Ct2002 P21 warning

c Curt

on March 22, 2019

I have uploaded my SDTMs to P21 and created the define file. In the SDTM issues I am getting a warning that VSTESTCD value not found in Vital signs Text Code extensible codelist. When I go to the terms in my define, the term is listed.

Why is P21 giving me this message?

Attached Files

Ct2002.PNG

terms.PNG

Forums: SDTM

s Sergiy

on March 27, 2019

It looks like correct expected validation result

Hi Curt,

You did not provide enough details.

My assumption is that your study has non-standard terms. You described correctly your study metadata. Validation of study datasets still complains about non-standard terms for VSTESTCD variable (CT2002 rule?) regardless of their documentation in Define.xml Codelist for VSTESTCD variable. This is a correct expected validation result.

There are two types of validation rules for Codelists.

1. Standard variables with expected standard CT should follow this CT. Any extended terms will be reported by the Validator. If standard CT Codelist is non-extensible, then extra terms will be considered as obvious Errors. If standard CT is extensible, then extra terms will be reported as Warning about potential data issue. (CT200x rules)

2. Another type of Codelist rules (SD0037, SD1228) is about correct metadata in Define.xml file. Define.xml file describes actual study data.

In your case you should not receive SD0037 validation Error message, but will still have CT2002 Warning to review and confirm correct extension of standard CT. For example, 'SYSTOLBP' is invalid extension of standard (VSTESTCD) Codelist as a synonym of existing standard term 'SYSBP'. Another example is 'SYSBPSIT' (Systolic Blood Pressure, Sitting Position' as a invalid splitting of existing standard term.

Kind Regards,

Sergiy