SDTM v1.3


Published Date:

Version 1.3 of SDTM v1.3 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.


Files

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SDTMIG v3.1.3
SDTMIG for Medical Devices v1.0