The checklist below is for evaluating whether a clinical trial or study is an Applicable Clinical Trial (ACT) under 42CRF 11.22(b) for the clinical trials initiated on or after January 18, 2017.
1. Is the study interventional (a clinical trial)?
2. Do ANY of the following apply?
Is at least one study facility located in the United States or a U.S. territory?
Is the study conducted under a U.S. FDA Investigational New Drug application (IND) or Investigational Devise Exemption (IDE)?
Does the study involve a drug, biological or device product manufactured in and exported from the U.S. or a U.S. territory for study in another country?
3. Does the study evaluate at least one drug, biological, or device product regulated by the U.S. FDA?
4. Is the study other than a Phase 1 trial of a drug and/or biological product or is the study other than a device feasibility study?
If you answer YES to all 4 questions and the study was initiated on or after January 18, 2017, the trial would meet the definition of an ACT that is required to be registered on Clinical Trials.gov under 42 CFR 11.2