ADaM Define-XML 2.0 Data set Order Section

2.2.0 Output  2.0.1 output 

Your define.xml file generated by P21 system looks as expected

Hi Gustav,

Your define.xml file generated by P21 system looks as expected.

Order of datasets is defined by Define-XML 2.0 standard. See section #3.4.2 on page 13:

3.4.2. Other Order Considerations for Elements

The Define-XML specification does not require that ItemGroupDef elements related to the SDTM follow a particular order. However, for purposes of regulatory submissions, ItemGroupDef elements should follow the order recommended in the SDTM-MSG. Note that the SDTM-MSG indicates that the datasets should be displayed in the following Class order:

• TRIAL DESIGN
• SPECIAL PURPOSE - Subject-Level
• INTERVENTIONS
• EVENTS
• FINDINGS
• FINDINGS ABOUT – not yet added to the NCI/CDISC Controlled Terminology as of the time of writing this document
• RELATIONSHIP

For regulatory submissions of ADaM datasets, a standard order of display has not been established. However, the following Class order seems reasonable, as it is consistent with the ordering of Class values in ADaM 2.1:

•  SUBJECT LEVEL ANALYSIS DATASET
•  ADVERSE EVENTS ANALYSIS DATASET – not yet added to the NCI/CDISC Controlled Terminology as of the time of writing this document
•  BASIC DATA STRUCTURE - datasets in alphabetical order by dataset name
•  ADAM OTHER

As additional ADaM dataset classes are defined, it would be reasonable to insert them between Basic Data Structure and ADaM Other.

Within each class the datasets should be displayed in ascending alphabetic order by Name as maintained in the value of the ItemGroupDef Name attribute.

There is some inconsistency around ADAE dataset. In an example above it’s before BDS datasets. However, ADAE belongs to a new ADaM Occurrence Data Structure. That’s why ADAE is after BDS datasets in P21 define.xml files.

Regards,

Sergiy

Why doesn't Pinnacle 21 use the reasonable class order?

Hi Sergiy,

I have a question about the ADaM dataset order. If there is a "reasonable" class order for ADaM, why is ADSL dataset (i.e. CLASS=SUBJECT LEVEL ANALYSIS DATASET) being in third position in Gustav's example 2.2.0?

Regards,

Genevieve

Dataset order

Just to state the obvious. The stylesheet will honor the dataset order in the XML file. It is the application that creates the Define-XML file that defines the dataset order.

This is obvious. The…

This is obvious. The question asked is about Pinnacle 21 xml creation.

Dataset order

Exactly! When solving issues about a Define-XML document, look at the XML. Don't try to solve it by looking through the stylesheet. Cut out the middle man!  

Define package

should SAP be as part of ADaM define?

Sergiy

on December 15, 2021

P21

It's nice to have a link to…

It's nice to have a link to SAP document in eCTD folder structure. However, this is not formally required.

thanks

thanks