Define.xml

Description

Questions about creating and validating Define.xml

January 30, 2025

I am just curious about the following finding:

I am using Define Standard 2.1 and correctly populated Excel Specs to generate the Define.

When applying a Comment on Valuelevel, then the corresponding Wording is displayed twice (see attached screenshot).

Interestingly, when having a derivation Method assigned on Valuelevel, this does not happen and the description of the Method is only shown once.

Within the code, the declarations seems reasonable:

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January 20, 2025

The derived variable IEDY is currently populated as 'No data' in the SDTM specification. Could you please guide us on how to include a comment to resolve the DD0134 issue for this in the SDTM specification?

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January 8, 2025

When validating the LB domain with the define.xml file, we came across a peculiar false positive for the SD1230 check in Community.

The message is "LBORRES datatype is not float when (LBCAT == 'HEMATOLOGY') @and (LBTESTCD == 'BASO' @or LBTESTCD == 'EOS') " and it references the Basophil LBORRES value being ".04".

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November 7, 2024

Hi!

These is an issue which I believe is false positive for my case:

Issue is SD1230: FAORRES datatype is not text when (FATESTCD == 'DESC') for one case, but in define.xml type is text in both variables and value level tabs, and value for FAORRES is a text "1.DEVIATION OF EYES TO ONE SIDE...". I think it might be due to value starts with number+dot and Pinnacle think that it is a float.

I'm using PMDA 2311.0 engine.

Thank,

Denys

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November 5, 2024

Hi Community.

We're doing the CRT review of variables and we encounter different approaches in setting length for *DT, *DTM variables in ADaM datasets. 

Should the length be set to max for *DTM variables? For example: datetime with datetime20. format is stored as "20JUN2022:09:37:00" but when the format is removed, it's stored as "1971337020". DataType is integer. Should the length be set to 8 or 10?

Thank you in advance.

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October 25, 2024

Dear all,

as I searched the web and didn't find any hint on this, therefore now here my question:

Is it possible to declare WhereClauses for ValueLevel metadata not relying on distinct values, but just on the plain existence/absence of data in the referred variable?

Example:

(1) Variable: ISREASND; WhereClause: ISREFID NE <null>
(2) Variable: ISREASND; WhereClause: ISREFID EQ <null>

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October 9, 2024

I wonder if P21 Enterprise can validate define.xml only without xpt files? In the community version, we can run p21 for define.xml rules only. Not sure if this is true in P21 E. Thanks a lot for your help.

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October 3, 2024

There are two (related) error messages in the Pinnacle 21 Enterprise Data Package Validation Report:

1.    DEFINE     DD0003     Missing required 'Structure' value for 'ItemGroupDef'

2.    DEFINE     DD0006     Missing required 'TranslatedText' value



I believe the two issues are related.  The count is "1" for both.

(a)  What do the messages mean?
(b)  What may be the resolution?

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September 25, 2024

This is another bug that I found, in the same circumstances as DD0138.

I get this message:

DEFINE DD0139: 1 Warning - Standard 'DEFINE-XML' is not referenced
   | Standard OID, Standard Type, Standard Name = std.ct.define, CT, DEFINE-XML | Standard 'DEFINE-XML' is not referenced (Warning)

This is a false positive: the Define-XML CT cannot be referenced inside the define.xml itself, as far as I understand from the specification.

 

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