Graduate School

There are four main components of a clinical trial. 

1. The study involves human subjects (de-identified data or specimens is not considered a human subject).
2. Participants are prospectively assigned to an intervention (therapies prescribed as part of clinical care are not prospectively assigned).
3. The study is designed to evaluate the effect of the intervention on the participants (intervention is not part of routine clinical care).
4. The effect being evaluated is a health-related biomedical or behavioral outcome.

If all four components are present in your project, it is likely a clinical trial and will be reviewed under the Full Board review process.

For more information on clinical trials, please visit the NIH Clinical Trial FAQs page found here.