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

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.