCOA Plus, ALCOA+
• Ancillary review
• Applicable Clinical Trial (ACT)
• Applicable regulatory requirements
• Approved drug
• Aspirational benefit
• Association for Clinical and Translational Science (ACTS)
• Association for the Accreditation of Human Research Protection Programs (AAHRPP)
• Association of Clinical Research Professionals (ACRP)
• Audit report
• Audit trail
• Baseline assessment
• Billing Coverage Analysis (BCA)
• Biological Product
• Biological specimen
• Biologics License Application (BLA)
• Biomedical Research Imaging Center (BRIC)
• Biospecimen
• Biospecimen Processing Facility (BSP)
• Breach of confidentiality
• Budget justification
• Budget period
• Budget revision
• Business Associate
• Business Associate Agreement (BAA)
• Carolina Data Warehouse for Health (CDW-H)
• Case Report Form (CRF)
• Ceded review
• Centers for Disease Control and Prevention (CDC)
• Centers for Medicare & Medicaid Services (CMS)
• Centralized monitoring
• Certificate of Confidentiality (CoC)
• Certified copy
• Clinical and Translational Research Center (CTRC)
• Clinical and Translational Science Awards (CTSA) Program
• Clinical development
• Clinical investigation
• Clinical monitor
• Clinical research
• Clinical Research Accountability Unit (CRAU)
• Clinical Research Associate (CRA)
• Clinical Research Coordinator (CRC)
• Clinical Research Management System (CRMS)
• Clinical Research Support Office (CRSO)
• Clinical significance
• Clinical study
• Clinical trial
• Clinical Trial Agreement (CTA)
• ClinicalTrials.gov
• Clinical Trials Quality Assurance (CTQA) Program
• Code of Federal Regulations (CFR)
• Co-investigator
• Collaborative Institutional Training Initiative (CITI)
• Collateral benefit
• Commercial Institutional Review Board (IRB)
• Common data model
• Common Rule
• Common Terminology Criteria for Adverse Events (CTCAE)
• Compensation
• Competitive Renewal
• Computable Phenotype
• Concomitant medication
• Confidential Disclosure Agreement (CDA)
• Confidentiality
• Conflict of Interest (COI)
• Conflict of Interest Office
• Consent capacity
• Continuing noncompliance
• Continuing review
• Contract Research Organization (CRO)
• Control group
• Coordinating Center (CC)
• Corrective and Preventive Action (CAPA) Plan
• Data acquisition
• Data and Safety Monitoring Board (DSMB)
• Data and Safety Monitoring Committee (DSMC)
• Data and Safety Monitoring Plan (DSMP)
• Database Management System (DBMS)
• Data encryption
• Data Integrity
• Data management
• Data Management and Sharing Plan (DMS Plan)
• Data Management Plan (DMP)
• Data Management System (DMS)
• Data Monitoring Committee (DMC)
• Data Use Agreement (DUA)
• Delegation of Authority (DOA) Log
• Demographic data
• Department of Health and Human Services (DHHS)
• Direct benefit
• Direct cost
• Disapproval
• Discontinue
• Disease registry
• Dosage regimen
• Dose Limiting Toxicity (DLT)
• Double blinding
• Drug toxicity
• ECRT (Effort Certification and Reporting Technology)
• Electronic Case Report Form (eCRF)
• Electronic Data Capture (EDC)
• Electronic Health Record (EHR)
• Electronic Informed Consent (eIC)
• Electronic Medical Record (EMR)
• Elements of informed consent
• Eligibility criteria
• Embryonic Stem Cell Research Oversight (ESCRO) Committee
• Encounter Level Data
• Environment, Health and Safety (EHS)
• Essential document
• Exclusion criteria
• Exculpatory language
• Exempt review
• Expanded access
• Expedited review
• Experimental drug
• Experimental group
• Export Compliance Office
• Export control
• Fabrication
• Falsification
• Family Educational Rights and Privacy Act (FERPA)
• FDA Form 482
• FDA Form 483
• FDA Form 1571
• FDA Form 1572
• Feasibility assessment
• Federalwide Assurance (FWA)
• Food and Drug Administration (FDA)
• Food, Drug and Cosmetics Act
• Free text data
• Full board review
• Generalizability, Generalization
• Good Clinical Practice (GCP)
• Grant application
• Grant Number
• Greater than minimal risk
• Health literacy
• Healthy volunteer
• HIPAA authorization
• HIPAA covered entity
• HIPAA (Health Insurance Portability and Accountability Act)
• HIPAA Privacy Rule
• Humanitarian Device Exemption (HDE)
• Humanitarian Use Device (HUD)
• Human Research Protection Program (HRPP)
• Human subject
• Human Subjects Research (HSR)
• Identifiable biospecimen
• Identifiable private information
• Impartial witness
• Inclusion criteria
• Inclusion/Exclusion (I/E) criteria
• Independent Ethics Committee (IEC)
• Independent IRB
• Indirect benefit
• Indirect Facility & Administrative (F&A) costs
• Individual Conflict of Interest (COI)
• Industry Contracting (IC)
• Industry sponsored study
• Informed Consent Form (ICF)
• Informed Consent (IC)
• Institution
• Institutional Biosafety Committee (IBC)
• Institutional Conflict of Interest (COI)
• Institutional Integrity and Risk Management (IIRM)
• Institutional Official (IO)
• Institutional Privacy Office (IPO)
• Institutional Privacy Officer
• Institutional Review Board Information System (IRBIS)
• Institutional Review Board (IRB)
• Interaction
• International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9CM)
• International Council for Harmonisation (ICH)
• Intervention
• Interventional study
• Investigation
• Investigational device
• Investigational Device Exemption (IDE)
• Investigational drug
• Investigational Drug Service (IDS)
• Investigational New Drug (IND)
• Investigational New Drug (IND) safety report
