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DD0024 andSDTM 3.2.xml
Forums: Define.xml
--STRTPT and codelists
Hi Sherry,
Did you include the define.xml when validating?
In your define.xml you can/should/must define which codelist you are using for your --STRTPT variables. As the define.xml is "the sponsor's truth", this should override what is in the configuration file. If you reference a STENRF codelist from your --STRTPT variables in your define.xml, and use that during validation, you should not get the aforementioned error anymore. If that error than still occurs, then I would consider that a bug in the software.
There is inconsistency across different versions of SDTM IGs
Hi Sherry,
There is inconsistency in a list of allowed terms for --STRTPT variables across different versions of SDTM IG. As you pointed out in IG 3.2 "ONGOING" is a valid term, while it's not a case in previous versions. Today validation of Define.xml file is not sensitive to version of SDTM standard. We are discussing different approaches on how to handle this new challenge. Meanwhile your only option is to document this validation message as a known bug in P21C v2.2.0 related to SDTM IG 3.2.
Kind Regards,
Sergiy
Define-XML and SDTM-IG Version
The version of the SDTM-IG that is used can be read from the define.xml file from the def:StandardName and def:StandardVersion attributes on the MetaDataVersion element: sie the Define-XML specification section 5.3.5 with an example in section 5.3.5.1.:
In Define-XML 2.1 one will be able to define IG versions at the domain/dataset level too.
Thank you for both of your…
Thank you for both of your explanation, I understand then at this moment this is something we cannot resolve and have to explain to our client.
Kind Regards,
Sherry.
Hi P21 team,
I have a question regarding DD0024 and using the CT C66728 in --STRTPT variables. Per the controlled terminology file, C66728 belongs to 'STENRF', and the SDTM v3.2 metadata released by CDISC also indicates --STRTPT variables can use STENRF. However, when running define v2.0 using the validator (version 2.2.0), DD0024 will come up, indicating that the value ONGOING (one of the codes in CC66728) is not valid.
I went in and checked SDTM 3.2 xml configuration and found ouf that the --STRTPT variables in the xml actually indicates e.g.
<ItemDef OID="IT.EVENTS.__STRTPT" Name="__STRTPT" DataType="text">
<Description>
<TranslatedText xml:lang="en">Start Relative to Reference Time Point</TranslatedText>
</Description>
<CodeListRef CodeListOID="CL.C66728.STRTPT"/>
</ItemDef>
Currently, there is no STRTPT in even the latest terminology 2017-03-31 (C66728 still belongs to STENRF). Is there any particular reason why this is set as such in SDTM v3.2.xml?
Thank you.