Troubleshooting and Problems

Hi,

Running Pinnacle 21 Community to validate ADaM datasets we get the following error message that we didn't get before with previous versions (i.e. with OpenCDISC Community): Variable label mismatch between dataset and ADaM standard

We get this error for all treatment date and/or time related variables in ADSL and all ADaM datasets where they had been copied to, e.g. for TR01SDT, label="Date of First Exposure in Period 01". I checked of course all corresponding variable labels but could not find anything wrong in it.

Please advise.

Hi,

The define-XML specification version 2.0 states:

Note that the SDTM-MSG indicates that the datasets should be displayed in the following Class order:
* TRIAL DESIGN
* SPECIAL PURPOSE - Subject-Level
* INTERVENTIONS
* EVENTS
* FINDINGS
* FINDINGS ABOUT – not yet added to the NCI/CDISC Controlled Terminology as of the time of writing this document
* RELATIONSHIP

Hi,

When validating a define.xml (SDTMIG 3.1.3), I get these messages:

DEFINE      Variable,DefineLabel,StandardLabel  it.IE.IETESTCD,Inclusion/Exclusion Criterion Short Name,Incl/Excl Criterion Short Name  DD0060    Define.xml/CDISC variable Label mismatch. Cross-Reference Error
DEFINE      Variable,DefineLabel,StandardLabel  it.SE.TAETORD,Planned Order of Element within Arm,Order of Element within Arm DD0060    Define.xml/CDISC variable Label mismatch. Cross-Reference Error

Hi,

When validating a define.xml (define-xml 2.0), I get paired DD0057/DD0007 messages:

DD0057    Missing Description value.  Error 9
DD0007    Invalid content was found starting with element 'def:DocumentRef'.  Warning 9

Here is an example of a MethodDef generating these messages:

Hi,

When validating a define.xml file (define-xml 2.0), I get the message:

DD0082    Codelist cl.SDTM-Roles is not referenced.

This codelist is referenced, e.g.:

Would anyone have any insight as to why the CLI command that works for 2.0.2 does not work for 2.1 when validating a "define.xml"?

With 2.0.2:

I have downloaded the "Pinnacle 21 Community 2.1.0" for Windows and used "Validator" for SDTM datasets with XPT files.

Previoulsy I used "Open CDISC Community 2.0.2" without any problems.

That said "validation complete, 0 messages were generated, 0 checks were performed".

In the report excel file, Reason for Un processed Souces is "Validation Aborted".

Can somebody help me to troubleshoot the problem or provide the steps to resolve this issue?

Find attached the logs and report file.

Thanks in advance.

in one of our study the usubjids only has numeric value i.e 111111.3777710 and in DM this usubjid value was fine but in pp domain for some issue related to csv to sas dataset conversion the last 0 got truncated so the usubjid in pp was 111111.377771, clearly this subject is not the same as in DM but this issue was not highlighted in opencdisc check, we were expecting a error with code FDAC040 i.e subject not present in DM domain. but this did not happen.

could this be a bug in opencdisc? please could you confirm.

OpenCDISC v2.0.2 Validator Report is showing the wrong version.  Excel shows it as "Engine Version: 2.0.1".

Hi,

When I tried to perform SDTM validation for MH domain (medical history), below information popped out:

--------- System Information ---------

 Version: 1.5

     JRE: 1.8.0_25

      OS: Windows Server 2008 R2 6.1 amd64

--------------------------------------

java.lang.RuntimeException: org.joda.time.IllegalInstantException: Cannot parse "1987-04-12": Illegal instant due to time zone offset transition (Asia/Shanghai)