Regulatory Open Forum

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  • 1.  1572 Labs

    This message was posted by a user wishing to remain anonymous
    Posted 19-Sep-2023 09:04
    This message was posted by a user wishing to remain anonymous

    Hi,

    Apologies if this is a a repeat, I did search but did not find a thread.

    The question of which labs should be included on the 1572 seems to come up a lot.  I have heard different answers so just wondering if some of you would put in your 2 cents?  Include local labs?  Only the central lab?  etc.

    Thoughts?

    Thanks in advance!



  • 2.  RE: 1572 Labs

    Posted 20-Sep-2023 06:53

    I am not sure I have ever seen a definitive answer to your question. My approach as always been to include labs that are used to collect data defined in the protocol as endpoints for efficacy and safety. I would not list a local lab if it was not the primary source for protocol defined results. Local labs may be used in some studies to follow up on laboratory abnormalities or other adverse events, but if the protocol has not defined them as an endpoint I would not include the lab on the 1572.



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    Glen Park PharmD
    Vice President, Regulatory Affairs and Quality Assurance
    Burien WA
    United States
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  • 3.  RE: 1572 Labs

    Posted 20-Sep-2023 11:08

    Thank you!



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    Allison Brookes
    Hopkinton MA
    United States
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  • 4.  RE: 1572 Labs

    This message was posted by a user wishing to remain anonymous
    Posted 20-Sep-2023 09:00
    This message was posted by a user wishing to remain anonymous

    Only the central lab(s).