CDISC-CDASH

CDISC CRF data collection standard.

Definition

CDASH keys: Domain Templates (DM, AE, CM, EX, etc.) aligned with SDTM, Common Data Elements (CDEs), CDASHIG Implementation Guide v2.2 published 2022. Tools: EDC vendors Veeva CDMS, Oracle Clinical, Medidata Rave implement CDASH templates. Enables CRF uniformity across studies and facilitates CDASH-to-SDTM mapping via Define-XML.

Origin

CDASH v1.0 published by CDISC 2008 ; v1.1 published 2011 ; v2.0 published 2014 ; CDASHIG v2.2 published 2022.

Example in context

Sanofi designs its CRFs for a phase III trial in Medidata Rave compliant with CDASHIG v2.2 ; 50% EDC build time reduction and facilitation of downstream SDTM transformation.

Related terms

• CDISC SDTM — downstream submission standard.