• Investigational plan
• Investigational product (IP)
• Investigator
• Investigator agreement
• Investigator-initiated study
• Investigator's Brochure (IB)
• IRB application
• IRB approval
• IRB Authorization Agreement (IAA)
• IRB expiration
• IRB of record
• Just-in-Time (JIT)
• Key information
• Legally Authorized Representative (LAR)
• Legally effective informed consent
• Letter of intent
• Life-threatening adverse event
• Limited dataset
• Lineberger Comprehensive Cancer Center (LCCC)
• Local considerations
• Longitudinal study
• Long Term Follow-Up (LTFU)
• Lost to Follow Up (LTFU)
• Manual of procedures (MOP)
• Material transfer agreement (MTA)
• Medical device
• Medical monitor
• Medical record
• Medical Record Number (MRN)
• Memorandum of understanding (MOU)
• Minimal risk
• Monitoring plan
• Monitoring report
• Multicenter study
• Multisite study
• National Institutes of Health (NIH)
• New Drug Application (NDA)
• NIH National Library of Medicine (NLM)
• NIH Public Access Policy
• No Cost Extension (NCE)
• Nonclinical study
• Noncompliance
• Nondisclosure agreement (NDA)
• Nonsignificant Risk (NSR) medical device
• Nonsignificant Risk (NSR) medical device study
• North Carolina Translational and Clinical Sciences (NC TraCS) Institute
• Not Human Subjects Research (NHSR)
• Notice of Award (NOA)
• Notice of privacy practices
• Not reasonably available (as it applies to locating a parent)
• Observational study
• Observational Study Monitoring Board (OSMB)
• Office for Human Research Protections (OHRP)
• Office for Innovation, Entrepreneurship and Economic Development (IEED)
• Office of Clinical Trials (OCT)
• Office of Human Research Ethics (OHRE)
• Office of Research Communications (ORC)
• Office of Research Development (ORD)
• Office of Research Information Systems (ORIS)
• Office of Research (OoR)
• Office of Research Support and Compliance (ORSC)
• Office of Sponsored Research (OSR)
• Office of Technology Commercialization (OTC)
• Office of the Vice Chancellor for Research (OVCR)
• Office of University Counsel (OUC)
• Off-label use
• On-site monitoring
• Open-label trial
• Organizational Conflict of Interest (COI)
• Package insert
• Parental permission
• Participant
• Participant engagement
• Participant partners
• Participating site
• Patient Centered Outcomes Research Network (PCORnet)
• Patient level data
• Patient registry
• Personnel Profile and Training System (PaTS)
• Pharmacogenomics
• Pharmacokinetics (PK)
• Pilot study
• Placebo effect
• Plain language
• Possibly related to the research
• Pragmatic trial
• Preclinical research
• Principal Investigator (PI)
• Privacy board
• Privacy Rule
• Private information
• Program announcement
• Program officer
• Promptly Reportable Information (PRI)
• Prospective study
• Protected Health Information (PHI)
• Protocol amendment
• Protocol deviation
• Protocol Review Committee (PRC)
• PubMed Central (PMC)
• Quality Assurance (QA)
• Quality Control (QC)
• Quality Improvement (QI)
• Questionnaire
• Radiation Safety Committee (RSC)
• Radiation Safety Subcommittee (RSS)
• Radioactive Drug Research Committee (RDRC)
• RAMSeS (Research Administration Management System & electronic Submission)
• Randomization
• Reasonable possibility
• Recruitment
• Recruitment period
• Recruitment plan
• Recruitment status
• REDCap (Research Electronic Data Capture)
• Registry study
• Regulatory binder
• Reliance agreement
• Relying Institution
• Research administrator
• Research Compliance Program (RCP)
• Research Coordination & Management Unit (RCMU)
• Research misconduct
• Research personnel
• Research plan
• Research registry
• Research study
• Research team
• Research team members
• Responsible conduct of research
• Retention plan
• Retrospective study
• Reviewing IRB
• Reviewing IRB Institution
• Risk-based monitoring
• Root Cause Analysis (RCA)
• Safety and Security Committee
• Schedule of activities (SOA)
• Schedule of Assessments
• School of Medicine (SOM)
• Scientific Review Committee (SRC)
• Screen failure
• Screening log
• Sensitive Information (SI)
• Serious Adverse Event (SAE)
• Serious and Unexpected Suspected Adverse Reaction (SUSAR)
• Serious noncompliance
• Short form consent
• Side effects
• Significant Risk (SR) medical device
• Significant Risk (SR) medical device study
• Single blinding
• Single IRB (sIRB)
• Site Initiation Visit (SIV)
• Site investigator
• Site Master File (SMF)
• Society of Clinical Research Associates (SoCRA)
• SOM Conflict of Interest Committee (COIC)
• Source data
• Source documents
• Sponsored Program Office (SPO)
• Sponsored Research Agreement (SRA)
• Sponsor-investigator
• Standard of Care (SOC)
• Standard Operating Procedure (SOP)
• Stopping rules
• Stratification
• Structured data
• Study Coordinator (SC)
• Study design
• Study documentation
• Study monitor
• Study population
• Sub-investigator
• Subject binder
• Subject chart
• Subject identification number/code
• Suspected Adverse Reaction
• Target enrollment
• Termination
• Test article
• Therapeutic misconception
• Tolerability
• Trial Master File (TMF)
• Unanticipated Adverse Device Effect (UADE)
• Unanticipated Problem Involving Risk to Subjects or Others (UPIRSO)
• UNC Health Network Entities
• UNC Health Privacy Office
• Underserved population
• Unexpected adverse event
• University of North Carolina at Chapel Hill
• Vulnerable populations
• Washout Period
• Work Instruction (WI)

