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Thread: Completing a 1572

  1. #1

    Completing a 1572

    Lots of non-USA investigators are completing a 1572 thereby committing themselves to comply with US Code of Federal Regulations, aspects of which are not possible to follow outside of the USA. FDA Guidance on this subject, published in 2010 indicates the need for foreign investigators working under an IND to apply to the FDA for a waiver. Is anyone aware of this happening and if so, what is the process for submitting a waiver and the timeline for response? What is MHRA's view on UK investigators signing a 1572?

  2. #2
    Forum Member
    Join Date
    Nov 2011
    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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