Trials to Register and Report

‘Applicable Clinical Trials’ include the following:

  • Trials of drugs/biologics. Controlled clinical investigations, other than phase 1 trials of drugs/biological products subject to FDA regs.
  • Trials of devices. 1) Controlled trials with health outcomes of devices subject to FDA regulation (other than small feasibility studies) and 2) pediatric post-market surveillance required by FDA
  • The trial has one or more sites in the U.S.
  • The trial is conducted under an FDA IND or IDE application
  • The trial involves a drug, biologic, or device that is manufactured in the U.S. or its territories and is exported for research

ACT Wizard:

Identifying an ACT under FDAAA


Trials that are Excluded:

  • (Non-serious/life-threatening) Phase 1 drug trials, including studies in which drugs are used as research tools to explore biological phenomena or disease processes
  • Small clinical trials to determine the feasibility of a device or a clinical trial to test prototype devices where the primary outcome measure relates to feasibility and not to health outcomes
  • Trials that do not include drugs, biologics, devices, or clinical procedures (e.g., behavioral interventions)
  • Non-interventional (observational) clinical research, such as cohort or case-control studies
  • Trials that were ongoing as of September 27, 2007, and reached the Completion Date before December 26, 2007