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The Research Glossary

The free online glossary for key terms and concepts used in clinical research.

Statement of the Investigator form that must be filed by an investigator running a clinical trial to study a new drug or agent. The investigator agrees to follow the U.S. Food and Drug Administration (FDA) Code of Federal Regulations for the clinical trial. The investigator verifies that he or she has the experience and background needed to conduct the trial and that it will be done in a way that is ethical and scientifically sound.

The portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA).

Electronic Records and Electronic Signatures-Provides guidance for companies using paperless record-keeping systems and ensures the use of electronic record-keeping systems are documented securely, authenticity, and are adequately maintained.

regulations pertaining to INDs

Protection of Human Subjects. Compliance with these parts is intended to protect the rights and safety of subjects involved in investigations filed with the Food and Drug Administration.

Financial Disclosure by Clinical Investigators.This section and conforming regulations require an applicant whose submission relies in part on clinical data to disclose certain financial arrangements between sponsor(s) of the covered studies and the clinical investigators and certain interests of the clinical investigators in the product under study or in the sponsor of the covered studies.

Institutional Review Boards. Ensures initial and continuing review of research. Regulates reportings, changes, approvals, and eliminates apparent immediate hazards to the human subjects. .

regulations pertaining to devices.

A value that is outside of the normal range value, both low or high.

Error free data, any changes or amendments should be accompanied by documentation to support the changes.

A list or disclosure of any known/potential costs that could accrue beyond the trial procedures

An unintended reaction to a drug taken at a normal dose.

any untoward medical occurrence in a study subject administered a pharmaceutical product; it does not necessarily have a causal relationship with the treatment.

a notice or announcement in a public medium promoting clinical trial.

Principles by which Good Documentation of data: Attributable, Legible, Contemporaneous, Original, Accurate, and Complete

Other available treatments or no treatment at all.

A professional group that publishes research to advance public health and advocates for the interests of registered physician-members

Used to express willingness to participate in research by persons who are by definition too young to give informed consent but are old enough to understand the proposed research in general, its expected risks and possible benefits, and the activities expected of them as subjects.

credentialing organization recognizing professionals involved in all aspects of clinical studies/trials who have demonstrated the knowledge, skills, and abilities to perform ethical and responsible clinical research by passing proctored exams.

This means that the evidence or data collected is attributable to the person collecting it. This ensures accountability. This contains a record of who performed an action and when.

The initial time point in a clinical trial that provides a basis for assessing changes in subsequent assessments or observations. At this reference point, measurable values such as physical exam, laboratory tests, and outcome assessments are recorded.

The potential positive outcomes that should be disclosed to the participants.

A point of view or preference which prevents impartial judgment in the way in which a measurement, assessment, procedure, or analysis is carried out or reported.

A sample of material, such as urine, blood, tissue, that may be used for a laboratory test or stored in a biorepository to be used for research.

The financial plan for clinical trials, including cost and expenses.

a record of the information collected from a subject during a trial. The information that is collected is based on what the protocol specifies.

is a division of the U.S. Food and Drug Administration (FDA) that monitors drugs.

A credential award for those who has met eligibility requirements, demonstrated proficiency of specific knowledge and job‐related skills, and passed the standardized certification exam.

An abnormal value with a result where a course of treatment has had genuine and quantifiable effects

Clinical trials are a kind of clinical research designed to evaluate and test new interventions such as a device or medications. Clinical trials are often conducted in four phases. The trials at each phase have a different purpose and help scientists answer different questions.

typically work for CROs. They are responsible for monitoring the study at study sites. They visit sites and look at the data collected and make sure the site is following the protocol. They work closely with the clinical research coordinators at the study sites.

