Vaccines

Vaccines Therapeutic Area User Guide v1.1

1.1
Release Date: 9 Apr 2018

Version 1.1 of the Vaccines Therapeutic Area User Guide (TAUG-Vax) was developed under the CDISC Standards Development Process and describes the most common biomedical concepts relevant to vaccines, and the necessary metadata to represent such data consistently with Terminology and SDTM.

If you previously downloaded v1, please replace it with v1.1. If you would like a list of the changes between the versions, we will provide this on request.

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 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

 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 links to the Standard.

The research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under grant agreement n°115308, resources of which are composed of financial contribution from the European Union's Seventh Framework Programme (FP7/2007-2013) and EFPIA companies’ in-kind contribution.

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Neither IMI nor the European Union, EFPIA, or any Associated Partners are responsible for any use that may be made of the information contained therein.