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Safety in numbers: Making sense of complex safety data for the clinical study report and the Common Technical Document Module 2.7.4 Summary of Clinical Safety

Authors: Matthew Edmonds, Paul McCormack

With ever increasing complexity in clinical studies and development programmes, clear and informative reporting of safety data is now more important than ever. The medical writer has a key role in guiding the team on the best approach for communicating the key safety findings. This article reviews strategies the writer can use when developing clinical study report safety sections and the Common Technical Document Module 2.7.4 Summary of Clinical Safety.

Medical Writing. 2025;34(4):48–51 | https://doi.org/10.56012/wrfn7799

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