Route validation not consistent between EX and TS?

b Bedeoan

on January 30, 2013

Hi all,

I'm getting the following warning for TS: "Value for TSVAL not found in (ROUTE) CT codelist".

My route value is not in the list of SEND Controlled Terms for the ROUTE CodeList, but it is added in define.xml as below:

<CodeList OID="CL.C66729.ROUTE" Name="Route of Administration" DataType="text">
                <CodeListItem CodedValue="myRoute">
                    <Decode>
                        <TranslatedText>myRoute</TranslatedText>
                    </Decode>
                </CodeListItem>
            </CodeList>

I would expect either to see the same warning also in EX, not only in TS, either to see no warning for route (since I added the value in define.xml for the ROUTE codeList and the codeList is extensible).

What do you think, guys?

Best regards

Forums: Validation Rule Suggestions

s Sergiy

on January 30, 2013

Hi Amelia, There are two

Hi Amelia,

There are two separate checks around CDISC CT (ROUTE) codelist.

CT0031 is a "variable-level" check, which applies to EX and other Interventions domains. You can overwrite CDISC CT (ROUTE) codelist by your custom one by providing it in define.xml.

CT0032 check is a "value-level" check. It works in TS domain, to ensure that TSVAL is under CDISC CT (ROUTE) codelist, when TSPARMCD = 'ROUTE'. Another codelist may be used for other TS record based on TSPATMCD value.

Unfortunately, there is no option to assign "value-level" codelist in define.xml v1. Therefore you can not overwrite pre-specified CDISC CT codelits.

My recommendations:

1. Try to not extend CDISC CT codelists in TS domain

2. Document and explain your case, if you need to use addiional values

3. Wait for define.xml v2 AND a new release of OpenCDISC validator after that as a long-term solution ;)

Thank you,

Sergiy

b Bedeoan

on January 31, 2013

Hi, Sergyi, Thank you for

Hi, Sergyi,

Thank you for the detailed explanation. However I'm not sure how one can achieve recommendation #1:

1. Try to not extend CDISC CT codelists in TS domain

The ROUTE CodeList is extensible; meaning the user can add to the list its custom values. And since a route is used in EX, it should also be listed in TS. Theferor... you can't really extend the ROUTE codelist just in EX and not in TS.

If you list in TS only the routes that match the CT codelist, you'll end up with some inconsistencies...

By the way, I don't think there is any cross-check for ROUTE between EX and TS, no? To make sure that TSVAL values from TS when TSPARMCD='ROUTE' match ROUTE values from EX.

Best regards,

Amelia