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Which Projects Are Accepting New Members? |
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This page provides the details on all PHUSE Working Group Projects that are currently accepting new members. Some projects will be in the kick off stages, others will be more established. Please click on the Working Group you are interested in from the list below, or scroll through the projects listed below.
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Anonymisation of Imaging Data - Started Q1 2024
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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. |
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EU CTR Implementation – Started Q
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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.
Current Status:
Regular Project Meeting Day/Time:
Key Skills:
Literature review
Experience in data handling, storage and transfer
Experience in processing metadata associated with imaging
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Educate the General Population on Data privacy and Data Sharing – Started Q
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Project Scope:
To create engaging content on data privacy and data sharing that can be understood and used by the general population (any member of the public regardless of their sector or profession) covering topics such as what is being done to share clinical trial data and information, where data goes and how it is used, what data privacy is, why it is needed, why it is important and the differences between mandatory vs. voluntary data sharing. The project is to follow a similar approach to the Data Transparency (DT) Terminology Harmonisation project, this time aiming towards a more general audience to address commonly asked questions surrounding data privacy and data sharing. The Terminology Harmonisation project creates an excellent set of deliverables better suited for those who work with data sharing on a more technical level.
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Current Status:
1.Publish Video 3: ‘What is Clinical Data?’
2.Publish PHUSE-MRCT Infographics Collaboration
3.Finalise the script for the last three videos in our series:
-Video 4: ‘Journey of a Data Point’
-Video 5: ‘What is Data Sharing?’
-Video 6: ‘What is Data Privacy?’
Regular Project Meeting Day/Time:
Bi-weekly: Fridays 3-4pm GMT
Key Skills:
Literature review
Experience in data handling, storage and transfer
Experience in processing metadata associated with imaging
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