Define v2.0 can't be used to transmit metadata for SDTM IG v3.1.1?

Define 2.0 transmit use cases

Dear Nathan,

Where did you read/find that?
Define.xml 2.0 can be used to transmit any tabular (clinical) data independent on whether it is SDTM, SEND or ADaM and independent of the version of these. It can even be used to transmit any other tabular data. So if you would like to transmit the schedule or results of the NBA basketball competition, you could do so using define.xml ;-) .

 

Define-XML-2-0-Specification.pdf, page#5

hi, I read it from "Define-XML-2-0-Specification.pdf", page#5...

This specification describes an updated Define-XML 2.0.0 model that is used to describe CDISC SDTM, SEND and ADaM datasets for the purpose of submissions to the FDA, as well as any proprietary (non-CDISC) dataset structure. Define-XML version 2.0.0 can be used to transmit metadata for the following CDISC standards:

SDTM Implementation Guide Versions 3.1.2 and higher

ADaM Implementation Guide Versions 1.0 and higher

SEND Implementation Guide Versions 3.0 and higher

 

 

Define 2.0 transmit use cases

Thanks Nathan,

I think this is an "overstatement".

It might have to do with FDA policy about which SDTM version is expected, and which define.xml version (they like 2.0). It is true that the example delivered with the define.xml 2.0 package is an SDTM-IG 3.1.2 example, but that is of course not normative. Essentially, I see no reason why define.xml 2.0 cannot be used with earlier versions of the SDTM-IG. If you want, I can ask my colleague define.xml team members why that statement is there.

 

Define 2.0 transmit use cases

Many thanks for the prompt reply.

Ideally, using define v1.0 or v2.0 for transmitting clinical metadata irrespective of SDTM IG version shouldn't be an issue. But the statement in Define-XML-2-0-Specification.pdf documentation is confusing, it’d be really great if you could check this with define.xml team members.

Cheers, Nathan

 

Define-XML v2 and SDTM-IG 3.1.1

If I remember well, the reason that we did not mention SDTM IG 3.1.1 anymore, is that we already knew that FDA support for this version was ending in January 2015. Keep in mind that the main use case for Define-XML v2 is regulatory submission of metadata. But technically, like Jozef and the specification mention, Define-XML v2 can be used with any tabular data structure. Lex Jansen

Define-XML v2 and SDTM-IG 3.1.1

Thanks you very much Lex for your detail explanation.

We have few old studies SDTM data already converted in IG v3.1.1 format for which we are planning to create define.xml v2.0 and the whole confusion is because of that statement.

 

Go ahead, but...

You can definitely use Define.xml for 3.1.1.   But since 3.1.1 is a complete subset of 3.1.2, why not just make the necessary tweaks (if any) to at least go to 3.1.2.  

Page 286 of the SDTM 3.1.2 APPENDIX E: REVISION HISTORY, Changes from CDISC SDTMIG V3.1.1 to V3.1.2

Even though there are 10 pages of changes, most of these are not anything that should cause a 3.1.1 submission from needing major rework to 3.1.2.  3.1.1 is really a complete subset of 3.1.2 (with regards to Domains and Variables) in that you should just try to relabel your entire submission as 3.1.2 wihtout making any changes and revalidate it to see what issues arise.  

 

the larger effort is when people go from 3.1.1/3.1.2 to 3.1.3/3.2.    For now, put a new "bow" on it and cross your fingers.

 

Thanks Michael

Dear Micheal,

Thank you for your excellent suggestions regarding 3.1.1 to 3.1.2 adjustments, shall make these changes in couple of studies and revalidate.