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Can a sponsor conduct a foreign clinical study under an IND, and if so, must investigators who conduct studies outside of the United States sign a 1572?

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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

Yes, the sponsor may decide to conduct a foreign study under an IND. If the sponsor decides to conduct the study under an IND, all the FDA IND requirements must be met unless waived. If the foreign study is not conducted under an IND, the sponsor must ensure that the study complies with 21 CFR 312.120 for FDA submission to support the clinical investigation conducted in the U.S. and/or marketing approval. An application only based on foreign clinical data must comply with 21 CFR 314.106.  

If the foreign study is conducted under an IND, then the investigator must sign the 1572 form, as required by FDA IND regulations. If the study is conducted outside of the U.S. and not under an IND, then the investigator does not need to sign a 1572. If the local laws prohibit signing of a 1572, then the study operated is considered to be conducted as a non-IND.

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