What is an Applicable Clinical Trial (ACT)?Dec 16, 2021
An Applicable Clinical Trial or ACT is a certain type of drug, biologic, or device trial that is required by U.S. law to be registered on ClinicalTrials.gov, and to have basic results data submitted there within 1 year of the primary completion date.
Applicable Clinical Trials...
- Are interventional
- Evaluate a drug, biologic, or device that is regulated by the FDA (even if it is approved!)
- Are NOT Phase 1 studies or early device feasibility studies (i.e., the "device version" of a Phase 1 study, with 10 participants or less)
- Meet at least one of the following criteria:
- At least one study facility is located in the U.S.
- The study involves a drug, device, or biologic that is being manufactured in the U.S., then exported for study in another country.
- The study is conducted under an IND or an IDE.
If you need an account, or have questions about accessing or using clinicaltrials.gov, contact email@example.com.