s S
on

 

Can we created Define.xml v1.0 by using OpenCDISC community or Pinnacle 21,

I knew that Define.xml v2.0 can be created using Pinnacle  21 

Forums: Define.xml

m Michael
on April 30, 2016

Since Define 1.0 is extremely inferior and outdated (published 2005) and a complete subset of Define 2.0 (published 2013).

it is not supported by Pinnacle 21 Community and will eventually be phased out by FDA and industry completely, as it does not support ADaM effectively

l Lex
on April 30, 2016

Agreed! I actually think that Define-XML v1 did not support ADaM better or worse than SDTM. For both there were gaps, especially in specifying Value Level Metadata. And there are many other improvements. Industry really needs to bite the bullit and make it a priority to move to Define-XML v2. It has been around for 3 years now, and tools are available. For companies that did Define-XML v1 the right way, they have most of the metadata. Just need to publish it different.

s S
on May 16, 2016

Thank you Lexjansen and mdigian for providing your inputs.

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