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DocumentStudy Data Tabulation Model
Short NameSDTM
Version1.5
ReleasedJune 2016



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hiddentrue

The Study Data Tabulation Model (SDTM) v1.5 was published in June 2016.

This page contains the working list of errata for the final version 1.5 of the SDTM. 

Note

This page lists errata for an older version of SDTM.


Study Data Tabulation Model

  • Page 14 / Section 2.2.3, The Findings Observation Class: In the description for --DISTR,  'Examples: "FOCAL", "MULTIFOCAL", "DIFFUSE", "FOCAL", "MULTIFOCAL"' should be changed to 'Examples: "FOCAL", "MULTIFOCAL", "DIFFUSE"'.
  • Page 17 / Section 2.2.5, Timing Variables for All Classes:  
    • TAETORD: The parenthesis at the end of the description for this variable should be changed from "(see .Timing v1.5, Section 3.2.2)" to "(see Section 3.1.2)"
    • EPOCH: The parenthesis at the end of the description for this variable should be changed from "(See Section 3.2.2)" to "(See Section 3.1.2)"
  • Page 25 / Section 3.1.2, Trial Arms: In the description for ARMCD, the second sentence, "If the timing of visits for a trial does not depend on which ARM a subject is in, then ARMCD should be null," should be removed.
  • Page 35 / Section 7.1, Changes from SDTM v1.4 to SDTM v1.5: In the bulleted list headed by "Table 2.2.3: Findings:", the item "--IMPLBL Implantation Site Label" should be removed.