FDAAA defines applicable clinical trials as Phase II-IV controlled interventional studies (with one or more arms) of drugs, biological products, or devices that are subject to FDA regulation, meaning that the trial has one or more sites in the United States, involves a drug, biologic, or device that is manufactured in the United States (or its territories), or is conducted under an investigational new drug application (IND) or investigational device exemption (IDE)… If the clinical trial is not of a drug or device subject to FDA regulation, and, thus, not an applicable clinical trial, it is not required to be registered or reported on ClinicalTrials.gov. My understanding is that data reviews and most exempt research are not controlled clinical trials involving an FDA-regulated intervention and would not be need to be registered or reported on ClinicalTrials.gov. FDAAA, however, does not prevent investigators from voluntarily reporting data from clinical trials that do not meet the definition of an applicable clinical trial. For additional clarification, please contact contact ClinicalTrials.gov at register@clinicaltrials.gov or Jarilyn Dupont (jarilyn.dupont@fda.hhs.gov) at the FDA.
