CDISC is developing a Safety User Guide, which will align the collection, tabulation, analysis and display of the most common safety data, to provide a common understanding of “how do we do safety”.
Currently, there is lack of a unified guidance, from data collection through analysis results, that addresses safety data. Each CDISC Foundational Standard includes information on safety data commonly collected across studies of a wide variety of indications, but the information does not align across Foundational Standards. CDISC Therapeutic Area User Guides (TAUGs) often collect disease-specific safety information and examples; TAUGs may touch on indication-specific safety endpoints but tend to focus on efficacy endpoints.
The Safety User Guide will provide:
- Implementation guidance and examples using the new analysis results standards
- Analysis datasets
- Tabulation datasets
- Data collection metadata
- eCRFs in the eCRF portal