A clinical trial enrolling participants only at locations outside the United States, but using a study coordinating center in the United States (with no participants enrolled at the coordinating center location itself), would not be considered to have a “Facility Location” in the United States.
The criteria for a study initiated on or after January 18, 2017, to be an applicable clinical trial (ACT) are specified in 42 CFR 11.22(b). One of these criteria is met if the clinical trial has “at least one Facility Location … within the United States or one of its territories” (42 CFR 11.22(b)(1)(ii)(D)(1) and 42 CFR 11.22(b)(2)(iv)(A)). Facility Location, a component of the Facility Information data element (see 42 CFR 11.28(a)(2)(iii)(C)), is addressed in 42 CFR 11.10(b)(31)(ii). It refers to the city, state, country, and Zip Code (for U.S. locations, including territories of the U.S.) for each “participating facility” in a clinical trial. Whether a site is considered a “participating facility” is dependent on whether participants can enroll at that site; this is reflected in 42 CFR 11.10(b)(31)(iii)(A), which describes Facility Contact Information in reference to enrollment at that particular site. A study coordinating center that may provide study oversight or data management and analysis support, but that does not enroll participants at that location, would not be considered a “participating facility” as described in Facility Location. Therefore, the coordinating center would not be considered a Facility Location for the purposes of 42 CFR 11.28(a)(2)(iii)(C) and the ACT criteria outlined in 42 CFR 11.22(b).
