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Pharmacy 2012 Paper DS06 DTM Domain Mapping with Structured Programming Methodology Changing Li, Bringer Ingraham, Ridgefield, CT Jing-Wei GAO, Bringer Ingraham, Ridgefield, CT Nancy Bauer, Bringer
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SDTM domain mapping is a process of mapping clinical data domains to the standard domains defined by the Study Data Tabulation Model (SDTM).
Anyone conducting a clinical trial or submitting clinical data to regulatory agencies is required to file SDTM domain mapping.
SDTM domain mapping can be filled out by mapping the specific clinical data domains to the corresponding SDTM domains using the SDTM Implementation Guide.
The purpose of SDTM domain mapping is to ensure consistency and standardization of clinical data across different studies and sponsors, allowing for easier aggregation and analysis of data.
The SDTM domain mapping should include information about the source clinical data domains, their mapping to the SDTM domains, and any additional mapping details or transformations.
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