CDAD Therapeutic Area User Guide v1.0

Release Date: 30 Apr 2019

Clostridium Difficile Associated Diarrhea (CDAD) is a major medical and infection control problem. It is particularly common among the elderly in long-term care or hospital facilities. A 2015 study from the US Centers for Disease Control and Prevention found that CDAD alone caused almost half a million infections among patients in a single year in the United States.

Version 1.0 of theTherapeutic Area User Guide for CDAD (TAUG-CDAD) was developed under the CDISC Standards Development Process and describes the most common biomedical concepts relevant to CDAD, and the necessary metadata to represent such data consistently with Controlled Terminology and SDTM. TA Standards extend the Foundational Standards to represent data that pertain to specific indications within disease areas. CDISC Standards specify how to structure the data; they do not specify what data should be collected or how to conduct clinical trials, assessments or endpoints.

Public Review Comments

CDISC posts Public Review comments and resolutions to ensure transparency and show implementers how comments were addressed in the standard development process.

TA Specifications

TA Specifications show how to modify TAUG examples for various versions of the SDTM and SDTMIG. These specifications assist the FDA and the Japanese PMDA with testing to enable support of the standards and inclusion in their respective Technical Conformance Guides.1,2

The specifications comprise five worksheets in an Excel workbook:

  1. Read Me – Information on how to read the other worksheets
  2. Summary – Table of Contents for the TAUG annotated with examples and the domains and variables they use
  3. Known Issues – A list of modeling issues noted in the TAUG
  4. Domains – Domains used and their status in different versions of the SDTMIG
  5. Variables – Variables used and their status in different versions of the SDTM