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  • 1.  1572 and CV for Initial IND Submission

    This message was posted by a user wishing to remain anonymous
    Posted 19-Mar-2021 08:57
    This message was posted by a user wishing to remain anonymous

    Is it true that at least one investigator should be identified or at least one signed 1572 and CV should be submitted for a new/initial IND submission of a FIH trial?

    Thank you!!


  • 2.  RE: 1572 and CV for Initial IND Submission

    This message was posted by a user wishing to remain anonymous
    Posted 19-Mar-2021 17:08
    This message was posted by a user wishing to remain anonymous

    Yes!
    Original Message


  • 3.  RE: 1572 and CV for Initial IND Submission

    Posted 20-Mar-2021 10:16
    Please share why you are asking this question. The regulations are quite clear about the requirements to have the legally binding, signed and dated, investigator statement (1572) in any drug trial which requires an IND. I have not seen a drug trial under an IND without the PI agreeing and formally signing the agreement in writing. The PI IS REQUIRED to understand and comply with the 9 requirements on the 1572 for their conduct in the drug clinical trial. I wonder if you are asking about a trial which does NOT require an IND. Many trials do not require an IND and would not require the 1572 legally-binding agreement with the FDA. For example: device trials, many (but not all) food and dietary supplement trials and some survey types of trials or registries. The IRB approval and other requirement still apply in most of these non-IND trials.

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    Joy Frestedt PHD, CPI, RAC, FRAPS
    President and CEO
    Frestedt Incorporated
    Saint Louis Park MN
    United States
    612-219-9982
    jf@frestedt.com
    ------------------------------

    Original Message


  • 4.  RE: 1572 and CV for Initial IND Submission

    Posted 20-Mar-2021 11:18
    Per 21 CFR 312.23 IND content and format, under 312.23.a.6.iii.b (protocols), 
    (b ) The name and address and a statement of the qualifications (curriculum vitae or other statement of qualifications) of each investigator, and the name of each subinvestigator (e.g., research fellow, resident) working under the supervision of the investigator; the name and address of the research facilities to be used; and the name and address of each reviewing Institutional Review Board.

    Thus, at least one Investigator 1572 and CV is submitted with the FIH trial, if applicable.




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    Robert Blanks RAC
    VP, Regulatory Affairs and Quality Assurance
    [Ardelyx]
    Auburndale MA
    United States
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    Original Message


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