What is a clinical trial?
The Revised Common Rule and the National Institutes of Health define a clinical trial as 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. Note that this new definition includes some social-behavioral studies that may not have been previously been defined as clinical trials.
If your study is a federally-funded clinical trial, the University of Tennessee, Knoxville requires you to register your study and post a consent form on ClinicalTrials.gov.
Clinical Trial Registration Requirements
Where Do I Register?
ClinicalTrials.gov is the primary database for registering and reporting clinical trial results.
Who should Register?
The Principal Investigator (PI) is responsible for registering the study as they are considered the “responsible party”. However,
- if there is an IND or IDE holder that is someone other than the PI, they are required to submit as the “responsible party”
- multi-site studies typically designate the lead institution as the “responsible party” required to register
The responsible party is required to ensure that the study registration, required record updates, and results are reported and completed in a timely manner according to HHS federal policy.
When do I register?
Federal regulations dictate that you are required to register no later than 21 days after the first participant has consented. Although, we recommend registering prior to any participant enrollment.
For questions please contact the Rob Withrow, at rwithrow@utk.edu.
What else do I do?
Add the following sentence to your informed consent (as listed in the consent template):
- A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time.