SDTM Conversion Programming & Validation

The SDTM (Study Data Tabulation Model) is a standard for human clinical trials (research) data tables and non-clinical data tables submitted by researchers to FDA and PMDA (Japan). The specification was developed by the Federation of Clinical data Exchange Standards (CDISC). Detailed information about FDA requirements is specified in FDA, NDA, ANDA and in some BLA submitted data standard directories. All SDTM data and metadata submitted to FDA will eventually be loaded into FDA’s Janus data warehouse. The following picture (Figure 1) shows the CDISC SDTM submission process.