Define.xml

Description

Questions about creating and validating Define.xml

January 22, 2016

Using P21-validator 2.1.0 on a define-xml v.2 file.

I have an ItemDef with 2 def:Origin child elements. This violates the current define-XML standard where "cardinality" for def:Origin is declared as "Zero or One". So the presence of two def:Origin child elements is a violation of the standard indeed (this will probably be relaxed in v.2.1).

The message I get is however very strange. It says "Missing Origin" (DD0072) although there are 2 ones.
It should be something like "Only 1 Origin child element is allowed".

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January 22, 2016

Using P21-validator 2.1.0 on a define-xml v.2 file.

Although my define.xml file does not have any "OrderNumber" attributes at all, I get a warning OD0042 "Duplicate Order number" for each of the variables. I consider this as false positives as the Define-XML 2.0 specification states:

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January 20, 2016

I generated a define.xml 2.0 file using the new Pinnacle 21 define generator that passed validation however there appears to be an issue with the WHERE clause in the Value Metadata.  It seems to repeat some of the criteria variables so it would show something like this in the WHERE column:

EGTESTCD='HR' and 

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January 12, 2016

Hi,

I post this here, although it could also be posted in ADaM:

When validating an ADaM package (define or data, with 2.1), we specify the ADaM CT version used. However, a typical ADaM submission will also use the SDTM CT, and there is no place where we can specify the SDTM CT version used. Question: what does the validator do:

* ignore anything related to SDTM CT?
* use a default SDTM CT version (which one?)
* something else?

Thanks,
-- Thierry

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December 30, 2015
In ADaM frequently numeric equivalents for NCI codelists are used (e.g. 1=MILD, 2=MODERATE etc.). We use to give them the name from the NCI codelist with addition of "(N)" (e.g. "Severity/Intensity Scale for Adverse Events (N)"). The validator is programmed to treat NCI codelist names with a small extension like "No Yes Response - subset Y" as a valid NCI codelist where NCI code is required. Would it be a good idea to exclude numeric codelists from this rule check to avoid false DD0031?

Thanks,

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December 21, 2015

When validating a define, the configuration only lets the user choose between "Define", or "Define (PMDA)".  Previous versions let the user choose between "Define 1.0" and "Define 2.0".  Define 1.0 is still being used. How should users handle this?

Thanks!

 

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December 21, 2015

Hello,

We are starting to use the new Pinnacle 21 community version 2.1 for our Define.xml v2 validation.

It goes pretty well, but we are getting errors in one occasion we do not agree with. For example when we have a subset DM and SUPPDM in the define.xml the ItemGroupDef is as follows:

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December 17, 2015

Hi,

I am trying to generate Define in version 2.1, For some reason the application stops working and throws a message "

Uh oh, a serious error has occurred..."

 and forces to restart the application. If the same specs are passed into version 2.0 it runs fine.

Can anyone please help me in identifying the reason for this.

 

Thanks!!!

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December 15, 2015

In P2.1 this rule should not be applied to Value level Itemdef

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December 15, 2015

I am getting this error for date/time variables like RFSTDTC etc in P2.1. I believe length is suppose to be missing

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