Define.xml

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

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.

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>

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.

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?

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.

I found a bug when validating a define.xml following the 2.1 standard.
As far as I can understand, it had nothing to do with the 2 existing messages for DD0138
(if Google Translate can be trusted for the Japanese conversation ^_^)

My define.xml file contains:

In Pinnacle 21 Community v4.1.0, we've been validating SEND 3.1 Define 2.0 files with engine FDA (2304.3) and have been receiving the "Invalid dataset label value" (DD0136) for a few domains like LB and PC.  In the Define-XML Conformance rules (from CDISC and posted on the Pinnacle 21 website), this rule should only be applied to Define XML 2.1, but it is being triggered on our Define XML 2.0 files.  Is this a mistake in the system?  Also, what is the best source for where the Dataset Labels are defined for each domain (to reference when we eventually move over to Define XML 2.1)?

Hi Team,

I am using pinnacle 21 to validate a SEND define.xml v2.1, but got an Error below: 

DD0073: For Define-XML v2.0, the Origin Type attribute must have a value of 'CRF', 'Derived', 'Assigned', 'Protocol', 'eDT', or 'Predecessor' for SDTM and ADaM data and 'COLLECTED', 'DERIVED', 'OTHER', or 'NOT AVAILABLE' for SEND data. For Define-XML v2.1, the Origin Type attribute must have a value of 'Collected', 'Derived', 'Assigned', 'Protocol', or 'Predecessor' for SDTM and SEND data and 'Derived', 'Assigned', or 'Predecessor' for ADaM.

Hi Team,

I am using pinnacle 21 to validate a SEND define.xml v2.1, but got an Error below: 

DD0073: For Define-XML v2.0, the Origin Type attribute must have a value of 'CRF', 'Derived', 'Assigned', 'Protocol', 'eDT', or 'Predecessor' for SDTM and ADaM data and 'COLLECTED', 'DERIVED', 'OTHER', or 'NOT AVAILABLE' for SEND data. For Define-XML v2.1, the Origin Type attribute must have a value of 'Collected', 'Derived', 'Assigned', 'Protocol', or 'Predecessor' for SDTM and SEND data and 'Derived', 'Assigned', or 'Predecessor' for ADaM.