Questions about creating and validating Define.xml

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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August 16, 2022


If import EXCEL SPEC in P21,the following ERROR is displayed.

Can you provide an EXCEL SPEC(Analysis Displays,Analysis Results sheet) for reference?



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August 5, 2022

Hi, Team

Using Pinnacle21C Ver.4.0, 
I am going to create Define-spec.xlsx with ARM from Define.xml where "Selection Criteria" entered.
But, only "Selection Criteria" column in the Analysis Results sheet of Define-spec.xlsx is blank.
The columns except "Selection Criteria" is filled.
Pinnacle21C may break down?

Best regards, Sato

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July 25, 2022

Can Pinnacle21 Enterprise a provide a define.xml for legacy analysis datasets (non-compliant ADaM)?

We were asked to do new ISS and ISE analysis, for a label change, on several NDA original studies from as far back as 2007.

We created ADaM-like datasets from the original raw data for this analysis.

Since this data will be submitted for the label update, we assume that a define.xml should be included.  


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July 24, 2022

Hi Team,

I tried to generate define.xml version 2.1, but the "Analysis Parameter(s)", "Analysis Variable(s)" and "Data References (incl. Selection Criteria)" were blank whatever I typed in the "Variabls" and  "Selection Criteria" column in the Analysis Results sheet of define-spec.xlsx.

Can you provide some examples?

Best Regards.


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