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 developed by the Analysis Results Standards team
• Tabulation datasets
• Data collection metadata
• eCRFs in the eCRF portal
CDISC is recruiting CDASH and SDTM experts to volunteer time and expertise on this important initiative. We are looking for volunteers to help draft CDASH and SDTM examples to represent data collection and data tabulation for the most commonly performed safety analyses across a variety of studies. The team will meet bi-weekly for 12 – 18 months.
If you would like participate in this exciting effort, sign up on the CDISC volunteer page and indicate Safety User Guide under the section Select the CDISC Standards Development team that you would like to join.