An individual that handles the administrative and day-to-day responsibilities of a clinical trial and acts as a liaison for the clinical site. This person may collect the data or review it before it is entered into a study database.

NIH defines a clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious, and effective. Behavioral clinical trials involving an intervention to modify behavior (diet, physical activity, cognitive therapy, etc.) fit this definition of a clinical trial.

CTA serve as a legally binding contract between a sponsor and site. It outlines each party's responsibilities and obligations for the clinical trial.

A software system used to manage clinical trials in clinical research. This CTMS will serve as a single, centralized, web-based enterprise resource to support clinical research studies conducted

This is a visit in which the sponsor of the research study ensure that all of the necessary aspects of the study closure have been completed

The Code of Federal Regulations is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government.

an overt or implicit threat of harm is intentionally presented by one person to another in order to obtain compliance or consent

Any form of reimbursement or monies for time/ or travel. This can be in many forms, checks, on a loaded payment card, gift card, or transportation card. Other compensations may include hotel, travel, and food.

Are there blank spaces in the data collection points? Even if there is an N/A you must write “N/A” in order to satisfy this element of ALCOA-C!

Prescription and over-the-counter drugs and supplements a study participant has taken along with the study intervention. This information may be collected as a history item as well as during the study_assignment. Some studies may collect only those medications that may interact with the study or intervention or that may exclude an individual from participating in a study_assignment.

Ensurance of the participants' private information being in compliance with HIPAA and all privacy laws.

A conflict of interest occurs when individuals involved with the conduct, reporting, oversight, or review of research also have financial or other interests, from which they can benefit, depending on the results of the research.

Potential issues that could result from a subject withdrawing prior to completion date.

Site information, including address, email address and phone numbers for study staff. Contacts may also include IRB and Sponsor information.

Is the documentation happening in real time vs. retroactively documenting an occurrence.

this is when the IRB re-reviews the study to determine if it is appropriate for the study to continue, as is or with modifications.

This is the Clinical Trial Agreement (CTA) of Clinical Research Agreement (CRA). This is an agreement with a for-profit company providing funding or a drug/device for a Clinical Trial. This can be a Sponsor-initiated or Investigator-Initial-Clinical Trial

The group of individuals in a clinical trial assigned to a comparison intervention.

The regimen is being compared to a control; the control being a placebo (medically ineffectual treatment) or a standard treatment.

A clinical trial in which at least one group of participants is given a test intervention, while at least one other group concurrently receives a control intervention.

A group organized to coordinate the planning and operational aspects of a multi-center clinical trial. CCs may also be referred to as Data Coordinating Centers (DCCs) or Data Management Centers (DMCs).

A CAPA Plan is a series of actions taken to resolve a compliance issue, and most importantly, to prevent further recurrence. A CAPA plan will focus on the immediate noncompliance and the broader scope of the problem.

The communication between site and sponsor, CRO, or any other important person(s).

a company that provides clinical trial management services for the pharmaceutical, biotech, and medical device industries.

A curriculum vitae is a document that showcases a persons’ academic and professional accomplishments. It is used to apply for positions within areas where a person's specific knowledge or expertise is required.

A software system to manage relationships with customers

a committe of experts reviewing clinical trial data on an ongoing basis to ensure the safety of study subjects and validity and integrity of the data.

Plan included with the grant application for clinical trials which establishes the overall framework for data and safety monitoring, how adverse events will be reported to the IRB and the NIH and, when appropriate, how the NIH Guidelines and FDA regulations for INDs and IDEs will be satisfied.

This is the process of locking a clinical trial database. This action is taken to prevent any further changes to the database. The database is locked after review, query resolution and determination that it is ready for analysis.

The processes of handling the data collected during a clinical trial from development of the study forms/CRFs through the database locking process and transmission to statistician for final analysis.

A plan that documents the processes for handling the flow of data from collection through analysis. Software and hardware systems along with quality control and validation of these systems, as relevant are described.

Trials executed through telemedicine and mobile/local healthcare providers, using processes and technologies that differ from the traditional clinical trial model

studies executed virtually through telemedicine with our without a “site”, using processes and technologies differing from the traditional clinical trial model.

is a set of ethical principles regarding human experimentation developed originally in 1964 for the medical community by the World Medical Association (WMA). It is widely regarded as the cornerstone document on human research ethics

a list of who is authorized to do certain tasks on a trial.

refers to the practice of looking for better ways to identify a particular disorder or condition.

A trial design in which neither the investigator or the subject knows which treatment the subject is receiving.

Indication that the clinical trial intervention produces a desired therapeutic effect on the disease or condition under investigation.

A test used to check a heart’s rhythm and electrical activity

an electronic record of the information collected from a subject during a trial. The information that is collected is based on what the protocol specifies.

A digital version of a COA (Clinical Outcome Assessment), which measures and records how a patient is feeling or functioning

is a web-based software application used to collect, clean, transfer, and process data in clinical trials.

is an electronic version of a patients medical history, that is maintained by the provider over time, including demographics, progress notes, problems, medications, ect.

an alternative to the conventional paper consent form, this must be desinged compliant with 21 CFR Part 11.

