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NIH Definition of Clinical Trial Case Studies

The case studies provided below are designed to help you identify whether your study would be considered by NIH to be a clinical trial. Expect the case studies and related guidance to evolve over the upcoming year. For continuity and ease of reference, case studies will retain their original numbering and will not be renumbered if cases are revised or removed.

The simplified case studies apply the following four questions to determine whether NIH would consider the research study to be a clinical trial:

  • Does the study involve human participants?
  • Are the participants prospectively assigned to an intervention?
  • Is the study designed to evaluate the effect of the intervention on the participants?
  • Is the effect being evaluated a health-related biomedical or behavioral outcome?

If the answer to all four questions is “yes,” then the clinical study would be considered a clinical trial according to the NIH definition.


See this page for more information about the NIH definition of a clinical trial.


On this page:

General Case Studies

Updated: 4/28/2021
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  • Does the study involve human participants? Yes, the study involves human participants.
  • Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to receive an intervention, one of two drugs.
  • Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of the drugs on the level of the protein in the participants’ blood.
  • Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the effect being evaluated, the level of a protein, is a health-related biomedical outcome.
This study is a clinical trial.
Keyword(s): Drug, Mechanistic
  • Does the study involve human participants? Yes, the study involves human participants.
  • Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to receive an intervention, the approved drug.
  • Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the drug’s effect on the level of the biomarker.
  • Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the effect being evaluated, the level of a biomarker, is a health-related biomedical outcome.
This study is a clinical trial.
Keyword(s): Drug, Mechanistic
  • Does the study involve human participants? Yes, the study involves human participants.
  • Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to receive an intervention, compound A.
  • Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate how the body interacts with compound A
  • Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the effect being evaluated, pharmacokinetic properties, is a health-related biomedical outcome.
This study is a clinical trial.
Keyword(s): Drug, Mechanistic
  • Does the study involve human participants? Yes, the study involves human participants.
  • Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to receive an intervention, the investigational drug.
  • Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to assess safety and determine the maximum tolerated dose of the investigational drug.
  • Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the effect being evaluated, safety and maximum tolerated dose, is a health-related biomedical outcome.
This study is a clinical trial.
Keyword(s): Drug
  • Does the study involve human participants? Yes, the study involves human participants.
  • Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to receive an intervention, the chronic disease management program.
  • Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to determine the maximum tolerated dose of the program to obtain adequate adherence.
  • Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the effect being evaluated, tolerable intensity and adequate adherence of the intervention, is a health-related outcome.
This study is a clinical trial.
Keyword(s): Clinical Care
  • Does the study involve human participants? Yes, the study involves human participants.
  • Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to receive an intervention, the investigational drug or placebo.
  • Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of the investigational drug on the participants’ symptoms.
  • Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the effect being evaluated, relief of symptoms, is a health-related outcome.
This study is a clinical trial.
Keyword(s): Drug
  • Does the study involve human participants? Yes, the study involves human participants.
  • Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to receive an intervention, the investigational drug.
  • Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of the investigational drug on the subject’s disease progression.
  • Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the effect being evaluated, disease progression, is a health-related outcome.
This study is a clinical trial.
Keyword(s): Drug
  • Does the study involve human participants? Yes, the study involves human participants.
  • Are the participants prospectively assigned to an intervention? No, in this context the IVD would not be considered an intervention. The IVD is being used to test its ability to measure antibody levels, but not to test its effects on any health-related biomedical or behavioral outcomes. 
This study is not a clinical trial.
Keyword(s): Device
  • Does the study involve human participants? Yes, the study involves human participants.
  • Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to an intervention, measurement of an antibody level, with the idea that knowledge of that antibody level might affect clinical management.
  • Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate how knowledge of the level of an antibody might inform treatment.
  • Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the effect being measured, how blood antibody levels inform treatment, is a health-related outcome.
This study is a clinical trial.
Keyword(s): Device, Clinical Care
  • Does the study involve human participants? Yes, the healthy volunteers are human participants.
  • Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to an intervention, different durations of sleep deprivation followed by a blood draw.
  • Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to measure the effect of different durations of sleep deprivation on stress hormone levels.
  • Is the effect being evaluated a health-related biomedical or behavioral outcome?
  • Yes, the effect being evaluated, stress hormone levels, is a health-related biomedical outcome.
This is a basic experimental study involving humans.
Keyword(s): Behavioral, Mechanistic, Basic Experimental Study Involving Humans (BESH)


