Project Volunteer Board

The Working Groups Project Volunteer Board provides an overview of all current projects that are open for volunteer contributions. Each listing includes key details about the project, its goals, and the specific skills or support needed.

Please use this board as a resource to identify opportunities and connect with project leads where applicable. If you are interested in contributing to any of these projects, please email workinggroups@phuse.global. 

Project Scope:

The scope of this project remains flexible, but initially we plan a literature review. The types of image files will be reviewed (X-rays, (f)MRIs, CT scans, etc.), their formats (DICOM, NIfTI, etc.), their positions (limbs, heads, organs, etc.) and all associated metadata. There will also be a discussion on data handling, storage and transfer. Any existing guidance and repositories will be reviewed. We will then focus on use cases that will have the most impact based on interest and complexity. Any use cases being presented will be in the context of a request alongside clinical data, in keeping with the main drivers behind the Data Transparency Working Group. There will be a strong focus on processing metadata associated with images as that is where the strengths of the Working Group lie (processing and anonymising data) and where most of the risk lies in the sharing of images.

Current Status:

• No update given

Key Skills:

• Literature review

• Experience in data handling, storage and transfer

• Experience in processing metadata associated with imaging

Project scope:

The EU Clinical Trial Regulation (CTR) has sweeping new requirements for the publication of clinical trial documents of trials conducted in the European Union. Documents will be subject to publication earlier in clinical development than before, and documents like the Investigator’s Brochure will be routinely published for the first time. 

The EU CTR has important implications for the planning of trials in the EU and for how sponsors prepare clinical trial documents. Stakeholders include any sponsor conducting an EU trial, including pharmaceutical and biotechnology companies and academic institutions. The initial deliverable for this project may build on a poster previously prepared by this Working Group outlining avenues of data disclosure. 

Types of document to be published under the EU CTR, their possible timelines for publication, the deferral mechanism for protecting confidential commercial information (CCI), which documents can be redacted for CCI and which cannot, and protection of personal protected data.