Date: Fri, 29 Mar 2024 07:24:20 +0000 (UTC) Message-ID: <160236065.59.1711697060228@ip-172-31-15-100.eu-west-2.compute.internal> Subject: Exported From Confluence MIME-Version: 1.0 Content-Type: multipart/related; boundary="----=_Part_58_1273420820.1711697060224" ------=_Part_58_1273420820.1711697060224 Content-Type: text/html; charset=UTF-8 Content-Transfer-Encoding: quoted-printable Content-Location: file:///C:/exported.html
Project Scope |
The EU Clinical Trial Regulation (CTR) has sweeping new requ= irements for the publication of clinical trial documents of trials conducte= d in the European Union. Documents will be subject to publication earlier i= n clinical development than before, and documents like the Investigator=E2= =80=99s 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 spo= nsors prepare clinical trial documents. Stakeholders include any sponsor co= nducting an EU trial, including pharmaceutical and biotechnology companies = and academic institutions. The initial deliverable for this project may bui= ld 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 po= ssible timelines for publication, the deferral mechanism for protecting con= fidential commercial information (CCI), which documents can be redacted for= CCI and which cannot, and protection of personal protected data. |
Project Leads | |
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George Allan, Johnson & Johnson | gal= lan4@its.jnj.com |
Lauren White, PHUSE Senior Project Coordinat= or |
CURRENT STA= TUS Q1 2024 |
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Objectives & Deliverables | Timelines |
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White Paper | Q2/Q3 2025 |
EU CTR Update: Year 1 Blog | 24-03-2023 |
Resources |
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Additional Content: |