* Basic Experimental Studies involving Humans (BESH) use an intervention to understand fundamental aspects of phenomena. These studies are subject to NIH stewardship policies including Good Clinical Practice Training and the NIH Policy on Dissemination of NIH-Funded Clinical Trial information. For more information, see our BESH webpage.
  • Does the study involve human participants? No, the study does not involve human participants because only de-identified samples and information are used.
This study is not a clinical trial.
Keyword(s): Drug, Biospecimans, Observational
  • Does the study involve human participants? Yes, patients are human participants because the blood and information are identifiable.
  • Are the participants prospectively assigned to an intervention? No, secondary research with biospecimens or health information is not a clinical trial.
This study is not a clinical trial.
Keyword(s): Drug, Biospecimans, Observational
  • Does the study involve human participants? Yes, the healthy volunteers are human participants.
  • Are the participants prospectively assigned to an intervention? No, sample collection (blood draw) is not an intervention in this context.
This study is not a clinical trial.
Keyword(s): Observational
  • Does the study involve human participants? Yes, the study involves human participants.
  • Are the participants prospectively assigned to an intervention? No, participants are not prospectively assigned to receive an intervention as they are receiving drugs as part of their clinical care. The surveys are being used for measurement, not to modify a biomedical or behavioral outcome.
This study is not a clinical trial.
Keyword(s): Drug, Observational
  • Does the study involve human participants? Yes, the study involves human participants.
  • Are the participants prospectively assigned to an intervention? No, there is no intervention. The therapies are prescribed as part of clinical care; they are not prospectively assigned for the purpose of the study. The study is observational.
This study is not a clinical trial.
Keyword(s): Clinical Care, Observational
  • Does the study involve human participants? Yes, the study involves human participants.
  • Are the participants prospectively assigned to an intervention? No, the measures needed to assess the outcomes are not interventions in this context, as the study is not intended to determine whether the measures modify a health-related biomedical or behavioral outcome.
This study is not a clinical trial.
Keyword(s): Mechanistic, Observational

The details of Case #13B have been revised and updated as of April 28, 2021.
  • Does the study involve human participants? Yes, healthy volunteers are human participants.
  • Are the participants prospectively assigned to an intervention? Yes, healthy volunteers are prospectively assigned to randomly selected combinations of allergens.
  • Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is evaluating the effects of different combinations of allergens on the immune response in healthy individuals.
  • Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the study evaluates the severity and mechanism of the immune reaction to allergens, which are health-related biomedical outcomes.
This is a basic experimental study involving humans
Keyword(s): Mechanistic; Basic Experimental Study Involving Humans (BESH)


* Basic Experimental Studies involving Humans (BESH) use an intervention to understand fundamental aspects of phenomena. These studies are subject to NIH stewardship policies including Good Clinical Practice Training and the NIH Policy on Dissemination of NIH-Funded Clinical Trial information. For more information, see our BESH webpage.
  • Does the study involve human participants? Yes, the study involves human participants.
  • Are the participants prospectively assigned to an intervention? Yes, participants are prospectively assigned to receive the investigational drug.
  • Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is evaluating the effects of the drug on participants’ memory.
  • Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the study evaluates memory, and retention and recall of information in the context of AD.
This study is a clinical trial.
Keyword(s): Drug, Behavioral
  • Does the study involve human participants? Yes, the study involves human participants.
  • Are the participants prospectively assigned to an intervention? Yes, participants are prospectively assigned to receive the investigational drug.
  • Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is evaluating the effects of the drug on participants’ memory.
  • Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the study evaluates memory, and retention and recall of information in the context of AD.
This study is a clinical trial.
Keyword(s): Drug, Behavioral
  • Does the study involve human participants? Yes, the study involves human participants.
  • Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to an intervention, the new visual acuity test.
  • Is the study designed to evaluate the effect of the intervention on the participants? No, the study is designed to evaluate the ability of the new visual acuity test to measure visual acuity as compared to the gold standard Snellen Test, but not to modify visual acuity.
This study is not a clinical trial.
Keyword(s): Behavioral

