Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

PHUSE collaborations are organised into a number of specialist Working Groups, each with a broad topic area. The Working Groups have specific projects designed to achieve a set of particular objectives. This page will highlight the latest news and information from our projects. Participation is open to anyone who wants to contribute and if you would like to get involved, please email workinggroups@phuse.global.

...

Data Transparency Webinar - Data Literacy: Enhancing Trust and Transparency

A key aspect of health literacy, especially in clinical research, is understanding what data is collected, how it is protected, and how it is used during and after a study. Truly informed consent requires transparency about data practices so that participants can make educated decisions.

The MRCT Center and PHUSE are collaborating to develop a suite of resources, including videos and infographics, to enhance data literacy in the clinical research context. Join us for this webinar as we discuss the importance of data literacy, explore practical applications for research teams, and unveil new materials designed to support participants and the broader research community.

Key Topics:

  • Advancing Data Literacy as a Component of Health Literacy

    • Explore how understanding research data supports informed decision-making and aligns with broader health literacy efforts.

  •  Applying Plain Language and Visual Tools to Data Communication

    • Learn how the MRCT Center and PHUSE have used plain language, infographics and videos, to make clinical research data more accessible.

  •  Empowering Participants with Transparent and Actionable Information

    • Identify ways to integrate data literacy resources into clinical research processes to support research trust and engagement.

The webinar will take place on 3 April, 9:00 (EDT) / 14:00 (BST) / 15:00 (CEST)

Info

Register Here

Real World Data Spring Event 2025

We're thrilled to announce a new Working Group event coming your way in 2025 – the PHUSE Real World Data Spring Event!

"It will bring together engaged speakers from the field ranging from data vendor and data registry representatives to pharmaceutical and biotech industry representatives who are sharing their knowledge and ideas around Real World Data utilisation in a fast-moving and challenging environment." 

-Berber Snoeijer, ClinLine – Real World Evidence Working Group Lead

The Real World Data Spring Event will take place on 9–10 April 2025 9:00-11:30(EDT) / 14:00-16:30(BST) / 15:00-17.30(CEST)

Info

Register Here

...

The SDTM ADaM Implementation FAQ project within the Optimizing the Use of Data Standards Working Group has published three new FAQs! They have answered two FAQs within Data Submission, the FAQ answered looks at the ‘Upversioning SDTM and ADaM Datasets for Older Studies’ and ‘Annotated CRFs for EDC and eCOA’. They have also answered a FAQ within SDTM/ADaM IG Nuances, that FAQ answered looks at the “ADAE dataset: AESEQ or SRCDOM and SRCSEQ'

You can view these questions and see the FAQ's this project has answered so far here

Do you have a SDTM ADaM Implementation FAQ question? You can send your questions to the team by emailing workinggroups@phuse.global

...

The SEND Coding Bootcamp is a new project within the Nonclinical Topics Working Group. Which is currently calling for volunteers. 

The 4-day SEND Coding Bootcamp aims to help those working with SEND datasets become more productive by teaching basic coding and plotting skills. Over the course of a series of separate hands-on coding sessions, participants will learn the basics of programming and plotting using the R programming language. The course will be oriented around SEND datasets and will include reading, writing, plotting, and manipulating SEND datasets stored in .xptformat. Basic knowledge of the SEND standard is expected. No previous knowledge about programming or the R programming language is needed.

If you would like to volunteer or learn more about this project, email workinggroups@phuse.global. Closing date: 1 April.

The Kick-Off Meeting for this project will be held 4 April 2025 11:00 (EDT) / 16:00 (BST) / 17:00 (CEST)

The Anonymization of Imaging Data project is looking for volunteers to join our ongoing project focusing on anonymization and sharing of images in clinical trials. Our recent literature review has highlighted a gap in existing research, particularly in the context of sharing images and related metadata in parallel to clinical trial data.

We will focus on DICOM images and related metadata in oncology. Our project will take our collective knowledge of clinical trial data and images to create guidance that will inform de-identification decisions in the anonymization process for the images. There will be a comprehensive review of DICOM image tags and relevant packages and methods that are used to process them. We aim to develop best practices for processing identifiers and anonymising images in oncology, ensuring both privacy and usability. 

If you have experience in processing and de-identifying images in clinical trials, particularly with DICOM images in oncology, we want to hear from you.

If you would like to volunteer or learn more about this project, email workinggroups@phuse.global. Closing date: 25 April.

The regular meeting series is currently bi-weekly on Tuesdays 9:00 (EDT) / 16:00 (BST) / 17:00 (CEST)

...