Questions about creating and validating Define.xml

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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September 13, 2022

How can I select define version (2.0 or 2.1) when generating define.xml using command line interface?

Find the solution in the forum, there's a new parameter --source.define.standard



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August 30, 2022


I am wondering how to write on length/significant digit in "ValueLevel" sheet. (for TYPE=float)

I have a ADaM dataset, and it has a variable which type is float.

For example, the value=1.03 then maximum number of integer is 1, and maximum number of decimal digits is 2.

Therefore, length=3 (1+2) and significant digit = 2.


However, the validation reports for ADaM (based on ADaMIGv1.1) find it has longer than defined max length.

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August 21, 2022

If I store category data (e.g. pH=3.5,. .6.5) described as numeric values into LBORRES in SEND dataset, should the DataType of Value Level of the LBORRES be "float"? Or should the DataType be "text"?

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August 18, 2022

Is it possible to specify links to multiple supplemental files in a single variable source/derivation, or do we need to provide value-level metadata pointing to each file separately?  We're creating Define-XML via P21C using the Excel specs template, and have tried associating all of the files with the same comment, and then referencing that comment from the variable metadata, but only the last file defined in the list is displayed in the resulting Define-XML file.  What are we doing wrong? 

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August 17, 2022

In the Excel define spec of Pinnacle 21 Community v4.0.1, a column named "Assigned Value" has been added to the Variable and ValueLevel sheets.
What should be entered in this column?
Which of the Element/Attribute defined in the Define-XML v2.1 specification issued by CDISC does this correspond to?

Kind regards,


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