Tip of the Week Archive

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... 

1. Are interventional
2. Evaluate a drug, biologic, or device that is regulated by the FDA (even if it is approved!)
3. 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)
4. 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 your study meets these four criteria, it must be registered and have results submitted to ClinicalTrials.gov . However, even if your study is NOT an ACT, it may still be subject to registration and results requirements by journal or funder policies (e.g. ICMJE, NIH).

If you need an account, or have questions about accessing or using clinicaltrials.gov, contact clinicalresearchsupportcenter@ucdenver.edu.