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SDTM Attribute Checking Tool

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Executive Summary

Converting clinical data into CDISC SDTM format is a high priority of many pharmaceutical/biotech companies. Most of these companies are ready to invest in obtaining a SDTM conversion tool that can do the job specifically designed for their company or to hire a CRO to convert the data for them. CDISC STDM conversion may sound like an easy job given the various available tools. What is important not to overlook is the validation of the resulting CDISC SDTM data. It can be quite challenging and time consuming validate SDTM submissions manually. Three targets or perspectives of validation can be categorized as structure, content and attributes.

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