The CDISC SDTM model is considered the most stable of the CDISC standards: version 3.1.1 of the Implementation Guide (IG) was published in August 2005; 3.1.2 in November 2008 which has remained the accepted standard. However, in this year’s European Interchange, CDISC revealed an aggressive timeline of therapeutic area (TA) SDTM domain development. From slides 17 and 18 of the presentation you can see that 14 new TA domains are intended to be developed in 2012 alone. The overall goal is to standardise efficacy data elements from 57 TAs in 7 years.
A member of the Clinical Programming Team writes about their experience at the CDISC European interchange in Stockholm held on 18th-19th April 2012.
As part of the CDISC European Interchange meeting, I contributed a presentation on how Quanticate have used the CDASH standards to facilitate data capture and transformation to the SDTM standard.
A member of the Clinical Programming Team writes about their experience at the CDISC interchange in Brussels held on 11th-12th April 2011.
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