2019-12-04 | 2.1 Draft | - 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.
- Revised assumption 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.
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