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Difference between DIBD and DSUR Data lock point

  • 1.  Difference between DIBD and DSUR Data lock point

    Posted 25-Oct-2020 21:06
    Hello RAPS members,

    I have a question concerning definitions described in the FDA's E2F Developmental Safety Update Report. How does a company define a Developmental International Birth Date, and how does that differ from Data Lock Point during IND maintenance?

    Thank you,
    Shai

    ------------------------------
    Shailaja Kunda
    Research Professional | Regulatory Affairs | Quality Assurance | Project Management
    Life Science & Healthcare
    Denver CO
    United States
    ------------------------------


  • 2.  RE: Difference between DIBD and DSUR Data lock point

    This message was posted by a user wishing to remain anonymous
    Posted 26-Oct-2020 09:04
    This message was posted by a user wishing to remain anonymous

    The DIBD is the initial/first date on which the investigational product becomes approved (ie, authorized for conduct in a clinical study) in any country. The following year, as well as annually thereafter, DLP is the date used to lock the database for the purpose of assessing the safety and efficacy data of the product up to that point.

    For example, if a company receives a 'Study May Proceed' letter from the FDA for its investigational drug on Jan 3, 2020, DLP would be designated as Jan 2, 2021. On DLP, the company locks the database and prepares the various sections of the DSUR. The reporting period of the DSUR would be Jan 3, 2020 to Jan 2, 2021. Submission would be due 60 days later. The following year, DLP would be Jan 2, 2022 (reporting period Jan 3, 2021 - Jan 2, 2022) and so on.

    Note: If an authorization was granted in a different country other than the US on an earlier date than Jan 3, 2020, then that date should be the DIBD. 


    Original Message


  • 3.  RE: Difference between DIBD and DSUR Data lock point

    Posted 26-Oct-2020 09:15
    Anonymous has provided the correct information but I can add some additional nuance. If the DIBD is based on a clinical trial application approval outside the US, once an IND is open it is possible to synchronize the due date for the IND Annual Report and the DSUR date. A request can be submitted to FDA review division to change the IND AR date as long as there is not more than a year gap between the due date of the AR and the DSUR.

    ------------------------------
    Glen Park PharmD
    Executive Director, Regulatory Affairs and Quality Assurance
    New York NY
    United States
    ------------------------------

    Original Message


  • 4.  RE: Difference between DIBD and DSUR Data lock point

    Posted 26-Oct-2020 13:03
    thank you!

    ------------------------------
    Shailaja Kunda
    Research Professional, Neurology, Mayo Clinic
    Denver CO
    United States
    ------------------------------

    Original Message


  • 5.  RE: Difference between DIBD and DSUR Data lock point

    Posted 11-Nov-2022 10:32
    Thank you Shailaja for posting this question! 

    Dear Glen, 
    Thanks for your response, may I ask a follow-up question, if the sponsor's DIBD was in Mar. 2, 2021 and their US SMP was received on Nov.2, 2021, they missed the initial harmonization date for submission DSUR (submit in Mar.2022), can they keep the reporting date of SMP and submit DSUR#1 covering Nov.2, 2021-Nov.1 2022? I mean if they don't request to harmonize the DIBD, is it ok to use US SMP date as data lock point? or they need to submit IND annual report instead to avoid this DIBD harmonize issue? Thanks!

    ------------------------------
    Ziqi Zhang
    Regulatory Project Manager
    Raleigh NC
    United States
    ------------------------------

    Original Message


  • 6.  RE: Difference between DIBD and DSUR Data lock point

    Posted 14-Nov-2022 07:51
    Dear Ziqi,

    The most important thing is not to let more than 1 year go pass between SMP date and submission of a safety report, whether it is an annual report or DSUR. You could update the March DSUR and submit or submit in an annual report format. Then, to harmonize for the future, request harmonization to the DIBD and submit a DSUR in all relevant jurisdictions the next March even tho you had submitted to FDA in November.

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

    Original Message


  • 7.  RE: Difference between DIBD and DSUR Data lock point

    Posted 14-Nov-2022 09:00
    Thank you very much Glen for the clear explanation! This is very helpful!

    ------------------------------
    Ziqi Zhang
    Regulatory Project Manager
    Raleigh NC
    United States
    ------------------------------

    Original Message


  • 8.  RE: Difference between DIBD and DSUR Data lock point

    Posted 26-Oct-2020 13:04
    Thank you for the clear explanation.

    ------------------------------
    Shailaja Kunda
    Research Professional, Neurology, Mayo Clinic
    Denver CO
    United States
    ------------------------------

    Original Message


  • 9.  RE: Difference between DIBD and DSUR Data lock point

    Posted 26-Oct-2020 13:02
    E2F defines DIBD as the "date of the sponsor's first authorization to conduct a clinical trial in any country worldwide". We interpret this to mean regardless of indication. We also use the DIBD if it was established by a previous sponsor.  In our case, we acquired a compound that had multiple INDs.  The date that the first IND was given authorization to conduct a trial via FDA's May Proceed letter was April 30 (date of the IND May Proceed letter).  So April 30 was established as the DIBD for all INDs.  Per E2F, the DLP is either "the last day of the one-year reporting period" which would be April 29 in this case or "if desired by the sponsor, the DLP can be designated as the last day of the month prior to the month of the DIBD" which would be March 31 in this case.  In our case we decided to use March 31. The DSUR is due to be submitted within 60 days of the DLP so in our case we go with May 31 at the latest, but often we submit sooner.

    ------------------------------
    Tom Stothoff
    Senior Director, Regulatory Affairs CMC
    Chicago
    ------------------------------

    Original Message


  • 10.  RE: Difference between DIBD and DSUR Data lock point

    This message was posted by a user wishing to remain anonymous
    Posted 22-Feb-2024 09:06
    This message was posted by a user wishing to remain anonymous

    Hi All, thank you very much for the above tips! 

    Just have an additional question related to the topic.

    Assume a company finalizes a development program, inactivates the related IND, notifies other competent authorities about the last DSUR submission therefore no DSURs are generated anymore - The DIBD was AA-BB-CCCC. 

    The company then decides to start a new development program with the same compound opening a new IND and getting the Study May proceed letter dated XX-YY-ZZZZ- Should I still use as DIBD  AA-BB-CCCC? 


    Original Message


  • 11.  RE: Difference between DIBD and DSUR Data lock point

    Posted 22-Feb-2024 09:23
    Yes. Use same IBD


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    Original Message


  • 12.  RE: Difference between DIBD and DSUR Data lock point

    This message was posted by a user wishing to remain anonymous
    Posted 22-Feb-2024 16:51
    This message was posted by a user wishing to remain anonymous

    I'd say the new one XX-YY-ZZZZ!


    Original Message


  • 13.  RE: Difference between DIBD and DSUR Data lock point

    This message was posted by a user wishing to remain anonymous
    Posted 23-Feb-2024 09:06
    This message was posted by a user wishing to remain anonymous

    Rationale, please?


    Original Message


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