WHAT IS A CLINICAL TRIAL AND DOES MY STUDY QUALIFY AS ONE?
A clinical trial is a research study in which one or 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.
If you answer yes to the following questions, your study qualifies as a clinical trial:
- Does the study involve one or more human subjects?
- Does the study involve the use of one or more interventions?
- Does the study prospectively assign human subject(s) to an intervention(s)?
- Does the study have a health-related biomedical or behavioral outcome(s)?
In addition, your study is a clinical trial if:
- You are studying healthy participants
- Your study does not have a comparison group (e.g., placebo or control)
- Your study is only designed to assess the pharmacokinetics, safety, and/or maximum tolerated dose of an investigational drug
- Your study is utilizing a behavioral intervention
- Only one aim or sub-aim of your study meets the clinical trial definition
CLINICAL TRIAL DEFINITION RESOURCES
Learn more about the NIH Clinical Trial Definition at grants.nih.gov (link is external), and see below for more helpful resources.
- NIH Decision Tool (link is external)
- Case Studies (link is external)
- Frequently Asked Questions (link is external)
After reviewing the information below, if you are still not sure whether or not you need to submit to the Clinical Research Hub, please submit an Intake Inquiry via the form below.
Not sure if your study requires assistance from the Clinical Research Hub? Request a Consult!
To learn more about how the NIH defines Clinical Trials, click the link below.
If you are not sure if you should submit to CRH, please submit an Intake Inquiry form via the link below to request a consult with the CRH Intake Team.
If you are certain that your study will require support from the Clinical Research Hub and have already reviewed the COS process, click the link below to move forward with your submission.
The Consult Request / Intake Inquiry form is much shorter than the full length Intake Study Submission form and is intended to provide the CRH Intake Team with some brief information about your study/project so they can assist with answering whether or not your study will need to go through the Clinical Research Hub Intake process. Upon submission the form will be routed directly to the CRH Intake Team who will reach out to you within 48 hours.