The details of Case #17 have been revised and updated as of April 28, 2021.
  • Does the study involve human participants? Yes, the study involves human participants.
  • Are the participants prospectively assigned to an intervention? No, the intervention (incentives to reduce re-hospitalization) were assigned by Medicare, not by the research study.
This study is not a clinical trial.
Keyword(s): Observational, Clinical Care
  • Does the study involve human participants? Yes, both the physicians and the patients are human participants.
  • Are the participants prospectively assigned to an intervention? Yes, physicians are prospectively assigned to receive genomic sequence information, which is the intervention.
  • Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of intervening with physicians, on the treatment they provide to their patients.
  • Is the effect being evaluated a health-related, biomedical, or behavioral outcome? Yes, the effect being evaluated, the extent to which providing specific information to physicians informs the treatment of patients, is a health-related outcome.
This study is a clinical trial.
Keyword(s): Clinical Care
  • Does the study involve human participants? Yes, the study involves human participants.
  • Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to an intervention, either the investigational intervention or an intervention in clinical use.
  • Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate whether the investigational intervention is as effective as the standard intervention, at changing behavior.
  • Is the effect being evaluated a health-related, biomedical, or behavioral outcome? Yes, the effect being evaluated, the interventions’ effectiveness in reducing the severity of the condition, is a health-related behavioral outcome.
This study is a clinical trial.
Keyword(s): Behavioral
  • Does the study involve human participants? Yes, both the physicians and the families are human participants.
  • Are the participants prospectively assigned to an intervention? Yes, physicians are prospectively assigned to use one of two apps, which are the interventions.
  • Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of intervening with physicians, on social service support referral for families.
  • Is the effect being evaluated a health-related, biomedical, or behavioral outcome? Yes, the effect being evaluated, the number of referrals, is a health-related outcome.
This study is a clinical trial.
Keyword(s): Clinical Care
  • Does the study involve human participants? Yes, the parents are human participants.
  • Are the participants prospectively assigned to an intervention? No, a focus group is not an intervention.
This study is not a clinical trial.
Keyword(s): Behavioral
  • Does the study involve human participants? Yes, study participants are human participants.
  • Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to a behavioral intervention.
  • Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of the intervention on adherence, and quality of life.
  • Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, adherence and quality of life are health-related outcomes.
This study is a clinical trial.
Keyword(s): Behavioral
  • Does the study involve human participants? Yes, sedentary individuals will be enrolled.
  • Are the participants prospectively assigned to an intervention? The participants will interact with the app for a week.
  • Is the study designed to evaluate the effect of the intervention on the participants? No. While the participants’ interactions are monitored (steps or heart rate may be recorded in this process), the study is NOT measuring the effect of using the app ON the participant. The study is only measuring the usability and acceptability of the app, and testing for bugs in the software. The effect on physical activity is NOT being measured.
  • Is the effect being evaluated a health-related biomedical or behavioral outcome?
  • N/A
This study is not a clinical trial.
Keyword(s): Behavioral

