Regulatory Open Forum

 View Only

  • 1.  [IND] Cross reference with closed study

    Posted 07-Jan-2021 03:27
    Our company has been doing several clinical studies of anticancer product in US.

    One phase 1 study finished and CSR was already made several months ago.
    Other several studies cross referenced with this phase 1 study about CMC and preclinical data.
    So we planned to close this phase 1 study.

    But our clinical division asked me whether it is possible to cross reference the close study number for current on-going studies.
    And whether it has an impact on current on-going studies or not.
    All studies are the same product.
    Should we keep this phase 1 study alive? 
    Or we can close this study and cross reference other study number?




    ------------------------------
    InPyo Hong MS
    Seoul
    ------------------------------


  • 2.  RE: [IND] Cross reference with closed study

    This message was posted by a user wishing to remain anonymous
    Posted 08-Jan-2021 11:36
    This message was posted by a user wishing to remain anonymous

    As long as the IND is open, you could close the study. I am assuming you have already submitted the CSR to the IND?
    Original Message


  • 3.  RE: [IND] Cross reference with closed study

    Posted 12-Jan-2021 02:16
    Thanks for your comment.

    We already submitted CSR of this study.
    It would be better decision to change the study status to "inactive" and no more submission about the related reports (safety reports) to FDA?

    It is difficult to understand the difference between "inactive" and "close" the study.
    Could you give your opinion about the difference for more clarification?

    Best regards,
    InPyo




    ------------------------------
    InPyo Hong MS
    Seoul
    ------------------------------

    Original Message


  • 4.  RE: [IND] Cross reference with closed study

    Posted 12-Jan-2021 20:08
    Here are my suggestions based on what the anonymous is referring to:

    Study closing versus IND closing.
    The CSR is submitted already to the IND correct? That means the study is over/completed. Once the study is completed and the final CSR is submitted there is no such thing as "study closing". Also no submission of safety reports because as you said the study is completed or more specifically you are not dosing any more patients. You did this study under an IND correct? It seems from your original question, you are planning to conduct or conducting other studies under the same IND? If so, don't make the IND inactive. The study is completed and therefore there is nothing to report from this study to the IND and in the annual reports! As long as the IND is open, you can conduct more studies under the IND and refer to the completed studies.
    Hope this helps!



    ------------------------------
    GRSAOnline
    ------------------------------

    Original Message


Related Content