SDTM Programming or the Study Data Tabulation Model (SDTM) was developed by the Common Data Standards Consortium (CDISC). It is now the approved way to provide clinical data for regulatory submissions. At ClinPlus, we understand the challenges that come with converting your SDTM data to ADaM data, and then to submission-ready tables, as well as accurately documenting the process.
One of the primary challenges is providing reviewers with complete documentation, including clear descriptions of the usage, structure, contents and attributes of all submitted datasets and variables.
A second challenge when creating tables and listings is providing traceability as to how the ADaM datasets were derived or calculated. This process tracks each variable in the ADaM dataset back to its original source. CDISC specifications also indicate that any variables copied or derived from an SDTM domain into an ADaM dataset must retain the integrity of the data in the SDTM domain. This allows reviewers to replicate most analyses, tables, graphs and listings, with minimal or no transformations, and to enable them to easily view and subset the data used to generate any analysis, table, graph or listing, without complex programming.
As experts in SDTM programming, ClinPlus offers consulting, SDTM/ADaM conversion services and training, as required by your organization.
As an additional service, DZS Clinical Services can support the necessity to customize any table or listing to meet your company needs or branding requirements.
ClinPlus® Report CDISC/SDTM/ADaM Conversion