b Bedeoan
on

 

Hello,

I'm having the following Warning reported for the CO (Comments) domain, for the variable values: COVAL1, COVAL2, COVAL3:

SE0058 - "Variable appears in dataset but is not in SEND standard" - Only variables listed in SEND should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified

Scenario: I have to represent in CO.xpt one domain comment of almost 600 characters. According to SENDIGv3.pdf, pages 43-45, the comment first 200 chars should be added into the COVAL variable, and then "Text over 200 characters can be added to additional columns COVAL1-COVALn".

In my case, for a 600+ chars text, in CO.xpt the comment is split under 4 columns: COVAL, COVAL1, COVAL2, COVAL3, which should be the proper way to represented, according to SEND specs... The data definition file (define.xml) also mentions these variables:

<ItemGroupDef OID="CO" Name="CO" Repeating="Yes" SASDatasetName="CO" Purpose="Tabulation" def:Label="Comments" def:Structure="One record per comment" def:Class="Special Purpose" def:DomainKeys="STUDYID,DOMAIN,USUBJID,COSEQ" def:ArchiveLocationID="ARCHIVELOCATION.CO">
<ItemRef ItemOID="CO.STUDYID" Mandatory="Yes" OrderNumber="1" Role="IDENTIFIER" RoleCodeListOID="CL.ROLES"/>
...

<ItemRef ItemOID="CO.COVAL" Mandatory="Yes" OrderNumber="9" Role="TOPIC" RoleCodeListOID="CL.ROLES"/>
<ItemRef ItemOID="CO.COVAL1" Mandatory="Yes" OrderNumber="10" Role="TOPIC" RoleCodeListOID="CL.ROLES"/>
<ItemRef ItemOID="CO.COVAL2" Mandatory="Yes" OrderNumber="11" Role="TOPIC" RoleCodeListOID="CL.ROLES"/>
<ItemRef ItemOID="CO.COVAL3" Mandatory="Yes" OrderNumber="12" Role="TOPIC" RoleCodeListOID="CL.ROLES"/>
<ItemRef ItemOID="CO.COEVAL" Mandatory="No" OrderNumber="13" Role="QUALIFIER.REC" RoleCodeListOID="CL.ROLES"/>
                ....
</ItemGroupDef>

...

<ItemDef OID="CO.COVAL" Name="COVAL" DataType="text" Length="200" Origin="COLLECTED" def:Label="Comment"/>
<ItemDef OID="CO.COVAL1" Name="COVAL1" DataType="text" Length="200" Origin="COLLECTED" def:Label="Comment"/>
<ItemDef OID="CO.COVAL2" Name="COVAL2" DataType="text" Length="200" Origin="COLLECTED" def:Label="Comment"/>
<ItemDef OID="CO.COVAL3" Name="COVAL3" DataType="text" Length="200" Origin="COLLECTED" def:Label="Comment"/>

...

However, the Validator reports the above Warnings. What do you think to be the problem here?

Thanks!

Amelia

 

Forums: Validation Rule Suggestions

s Sergiy
on April 5, 2012

Yes, I know about this bug. It's fixed, but will not be updated on the site untill the next tool release.

BTW there are some other bugs we already identified and fixed in SEND validator. For now I can email you a corrected version if you want. 

If you like to fix this particular bug by yourself, you need to edit "config/data/SEND Metadata 3.0.csv" file:

1. Open the file (by MS Excel or similar software)

2. Do search "COVAL"

3. Add additional records: COVAL1, COVAL2, ...COVAL9

4. Use the same values for Domain, Variable Label, Type, Role, Core columns as for the COVAL record

5. Re-order variables for CO domain (Seq column values)

6. Save the file

 

b Bedeoan
on April 6, 2012

Hello Sergiy,

Yes, I would be interested in having a corrected version. If it's on SVN already, I can take it from there also.

Thanks!

 

 

s Sergiy
on April 6, 2012

No, it's not available outside OpenCDISC development team. You can contact me directly by email:

sergiy at opencdisc.org

Reagrds, 

Sergiy

s Sergiy
on April 6, 2012

 

Hi Amelia,

I was wrong. Our technical people corrected me. You can find in-development files at http://svn.opencdisc.org/validator/trunk/

If you work with SEND standard only you need to update config-send-3.0.xml from http://svn.opencdisc.org/validator/trunk/config/

and  SEND Metadata 3.0.csv from http://svn.opencdisc.org/validator/trunk/config/data/

Regards

Sergiy

 

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