Pain

Pain Therapeutic Area User Guide v1.1

1.1
Release Date: 13 Dec 2016

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

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
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