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Thread: Image files as Source Data

  1. #1
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    Nov 2011
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    Image files as Source Data

    Has anyone else come across using scans results and image files as source data and then used within the analysis.

    the issue i have is creating a validated process in how an imagine and its results produced within excel files, can be used for analysis.

    Would these have to be documented within the database or could the statistician use the raw data for their analysis as is?

    hope that makes sense

  2. #2
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    Nov 2011
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    Hi Itebbs,

    It is always desirable, however not always possible, to have a validated system which uses the source data as it is to do the final analysis as this eliminates the chances of errors. If such system is not possible, and if you have to transport the data to Excel files, then this transcription should be checked in 100% by another qualified person other than the one inputting the data. The Excel sheet should be signed and dated by the person entering the data and the person checking the data. This spreadsheet can be used by the statistician, but the entry of this data by statistician in their 'special program' should be checked 100% by another qualified person. Normal rule of signing applies. If the Statistician is qualified to read the data from the image files, then I, personally, don't see any problem them entering the data directly for analysis as long as the input is being checked independently by a qualified person. Regardless of the path you follow, it should be documented prior to execution.

    I hope this helps.

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