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  • 1.  Targets for Ontime Adverse Event Reporting

    This message was posted by a user wishing to remain anonymous
    Posted 25-Jan-2024 09:17
    This message was posted by a user wishing to remain anonymous

     Hi All,

    We are in the process of adapting our KPI metrics for adverse event reporting.

    1) Can you share any insight you may have to KPI targets for adverse event reporting?

    2) What outcomes have you experienced or seen for isolated incidences of missed reporting due dates or for a pattern of missed reporting due dates.  

    Thank you in advance.



  • 2.  RE: Targets for Ontime Adverse Event Reporting

    Posted 25-Jan-2024 10:43

    We need to know what jurisdiction(s) and product type(s) are the subject of your questions.  In the meantime, I can give some general opinions.

    Specifically, in my opinion, the only sensible and safe KPI target for adverse event reporting is that all (100% of) adverse event reports are submitted on time, all the time.  I advise against letting the corporate KPI process and its bells and whistles cause you to get too creative about this.  For example, tardy adverse event reports iare an automatic trigger for the U.S. FDA to automatically consider a Warning Letter for some products.



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    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright by ComplianceAcuity, Inc. All rights reserved.
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    Original Message


  • 3.  RE: Targets for Ontime Adverse Event Reporting

    Posted 25-Jan-2024 16:49

    Hi Anon.

    I actually completely agree with Kevin's position on this one.  You really should not reasonably be considering any "KPI" less than 100% in this case.  First, there is a legal obligation under the regulations in the US and most other jurisdictions that puts a time limit on how long you have to report adverse events and anything longer than that is a liability.  I have never used the corporate KPI process to potentially incur a liability against a company and would argue that this would be the exact opposite of the purpose for having the KPI.

    That said, I do agree that an ongoing measurement of your reporting is a valid and important auditing tool for you and your staff internally.  What you might consider as your KPI is more around the follow-up contacts or the time between initial report receipt and reportability determination being completed.  These could be set to a maximum number of days and not to a percentage and then an average could be used as your KPI.  So for example, you might set a KPI that says that you expect a reporting determination to be made within 3 days of initial report receipt and that less than 10% of determinations are made more than 3 days after receipt.  You now have 2 KPIs around adverse events that can be measured: (1) how long it takes you on average to make a determination of whether an event qualifies as reportable; and (2) how many determinations were not finalized on time.  Notice that neither of these will cause you to miss your required timing for reporting (you set the days number based on your most stringent timing for reporting thereby allowing yourself enough time in all countries to perform the reporting function) but they provide evidence of the efficiency of your processes.



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    Victor Mencarelli MS
    Global Director Regulatory Affairs
    New YorkNY
    United States
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    Original Message


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