CDISC models implemented in this guide to standardize data collection, data tabulation, and creation of analysis datasets for each use case category are summarized below.
Category | Collection | Tabulation | Analysis |
---|---|---|---|
Product Description | Study Data Tabulation Model (SDTM) | ||
Nonclinical | Study Data Tabulation Model (SDTM) | ||
Product Impact on Individual Health | Clinical Data Acquisition Standards Harmonization (CDASH) | Study Data Tabulation Model (SDTM) | Analysis Data Model (ADaM) |
Product Impact on Population Health | Analysis Data Model (ADaM) |
All models implemented as part of this guide collect and represent data by common topics with:
- CDASH and SDTM organizing related data points in groupings called domains; and
- ADaM dataset design customized to support analysis requirements.
ADD MORE TEXT HERE
Overview
Content Tools