The details of Case #29 have been revised and updated as of April 28, 2021.
  • Does the study involve human participants? Yes, family members of patients are human participants.
  • Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to one of two CPR educational strategies.
  • Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of educational strategies on CPR skills.
  • Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, retention of CPR skills is a health-related behavioral outcome.
This study is a clinical trial.
Keyword(s): Behavioral
  • Does the study involve human participants? Yes, the study involves human participants.
  • Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to receive one of three types of CPR training, which is the intervention.
  • Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of different CPR training strategies on patient survival rates post cardiac arrest.
  • Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, out-of-hospital cardiac arrest survival is a health-related outcome.
This study is a clinical trial.
Keyword(s): Behavioral
  • Does the study involve human participants? Yes, children are human participants.
  • Are the participants prospectively assigned to an intervention? No, in this context the monitoring methods would not be considered an intervention. The study is designed to test the accuracy of two monitoring methods, but not to test the effect on any health-related biomedical or behavioral outcomes. 
This study is not a clinical trial.
Keyword(s): Behavioral
  • Does the study involve human participants? Yes, children are human participants.
  • Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to two food monitoring methods.
  • Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to determine whether using the monitoring methods changes eating behavior.
  • Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, eating behavior is a health-related outcome.
This study is a clinical trial.
Keyword(s): Behavioral
  • Does the study involve human participants? Yes, the children participating in this study are human participants.
  • Are the participants prospectively assigned to an intervention? No, not in this context. The study involves observing and measuring eating behavior, but not modifying it. This is an observational study.
This study is not a clinical trial.
Keyword(s): Behavioral, Observational
  • Does the study involve human participants? Yes, children are human participants.
  • Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to see different advertisements.
  • Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the advertisements.
  • Is the effect being evaluated a health-related biomedical or behavioral outcome? No, preferences are not health-related biomedical or behavioral outcomes.
This study is not a clinical trial.
Keyword(s): Behavioral, Observational
  • Does the study involve human participants? Yes, the study involves human participants.
  • Are the participants prospectively assigned to an intervention? Yes, the participants are randomized to undergo CT angiography or an exercise stress test.
  • Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to determine whether the initial test done affects long-term rates of certain clinical events.
  • Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, premature death, stroke, and myocardial infarction are health-related biomedical outcomes.
This study is a clinical trial.
Keyword(s): Clinical Care
  • Does the study involve human participants? Yes, the study involves human participants.
  • Are the participants prospectively assigned to an intervention? No, the intervention is not prospectively assigned by the investigators. Rather, the intervention, in this case diagnostic study, occurs as part of routine clinical care.
This study is not a clinical trial.
Keyword(s): Clinical Trial, Observational
  • Does the study involve human participants? Yes.
  • Are the participants prospectively assigned to an intervention? No, not in this context.  Antipsychotic medications are given as part of clinical care, not as part of a prospective, approved research protocol.  
This study is not a clinical trial.
Keyword(s): Behavioral, Clinical Care, Observational
  • Does the study involve human participants? Yes.
  • Are the participants prospectively assigned to an intervention? Yes, although participants are all receiving antipsychotic medication as part of their standard medical care, the dose of the antipsychotic medication is determined by the research protocol, rather than individual clinical need.
  • Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of a dose of antipsychotic medication on brain function.
  • Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, brain function measured by imaging is a health-related outcome.
This study is a clinical trial.
Keyword(s): Behavioral, Clinical Care
  • Does the study involve human participants? Yes.
  • Are the participants prospectively assigned to an intervention? Yes, participants are assigned to wear a thermal compression device.
  • Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of the thermal compression device on participant core temperature, comfort, and presence of skin injury.
  • Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, participant core temperature, comfort, and presence of skin injury are health-related biomedical outcomes.
This study is a clinical trial.
Keyword(s): Clinical Care
  • Does the study involve human participants? Yes, the study involves human participants.
  • Are the participants prospectively assigned to an intervention? No, the interventions were assigned by state laws and state of residence, not by the research study.
This study is not a clinical trial.
Keyword(s): Clinical Care, Observational
  • Does the study involve human participants? Yes, the healthy volunteers are human participants.
  • Are the participants prospectively assigned to an intervention? Yes, healthy volunteers are prospectively assigned to receive TMS stimulation protocols during a working memory task.
  • Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is evaluating the effects of local TMS stimulation on working memory performance and oscillatory brain activity in healthy individuals.
  • Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the study evaluates working memory processes, which are health-related biomedical outcomes.
This is a basic experimental study involving humans
Keyword(s): Mechanistic, Basic Experimental Study Involving Humans (BESH)


* Basic Experimental Studies involving Humans (BESH) use an intervention to understand fundamental aspects of phenomena. These studies are subject to NIH stewardship policies including Good Clinical Practice Training and the NIH Policy on Dissemination of NIH-Funded Clinical Trial information. For more information, see our BESH webpage.
  • Does the study involve human participants? Yes, healthy volunteers are human participants.
  • Are the participants prospectively assigned to an intervention? Yes, healthy volunteers are prospectively assigned to receive tolcapone during a social valuation task.
  • Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is evaluating the effects of modulating dopamine tone on social decision-making. Although this study uses an FDA-approved drug to modulate dopamine tone, the goal of this intervention is to understand the role of dopamine in a fundamental phenomenon (social valuation), and not to study the mechanism of action of the drug or its clinical effects.
  • Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the study evaluates working memory processes, which are health-related biomedical outcomes.
This is a basic experimental study involving humans
Keyword(s): Mechanistic, Drug, Basic Experimental Study Involving Humans (BESH)


