Comments due: 
3 Jul 2019

A draft of version 2.1 of the Clinical Data Acquisition Standards Harmonization (CDASH) is available for Public Review. CDASH v2.1 comprises the CDASH Model v1.1 and CDASH Implementation Guide v2.1. Significant changes include:

  • Inclusion of remaining SDTMIG v3.2 domains not published in CDASHIG v2.0 (i.e., MB, MS, TU, TR, RS, AP--).
  • Conversion of all CRF examples to metadata table-defined aCRFs.
  • Resolution of issues submitted for enhancements and error corrections identified in CDASHIG v2.0 and CDASH Model v1.0.
  • Changed CDASHIG and CDASH Model Variable Labels, where needed, to more closely align with SDTMIG and SDTM Variable Labels, respectively.

CDISC relies on your input to ensure neutral, consensus-based data standards are developed and adopted by a diverse global community interested in bringing clarity to data.

View the drafts: CDASH Model v1.1 and CDASHIG v2.1

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