HIV Therapeutic Area User Guide v1.0

1.0
Release Date: 18 Jan 2019

HIV, the virus that causes AIDS, is one of the world’s most serious health and development challenges. According to the Joint United Nations Programme on HIV/AIDS (UNAIDS), there were approximately 36.9 million people worldwide living with HIV/AIDS at the end of 2017. Of these, 1.8 million were children (<15 years old).

Version 1.0 of the HIV Therapeutic Area User Guide (TAUG-HIV) was developed under the CDISC Standards Development Process and covers the areas of prevention, vaccines and treatment. TAUG-HIV describes the most common biomedical concepts relevant to HIV, and the necessary metadata to represent data consistently with CDASHSDTM, 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.

HTML Format

This release is published in HTML format, which expedites delivery of the standard and is viewable in any standard browser. HTML format allows users to search for keywords within the page, and bookmark the information in a browser. Implementers can also print the page, or export the information into other formats (e.g., PDF). To save a copy of the HTML publication on your desktop to access the document offline, press CTRL-S (PC) or COMMAND-S (Mac) on your keyboard. Please log in or create an account to access the link to the Standard.

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. Please log in or create an account to access the link to the Standard.

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:

  • 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