* Basic Experimental Studies involving Humans (BESH) use an intervention to understand fundamental aspects of phenomena. These studies are subject to NIH stewardship policies including Good Clinical Practice Training and the NIH Policy on Dissemination of NIH-Funded Clinical Trial information. For more information, see our BESH webpage.
  • Does the study involve human participants? Yes, the study involves human participants.
  • Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to receive an intervention, drug A or placebo.
  • Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of drug A and placebo on the presence and type of polyps.
  • Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the effect being evaluated, the presence and type of polyps, is a health-related biomedical outcome.
This study is a clinical trial.
Keyword(s): Drug
  • Does the study involve human participants? Yes, patients are human participants because the plasma and information are identifiable.
  • Are the participants prospectively assigned to an intervention? No, because the assignment of participants to an intervention occurs as part of an existing, separately funded clinical trial. This proposal would be considered an ancillary study that is not an independent clinical trial.
This study is not a clinical trial.
Keyword(s): Mechanistic
  • Does the study involve human participants? Yes, the study involves human participants.
  • Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to receive an intervention, drugs A and B.
  • Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of drugs A and B on renal function.
  • Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the effect being evaluated, renal function, is a health-related biomedical outcome.
This study is a clinical trial.
Keyword(s): Drug
  • Does the study involve human participants? Yes, healthy young adults will be enrolled in this study.
  • Are the participants prospectively assigned to an intervention? Yes, the participants will be prospectively assigned to perform a Go/No-Go task, which involves different levels of inhibitory control.
  • Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of the Go/No-Go task on neural activation in the frontal cortex. The study will measure inhibitory control and the neural systems being engaged. In this study, the Go/No-Go task is the independent variable, and behavioral performance and the associated fMRI activations are the dependent variables.
  • Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the neural correlates of inhibitory control and behavioral performance are health-related biomedical outcomes.
This is a basic experimental study involving humans
Keyword(s): Basic Experimental Study Involving Humans (BESH)


* Basic Experimental Studies involving Humans (BESH) use an intervention to understand fundamental aspects of phenomena. These studies are subject to NIH stewardship policies including Good Clinical Practice Training and the NIH Policy on Dissemination of NIH-Funded Clinical Trial information. For more information, see our BESH webpage.
  • Does the study involve human participants? Yes, adolescents will be enrolled in this study.
  • Are the participants prospectively assigned to an intervention? No, there is no intervention in this study and no independent variable manipulated. The adolescents are not prospectively assigned to an intervention, but instead the investigator will examine variables of interest (including the Stroop test) over time. The Stroop effect is used as a measurement of point-in-time data.
  • Is the study designed to evaluate the effect of the intervention on the participants? No, there is no intervention. Performance on the Stroop test is a well-established measure of executive function and the test is not providing an independent variable of interest here. It is not being used to manipulate the participants or their environment. The purpose is simply to obtain a measure of executive function in adolescents over the course of the school year.
  • Is the effect being evaluated a health-related biomedical or behavioral outcome? N/A. No effect of an intervention is being evaluated.
This study is not a clinical trial.
Keyword(s): Behavioral, Observational
  • Does the study involve human participants? Yes, participants with social anxiety will be enrolled in this study.
  • Are the participants prospectively assigned to an intervention? Yes, the participants will be prospectively assigned to perform a modified Stroop test using different colored emotional/neutral faces to explore emotional processing in people with social anxiety. Note that the independent variable is the presentation of emotional vs neutral faces.
  • Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to measure the effect of emotional valence (i.e. emotional faces) on participant response time to name the color. The purpose is to determine whether the response time to emotional faces is exaggerated for people with social anxiety as compared to neutral faces. Note that the response time to name the colors is the dependent variable in this study.
  • Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the processing of emotional information is a health-related biomedical outcome.
This is a basic experimental study involving humans.
Keyword(s): Behavioral, Basic Experimental Study Involving Humans (BESH)


