Applicable Clinical Trial (ACT)

Applicable clinical trial is the term used in 42 CFR Part 11, Clinical Trials Registration and Results Information Submission to designate the scope of clinical trials that may be subject to the registration and results reporting requirements in ClinicalTrials.gov. Public Health, Public Health Service, DHHS: 42 CFR 11, Clinical Trials Registration and Results Information Submission

A clinical trial or study that, at any point in time, meets the conditions below is an ACT:

Applicable device clinical trial. A clinical trial or study that meets the conditions listed below is an applicable device clinical trial:
• The study is a pediatric postmarket surveillance of a device product as required by FDA under section 522 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 3601).
• The study is a clinical trial with one or more arms that meets all of the following criteria:
o Study Type is interventional;
o Primary Purpose of the clinical trial is other than a feasibility study;
o The clinical trial Studies a U.S. FDA-regulated Device Product; and
o One or more of the following applies:
– At least one Facility Location is within the United States or one of its territories,
– A device product under investigation is a Product Manufactured in and Exported from the U.S. or one of its
territories for study in another country, or
– The clinical trial has a U.S. Food and Drug Administration IDE Number.

Applicable drug clinical trial. A clinical trial with one or more arms that meets the following conditions is an applicable drug clinical trial:
• Study Type is interventional;
• Study Phase is other than phase 1;
• The clinical trial Studies a U.S. FDA-regulated Drug Product; and
• One or more of the following applies:
o At least one Facility Location for the clinical trial is within the United States or one of its territories,
o A drug product (including a biological product) under investigation is a product manufactured in and exported from
the U.S. or one of its territories for study in another country, or
o The clinical trial has a U.S. Food and Drug Administration IND Number.