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RSTESTCD value not found in 'Oncology Response Assessment Test Code' extensible codelist
SergiyYou need to explain it in Reviewer's Guide
Hi Tina,
According CDISC SDTM IG, RSTESTCD variable is assigned to (RSTESTCD) CT. P21 Validator enforces this rule from CDISC documentation. You cannot rid of this validation warning. Instead, you need to explain it in Reviewer's Guide.
Kind Regards,
Sergiy
RSTESTCD value not found in 'Oncology Response Assessment Test .
May I ask why you use PANSS which is for schizophrenia? Or is this a study about schizophrenia patients that develop cancer (see e.g. https://onlinelibrary.wiley.com/doi/full/10.1111/j.1440-1819.2006.01509.x)?
Important is that in the define.xml, you assign the codelist that you really used for RSTESTCD, even if that is not the expected codelist from the SDTMIG.
As Sergiy wrote, document this warning (i.m.o. it should be an "INFO") in the reviewers guide. Remark that in P21, a "warning" means "something unusual", not that it is wrong.
I would also (additionally) add a comment (using def:CommentDef referenced by ItemDef/@def:CommentOID) for the RSTESTCD variable that PANSS was used, in the define.xml itself. That makes it immediately clear for the reviewer that PANSS was used (and maybe why) without him/her needing to start digging into the Reviewers Guide.
On the other hand, the RSTESTCD and RSTEST codelists are extensible, so you could (but I don't say that that is the best solution) drop all existing terms from it and add all the PANSS codes and mark them as "extended" (using def:ExtendedValue="Yes").
Also remark that the codelists RSTESTCD and RSTEST do not appear anymore in the latest CT versions 2019-03-29 and 2018-12-21. I haven't found out yet why, but I presume that it is exactly due to this kind of discussions, i.e. "over-coding".
What version of CT are you using?
We collect PANSS data and we map to RS per CDISC implementation, however, it seems that Pinnacle 21 is expecting the RSTESTCD to come from the Oncology Response Assessment Test Code. The latest CT has PANSS mapped to Clinical Classification Test Code, so regardless of what we do, this Warning will always fall out in P21. Do you have a recommendation of how I can get rid of this warning from P21 or how should we explain this warning if we leave it as is?