b Brian
on

 

Hi,

I am getting a Warning about ECSTDTC and ECENDTC being in the wrong order within the EC domain, however the dataset appears OK to me.  

The config-sdtm-3.2.xml file looks like there may be some issues in the OrderNumber values for the EC domain, and assuming these values are used to check variable order, this could be the problem?

Thanks,

Brian

 

Forums: Troubleshooting and Problems

s Sergiy
on December 9, 2014

Hi Brian, 

The information you provided is not enough for diagnostics of issue. One possible reason could be that your data have VISIT variable which is after ECSTDTC, ECENDTC variables.

The SD1079 check message says that reported variables were placed ahead of some other variables in standard structure. You need to look at your dataset for all details.

Kind Regards, 

Sergiy

b Brian
on December 11, 2014

Hi,

Thanks for the response.  What I meant to convey was that I thought the rule could be generating a false positive in the case of EC.  When researching the issue, I began wondering if OpenCDISC uses the OrderNumber attribute to check variable order.  If so, numbers 1, 2, and 3 are duplicated below, which could affect ECSTDTC / ECENDTC.

ItemRef ItemOID="EC.ECDTC" OrderNumber="1" Mandatory="No" Role="Timing" val:Core="Model Permissible"/>

                <ItemRef ItemOID="EC.STUDYID" OrderNumber="1" Mandatory="Yes" Role="Identifier" val:Core="Required"/>

                <ItemRef ItemOID="EC.ECSTDTC" OrderNumber="2" Mandatory="No" Role="Timing" val:Core="Expected"/>

                <ItemRef ItemOID="EC.DOMAIN" OrderNumber="2" Mandatory="Yes" Role="Identifier" val:Core="Required"/>

                <ItemRef ItemOID="EC.USUBJID" OrderNumber="3" Mandatory="No" Role="Identifier" val:Core="Expected"/>

                <ItemRef ItemOID="EC.ECENDTC" OrderNumber="3" Mandatory="No" Role="Timing" val:Core="Expected"/>

                <ItemRef ItemOID="EC.ECRFTDTC" OrderNumber="4" Mandatory="No" Role="Timing" val:Core="Permissible"/>

                <ItemRef ItemOID="EC.POOLID" OrderNumber="4" Mandatory="No" Role="Identifier" val:Core="Model Permissible"/>

 

Thanks-
Brian

 

s Sergiy
on December 11, 2014

Hi Brian, 

I see now. In v1.5 "SDTM 3.2" config has incorrect variable order numbers in CE domain.

It was fixed just after v1.5 release. v2.0 config file have correct metadata for CE domain. Please watch for its release tomorrow morning.

Thank you,

Sergiy 

b Brian
on December 12, 2014

Great thanks!

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