DD0059

Pinnacle 21 Support Define.xml
1

I checked in the SDTM-IG 3.1.3 (I presume that is the one that you meant …)

Very interesting !!!

The SDTM-IG contradicts itself! One finds both (singular and prural) for both cases.
Unfortunately, it is nowhere stated in the SDTM-IG what exactly the content of the label is, each time a “value” for a “label” is mentioned, it doesn’t even speak about a label.

Also see: Working on and with CDISC Standards: SDTM labels: freedom or slavery?

2

Hello,

Did you find the answer for your question?

3

Hi,

validating my define.xml I get two DD0059-Error:

  • For IE the dataset label “Inclusion/Exclusion Criteria Not Met” is expected, whereas I am using the label “Inclusion/Exclusion Criterion Not Met”. This label is defined in the Clinical Standard Toolkit (…standards\cdisc-sdtm-3.1.3-1.5)
  • For QS the dataset label “Questionnaires” is expected, whereas I am using the label “Questionnaire”. Again this is the label defined in CST.

Which labels are the correct ones, those expected by OpenCDISC Validator or those defined in CST?

The validation of the SDTM datasets didn’t cause any Errors.

I am using Pinnacle 2.1.0 and CST 1.7

Regards

susanne