UNCG ClinicalTrials.gov Registration Criteria
Registration on ClinicalTrials.gov is required if a study meets any of the following criteria:
- Applicable Clinical Trials (regardless of funding)
- NIH-funded and any externally funded studies that meet the NIH definition of clinical trial
- A clinical trial subject to the revised common rule – a clinical trial conducted or supported by a Federal department or agency (45 CFR 46.116 (h) Posting of clinical trial consent form)
- Billing insurance (per CMS policy) – regardless of funding, although these almost always fall into one of the other categories anyway
Studies that are clinical trials, but do not meet any of the above criteria are not required to register, however, the UNCG IRB Office of Research Integrity encourages registration for publication and to promote transparency.
NOTE: If a researcher plans to submit to an ICMJE journal for publication, *ICMJE requires, and recommends that all medical journal editors require registration of clinical trials in a public trials registry at or before the time of first participant enrollment as a condition of consideration for publication.