How OpenCDISC Validator is identifying a new domain into Findings/Interventions/Events etc.

d DATTI

on August 2, 2011

Hi,

I created a Define.xml using an OpenCDISC Validator. If there are any new domains like SG(Surgery),ML(Meals) etc. which are not in SDTMIG 3.1.2 and OpenCDISC's config file(config 3.1.2.xml) then how OpenCDISC Validator will classify them as Events or Interventions or Findings or Observations etc...

Thank You,

Ashok

Forums: Define.xml

d Dirk

on February 1, 2012

Classifying mantra

This is the classifying mantra I use when giving training:

Interventions always have a treatment (--TRT variable) given,

Findings always have a test (--TEST variable) performed,

Events always have a term (--TERM variable) to report.

In short: the topic variable tells you what domain class you are in, I do not know about how OpenCDISC works with 100% certainty, but I suspect this is probably also based on this mantra...

m Michael

on February 1, 2012