Investigators are responsible for complying with the applicable laws and regulations of the country in which the study is being conducted, regardless of whether the study is being conducted under an IND. We recommend that sponsors obtain signed, written statements from investigators acknowledging their commitment to comply with local
laws and requirements. In addition, if a foreign clinical study is being conducted under an IND, the investigator must sign Form FDA 1572 (investigator statement) and ensure that the study is conducted in accordance with the investigator statement and all other applicable regulations under 21 CFR Part 312.
