100% raw data presentation in BA report [Bioanalytics]

posted by jag009  – NJ, 2018-05-18 16:23  – Posting: # 18784
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(edited by jag009 on 2018-05-18 16:34)

Hi,

Does anyone know what items are required to be presented in the "100% Raw data" tables in a BA report (For FDA)? Is there such a list of required items?

The reason I asked is because I have came across reports from several labs and they don't have the same # of items presented in this "100% raw data" table. Of course the crucial ones are presented, but some such as dilution factor, analysis date, IS and analyte retention times are absent from the tables generated by some labs.

Thanks
John

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