Version 1.0 of the Post Traumatic Stress Disorder Therapeutic Area User Guide (TAUG-PTSD) was developed under the CDISC Standards Development Process and describes the most common biomedical concepts relevant to PTSD, and the necessary metadata to represent data consistently with 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.
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.
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 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