What are "Applicable Clinical Trials" (ACTs)?Mar 17, 2022
Applicable Clinical Trials (or "ACTs") are trials that are required by federal laws and regulations to be registered on and have results data reported to ClinicalTrials.gov.
An ACT must meet the following criteria:
- Study is initiated on or after September 27, 2007
- AND evaluates a drug, biologic, or device regulated by the FDA (whether it has marketing approval or not)
- AND is interventional
- AND at least one of the following applies:
- The study is conducted under an IND or IDE, OR
- Has at least one site within the U.S. or a U.S. territory, OR
- The drug/device/biologic being studied is manufactured in and exported from the U.S./a U.S. territory for study in another country
- AND none of the following apply
- Study is a Phase I
- Study's primary purpose is to assess device feasibility (i.e. the "device version of a Phase I", should include no more than 10 participants)
ACTs are not the only types of trials that are required to be registered or report results to ClinicalTrials.gov. Most federally-funded trials, even those that don't meet the criteria of an ACT, are also subject to these requirements. Journal policies also require registration of most interventional studies.
If you have questions about registration or results reporting requirements for your research, contact firstname.lastname@example.org.
Tags: 42CFR11 ACT ACTS clinical trial FDAAA FDAAA801 federal registration regulations reporting results