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EU CTR Implementation – Started Q2 2021 | |
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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: (currently being reviewed by WG Leads)
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Educate the General Population on Data privacy and Data Sharing – Started Q2 2021 | |
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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. | Current Status:
Regular Project Meeting Day/Time:
Key Skills: (currently being reviewed by WG Leads)
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