Page History

IS Example 11 in the SDTMIG 3.4 needs to be updated to cix SuppIS dataset.

Related JIRA issues: SDS-2553; SDS-2563

Discussion with Richard Marshall: https://wiki.cdisc.org/x/-otLCQ

Suggested changes:

1. change IDVAR to ISSEQ in both suppIS datasets.
2. change QNAM and QLBEL if need be, discuss with team, but suppIS row 1 should be QNAM = "MULTIPLE" followed by QNAM = XXXXXX1-4.
3. change QVAL to Dog Dander, Cat Dander, Horse Dander, Cow Dander

Richard's comments were that if you were to use the "MULTIPLE" convention in IS row 1 as appeared in the original example, ISBDAGNT= ANIMAL MIX ANTIGENS, MULTIPLE, then the suppIS dataset was created incorrectly. "MULTIPLE" requires QNAM to be xxx1-4. So if we want to keep the "MULTIPLE" in binding agent IS row 1, QNAM must be ISBDAG1-4.

However since the panel allergy results can also be reported by the region (as regional mixes), this ISBDAGNT= ANIMAL MIX ANTIGENS, MULTIPLE, doesn't make sense because this also implies multiple regions are associated with a single record, when in fact the IS row 1 record only indicates one region. So it is best to take the word "MULTIPLE" out of ISBDAGNT IS row 1.

Lastly, it seems odd to have dog, cat, horse, cow in QVAL because the panel antibody test targets dog dander, cat dander, horse dander, cow dander. QVAL values are imprecise and should be updated.