Transcription of Study Data Specifications - Food and Drug …
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Study Data Specifications - Food and Drug …
Study data Specifications Study data Specifications Revision History Date Version Summary of Changes 2004-07 Original version 2005-03-18 Addition of Specifications for and SAS XPORT transport files Specifications . Changes in document organization. 2006-03-04 Update information on annotated ECG waveform data . Delete ecg folder under Specifications for Organizing the Datasets. 2006-11-27 Addition of Specifications for submitting tumor datasets ( ) from rodent carcinogenicity studies. 2007-08-01 Addition of hyperlink to information for datasets 2009-10-30 Modified introduction. Additional Specifications for submitting data tabulation datasets. Additional Specifications for analysis datasets. Revision of maximum file size restrictions. Addition of hyperlink to information for datasets.
Study Data Specifications STUDY DATA SPECIFICATIONS . These specifications are for submitting animal and human study datasets in electronic format.
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