- Converted the supplement to the current WIKI QRS supplement template.
- Annotated CRF updated to the MSG V2.0 annotation guidelines, including following updates:
a. Change of QSEVLINT to QSEVINTX for the Evaluation Interval Text of "LIFETIME"
b. Added annotations for QSSTRESC/QSSTRESN wherever applicable
- Added the first assumption to include details on every item of the instrument.
- The QSEVAL and QSEVALID assumption and variables were variable was removed from this supplement since it is not captured on the CRF and no assumptions are made on the potential values.
- Added assumptions 4, 5 and 6 for conditional branching. The example was updated to include records for these items.
- Added QSLOBXFL variable to the example to represent a baseline response for visit 1
- Added example to represent skipped visit (VISITNUM = 2)
- Added QSDRVFL variable to the example to represent items not done due to conditional branching.
- Section 4 (SDTM mapping strategy): Added an additional column in the table for "Most Recent Attempt", "Most Lethal Attempt" and "Initial/First Attempt" (QSTESTCD = "CSS0121B", "CSS0122B", and "CSS0123B") to indicate CRF Text over 200 characters
- Added example for SUPPQS dataset
- Added section 5 Supplemental Qualifier Name Codes.