SDTM v1.4, SDTMIG v3.2, and SDTMIG-AP v1.0

Pinnacle 21 General News
1

Sergiy,

Is there a time schedule to when OpenCDISC plans to support SDTM IG 3.2 validation?

2

Hi Pablo,

SDTM IG 3.2 validation will be released in 2014Q1. I hope it can be in February.

Regards,

Sergiy

3

New SDTM version is released. See http://www.cdisc.org/sdtm

Major updates are

  1. A version of new SDTM IG is 3.2, rather than 3.1.4

  2. New design of SDTM IG document as PDF portfolio

  3. New variables were added into SDTM model

  4. 11 new domains in IG

  5. New IG-AP descibes how to handle data about devices and persons who are not study subjects