- 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 "Since Last Visit"
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 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 QSTESTCD = "CSS0222B" QSTEST = "CSS02-Most Lethal Attempt Damage" to indicate CRF Text over 200 characters
- Added example for SUPPQS dataset
- Added section 5 Supplemental Qualifier Name Codes.