Clinical trials - definitions and requirements

NIH defines a clinical trial as a research study in which one more 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.

To determine if NIH would consider a research study to be a clinical trial, ask the following questions:

• 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 outcomes?

NIH has provided several case studies to assist in determining whether a study would be considered a clinical trial by NIH.

Requirements for NIH-funded Clinical Trials:

• All NIH-funded clinical trials are expected to register and submit results information to ClinicalTrials.gov.
• All NIH-funded clinical investigators and clinical trial staff who are involved in the design, conduct, oversight, or management of clinical trials must receive training in Good Clinical Practice (GCP).  Training can be completed through the CITI program.