Today, SDTM is the general framework for organizing clinical trial information that is submitted to the FDA. SDTM can be developed at different stages in the clinical data management process. SGS Biostatisticians have converted legacy data into SDTM for more than 230 trials on behalf of multiple clients.
SDTM Conversions ,Validation and Migration Techniques
What is Sdtm mapping?
SDTM (Study Data Tabulation Model) defines a standard structure for human clinical trial (study) data tabulations and for nonclinical study data tabulations that are to be submitted as part of a product application to a regulatory authority such as the United States Food and Drug Administration (FDA).
What is Sdtm in clinical data management?
SDTM provides a standard for organizing and formatting data to streamline processes in collection, management, analysis and reporting. … SDTM is also used in non-clinical data (SEND), medical devices and pharmacogenomics/genetics studies.