TS DOMAIN (EXTTIND, SDTIGVER, SDTMVER)

a Angela

on December 17, 2019

Dear all,

Validating the TS domain we get the following WARNING if the TSPARMCD EXTTIND, SDTIGVER or SDTMVER is missing: Missing …… Trial Summary Parameter
which can not be found in the Validation Rules here at P21.

TS   SD2273   Missing EXTTIND Trial Summary Parameter
TS   SD2280   Missing SDTIGVER Trial Summary Parameter
TS   SD2281   Missing SDTMVER Trial Summary Parameter

If we implement these parameters with

EXTTIND – ExtensionTrial Indication
SDTIGVER – SDTM IG Version
SDTMVER – SDTM Version

ee get TSPARMCD /TSPARM value not found in 'Trial Summary Parameter Test Code' extensible codelist which is rather confusing as it seems to be well known – otherwise it wouldn’t be considered as missing, when not implemented.

The messages do not seem to refer to the entered values (TSVAL).

Can somebody help to get rid of these messages or explain, why they are popping up?

Many thanks in advance

Best regards,

Angela

(Biotest AG)

Forums: SDTM

Sergiy

on January 6, 2020

P21

Hi Angela

Hi Angela,

1. 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.

2. 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.

3. 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