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Industry standard for selecting sample size

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  • #44657

    Sorour
    Participant

    Is there an industry standard for determining sample size and acceptable error rate for auditing Case Report Forms (CRFs) in a clinical trial against source documents (ex. measurements on an image file)?
    The number of new time points or visits that I would be auditing per project would only be between 35-100.

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    #143620

    LBJ
    Participant

    General rule of thumb from the few books I have studied says 30 data points or more should give you normal distribution. But one who have to admit as much data as you can possibly manage should be used.  more data gives you greater precision. 

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