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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 gallan4@its.jnj.com
Lauren White (PHUSE Project Coordinator) lauren@phuse.global 
Objectives & DeliverablesTimelines
Poster Q32021

CURRENT STATUSQ3/42021

Project on hold until Q1 2022. Will meet again in March 2022 (and likely monthly thereafter) to discuss any learnings from pilots and initial trials going through the Regulation. Will also discuss more concrete next steps at that time, 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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