Questions about creating and validating Define.xml

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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March 7, 2023

Hi all,

Our team recently started evaluating our Define v2.1 files for SEND 3.1 datasets and after reviewing the Pinnacle 21 validation reports, I identified a few potential checks that may be incorrect:

  • DD0004 - "Attribute 'def:HasNoData' is not allowed to appear in element 'ItemRef'":  This is being triggered when def:HasNoData is applied at the value level for blank results, which is acceptable per Define XML 2.1 spec.  Adding comments to the value level ItemDef did not resolve the validation issue.

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February 16, 2023



I'm writing to ask some clarification about source for define v2.1 when type is Collected.

We have some data (in this case protocol deviations) collected outside the CRF, but it is not collected by a vendor so we were trying to use source=Subject. In this case when we generate define.xml we automatically get the link to the CRF with the error "Missing Pages value", but data is not collected from CRF so we can't really insert a page linking to the CRF here.

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November 11, 2022

In P21 generated spec, I would like to give comments for assigned variables DICTNAME and DICTVER in SUPPAE, but the assigned value will appear twice in define.xml, how should I fix this situation? And is there another way to put assigned value for variable?


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October 28, 2022


While validating define xml 2.1 with Engine FDA (2204.1)/SDTMIG3.3, I have the ‘DD0138-Referenced Standard is missing’ error.

I have this error for the 2 standards other than SDTMIG3.3 (ie SDTMIG 3.4, SDTMIG-MD 1.1 are used for some datasets).

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October 19, 2022


1, At the Standards Area(or block): the block of type=CT was tested by imputing like figure1(F1.png) to achieve, i don't is this the correct way. my questions are: a prefix string "CDISC/NCI" seems added to the entry word, if i delete the "CDISC/NCI" from entry, the Standard order goes wrong(CT display before IG); also i don't know how to achieve the Documentation column's entry in spec, when i entry at Codelists sheet - Comment column(and Comment sheet to describe), the entried Description text goes to CodeLists Area of the Define-XML...

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October 13, 2022

1. "Analysis Parameter(s)", "Analysis Variable(s)", "Data References (incl. Selection Criteria)" were blank in ARM.

So, data was input to add, the same error as the capture was generated. Please check which one is the problem.


2.  I download  blank template EXCEL SPEC.

There is "Analysis Criteria"  sheet in EXCEL SPEC.

Please give me example "Analysis Criteria"  sheet.

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September 21, 2022


I have a where clause statement AWRANGE EQ 'Weeks 19-24'. However, when generating the define.xml from P21 Community, it converts the content of VALUE column to upper case letters (WEEKS 19-24) and when validating the define.xml together with the xpt datasets, it can't find any values with that kind of where statement (as the value available in data is 'Weeks 19-24' instead of 'WEEKS 19-24'). 

Below is a snap shot of excel spec from where the P21 generates the define.xml. 

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