CT0005

Hi,

We have been doing some testing of the validator and encountered some problems CT0005.

Digging into it turned out that there is not anything wrong with the functionality, however some of the descriptive texts could be more precise.

The description for CT0005 is “Variable values should be populated with terms found in 'Age Unit' (C66781) CDISC controlled terminology codelist”

The message for CT005 is “for TSVAL not found in AGEU controlled terminology codelist”

Examining the XML syntax of the check definition (inserted below reveals that it only applies when “TSVAL != '' @and TSPARMCD == 'AGEU'”, which makes absolutely perfect sense.

But it is not really what the descriptive texts says. My suggestion is to change the description and message to:

Description : “Variable values should be populated with terms found in 'Age Unit' (C66781) CDISC controlled terminology codelist WHEN TSPARMCD equals ‘AGEU’”

The message is “for TSVAL  not found in AGEU controlled terminology codelist WHEN TSPARMCD equals ‘AGEU’”

Br

Niels

THE XML SYNTAX:

<val:Lookup ID="CT0005"

Variable="CDISCSubmissionValue == TSVAL"

From="FILE:TAB:%System.ConfigDirectory%/data/SDTM Terminology.txt"

Where="CodelistCode == 'C66781'"

When="TSVAL != '' @and TSPARMCD == 'AGEU'"

ActiveUnless="%Variables[TSVAL].Define.WithCodeList%"

Message="Value for TSVAL not found in AGEU controlled terminology codelist"

Description="Variable values should be populated with terms found in 'Age Unit' (C66781) CDISC controlled terminology codelist"

Category="Terminology"

Type="Warning"

Severity="Medium"/>