NIH Definition of Clinical Trial Case Studies

The National Institutes of Health has provided a number of case studies to help to identify whether a proposed study would be considered a clinical trial. Be aware that these case studies and related guidance will evolve over the upcoming year.

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.

Note that studies that involve secondary research with biological specimens or health information are not clinical trials.

Click here to review the case studies.

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