t Thierry
on

 

Hi,

I post this here, although it could also be posted in ADaM:

When validating an ADaM package (define or data, with 2.1), we specify the ADaM CT version used. However, a typical ADaM submission will also use the SDTM CT, and there is no place where we can specify the SDTM CT version used. Question: what does the validator do:

* ignore anything related to SDTM CT?
* use a default SDTM CT version (which one?)
* something else?

Thanks,
-- Thierry

Forums: Define.xml

m Michael
on January 12, 2016

In the latest Pinnacle Community 2.1.0, the ADaM configuration will only allow you to select on of the ADaM published CT found in components\config\data\CDISC\ADaM.  You are correct in that ADSL and ADAE does have some fields that should be validated against SDTM CT lilke RACE, SEX, AGUE, SEVERITY, etc...

Currently Pinnacle 21 Enterprise allows ADaM to be validated against both ADaM and SDTM CT simultaneously.   Community does not have this option (which would require another drop down and logic to read and apply both correctly).    So in essensce it ignores SDTM CT checks.

j Jozef
on January 12, 2016

Dear Thierry,

Additionally, you can also easily perform such checks using a CDISC RESTful web service. Take a look at http://xml4pharmaserver.com/WebServices/index.html#CDISCCT and you will find a web service "Get whether a coded value is a valid value for the given codelist". We have implemented this for SDTM (ADaM soon coming). As SAS supports RESTful web services, you can probably easily write a little SAS program that calls the service, and checks each of your SDTM-CT-Terms whether it is a valid value for the given codelist. You can of course do similarly in any other modern programming language (Java, C#, C++, XQuery, ...).

Best regards,

Jozef

j Jeroen
on October 6, 2016

Hi,

When specifying an ADaM Codelist using the latest P21 Community 2.2.0, several messages appear in the desktop.log4j2.log regarding unknown SDTM codelists for typical SDTM variables such as RACE, SEX, ... (see below)

10:38:59.709 [RxCachedThreadScheduler-1] DEBUG org.opencdisc.validator.cli.Connector - Triggering start of validation
10:39:01.302 [Thread-1] INFO  org.opencdisc.ipc.Bridge - The ItemDef IT.ADAE.AEACN contains a reference to the unknown codelist CL.C66767.ACN
10:39:01.318 [Thread-1] INFO  org.opencdisc.ipc.Bridge - The ItemDef IT.ADAE.AESER contains a reference to the unknown codelist CL.C66742.NY
10:39:01.318 [Thread-1] INFO  org.opencdisc.ipc.Bridge - The ItemDef IT.ADAE.AESEV contains a reference to the unknown codelist CL.C66769.AESEV
10:39:01.318 [Thread-1] INFO  org.opencdisc.ipc.Bridge - The ItemDef IT.ADAE.AETRTEM contains a reference to the unknown codelist CL.C66742.NY
10:39:01.318 [Thread-1] INFO  org.opencdisc.ipc.Bridge - The ItemDef IT.ADSL.AGEU contains a reference to the unknown codelist CL.C66781.AGEU
10:39:01.334 [Thread-1] INFO  org.opencdisc.ipc.Bridge - The ItemDef IT.ADSL.RACE contains a reference to the unknown codelist CL.C74457.RACE
10:39:01.334 [Thread-1] INFO  org.opencdisc.ipc.Bridge - The ItemDef IT.ADSL.SEX contains a reference to the unknown codelist CL.C66731.SEX
10:39:25.002 [Thread-1] INFO  org.opencdisc.validator.cli.Connector - Validation complete, threaded process ending

Can these messages be avoided/removed from the log file?
Since only one codelist at a time can be checked with the Community version, these messages seem not applicable for ADAM codelists.

Thanks for your reply,
Jeroen Den Herder

Want a demo?

Let’s Talk.

We're eager to share and ready to listen.

Cookie Policy

Pinnacle 21 uses cookies to make our site easier for you to use. By continuing to use this website, you agree to our use of cookies. For more info visit our Privacy Policy.