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The Implementation of Estimands (ICH E9 (R1)) using Data Standards project within the Optimizing the Use of Data Standards Working Group, have published a new White Paper and Example Document! This white paper provides recommendations and examples to illustrate the implementation of the estimands framework introduced by the ICH E9(R1) Addendum on Estimands and Sensitivity Analysis in Clinical Trials to the Guideline on Statistical Principles for Clinical Trials [ICH E9(R1), 2019] using data standards (as part of the clinical data flow). |
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The Dataset-JSON as Alternative Transport Format for Regulatory Submissions project within the Optimizing the Use of Data Standards Working Group, has published its Business Case. Dataset-JSON is a widely accepted data format that will streamline data exchange between organisations. Moving to Dataset-JSON will prepare us for the current digital world and enable companies to more accurately, completely and efficiently represent their clinical research data, to better serve their patients/customers. Dataset-JSON supports current data standards but also allows for standards to evolve and removes current limitations imposed by xpt format. |
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If you would like to get involved in a PHUSE Working Group Project, please explore the projects via the Volunteer Board and contact the PHUSE Office on workinggroups@phuse.global to express your interest. |
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