If a foreign clinical study is conducted under an IND, then all FDA IND regulations,
including the requirement to obtain a signed 1572, must be met. If a clinical study is
conducted outside of the U.S. and is not conducted under an IND, then the investigator
need not sign a 1572. If local laws or regulations prohibit the signing of a 1572, FDA
would expect the sites to operate as non-IND sites and the study conducted as a non-IND
study. If the study data is to be submitted to support a marketing application (e.g., a new
drug application (NDA)), the study must be conducted in compliance with 21 CFR
312.120.