An electronic investigator site file (eISF) is a technology solution designed to organize, collect, store, track, and archive required and essential study documents for an individual site involved in a particular research study

Electronic patient-reported outcomes (ePRO) are patient-provided information about symptoms, side effects, drug timing and other questions recorded on an electronic device during a clinical trial

An electronic version of regulatory at the CRO and Sponsor level. Tells the story of how the trial ran across all sites told by the official documents maintained.

List of criteria guiding enrollment of participants into a study_assignment. The criteria describe both inclusionary and exclusionary factors, (e.g. inclusion criterion - participants must be between 55 and 85 years old; exclusion criterion

The process of registering or entering a patient into a clinical trial. Once a patient has been enrolled, the participant would then follow the clinical trial protocol

an electronic version of the story of how a trial ran, told by the official documents maintained. Referred to as a “reg binder” or “ISF” at the site level.

When correcting data, it should meet the ALCOAC GDP with one line crossing out the error, then initial, date, and short explanation of the correction.

A type of eligibility criteria. These are reasons that a person is not allowed to participate in a clinical study

This is also known as the “Inspectional Observations”. This is a list of conditions or practices that indicate the potential violation of the FDA’s requirements. The observations on the FDA Form 483 are listed in descending order of importance. This is not an all inclusive list but more of a snapshot of possible issues noted at the site. This form is a public document that is available only by request.

Is the process of evaluating the particular site for the possibility of conducting the clinical trial or study. This process is to ensure that the site is able to to conduct the trial, within the budget and the timeline as well as maintain the integrity of the data and participant safety

When a clinical investigator or staff member has disclosable financial interests and arrangements, the disclosure statement submitted to FDA is required to include a description of any steps taken to minimize the potential for bias resulting from any of the disclosed financial interests and arrangements.

The United States Food and Drug Administration is a federal agency of the Department of Health and Human Services. The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.

A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial participants are protected.

The guideline that outlines requirements for designing, conducting, recording and reporting trials that involve the participation of human subjects

The term that describes the standard by which documents are created and maintained.

is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

A government agency that provide health services to Americans.

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) is a federal law that required the creation of national standards to protect sensitive patient health information from being disclosed without the patient's consent or knowledge.

The first comprehensive Federal protection for the privacy of personal health information. The Privacy Rule regulates the way certain health care groups, organizations, or businesses, called covered entities under the Rule, handle the individually identifiable health information known as protected health information (PHI).

A patient or healthy individual who is or becomes a participant in research, either as a recipient of the intervention or as a control.

Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) Identifiable private information

A type of eligibility criteria. These are the reasons that a person is allowed to participate in a clinical study

The protocol will specify the inclusion/exclusion criteria for enrollment into a clinical trial. This is colloquially referred to as I/E ("I" "E") in the field. The inclusion criteria must be present and the exclusion criteria absent for a subject to be eligible for the trial.

An informed consent document is typically used to provide subjects with the information they need to make a decision to volunteer for a research study. Federal regulations (45 CFR 46.116 ) provide the framework for the type of information that must be included as part of the consent process.

An informed consent form is a document used in clinical research that outlines important information about the study to potential participants. It is a legal document that provides prospective participants with an explanation of the purpose, procedures, and risks associated with the research study, as well as the potential benefits and alternatives. The informed consent form also explains the participant's rights and obligations during the study, including their ability to withdraw at any time without penalty. The form is usually written in lay language and must be signed by the participant or their legally authorized representative before they can participate in the study. The informed consent process is an essential part of ethical research, ensuring that participants fully understand the risks and benefits of the study before they decide to participate. It is also a legal requirement in most countries and is necessary to protect both the participants and the researchers.

A document that describes the rights of a study participant and provides details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document.

In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects. Sometimes called an Independent Ethics Committee(IEC)

An independent body constituted of medical, scientific, and nonscientific members whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trials, protocols and amendments, and of the methods and material to be used to obtaining and documenting informed consent of the trial participant.

Helps clinical trial sponsors and sites manage the patient and drug supply logistics throughout a clinical trial.

are the technologies that research sites use to enroll patients into clinical trials, randomize patients, and manage study drug supplies. Othernames: Interactive Web Response System (IWRS)/Interactive Voice Response System (IVRS)

This visit is conducted by the CRA to review source documents and study related materials to ensure protocol and regulatory compliance. This visit is completed during the conduct of the study

supports aviation with global standards for airline safety, security, efficiency and sustainability.

an organization that brings together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration.

A procedure or treatment such as a drug, nutritional supplement, gene transfer, vaccine, behavior or device modification that is performed for clinical research purposes.

a request from a study sponsor to obtain FDA approval to administer investigational drug to humans.

The IP may be a drug, biologic, medical device, or combination product that has not received a marketing approval.

(sometimes called Clinical Investigator or more often Principal Investigator (PI)) is an individual responsible for the preparation, conduct, and administration of a clinical trial.

This is a meeting where everyone involved with the new clinical trial to meet and become familiar with the study, including learning about the roles of the study

The Investigator’s Brochure is a comprehensive compilation of clinical and nonclinical data on the investigational product (drug, supplement, device or other product) maintained by a drug developer or investigator that contains the body of information about the investigational product obtained before and during a drug trial.

