Define.xml

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

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.

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 Community. 

We're working on CRT review and based on my knowledge, we should create UNIT codelists separately per domains. 

While reviewing AVISIT codelist, I see also that analysis visits differ from domain to domain. 

Should the approach be the same for Anlysis Visits too? Separate codelists per domains?

I appreciate your opinions.

Thank you. 

Hi all,

does anyone know how to handle different TESTCD codelists in define.xml without getting P21 issues? For example, we can have several different codelists for QSTESTCD as per cdisc CT depending on questionnaires. In Order to define them I would need to remove the codelist “QSTESTCD” on variable level. How do I put the information in VLM and codelists tab? Or do we still create one QSTESTCD codelist and put all values in there? 
 

Best

Manolya

Hi Everyone, 

we're working on specification on a project and we've encountered two different approaches in derivations. 

One uses symbols like =, =>, <= in derivation and other uses SAS symbols EQ, NE, LE, GE etc. 

Could you please advise if there is any unification established? I was not able to find any. 

Thank you in advance.