Therapeutic Area Standards

Therapeutic Area Public Review

The following updated Therapeutic Area User Guides (TAUG) and Specifications are now available for public review. These updates seek to improve consistency among the TA User Guides as well as address administrative changes and formatting. These updates may include:

  • document adapted to the CDISC Wiki environment
  • errata identified for versions 1.0 or 2.0 incorporated
  • concept maps updated to conform to current practice
  • organizational updates and modeling changes

Reviewers are strongly encouraged to focus their review on items listed in the “Changes from Version X” section included at the beginning of each TAUG posting package. Please contact should you have questions or need further clarification.


To view the updated TAUG, TA specific updates and instructions for reviewers, use the links below.



CDISC Wiki is a different login from You will need to login or register for the CDISC Wiki to provide comments. 

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CFAST Therapeutic Area Standards Program

The Coalition for Accelerating Standards and Therapies (CFAST), a joint initiative of CDISC and the Critical Path Institute (C-Path), was launched to accelerate clinical research and medical product development by facilitating the establishment and maintenance of data standards, tools and methods for conducting research in therapeutic areas important to public health.


CFAST partners include TransCelerate BioPharma Inc. (TCB), the U.S. Food and Drug Administration (FDA), and the National Cancer Institute – Enterprise Vocabulary Service (NCI-EVS), with participation and input from additional organizations. For more information on the CFAST relationship, please visit the CFAST Collaboration page


Current CFAST Project Status (Click on a project name to view description)


CFAST Program Overview




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