Therapeutic Area (TA) Standards extend existing CDISC standard metadata to include disease-specific metadata, examples and guidance on implementing standards for a variety of uses, including global regulatory submissions. To date, CDISC has developed TA standards for over 30 indications.

CDISC carried out public review for three Therapeutic Area User Guides (TAUG) during the fourth quarter. 

  • The Public Review period for Version 1.0 of the Colorectal Cancer TA User Guide (TAUG-CrCa) ended 25 AUG 2017. We currently reviewing comments; TAUG-CrCa is estimated to be published Q1 2018.
  • The Public Review period for Version 1.0 of the Huntington's Disease TA User Guide (TAUG-HD) ended 10 NOV 2017. We currently reviewing comments; TAUG-HD is estimated to be published Q1 2018.
  • The Public Review period for Version 1.0 of the Post Traumatic Stress Disorder Therapeutic Area User Guide (TAUG-PTSD)  ended 13 NOV 2017. We currently reviewing comments; TAUG-PTSD is estimated to be published Q1 2018.

We are grateful to those who provided comments. It is the feedback from stakeholders that ensures neutral, consensus-based data standards are developed.

News about CDISC's Duchenne Muscular Dystrophy Therapeutic Area Standard

Accelerating the Clinical Trial Process in Duchenne - Read the blog post from the Parent Project Muscular Dystrophy Community about Duchenne Muscular Dystrophy Therapeutic Area User Guide (TAUG-DMD v1.0).