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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. 

Project LeadsEmail 
George Allan (Janssen Research & Development)gallan4@its.jnj.com
Paula Rowley (PHUSE Project Assistant) paula@phuse.global
Objectives & DeliverablesTimelines
White PaperOngoing

CURRENT STATUSQ2/3 2022

Project is discussing any learnings from pilots and initial trials going through the Regulation. Also including how best to summarise learnings and when to aim for deliverables. 
Project MembersOrganisation 
Alex NasrAbbVie 
Brenda Tiffin ClaritiDox
Christa PolidoriRegeneron
Devaki ThavarajahIndustry
Erik LakesBeiGene
Julie HoltzopleAstraZeneca
Lora Killian Pfizer
Matt DefrancoPharma Intelligence 
Mekhala AcharyaTakeda
Niamh McGuinness Privacy Analytics
Olude ObaraboyePrivacy Analytics
Sanjay BaganiXogene

Shalini Dwivedi

Kinapse
Wendy WimmerMerck


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