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8th Feb 2019, 10:25 AM
#2
Interesting, in that the FDA itself does not advise that non-US sites trials are conducted under an IND! You can use the same protocol for US IND sites and for non-US non-IND sites. Therefore non-US sites do not need to sign a 1572. However if you are foolish enough to conduct non-US sites under an IND then you do need to complete a 1572 form for all sites under the IND. FDA Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions – Statement of Investigator (Form FDA 1572) May 2010
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