EU CTR Implementation
Project Description |
This project addresses the implications of the EU Clinical Trials Regulation (CTR) on the publication of clinical trial documents. The regulation introduces earlier and broader disclosure requirements, including the routine publication of documents such as the Investigator’s Brochure, significantly impacting how sponsors plan and prepare trial documentation. The project will examine the types of documents subject to publication, expected timelines, and the application of deferral mechanisms to protect confidential commercial information (CCI). It will also clarify which documents can be redacted, the extent of permissible redactions, and considerations for protecting personal data. Target stakeholders include pharmaceutical and biotechnology companies, as well as academic sponsors conducting trials in the EU. Building on prior work, the project may expand existing materials into a comprehensive deliverable outlining disclosure pathways, requirements, and practical considerations. The outputs will provide clear, actionable guidance to support compliance, improve planning, and ensure appropriate protection of sensitive information under the EU CTR. |
Project Leads | |
|---|---|
Christa Polidori, Regeneron | |
Sanjay Bagani, Xogene Services | |
Alex Pearce, PHUSE Project Coordinator |
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