Hi Angela,
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Pinnacle 21 rules webpage (https://www.pinnacle21.com/validation-rules/sdtm) you refer to is dedicated to Community version which today includes FDA engine 1903.1. The FDA rules you refer to (SD2273, SD2280 and SD2281) were introduced in later P21 engine 1907.0. That’s why you do not see these rules on Community support webpage.
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It looks like you used incorrect non-standard terms for TS Parameters.
There are two related codelists in CDISC SDTM CT: TSPARMCD (Trial Summary Parameter Test Code) and TSPARM (Trial Summary Parameter Test Name). The relationship is provided by NCI Code which is the same for paired terms.
For example, a term ‘EXTTIND’ in TSPARMCD codelist has NCI Code C139274. The same NCI Code C139274 represents a term ‘Extension Trial Indicator’ in TSPARM codelist. It means that in TS domain record with TSPARMCD = ’EXTTIND’ should have also TSPARM = ‘Extension Trial Indicator’.
In you example, TSPARM value is implemented incorrectly as ‘ExtensionTrial Indication’. Therefore, you are expected to receive CT2003 validation message ‘Coded and Decoded values do not have the same Code in CDISC CT’
Two other your examples looks OK! regarding CT2003 rule.
- You did not provide enough information about your issue. Therefore, I have many assumptions: validation of your SDTM data was done with P21 Enterprise, engine 1907.1 and using CDISC SDTM CT 2017-03-31
In this version of CDISC SDTM CT, your reported terms did not exist. Therefore, validator complains about them as non-standard terms.
Term ‘EXTTIND’ was introduced in CDISC SDTM CT 2017-09-29. Therefore, it is considered as a standard term only in this and later versions of SDTM CT. You will not receive CT2002 validation message for ‘EXTTIND’ if you will use SDTM CT version 2017-09-29 or any other more recent ones.
Similar, ‘SDTMVER’ and ‘SDTIGVER’ terms were introduced in SDTM CT 2018-12-21. Therefore, they will be reported as non-standard terms in all previous versions of SDTM CT.
Kind Regards,
Sergiy