Troubleshooting and Problems

Hi Gerard, thank you for answering my previous question.

Here is my another question:

You have follwoing check in config_sdtm_1.5.xml for EQ-5D-5L testcds

December 2015 CT release does not have separate QS-FT file for both 1.5 and 2.01 versions. Could you please let us knw the reason behind this?

Some of the rules for QSTESTCD and QSTEST are not in configuration file for ACQ category. Could you please let us knw the reason behind this?

Regards,

Megha

Hi, I was wondering if anyone could point me in the right direction.

I have the following command string when running OCV using CLI on ADaM xpt files:

CDISC Validator 2.0.2 for CT- 2015-09-25 is not querying any errors or warning if a unit /other CT variable of an extensible codelist has been used. Is there any particular reason why this rule is not working for this CT alone for the version 2.0.2?

Plese let me report an issue that Pinnacle 21(ver 2.1) crashed while validation of define.xml(ver.1.0). The issue happened not in ver.2.0 but only in ver.2.1. 

I tried several times changing structure of define.xml and finally found this issue was caused by 'SASDatasetName' attribute in ItemGroupDef tag. Once I removed the attribute, validation finished without crash.  

Could you investigate and fix this issue? Thank you.

I generated a define.xml 2.0 file using the new Pinnacle 21 define generator that passed validation however there appears to be an issue with the WHERE clause in the Value Metadata.  It seems to repeat some of the criteria variables so it would show something like this in the WHERE column:

EGTESTCD='HR' and 

EGCAT='MEASUREMENT' and

EGTESTCD='HR' and

EGCAT='MEASUREMENT'.

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: