On a recent monitoring visit a Research Coordinator was inquiring about a Sponsor’s international research sites and if there were any specific policies on accepting clinical data from foreign/non-U.S. clinical sites.  For this particular study the Research Coordinator expressed interest on how these sites support a premarket submission study conducted in the United States.

Section 569B of the Federal Food, Drug, and Cosmetic Act states that “In determining whether to approve, license, or clear a drug or device pursuant to an application submitted under this chapter, the Secretary shall accept data from clinical investigations conducted outside of the United States, including the European Union, if the applicant demonstrates that such data are adequate under applicable standards to support approval, licensure, or clearance of the drug or device in the United States.” In other words, any data obtained from outside of the United States for a clinical study will be held to the same standards as that data obtained within the U.S.