Contains Nonbinding Recommendations
9. Must a sponsor conduct a foreign clinical study under an IND?
No. A sponsor may choose, but is not required, to conduct a foreign clinical study under
an IND. When a foreign clinical study is conducted under an IND, all FDA IND
requirements must be met unless waived (see #12 and #13 below). When the foreign
clinical study is not conducted under an IND, the sponsor must ensure that this study
complies with 21 CFR 312.120, “Foreign clinical studies not conducted under an IND,” if
the sponsor intends to submit the study to FDA to support clinical investigations
conducted in the United States and/or marketing approval. An application based solely
on foreign clinical data must meet criteria listed in 21 CFR 314.106.
10. Must investigators who conduct studies outside of the United States sign a 1572?
3
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.
11. If a foreign clinical study is being conducted under an IND, what are the
investigator’s responsibilities with respect to local laws and regulations?
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.
12. For foreign clinical studies conducted under an IND, how can an investigator sign
the 1572 when the investigator knows he/she cannot commit to all of the requirements
on the form, specifically IRB membership (21 CFR 56.107)?
IRB review and approval is required before a clinical study can be initiated under an IND
(21 CFR 56.103(a)). FDA may waive any of the IRB requirements for specific research
activities or for classes of research activities otherwise covered by the IRB regulations
(21 CFR 56.105), but FDA uses the waiver provision only when alternative mechanisms
for ensuring protection of the rights and welfare of human subjects are acceptable. The
most common circumstance for which FDA receives a waiver request is when a sponsor
3
Investigators conducting studies outside of the U.S. may want to consult with local regulatory authorities
for additional guidance when considering whether to conduct studies under an IND.
7