Unclear messages (DD0003 and DD0006) in the Pinnacle 21 Enterprise Data Package Validation Report

Pinnacle 21 Support Define.xml
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Please read the Define-XML specification! You can find it distributions for both 2.0 and 2.1 at: Define-XML | CDISC
And/or take a Define-XML course from CDISC.
It’s easy:

  • Missing required “Structure” value for “ItemGroupDef”
    means that you have a dataset definition (i.e. ItemGroupDef in the XML) for which the mandatory “def:Structure” attribute is missing.
    Typical examples are
    def:Structure=“One record per subject” in the case of DM, or
    def:Structure=“One record per adverse event term per subject” in the case of AE
    Of course, the message could be better by giving the information on WHICH ItemGroupDef, “def:Structure” is missing

  • Missing required ‘TranslatedText’ value
    meaning that in your XML, you have a “Description” element for which the child element “TranslatedText” is missing.
    Of course, the message could be better by giving the information on WHICH “Description” element, “TranslatedText” is missing.

You can easily find out where these occur by opening your define.xml e.g. in NotePad++, or better in an XML-editor.
With the latter, if you validate the XML against the XML-Schema (define2-1-0.xsd - also in the distribution package from CDISC), the XML editor will even show you exactly where your XML is wrong.

But, first of all, download and read the Define-XML specification …

2

Hello Mujahid,

This is an Enterprise related question, so I will open a ticket on your behalf and follow up there.

Kind regards,

Matt

3

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?