FDA Announces Standards for Submitting Clinical Data

 
 
By eweek  |  Posted 2004-07-22 Email Print this article Print
 
 
 
 
 
 
 

Biostatisticians sometimes must spend hours reorganizing data from various formats. The FDA hopes that its experts and those at drug sponsors can soon use more of that time to actually analyze the data because more data sets will come in a standard format

Biostatisticians sometimes must spend hours reorganizing data from various formats. The FDA hopes that its experts and those at drug sponsors can soon use more of that time to actually analyze the data because more data sets will come in a standard format, the study data tabulation model (SDTM) developed by the Clinical Data Interchange Consortium. The standard was announced Wednesday in Washington.

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