Table 1.

NIH Clinical Trials Definition Criteria with Behavioral and Social Science Examples

Criterion	Is Not a Clinical Trial	Is a Clinical Trial
Human Participants Research	Longitudinal social network and physical activity data from an existing cohort are obtained and analyzed to assess how social networks and physical activity levels covary over time.	A sample of cohort participants are sent a fitness tracker and randomly assigned to have the information from the tracker sent to key social network connections to determine how this information influences physical activity among those within the social network.
Prospectively Assigned	A school system with limited resources provides an early childhood intervention only in some schools. Five years later, investigators evaluate health status and social functioning of the children in the schools who did and did not receive this intervention.	Investigators assign schools within a school system to deliver an early childhood intervention program. Over the next five years, the investigators assess health status and social functioning of those who did or did not receive the intervention.
Evaluate the Effect of the Intervention	Healthy volunteers and patients with Generalized Anxiety Disorder (GAD) are evaluated using a standard decision under ambiguity laboratory procedure that involves repeated within-subject trials (e.g., Iowa Gambling Task). fMRI, cortisol, electrodermal response, and perceived stress also are assessed, and healthy and GAD participants are compared on these measures and on the associations within each group.	Healthy volunteers are randomly assigned to a stress induction procedure prior to being evaluated using a standard decision under ambiguity laboratory procedure that involves repeated within-subject trials (e.g., Iowa Gambling Task). fMRI, cortisol, electrodermal response, and perceived stress also are assessed, and participants under stress induction and no stress induction conditions are compared on these measures.
Health-related Biomedical or Behavioral Outcome	Investigators compare an opt-in vs. opt-out method for establishing and contributing to health savings accounts. The investigators evaluate the effect of these two approaches on income stability, financial status, and net assets.	Investigators compare an opt-in vs. opt-out method for establishing and contributing to health savings accounts. The investigators evaluate the effect of these two approaches on healthcare access and health status.