This is the process in accordance with FDA regulations, to which the IRB must review and approve all research involving humans prior to any research activities may begin. The IRB has the authority to approve, require modification in or disapprove the research.

Documentation after it has happened and notating it as “late entry”.

Is the documentation able to be read easily and clearly.

The long form embodies all the elements of informed consent as required under 21 CFR 50.25. When the long form is used, a copy must be provided to the person signing the form, that is, the subject or the subject's legally authorized representative.

A set of procedures describing study conduct. A MOP is developed to facilitate consistency in protocol implementation and data collection across study participants and clinical sites.

A procedure in which the investigator administering the assessments and intervention as well as the participants in a clinical trial are kept unaware of the treatment assignment(s). Single blinding usually refers to the study participant(s) being unaware, and double blinding usually refers to the study participant(s) and any of the following being unaware of the treatment assignment(s): investigator(s), monitor, and data analyst(s).

The primary Federal agency for conducting and supporting medical research.

A unique identification code given to each clinical study record registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier

An application submitted by the manufacturer of a drug to the FDA, after the clinical trial has been completed, for a license to market the drug for a specified indication.

Also know as a confidently agreement. This is a contract that establishes a confidential relationship. The party or parties signing the agreement agree that sensitive information they may obtain will not be made available to any others.

A abnormal value that does not have a genuine effect.

The total amount of subjects the sponsor wants to enroll into participation in the study.

A ten point code that describes the basic principles of ethical behavior in the conduct of human experimentation.

The safety and data monitoring body for observational studies with large or vulnerable populations or risks associated with tests or standard of care.

A federal government agency within the Department of Health and Human Services (DHHS) charged with the protection of human subjects participating in government funded research. It issues assurances and oversees compliance of regulatory guidelines by research institutions.

Provides leadership in the protection of the rights, welfare, and wellbeing of subjects involved in research conducted or supported by the U.S. Department of Health and Human Services.

A study in which the subjects and the investigator are aware of the drug and/or dose that is being administered.

A clinical trial in which investigators and participants know which intervention is being administered.

Is the documentation the first pen to paper? Fun fact- if you take your measurements down on a napkin- that napkin is now SOURCE! Original records should be preserved, meaning the material used should be durable, in the case of duplicates, the creator of the original records should confirm the authenticity of the copies.

Refers to a medicine that can be bought without a prescription.

Subject, Sponsor, and/or Site has the right to terminate their participation at any point during the trial.

not inclusive ● Study Title- This is meant to explain the key features of the study purpose, design, population , procedures, timeline, and participant safety. ● Study Name ● Title Page ● Summary ● Flow Chart/Study Schema/Schedule of Events ● Baseline -An initial measurement that is taken at an early time point and used for comparison over time to look for changes. ● Introduction ● Study Objectives ● Study Design ○ Is it controlled? If so, what is the control? ○ Is it randomized? ○ Is it blinded? ● Randomization procedures ● Blinding ● Unblinding (breaking the blind) procedures ● IP ○ Name ○ Storage ○ Dosage ○ Formulation ○ Route of administration ○ Regimen ● Subject Selection ● I/E ● Enrollment Procedures ● Pre-Screening ● Screening ● Concomitant Medications (“Conmeds”) ○ Prescription ○ OTC ○ Herbal Supplements ○ Vitamins ● Exclusionary Medications ● AEs ● SAEs ● Data Recording ● Data Quality Assurance ● Data Analysis/Statistics

A type of observational study that collects information about patients' medical conditions and/or treatments to better understand how a condition or treatment affects patients in the real world

The process (in a living organism) of absorption, distribution, metabolism, and excretion of a drug or vaccine.

Researchers test an experimental drug or treatment in a small group of people for the first time. The researchers evaluate the treatment’s safety, determine a safe dosage range, and identify side effects.

The experimental drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.

The experimental study drug or treatment is given to large groups of people. Researchers confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.

Post-marketing studies, which are conducted after a treatment is approved for use by the FDA, provide additional information including the treatment or drug’s risks, benefits, and best use.

A placebo is an inactive treatment. In fact, a placebo may be in a pill or tablet form, or it may be an injection or a medical device. Whatever the form, placebos often look like the real medical treatment that is being studied except they do not contain the active medication.

A method of investigation in which an inactive substance/treatment (the placebo) is given to one group of participants, while the test article is given to another group. The results obtained in the two groups are then compared to see if the investigational treatment is more effective in treating the condition.

The aim of a preclinical study is to collect data in support of the safety of the new treatment. Preclinical studies are required before clinical trials in humans can be started.

Activities before obtaining informed consent to determine initial eligibility for and interest in a study. Pre-screening may be performed over the telephone, in-person or on-line and may not include any research procedures

A visit to ensure pre-qualification of a site and eliminate sites that do not possess adequate qualities to conduct the trial.

