Regulatory Open Forum

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  • 1.  Sponsor Investigator IND

    Posted 27-Oct-2015 19:22


    Hi All,

    Is it acceptable to run a sponsor investigator clinical trial at multiple unrelated clinical sites?

    To put it another way, is it acceptable to have multiple 1572's in a sponsor investigator clinical trial? My sense is that it would not be acceptable but I am hoping for a reality check.

    Further, is it acceptable to list individuals from multiple clinical sites as sub-investigators on a 1572? I doubt this would be acceptable as well.

     

    Thanks in advance,

    Gene

     

    ------------------------------
    Eugene Helsel
    Senior Director Regulatory Affairs
    Fate Therapeutics
    San Diego CA
    USA
    ------------------------------


  • 2.  RE: Sponsor Investigator IND

    Posted 27-Oct-2015 22:44
    Q: is it acceptable to have multiple 1572's in a sponsor investigator clinical trial? 

    YES

    Q:  is it acceptable to list individuals from multiple clinical sites as sub-investigators on a 1572?

    NO. Each should fill out Form FDA 1572 as sub-investigators are viewed as far as the Form FDA 1572 is concerned.

    You may refer to FDA guidance on FAQs at http://regulatorydoctor.us/?attachment_id=21494

    Thank you.  

    s/ David
    ____________________________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    President and CEO | REGULATORY DOCTOR and GCS
    Phone (Toll-Free): 1-(800) 321-8567


    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

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  • 3.  RE: Sponsor Investigator IND

    Posted 27-Oct-2015 22:48
    I meant to mean "sub-investigators are viewed as investigators" as far as the Form FDA 1572 is concerned.