Data Management

Automating SDTM File Creation: Metadata Files Speeding the Process

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Executive Summary

For small to mid-size companies that cannot afford to purchase expensive tools to "Automate" the SDTM file creation process, tools can be prepared to streamline this process. SDTM conversion can be complicated as clinical study nuances have to be built into process. Metadata files that are built first by knowing what data are coming from the Clinical Data Management (CDM) system along with describing each CRF field as an SDTM variable begin the mapping process. Adding to these metadata files key information on how to transform the data from its source files into the resulting SDTM target variables round out the metadata files.

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