w wonseok
on

 

We are developing dataset of SDTM/ADaM/SEND/define.xml following OpenCDISC Validator v1.3

The version we followed is as below
* SDTM 3.1.2 Amendment 1
* Define.xml 1.0
* ADaM 1.0
* SEND 3.0

However, the version of validator and rule is updated as 3/14

We found the rule of SDTM/ADaM/SEND/define.xml is changed yet.
* SDTM 3.1.2 Amemdment 1 --> SDTM 3.1.3 : no change
* Define.xml 1.0 --> Define.xml 1.0 : no change
* ADaM 1.0 --> ADaM 1.0 : Description :error fix (2 items)
* SEND 3.0 --> SEND 3.0 : no change

Please confirm the contents of the above are correct.

Greatly appreciated!

Forums: General Discussion

m Michael
on April 4, 2013

SDTM 3.1.2 Amendment 1 has been deprecated and now replaced by SDTM 3.1.3.   There were many new rules added to 3.1.3.   For a complete set of changes, you can compare the release notes from 1.3 and 1.4:

OCV 1.4 latest release notes:  http://svn.opencdisc.org/validator/trunk/config/CHANGELOG.txt

Use the dates as a guide.

 

  1. 2012-Mar-29 - v1.3
  2. 2013-Mar-14 - v1.4

 

As an example, the config-sdtm-3.1.3.xml version has 359 distinct rules, assigned a total 3346 times across all the standard domains.   You may want to use that as a comparison.


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