Where to begin with Define.xml from Pinnacle 21 Community

d Dina

on September 5, 2023

Hi all -

Please forgive the very BASIC nature of my questions, but I'm looking for information or documentation on where and how to begin filling in the missing info on the various tabs of the Define.xml spec that is generated by Pinnacle 21 Community.

We have 36 SAS transport files representing SDTM domains and SUPPXX domains. We have run them through the validation part of the software, eliminated the issues we could and addressed the rest in the SDTM Reviewer's Guide, EXCEPT for the global issue that indicates we're missing the Define.XML file.

We created the spec document using those 36 files, and it filled in the datasets and certain info about the variables. What I'm looking for is guidance on what to do next.

- Is there a document that describes what each column on the various tabs refers to?

- Which columns on which tab should we complete first?

- Where can I see example documents on what is needed in the ValueLevel tab?

- in general, how to get started completing this document?

It seems like all of the online documentation I find is addressing very specific issues such as the difference between 2.0 and 2.1, or how to address certain bugs, etc. Is there a general "How To" document or set of documents?

Thanks in advance -

Dina Appleby

Forums: Define.xml

n Nancy

on September 8, 2023

PharmaSUG 2018 paper

Hi Dina,

There's a PharmaSUG 2018 paper by Pinky Anandani Dutta at https://www.lexjansen.com/pharmasug/2018/AD/PharmaSUG-2018-AD29.pdf that describes the process for creating Define.xml v2.0 from the P21 spreadsheet- while that's a version behind the current one, it should provide enough information, along with the response to a forum post in https://www.pinnacle21.com/forum/overview-new-template-sdtmadam-specification, to get you started.

Hope this helps,

Nancy