SDTM provides a standard for organizing and formatting data to streamline processes in collection, management, analysis and reporting. Implementing SDTM supports data aggregation and warehousing; fosters mining and reuse; facilitates sharing; helps perform due diligence and other important data review activities; and improves the regulatory review and approval process. SDTM is also used in non-clinical data (SEND), medical devices and pharmacogenomics/genetics studies.
SDTM is one of the required standards for data submission to FDA (U.S.) and PMDA (Japan).
Details on the requirements for FDA are specified in the FDA’s Data Standards Catalog for NDA, ANDA, and certain BLA submissions. For more information, please visit the FDA Guidance on Standardized Data.
Details on the requirements for PMDA can be found on the Advanced Review with Electronic Data Promotion Group page.
Please be aware that the SDTM and SDTMIG have separate web pages. The SDTM supports multiple implementation guides (IG) and a new version of the SDTM will appear to support a new version of any one of those IGs.
- There will always be a one-to-one relationship between a version of the standard (SDTM) and a version of an implementation guide (IG). This applies to all IGs (SDTMIG, SDTMIG-AP, SDTMIG-PGx, SDTMIG-MD, SENDIG, SENDIG-DART, CDASHIG, etc.).
- Each IG will reference the SDTM version it is associated with.
- One SDTM version can be referenced by multiple IGs.
- One SDTM version can be referenced by multiple IG versions – dependent on whether the IG content necessitates a model update
