Define.xml

Description

Questions about creating and validating Define.xml

June 24, 2020

Can "Predecessor" be used as ORIGIN for those variables which has been inherited from one of the study included as part of integration in SDTM? 

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June 24, 2020

For pooling studies, how do we approach the annotation of the CRFs in the final define.xml?

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June 17, 2020

In SDTM when i have SUPPQUAL and SU domain i get the below error when checking define.xml

Split and unsplit datasets are both listed

This comes for all SUPPQUALS linking with SU

suppae, su

suppcm, su

suppdm, su

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June 12, 2020

Hi,

We are validating define xml with P21-community 2.2.0 version.

Here, we are getting DD0099 & DD0100 warnings when referring the latest ADaM terminology file [2019-12-20, 2020-03-27]. While looking into it, both Analysis purpose and reason are removed in the latest CT file. 

Please suggest how to resolve this.

Thanks in Advance.

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June 2, 2020

Hello,

I'm working on creating define.xml for SDTM using community edition. In whereclauses tab, if I add LBTESTCD EQ ALB, I see LBTESTCD= "ALB" (Albumin Measurement) in "Where Condition" section of define file i.e.  (Albumin Measurement) is getting added automatically.

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May 16, 2020

I'm working on creating define.xml for a study. We're incorporating external lab data in LB domain. Due to need for reconciliation, the external lab data was imported in study database i.e. data management team created separate CRFs for this externally imported lab data.

My question is, as this external lab data is imported to study database:

Do we need to annotate the CRFs for this lab data. If yes, then what will be the origin "CRF" or "eDT"? 

 

 

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May 7, 2020

Hi,

ARM Section : Analysis Parameter row : Would like to know, whether is it possible to display Only one data set PARAMCD's  OR  can we list out more than one data set PARAMCD's in this row?

The table generated based on more than one BDS data sets. So wanted to display more than one data set PARAMCD's in the Analysis Parameter row. 

Thanks.

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April 6, 2020

I see examples for validating define.xml using the command line interface. Is there a way to use the CLI to generate the Excel metadata and define.xml? If so, is there somewhere I can see an example? Thanks.

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March 6, 2020

I get the error "Missing Alias" in define.xml for a few ADaM datasets and i do not have any split datasets along with "Domain/SASDatasetName mismatch for split dataset" for the same datasets names:

adcgas

adcgii

adcgis

admasc

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February 19, 2020

My ItemDef:

<ItemDef DataType="text" Length="8" Name="HBA1C Units" OID="IT.HBA1C.UNITS" SASFieldName="HBA1CUNITS">
            <Description>
               <TranslatedText xml:lang="en">Units for LBTESTCD=ALB</TranslatedText>
            </Description>
            <CodeListRef CodeListOID="CL.C71620.LBORRESU.HBA1C.UNIT"/>
</ItemDef>

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