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 that sponsors must use as specified in the FDA’s Data Standards Catalog (see section II.C) for NDA, ANDA, and certain BLA submissions effective December 2016. For more information, please visit the Guidance on Standardized Data.
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
CDISC Study Data Tabulation Model (SDTM) v1.4
SDTM v1.4 – Adds variables to the general observation classes for clinical and non-clinical trials.
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