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  • 1.  IND Annual Reports - Most Frequent AEs

    This message was posted by a user wishing to remain anonymous
    Posted 16-Oct-2018 15:56
    This message was posted by a user wishing to remain anonymous

    Dear Community-

    I am in the process of compiling my first IND annual report.  The regulations state that the annual report needs to include a narrative or tabular summary of the most frequent AEs by body system.  How do you determine the most frequent AE Criteria -  is it greater than 2% or another percentage?

    Thank you for your help!


  • 2.  RE: IND Annual Reports - Most Frequent AEs

    Posted 17-Oct-2018 07:37
    There is not a set frequency for "most frequent" and it will change over the life of the IND as you increase the N of subjects in the report.  Generally, early in development I will include everything, but as the numbers increase I might choose 5% and then eventually down to 2%. Another criteria that I have used with small numbers (say in an orphan product development) I will use a cutoff of events that occurred at least twice, for example.  Note that the same "rule" applies for labeling for an approved drug with 2 or 5% being the most common cutoffs.

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    Glen Park
    Jersey City NJ
    United States
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    Original Message


  • 3.  RE: IND Annual Reports - Most Frequent AEs

    This message was posted by a user wishing to remain anonymous
    Posted 17-Oct-2018 11:01
    This message was posted by a user wishing to remain anonymous

    Please check your clinical protocol for the study and also the investigator brochure for any criteria that your clinical team has stipulated. If you are a regulatory person, please always work closely with your clinical team for questions on AEs so that all these critical documents are in sync.
    Original Message


  • 4.  RE: IND Annual Reports - Most Frequent AEs

    Posted 17-Oct-2018 11:38
    Yes, usually the range is 2-5% with the goal to capture AEs that occurred in more than 1-2 subjects - so it varies by product, stage of development and the % needs to be set in conjunction with your Medical Director for the program.

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    Meredith Brown-Tuttle, RAC, FRAPS
    President
    Regulatorium
    Santa Clara CA
    United States
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    Original Message


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