* Basic Experimental Studies involving Humans (BESH) use an intervention to understand fundamental aspects of phenomena. These studies are subject to NIH stewardship policies including Good Clinical Practice Training and the NIH Policy on Dissemination of NIH-Funded Clinical Trial information. For more information, see our BESH webpage.
  • Does the study involve human participants? Yes, the healthy volunteers are human participants.
  • Are the participants prospectively assigned to an intervention? No, in this context the different pulse sequences would not be considered an intervention. The pulse sequences are not being used to modify any biomedical or behavioral outcome; rather the investigator is comparing performance characteristics of the two pulse sequences.
This study is not a clinical trial.
Keyword(s): Behavioral
  • Does the study involve human participants? YES. Aim one will study ten healthy volunteers and aim two will stud.y ten patient volunteers
  • Are the participants prospectively assigned to an intervention? Yes, participants will be prospectively assigned to be evaluated with a new imaging technology and the gold standard technology.
  • Is the study designed to evaluate the effect of the intervention on the participants? No, the study is not measuring the effect of the technologies ON the human subjects. The study is determining if the new technology is equivalent or better than the gold standard technology. No effect on the participant is being measured.
This study is not a clinical trial.
Keyword(s): Device

Institute or Center specific Case Studies

New: 1/4/18
  • Does the study involve human participants? Yes.
  • Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to an intervention, abstaining from normal oral hygiene for a portion of the mouth, to induce gingivitis.
  • Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of the induced gingivitis on microbial composition and levels of inflammatory chemokines in oral samples.
  • Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the microbial composition and chemokine levels in oral samples are health-related biomedical outcomes.
This study is a clinical trial.
  • Does the study involve human participants? Yes, the study enrolls older adults with hearing loss.
  • Are the participants prospectively assigned to an intervention? Yes, participants are randomized to receive enhanced HCC or usual HCC interventions.
  • Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study will evaluate enhanced HCC’s effectiveness in modifying participant behavior and biomedical outcomes.
  • Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, rate of technology/service utilization is a behavioral outcome and quality of life, communications, and cognition are biomedical outcomes that may be impacted by the interventions.
This study is a clinical trial.
  • Does the study involve human participants? Yes, the study involves human participants.
  • Are the participants prospectively assigned to an intervention? Yes, the participants are assigned to either exercise training or a diet.
  • Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to compare the effects of the interventions on muscle metabolism.
  • Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, muscle metabolism/signaling is a health-related outcome.
This study is a clinical trial.
  • Does the study involve human participants? Yes, the study involves human participants.
  • Are the participants prospectively assigned to an intervention? Yes, the participants are assigned to undergo a fast.
  • Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to compare the effects of the fast on molecular parameters of metabolism.
  • Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, metabolism is a health-related outcome.
This study is a clinical trial.
  • Does the study involve human participants? Yes, the study involves human participants.
  • Are the participants prospectively assigned to an intervention? Yes, the participants are assigned to receive two different drugs.
  • Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to compare the effects of the drugs on vascular function.
  • Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, vascular function is a health-related outcome.
This study is a clinical trial.
  • Does the study involve human participants? Yes, the study involves human participants.
  • Are the participants prospectively assigned to an intervention? Yes, the participants are assigned to receive medication or placebo.
  • Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to compare the effects of the drugs on vascular function and kidney size.
  • Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, vascular function and kidney size are health-related outcomes.
This study is a clinical trial.
  • Does the study involve human participants? Yes, the study involves human participants.
  • Are the participants prospectively assigned to an intervention? No, the participants are not assigned to receive an intervention. They undergo transplantation as part of their routine clinical care. The imaging procedure is a measure and not an intervention.
This study is not a clinical trial.
  • Does the study involve human participants? Yes, the study involves human participants.
  • Are the participants prospectively assigned to an intervention? Yes, the participants are assigned to receive either a micronutrient supplement or nothing.
  • Is the study designed to evaluate the effect of the intervention on the participants? No, the intervention is being used to assess the performance of the probe and is not looking at an effect on the participant.
This study is not a clinical trial.
  • Does the study involve human participants? Yes, the study involves human participants.
  • Are the participants prospectively assigned to an intervention? Yes, the participants are assigned to receive a controlled diet for three days.
  • Is the study designed to evaluate the effect of the intervention on the participants? No, the intervention (controlled diet) is being used to minimize exogenous dietary sources of oxalate in the participants prior to the labeled tracer infusion. The study will not be evaluating the effect of the diet on the participants.
This study is not a clinical trial.
This page last updated on January 7, 2019
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