Study Data Tabulation Model (SDTM)
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
Here’s a diagram to illustrate the point:
Study Data Tabulation Model (SDTM) v1.5
SDTM v1.5 – This version of the SDTM has been released to specifically support SENDIG v3.1. It 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:
- Text corrections and clarifications.
- It introduces the concept of domain specific variables. These are variables for use only in a specific domain.
- New tables to relay data about disease milestones at the subject and trial level and domain-specific variables.
- New variables have been added to the general observation class tables.
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.
CDISC Study Data Tabulation Model (SDTM) v1.4
SDTM v1.4 – Adds variables to the general observation classes for clinical and non-clinical trials.
Study Data Tabulation Model (SDTM) v1.3
SDTM v1.3 - This version of the SDTM has been released to primarily support SDTMIG v3.1.3, and includes:
- Additional variables in the general observation classes for clinical and non-clinical trials
- Content previously published in the SDTM Amendment 1
- Changes to the trial design section
- Document formatting updates
- TU/TR/RS Oncology domains developed as the Oncology Disease-specific Therapeutic Area Supplement.
Note: Amendment 1 to the SDTM v1.2, originally published in 2011, has been incorporated in SDTM v1.3. The original posted version of Amendment 1 can be accessed for reference purposes in the Members Only Area.