Do you do research with human subjects?

Under the NIH's new definition of "clinical trial", your study might become one, soon.

Due to upcoming policy changes in the definition which broaden the requirements that qualify a study as a clinical trial, you may have to start checking "yes" to clinical trial on the Notice of Intent to Submit form and registering your studies on ClinicalTrials.gov, when you did not have to do so previously.

The NIH has created a helpful page at https://grants.nih.gov/policy/clinical-trials.htm that provides more information about the changes in policy, and the four questions which, if you answer "yes" to all, will define your human-subject study as a clinical trial.