Does your human subjects research study meet the NIH Definition of a clinical trial?

The NIH definition of a clinical trial is very broad. Some investigators conducting human subjects research may not be aware that NIH considers their study to be a clinical trial. Use this tool to help determine if your research meets the NIH definition of a clinical trial.

For application due dates on/after January 25, 2018, identifying whether your study is a clinical trial will be important for:

  • picking the right NIH funding opportunity
  • ensuring your application includes all the information required for peer review
  • complying with the appropriate policies and regulations

Answer a few simple questions to set you on the path for success

Note for ancillary studies:
When answering the following questions, take into account only the work being proposed in the ancillary study, not the work being done in the parent project.

1. Does the study involve human participants?

Unsure how to respond? Our case studies and FAQs may help you decide.