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The Analyses & Displays for Hepatotoxicity project within the Safety Analytics Working Group have published a new White Paper! This White Paper provides recommendations for displaying, summarising and analysing measures of hepatotoxicity in tables, figures and listings (TFLs). The suggested TFLs will have implications for what and how liver-related data should be collected. If the data required to populate these TFLs is not collected, then there may be insufficient information to adequately assess the potential for a drug to cause or contribute to the cause of hepatotoxicity. |
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A new Data Transparency deliverable is out for public review!
The Rare Disease/Small Population Data Sharing project has produced a new White Paper - “Rare Disease Clinical Data Sharing” and are seeking your feedback. The purpose of this White Paper is to review potential barriers to the sharing of rare disease data such as risk of re-identification and invasion of privacy (balanced against maintaining data utility) and understand if, and how, these barriers apply to controlled access data sharing under specific contextual assumptions. The development of strategies to enable rare disease data to be shared effectively and be reused is needed to advance research and clinical trial design where there is significant unmet need.
Email workinggroups@phuse.global byThe SDTM ADaM Implementation FAQ project within the Optimizing the Use of Data Standards Working Group has published three new FAQs! They have answered two FAQs within Data Submission, the FAQ answered looks at the ‘Upversioning SDTM and ADaM Datasets for Older Studies’ and ‘Annotated CRFs for EDC and eCOA’. They have also answered a FAQ within SDTM/ADaM IG Nuances, that FAQ answered looks at the “ADAE dataset: AESEQ or SRCDOM and SRCSEQ' You can view these questions and see the FAQ's this project has answered so far here. Do you have a SDTM ADaM Implementation FAQ question? You can send your questions to the team by emailing workinggroups@phuse.global. |
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