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AE.AECONTRT codelist
Hi David, Yes, you are
Hi David,
Yes, you are correct. AE Seriousness Criteria variables may have "N" value depends on particular sponsor implementation.
We've already fixed this CT and corrected version will be available in the next update.
Thank you for reporting this bug!
Kind Regards,
Sergiy
Codelist mixup for C66742 for AECONTRT in some CT versions
Hi Sergiy,
I think that in most recent versions of SDTM CT before 2014-12-19, stored in the .ODM file in the /config/data library, there are multiple codelists for NY, NYNA, etc that somehow were all assigned to CL C66742.
So I find that where I manually added an ODM file for the newer one, for 2014-12-19, the newer CT file does not have the conflict, and then our AECONTRT (with values of N or Y) seems to validate fine against the newest list.
If I run against 2014-06-27 or 2014-09-26, then it fails for that variable. I definitely am seeing > 1 codelist for C66742 in the 09-26 .ODM one; I haven't searched through any other ones, but I suspect it may have similar issue in another one.
So I think some adjustment needs to be made for the codelist issue.
Thanks,
Joan
Hi Joan, As I said before,
Hi Joan,
As I said before, it's a bug which is fixed. However you need to wait for a new version 2.01 which will be available today.
Thanks,
Sergiy
Thanks. I guess we are talking about the same thing then.
You wrote about AESER. Our question came up only for AECONTRT somehow, where the error gets flagged. (The question from me and the original poster is AECONTRT.) AESER in (Y, N) is not getting flagged, and AECONTRT in (Y, N) is getting flagged.
I am glad the codelist issue will be fixed in 2.01
Thank you.
I am using the config file SDTM 3.1.2 (FDA).xml in the v2.0 validator and have a question about the codelist association for AE.AECONTRT. My SDTM.AE data has values of 'Y' and 'N' for this variable, and the validator throws errors for the 'N' values.
Looking at the config file AE.AECONTRT is associated with the codelist <CodeListRef CodeListOID="CL.C66742.Y"/> which appears to be a subset of CL.C66742 with only the 'Y' value, and as a result AECONTRT is being validated as if it were a "check if yes" variable. There are other variables in AE with "CL.C66742.Y" codelist association, AE.AESDTH is an example. Looking at the SDTM IG 3.1.2 it would appear that the codelist should allow both 'Y' and 'N'; the 'Controlled Terms, Codelist or Format' column has a link to the full 'Y/N/U/NA' codelist. Could you point me to the guidance that makes AECONTRT = 'N' produce an error?
-Thanks.