DD0107 issue for ADCO dataset

c Cacia

on July 3, 2023

Hi all,

While validating the adam define.xml, the issue DD0107 - "Origin for RDOMAIN variable is not set to Assigned" appeared for the ADCO (Comments) analysis dataset.

In the ADCO analysis dataset, the origin of the ADCO.RDOMAIN is set to Predecessor because the values are copied straight out of the variable SDTM.CO.RDOMAIN.

Is it acceptable to add a comment to explain the issue? I have cross-checked the ADaM IG and noticed that the variable SCRDOM is used for the SDTM or ADaM name that relates to the analysis value, not sure if it is suitable for the ADCO dataset.

Many thanks!

Forums: Define.xml

j Jozef

on July 3, 2023

DD0107 issue for ADCO dataset

As one of the developers of the define.xml standard, I don't understand this rule: it is always up to decide to the user what value the "Origin" should be set to. Not to FDA nor to P21.
It surely is NOT a CDISC rule.
It might be one of these P21 "quality rules", meaning "this is something unusual, please check it". If so, the level should be "info".
If this is so, the best is indeed to make a note in the "ADaM Study Reviewers Guide", explaining what and why you did as you did, as I consider it to be legimitate.