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.
Here’s a diagram to illustrate the point:
SDTM v1.6 in New HTML Format
SDTM v1.6 is the second CDISC standard to be published in HTML format, which expedites delivery of the standard and is viewable in any standard browser. HTML format allows users to search for keywords within the page, and bookmark the information in a browser. Implementers can also print the page, or export the information into other formats (e.g., PDF). To save a copy of the HTML publication on your desktop to access the document offline, press CTRL-S (PC) or COMMAND-S (Mac) on your keyboard.
SDTM v1.6 supports the SENDIG-DART v1.1 and includes additional variables related to developmental and reproductive toxicology (DART) animal studies. A full description of all changes from the prior version is provided in Section 7.
Metadata files as well as a Diff file, which summarizes the changes from SDTM v1.5 to SDTM v1.6, including new, updated and deprecated/removed content, are available to CDISC Members from CDISC SHARE Exports. If you are an employee of a CDISC Member Organization, you can access this metadata by logging into your account and visiting the Members Only Area in the upper right-hand corner of the web site.
Version 1.5 of SDTM specifically support SENDIG v3.1 and contains the following new variables to support SEND that will not be used in human clinical trials: --USCHFL, --DTHREL, --EXCLFL, --REASEX, FETUSID, --NOMDY, --NOMLBL, EXMETHOD, ICIMPLBL.
SDTM v1.5 includes content that is more broadly applicable to the SDTM family of implementation guides, such as:
Details of these additions can be found in section 7 of the document.
A future version of the SDTMIG will be published that incorporates variables found in SDTM v1.5 however, sponsors cannot use the new domain variables in a conformant manner until that future version of SDTMIG is finally published.
The use of any content in SDTM v1.5 is for SEND implementation only. The use of SDTM v1.5 content for human clinical trials needs to be carefully considered. It would not be valid to use new variables found SDTM v1.5 with any previously published implementation guide. Each implementation guide specifies the version of the SDTM that it is associated with. For example, any domains developed from SDTMIG v3.2 would fail conformance checks if they utilized new variables found in SDTM v1.5. The only valid way to include these variables in a human clinical trial would be to use them as supplemental qualifiers. If one is using a supplemental qualifier that contains content appropriate for one of the new variables, it may be better to give that supplemental qualifier the name of the new variable, rather than some other name.
Version 1.4 of SDTM adds variables to the general observation classes for clinical and non-clinical trials.
Version 1.3 of SDTM v1.3 primarily support SDTMIG v3.1.3 and includes:
Note: Amendment 1 to the SDTM v1.2, originally published in 2011, has been incorporated in SDTM v1.3.