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Optimizing the Use of Data Standards |
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The SDTM ADaM Implementation FAQ project Project within the Optimizing the Use of Data StandardsWorking Group is pleased to announce that all published FAQ’s are now available on the PHUSE Deliverable website. Click here to view the categories of answered FAQs. |
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SEND Industry Feedback Survey | ||
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The SEND Industry Feedback Survey project Project within the Nonclinical Topics Working Group have published their 2025 SEND Survey, marking a significant milestone as it enters its 10th consecutive year of providing valuable industry insights. The survey will remain open from 14 November to 2 3 December. All responses will be collected anonymously. The results will be presented at the Nonclinical Advance Event 10–12 February 2026 and subsequently published on the PHUSE Archive.
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Data Transparency |
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The Participant Data Return team has published a blog on their recent survey findings. Participant data return is the act of granting clinical trial participants access to the data that was collected about them during a clinical trial. In current clinical trial practice, we take measurements, conduct tests, and perform procedures. The results are reviewed by the investigator and stored by the sponsor, but participants rarely see their own results. In spring 2025, PHUSE established the Patient Participant Data Return Project, with the aim of highlighting current industry practice and identifying gaps and challenges in implementation to speed industry uptake. As a first action, in summer 2025, we assessed the current state of data return throughout the industry by surveying PHUSE member companies. PHUSE received a total of 14 responses representing 14 companies worldwide. The published blog summarises findings and next steps for this project team. If you are interested in getting involved please email workinggroups@phuse.global. |
Data Transparency |
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The /wiki/spaces/WEL/pages/220168194 team has completed their system review and documented their feedback. The International Standard Randomised Controlled Trial Number registry (ISRCTN) recently released information for public review and comment regarding the new registry they are working on, and the results system prototype was open for review until the end of September. The PHUSE project team assembled to review the prototype was a diverse group of experts from the PHUSE Data Transparency Working Group. For the purposes of providing feedback, fields were tested but no results submitted. The summary of comments, included in the ISRCTN results system prototype feedback collated from our review at PHUSE can be found in this document. |
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The Value of Plain Language Summaries (PLSs) project team within the Data Transparency Working Group, is calling for volunteers! This project has been initiated because whilst the industry has put significant efforts into developing and disseminating plain language summaries of trial results (PLSs) to promote transparency and engagement, there remains a gap in quantitative evidence of how these documents are used and what value they bring to the trial participants and the general public. Gathering feedback from trial participants – the primary audience for PLSs – and other readers will provide meaningful insights into their value and inform improvements. The team will be creating a survey to evaluate the value of PLSs and the survey feedback will be shared as a white paper authored by the group. If you’d like to become a valued project member, please get in touch with workinggroups@phuse.global by 19 January 2026 ahead of the kick off meeting scheduled for Tuesday 20 January 08:00 EST / 13:00 GMT / 14:00 CET. |
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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