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  • 1.  1572 Sites Refuse to sign 1572

    This message was posted by a user wishing to remain anonymous
    Posted 24-Jan-2023 08:15
    This message was posted by a user wishing to remain anonymous

    I have a question about sites that refuse to sign a 1572 or equivalent document.  For IND studies, what are the implications of including the site in the study and would the FDA accept the data from these sites?  
    Thank you in advance!


  • 2.  RE: 1572 Sites Refuse to sign 1572

    Posted 25-Jan-2023 01:06
    A clear message is needed here: Find another investigator.

    The Sponsor of an IND study should not engage an investigator who declares their unwillingness to sign a Form FDA-1572, and certainly should not allow either initial or continuing participation of an investigator/site that may have been signed up with the Sponsor but then refuses to complete this necessary attestation. This is a clear requirement in the IND regulations at 21 CFR 312.53(c)(1), where the message is "...the sponsor shall obtain...(1) A signed investigator statement (Form FDA-1572)...," - emphasis on "shall." Yes, there are instances where use of the Form FDA-1572 itself could be accomplished by another document, particularly for non-US sites who argue the US form format is possibly not legally binding in their country, but that means little as GCP has virtually identical requirements that must be attested to in a written investigator agreement with the Sponsor. In that case, aligning the text exactly may be the best option. The IND regulation includes a list of specific details that are critical for assigning/accepting responsibilities of an investigator, as outlined on the form and copied from the regulation. It's pretty straight forward from a regulatory standpoint. Not agreeing to those conditions means the investigator is not qualified, if not really interested, and Sponsors must, among other requirements, select qualified investigators.

    Any Sponsor who decides to proceed anyway, not only risks having the FDA invalidate data submitted from that site-yes, this really happens- but will spend perhaps significant monetary and time costs in dealing with this for little useful outcome.

    I repeat: Find another investigator.

    Best regards,

    ------------------------------
    Jan S. Peterson, MS, CCRA, RAC, ASQ CBA, ACRP-CP
    Consultant
    United States
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    Original Message


  • 3.  RE: 1572 Sites Refuse to sign 1572

    Posted 25-Jan-2023 08:50
    Anon - Are these foreign sites? if so, then FDA's guidance on the Form 1572, with FAQs, is what you need (https://www.fda.gov/media/78830/download). If these are US sites, then Jan's comment is a point well taken.

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    David Jensen PhD, RAC
    Regulatory Affairs Scientist
    Durham NC
    United States
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    Original Message


  • 4.  RE: 1572 Sites Refuse to sign 1572

    Posted 25-Jan-2023 10:52
    There have been many posts on this topic in the past year. See if you can search the Forum on RAPS.org.  There are also a couple FDA guidances/Q&A on this.

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    Tom Stothoff
    Senior Director, Regulatory Affairs CMC
    Chicago
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    Original Message


  • 5.  RE: 1572 Sites Refuse to sign 1572

    Posted 26-Jan-2023 07:37
    Hello, 

    Based on my experience managing ex-US PIs who is not willing to sign FDA form 1572, sponsor must obtain a 1572 Waiver Request granted letter from FDA in order to provide FDA with equivalent form to 1572. This form called Attestation Form signed by PI which must follow same GCP practice and principals. After obtaining waiver from FDA, sponsor then can submit attestation form to FDA for ex-US PIs. Hope this helps.

    ------------------------------
    Prakash Patel
    Sr. Manager Global Regulatory Affairs
    South Grafton MA
    United States
    ------------------------------

    Original Message


  • 6.  RE: 1572 Sites Refuse to sign 1572

    Posted 27-Jan-2023 08:23
    Hello Prakash,

    There is no regulation or interpretation of a regulation that states a sponsor "must" obtain a waiver for 1572's equivalents. It is an option provided by FDA to do so, but I and others I have worked with on global clinical trials take an alternate option of obtaining signed GCP statements (or attestations) and describing the steps taken by the sponsor to assure GCP compliance in the clinical study report. It is not a good practice to state that a sponsor "must" do something unless a regulation states that something "shall" be done.

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    Glen Park PharmD
    Vice President, Regulatory Affairs and Quality Assurance
    New York NY
    United States
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    Original Message


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