Prostate Cancer Therapeutic Area User Guide v1.0
Version 1.0 of the Prostate Cancer Therapeutic Area User Guide (TAUG-PrCa) was developed under the CFAST Program and the CDISC Standards Development Process. The TAUG-PrCa describes the most common biomedical concepts relevant to Prostate Cancer, and the necessary metadata to represent such data consistently with the 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.
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
COMET Initiative Clinical Outcome Sets for prostate cancer were reviewed and included in the scoping stage of this project.
Research reported in this publication was supported by the FDA Center for Drug Evaluation Research (CDER), FDA grant number 1U24FD005243-01. The content is solely the responsibility of the authors and does not necessarily represent the official policy of the FDA.