Page History

• The HAMD 17 v2.0 supplement was updated to the WIKI clinical classifications supplement template.
• Annotated CRF was revised to a CDISC CRF to avoid complications with HAMD 17 CRFs included in copyrighted publications.
• The RSEVAL assumption and variable was removed from this supplement, since it is not captured on the CRF and no assumptions are made on the potential values.
• Section 3.1 reference to the total score of 54 was revised to 53.
• Revised assumption 2 to to be a sponsor's stated evaluation interval. 
• Added assumption 4 describing how question 16A and 16B are handled and included the “Presence of Data” items missing data rule.
• The example replaced the RSBLFL variable with RSLOBXFL, added the RSDTC variable and uses the RSTAT and RSREASND variables for the unanswered question 16B.
• All responses were updated to end in a "." punctuation as represented on the CRF.

• The following example row values were revised:

  • Row 3 RSTESTCD = “HAMD103 original RSORRES = “Ideas or gestures suicide.” was revised to “Ideas or gestures of suicide.”
  • Row 8 RSTESTCD = “HAMD108 original RSORRES = “Complete stupor.”  RSSTRESC = 4 and RSSTRESN = 4 was revised to RSORRES = “Slight retardation during the interview.”  RSSTRESC = 1 and RSSTRESN = 1.

• This measure was re-evaluated to fit the definition of a clinical classification measure.  The domain was changed from the QS to RS domain.

• Q16 only uses Part A or Part B and not both questions
• Revised annotated CRF to meet annotation font standards

Final