Virology

Virology Therapeutic Area User Guide v2.0

2.0
Release Date: 30 Sep 2015

Version 2.0 of the Virology Therapeutic Area User Guide (TAUG-Virology) was developed under the CDISC Standards Development Process. The TAUG-Virology describes the most common biomedical concepts relevant to virologic studies, and the necessary metadata to represent such data consistently with CDISC standards, such as CDASH, SDTM, and ADaM.

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.

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

Virology Therapeutic Area User Guide v2.1

2.1
Release Date: 3 Aug 2017

General updates include document adapted to the CDISC Wiki environment, errata identified for versions 1.0 incorporated, concept maps updated to conform to current practice, organizational updates and modeling changes.

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.

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

TA Specifications show how to modify TAUG examples for various versions of the SDTM and ADaM. 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:

  • Read Me – Information on how to read the other worksheets
  • Summary – Table of Contents for the TAUG annotated with examples and the domains and variables they use
  • Known Issues – A list of modeling issues noted in the TAUG
  • Domains – Domains used and their status in different versions of the SDTMIG
  • Variables – Variables used and their status in different versions of the SDTM
  1. http://www.fda.gov/downloads/ForIndustry/DataStandards/StudyDataStandards/UCM384744.pdf
  2. https://www.pmda.go.jp/files/000206449.pdf