This is to ensure pre qualification of the site and eliminates sites that do not meet the qualifications to conduct the clinical trial or study. This visit must take place to determine if additional resources should be used in order to perform a Site initiation Visit

Looks for better ways to prevent disorders from developing or returning. Different kinds of prevention research may study medicines, vitamins, vaccines, minerals, or lifestyle changes.

The person in charge and responsible for a clinical trial.

A pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo or other control) of the clinical trial.

A person's health information including but not limited to demographics, medical history, test/lab results, insurance information, ect.

Directions for how to run a particular trial.

A written description of a change(s) to or formal clarification of a protocol.

Failure to conduct a study as described in the protocol. The failure may be accidental or due to negligence and in either case, the protocol deviation should be documented. This also includes failure to comply with federal laws and regulations, the institution's commitments and policies, and standards of professional conduct and practice. Examples of noncompliance include:

Internal document created as part of the ongoing quality control process summarizing compliance with the protocol and listing protocol deviations and/or violations.

The reasoning behind a trial being conducted- what is the end goal? What is the desired outcome?

All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded) and reported in compliance with GCP and the applicable regulatory requirements.

The internal operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of trial related activities have been fulfilled (e.g., data and form checks, monitoring by study staff, routine reports, correction actions, etc.).

explores ways to improve comfort and the quality of life for individuals with a chronic illness.

The process of assigning clinical trial participants to treatment or control groups using an element of chance to determine the assignments in order to reduce bias.

The patient population is randomly allocated to treatment groups. This helps reduce bias by ensuring there isn’t a pattern in assigning treatment to the subjects.

The act of trying to find the right patients for a clinical trial.

The targeted number of patients to screen or enroll in a clinical trial.

Advertisements and other items used to help find participants in the study.

The plan that outlines how individuals will be recruited for the study and how the study will reach the recruitment goal.

The story of how a trial ran is told by the essential documents maintained. Referred to as “reg binder” or “ISF” at the site level.

A systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

the process of keeping patients/subjects in the study or engaged to participate in the study.

The strategy and tactics designed to keep patients enrolled in clinical trials, and from discontinuing participation and “dropping out.”

the targeted number of patients to keep in the tria after enrollment. Should be as close to 100% as possible.

The site’s plan to keep patients in the study long-term.

The potential negative outcomes that need to be disclosed to the participants.

an adaptive approach that directs monitoring focus and activities to the evolving areas of greatest need which have the most potential to impact patient safety and data quality.

A plan that outlines the oversight of a clinical trial.

An independent individual, often a clinician who is appointed by the NIA and performs data and safety monitoring activities in low-risk, single site clinical studies. The SO advises the NIA regarding participant safety, scientific integrity, and ethical conduct of a study_assignment. The SO is advisory to the Institute Director.

the process by which activities are evaluated to determine whether they are eligible for enrollment in a clinical trial.

An essential document that records all individuals who entered the screening process. The screening log demonstrates the investigator’s attempt to enroll a representative sample of participants.

A process designed to determine individual’s eligibility for participation in a clinical research study_assignment.

aims to find the best ways to detect certain disorders or health conditions

This is any untoward medical occurrence at any dose that results in death, is life-threatening, requires hospitalization (or prolongation of hospitalization), results in persistent or significant disability, or is a birth defect.

An IRB approved short form may be used in appropriate situations where the elements of the consent form are presented to the subject or subject’s legal authorized representative. It is a written summary of the information to be presented orally which is signed by the subject or subject’s LAR.

A study that is set up so that participants do not know which study treatment they are getting.

This is a visit conducted to evaluate the sites and it’s investigators, resources and the sites capabilities to conduct study terms. Infrastructure, adequacy and availability of the site facilities

The site initiation visit is a required visit to prepare and set up a research site to conduct a study and must occur prior to patient recruitment.

This is a critical visit that’s completed by the Sponsor prior to the start of the study. During this visit the Sponsor ensures that the investigators team has all of the necessary resources and is ready to conduct the human subjects research conducted under the Investigational New Drug (IND) or Investigational Device Exemption Application (IDE). The SIV ensures that the Investigator and team is aware of the responsibilities with the Study Protocol and are familiar with the study documentation, investigational product management and administrative procedures.

This is a meeting with a sponsor representative in order to ensure that the institution is fully capable and equipped to run the clinical study or trial. This visit may also be referred to as the Site Selection Visit (SSV) or Pre Study Qualification Visit (PSQV)

Record of the monitor (CRA) visiting the site. They are required to sign in and sign out.

an organization established to support global clinical research communities

Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, participant diaries, recorded data from automated instruments, x-rays, etc.) that are used in a clinical trial.

documents in which data collected for a clinical trial is first recorded. The data is usually later entered in an electronic data capturing system (EDC).

This is the process by which the data within the CRF or other data that has been collected is compared against the original source of information

The company, institution or organization that takes on legal responsibility for the initiation, management and/or financing of the research.

Treatment that is accepted by medical experts as a proper treatment for a certain type of disease and that is widely used by healthcare professionals.

Detailed written instructions to achieve uniformity of the performance of a specific function across studies and patients at an individual site.

Established safety criteria that would either pause or halt a study due to reasons including but not limited to futility or risk(s) to the participants.

