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: http://grants.nih.gov/clinicaltrials_fdaaa/docs/Flow_chart-ACT_only.pdf
Identifying an ACT under FDAAA http://grants.nih.gov/ClinicalTrials_fdaaa/ACTs_under_FDAAA.htm
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