t Takayuki
on

 

In the Excel define spec of Pinnacle 21 Community v4.0.1, a column named "Assigned Value" has been added to the Variable and ValueLevel sheets.
What should be entered in this column?
Which of the Element/Attribute defined in the Define-XML v2.1 specification issued by CDISC does this correspond to?

Kind regards,

Takayuki

Forums: Define.xml

Sergiy
on August 17, 2022

Hi Takayuki, 

This column is some P21 extension designed for prescriptive define.xml files and stores a single term. It's redundant representation of Codelist with a single "assigned" term. For example, it could be useful for such variables like STUDYID, DOMAIN, LBNAM. For your purpose to create descriptive define.xml file for submission, you can ignore it. 

Kind Regards,
Sergiy

t Takayuki
on August 18, 2022

Hi Sergiy,

Thank you for the explanation.
It's clear now.

Kind regards,

Takayuki

c Cori
on March 9, 2023

Hi Sergiy, does this column output into the define? I've tried testing it out and don't see an output but I wanted to confirm. Thanks!

j Jozef
on March 10, 2023

What are "descriptive" and "prescriptive" define.xml files? The Define-XML specification doesn't mention these.

Trevor
on March 13, 2023

"Hi Sergiy, does this column output into the define? I've tried testing it out and don't see an output but I wanted to confirm. Thanks" - Cori

The Assigned Value column and values do not go into the generated define.xml.  It's a field used for our P21 Enterprise UI only.  We share the same template for P21 Community.

"What are "descriptive" and "prescriptive" define.xml files? The Define-XML specification doesn't mention these" - Jozef

When we refer to "descriptive" and "prescriptive" define.xml, we aren't talking about the CDISC deliverable define.xml file itself -- which is obviously intended to describe what was done (descriptive).  Some of our customers consider creating a define.xml early on in the process, even before programming begins.  In this case, we consider it as a prescriptive define.xml that talks about what will be done.  Ultimately, the deliverable itself still has to conform to the CDISC requirements.

Thanks,

Trevor

        j Jozef
        on March 15, 2023

        Thank you for the explanation Trevor!
        Whereas P21 uses the term "prescriptive", we use the term "define.xml template" or "prototype define.xml", which is in ... Define-XML format and is used by the GUI of our SDTM-ETL (SAS-free) mapping software. We have generated these templates (one for each version of the SDTMIG and SENDIG) fully automatically directly from the CDISC Library API. That also means that for each new version of an SDTMIG or SENDIG, we can generate a what you call "prescriptive define.xml" by a push of the button in just a minute. The same applies when new domains from TAUGs are published.
        IMO, starting working on the define.xml even before the start of the data collection is the best practice. After all, such a define.xml essentially is what you also call "the plan for the submission datasets and variables". The main difference is that we don't need Excel, as the user can add information, and even the mappings themselves, using the graphical user interface. In our case, the mappings defined within the define.xml even steer the generation of XPT datasets.

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