Define.xml

Description

Questions about creating and validating Define.xml

July 13, 2023

Hi,

It seems that P21 has wrong labels in its model SDTMIG 3.3:

- ECOCCUR: expects 'Occurrence Indicator' while SDTMIG has 'Occurrence' (source: SDTMIG 3.3 section 6.1.3.2)

- TSVAL1, 2, 3...: expects 'Parameter Value 1, 2 ...' while SDTMIG has 'Parameter Value' (source: SDTMIG 3.3 section 4.5.3.2)

Could this be corrected? Or do I miss something?

Thank you.

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July 3, 2023

Hi all,

While validating the adam define.xml, the issue DD0107 - "Origin for RDOMAIN variable is not set to Assigned" appeared for the ADCO (Comments)  analysis dataset. 

In the ADCO analysis dataset, the origin of the ADCO.RDOMAIN is set to Predecessor because the values are copied straight out of the variable SDTM.CO.RDOMAIN.

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June 26, 2023

Dear all,

 

When generating define.xml and using P21 Community validator, we found a quite interesting issue, DD0112 'Missing MedDRA definition':

There was information of MedDRA with a name and version in both variable's CT and External Dictionaries parts, however this issue still came out without more information about why and how this issue occurred or resolved. 

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June 26, 2023

I have a type of CRF Page number like 1-8 20 with both PageRefs and PageFirst/PageLast, is there any proper way in define specification to make the link available for all the numbers?

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June 22, 2023

Hi,

I'm attempting to create an SDTM Define (using 2.1 standards) and I'm getting the following rule triggering for a number of my codelists:

DD0132: 'Invalid use of def:ExtendedValue attribute'

I'm not sure where its getting the idea that I've extended these codelists because I don't think I have - as an example, it's triggering on the codelist 'Age Unit', on the term 'YEARS' (and this is the only term used). Is there something I could be doing by accident that is causing this error to appear?

Many thanks

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June 8, 2023

AppId: us-east-1:afa1e0dc-841c-42d9-babf-764e9c6589d8
PinnacleId: xinhua.zhou@immunogen.com
Application Version: 4.0.2
Platform: win32
Architecture: ia32
Release: 10.0.19045
Free Memory: 6401458176
Total Memory: 17013338112
CPUs: 8
RDP: false
Citrix: false
ErrorId: e18488b435720efb97c5db29319e600c

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June 8, 2023

Is this the issue of P21 bug or define.xml syntax issue?

 

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May 25, 2023

While creating define.xml using define 2.1 specifications, it allows to add metadata for empty datasets. In this case, xpt will not be available to hyperlink in the define.xml. However, while validating this define I am getting a message "Missing required 'def:leaf' value".

 

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May 19, 2023

I am generating a v2.1 define file from the workbook.  I have where clauses on my ValueLevel tab that are the same for various variables within a domain, but with different comment values in the comment column.  For most of the variables where the Origin is Assigned and the Source is Sponsor, I either get two of the same comment or two different comments.  The comments are ones that are associated with the value in the where clause just not necessarily for the current variable.  I have looked at the XML and I can't see the duplicate comments in there, but it also looks like the comment is a

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April 9, 2023

pinnacle21 担当者様

現在Pinnacle21 Community version4.0.1 の「Define.xmlのGenerate Define」よりExcel SpecからDefine.xmlを作成を行うと「Generating Define.xml」のウィンドウに「Parsing Excel template」の表示が出たままストップし先に進みません。お手数ですが,解決策をご教授いただけないでしょうか?

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