SDTM ADaM Implementation FAQ
Project Description |
This project was initiated following the Standards Implementation Nuances sessions held at the March 2016 US CSS and the June 2016 EU CSS, which highlighted common challenges faced by SDTM and ADaM implementers and consumers. Discussions also revealed numerous questions relating to data submission requirements across regulatory agencies, including the FDA, PMDA and NMPA, demonstrating the need for a centralised forum and knowledge base. The project team collaborates with industry subject matter experts (SMEs), CDISC and regulatory agencies to address these challenges. Its objectives are to collect frequently asked questions from the industry, assess their relevance, and develop clear, consistent responses. Where necessary, the team engages with CDISC and regulatory bodies to ensure accuracy and clarity. All validated FAQs and responses are published on the PHUSE website, providing a reliable, accessible resource to support consistent implementation and informed decision-making across the industry. |
Project Leads | |
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Aatiya Zaidi, Gilead | |
Michael Wise, Edwards | |
Alex Pearce, PHUSE Project Coordinator |
Published Responses |
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Publish responses to questions received under: |
Click above for the latest project status. |