Separation of a study cohort into subgroups or strata according to specific characteristics such as age, gender, etc., so that factors which might affect the outcome of the study, can be taken into account.

This is also known as the Feasibility Award, when a site is chosen by the sponsor to conduct a trial based on their feasibility.

in a clinical trial, the participants make up the study population.

A delegated member of the research tream that helps back up the PI and preform study related procedures.

Any unfavourable occurrence in a trial participant that is judged to have a major impact on their health and was not anticipated and could potentially be due to the intervention under investigation.

The Belmont Report summarizes ethical principles and guidelines for research involving human subjects. Three core principles are identified: respect for persons, beneficence, and justice.

Regulatory at the CRO and Sponsor level. Tells the story of how the trial ran across all sites told by the official documents maintained.

a list of who is trained to do what on a trial.

looks for better ways to treat disorders from developing or returning. Different kinds of prevention research may study medicines, vitamins, vaccines, minerals, or lifestyle changes.

The trial master file (TMF) is the collection of essential documents which allows the conduct of a clinical trial to be reconstructed and evaluated

Any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in a nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application) or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.

Unanticipated problems involving risks to subjects or others, which meet all of the following criteria:

Any problem or event that in the opinion of the local investigator meets all three of these criteria: Serious, Unanticipated (Not already described as a potential risk in the approved materials), and Related.

A procedure in which one or more parties to the trial are made aware of the treatment assignment(s).

A response to the Tuskegee Syphilis Study. Signed into law in 1974 and created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Identifies the basic principles of research conduct and oversees human experimentation in medicine

Third party companies to help with services and ancillary procedures of the clinical trial. Some examples may be payment services, central readers for procedures or imaging, and/or recruitment companies.

Ensuring patients agree completely unforced or uncoerced to be a subject in the study trial. Giving the patient alternatives, risk/benefits, and ample time to consent.

Includes children, pregnant women, prisoners, handicapped persons, the mentally disabled, people with acute or chronic severe mental illness, economically disadvantaged, and educationally disadvantaged. When some or all of the subjects are likely to be vulnerable to coercion or undue influence additional safeguards should be included in the study to protect the rights and welfare of these subjects.

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Nih clinical research trials and you, glossary of common terms, clinical research.

Clinical research is medical research that involves people to test new treatments and therapies.

Clinical Trial

A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

Healthy Volunteer

A Healthy volunteer is a person with no known significant health problems who participates in clinical research to test a new drug, device, or intervention.

Inclusion/Exclusion Criteria

Inclusion/Exclusion Criteria are factors that allow someone to participate in a clinical trial are inclusion criteria . Those that exclude or not allow participation are exclusion criteria .

Informed Consent

Informed consent explains risks and potential benefits about a clinical trial before someone decides whether to participate.

Patient Volunteer

A patient volunteer has a known health problem and participates in research to better understand, diagnose, treat, or cure that disease or condition.

Phases of Clinical Trials

Clinical trials are conducted in “phases.” The trials at each phase have a different purpose and help researchers answer different questions.

• Phase I trials — An experimental drug or treatment in a small group of people (20–80) for the first time. The purpose is to evaluate its safety and identify side effects.
• Phase II trials — The experimental drug or treatment is administered to a larger group of people (100–300) to determine its effectiveness and to further evaluate its safety.
• Phase III trials — The experimental drug or treatment is administered to large groups of people (1,000–3,000) to confirm its effectiveness, monitor side effects, compare it with standard or equivalent treatments.
• Phase IV trials — After a drug is licensed and approved by the FDA researchers track its safety, seeking more information about its risks, benefits, and optimal use.

A placebo is a pill or liquid that looks like the new treatment but does not have any treatment value from active ingredients.

A Protocol is a carefully designed plan to safeguard the participants’ health and answer specific research questions.

Principal Investigator

A Principal Investigator is a doctor who leads the clinical research team and, along with the other members of the research team, regularly monitors study participants’ health to determine the study’s safety and effectiveness.

Randomization

Randomization is the process by which two or more alternative treatments are assigned to volunteers by chance rather than by choice.

Single- or Double-Blind Studies

Single- or double-blind studies (also called single- or double-masked studies) are studies in which the participants do not know which medicine is being used, so they can describe what happens without bias. In single-blind ("single-masked") studies, you are not told what is being given, but the research team knows. In a double-blind study, neither you nor the research team are told what you are given; only the pharmacist knows. Members of the research team are not told which participants are receiving which treatment, in order to reduce bias. If medically necessary, however, it is always possible to find out which treatment you are receiving.

Types of Clinical Trials

• Diagnostic trials determine better tests or procedures for diagnosing a particular disease or condition.
• Natural history studies provide valuable information about how disease and health progress.
• Prevention trials look for better ways to prevent a disease in people who have never had the disease or to prevent the disease from returning.
• Quality of life trials (or supportive care trials) explore and measure ways to improve the comfort and quality of life of people with a chronic illness.
• Screening trials test the best way to detect certain diseases or health conditions.
• Treatment trials test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.

This page last reviewed on April 20, 2023

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