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Data Transparency | ||
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The Data Transparency Autumn Event will take place from . 16–18 September 2025. at 10:00-12:30 (EDT) / 15:00-17:30 (BST) / 16:00-18.30 (CEST)
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Data Transparency |
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The Good Transparency Practicesproject has published a new Guideline. Good Transparency Practice (GTP) is a guideline developed by the PHUSE Data Transparency Working Group to create a set of best practices to govern the anonymisation of clinical trial data, for external sharing or disclosure. Although there are transparency initiatives across the globe, with differing guidelines, the common goal is to uphold patient privacy and data utility to the highest standards. |
Data Transparency |
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The Rare Disease/Small Population Data Sharing project within the Data Transparency Working Group has published a new White Paper. 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), to understand if and how these barriers apply to controlled access data sharing under specific contextual assumptions. |
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Real World Evidence: Calling For Feedback |
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The RWD Guideline for Programming and Analysis Processes project within the Real World Evidence Working Group has produced a White Paper, ‘RWD Guideline for Programming and Analysis Processes’ which is calling for feedback. As per FDA1.1, Real-World Data (RWD) are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. Examples include data derived from Electronic Health Records (EHRs), Claims and/or billing data, Product and/or disease registry data , and other data sources that can inform on health status (e.g., data collected from wearables, patient-generated data). Please provide your comments by emailing workinggroups@phuse.global. Closing date for comments: 5 September. |
Risk Based Quality Management: SDR/SDV in China Survey | ||
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The Risk Based Quality Management Working Group have produced a survey on the topic of SDR/SDV in China. The goal of this survey is to gain insight into how companies across the industry are implementing SDR and SDV in sites in China. The output of the survey will be used to develop a reference document for informing future study approaches and/or adjusting current approaches to better align with global standards. The closing date for completing the survey: 20 September.
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