CG0021 Variable value not found in extensible codelist

p Priyanka

on January 6, 2020

Hi Team,

Why do we have P21 validator throwing WARNINGS for the values added as extensible codelist ? Can these be ignored if the extensible values are added to the codelist? I can see the values in define with an asterix however still getting such Warning messages.

Forums: SDTM

Sergiy

on January 6, 2020

P21

Warning message means potential issue and requires manual review

Hi Priyanka,

Warning message means a potential issue which required manual review. Some business rules cannot be fully automated to avoid false-positive messages. Extensible codelist is an example of such business rule.

You can add new terms to an extensible codelist. However, they should not be synonyms or split of existing standard terms. Also, new terms should be applicable for your variable.

From my personal experience in most studies ~30% of reported issues are actual errors rather than false-positive messages. Here are some examples:

"ng/mL" is invalid extension of (UNIT) codelist because it's a synonym of standard term "ug/L"
"Left Arm" is invalid extension of (LOC) codelist because it include non-applicable information "Left" which should be stored in a separate variable --LAT
"100 mg per day" is invalid extension of (UNIT) codelist for CMDOSU variable collected as a free text
"Tidal Volume" is invalid extension of (VSTEST) codelist because this information is not Vital Signs and should be stored in other standard domain RE (Respiratory System Findings)

While we are working noise reduction and better diagnostics of our validation rules, some of them still required additional manual review.

Kind Regards,

Sergiy