CTR Resource Hub

EU CTR Resource Hub

Your one-stop-shop to ensure regulatory compliance

Get all the latest news, learn best practices, and hear what strategies your peers are adopting to comply with the EMA Clinical Trials Regulation (CTR) that went into effect for all new studies on 31 January 2023.

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Resource Spotlight

How are the new EU CTRs shaking up the established system?

Learn how the industry is reacting to EU CTR, its impact on clinical trials disclosure, and the role of technology.

Q&A with Novo Nordisk: Orchestrating Your Company’s Response to EU CTR

Novo Nordisk shares how to address some of the major process changes required by the EU CTR.

Technology Best Practices for EU CTR Compliance

Get practical tips to manage EU CTR processes in Veeva Vault.

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Quick Links

What is CTR?

The EMA Clinical Trials Regulation (CTR) aims to create an environment that is favorable to conducting clinical trials in the European Union (EU)/European Economic Area (EEA), with the highest standards of safety for participants and increased transparency of trial information.

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What is CTIS?

The regulation harmonises the assessment and supervision processes for clinical trials throughout Europe, via a Clinical Trials Information System (CTIS) – a centralised portal and database for clinical trials. CTIS is the entry point to submit all the required data for a clinical trial following CTR, and is the interface between Sponsors and Member States.

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How can I stay on top of CTR updates?

Subscribe to the EMA CTIS newsletter for updates on CTIS usage, key facts, tips, and reference materials.

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Organizational Readiness

Clinical Trials: Shifting from Directive to Regulation

Discover which clinical trials need to be transitioned from the CTD to the CTR, timeline for the shift, tips for sponsors, and more.

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EU CTR: Sponsors Embrace the Change

CTIS uptake is growing but sponsors still face technical limitations while breaking down the traditional silos.

The EU Clinical Clock Is Ticking

The transition period is ending. Are you prepared?

What You Need to Know as the Deadline Approaches

Get tips on how sponsors and CROs can ease the transition to CTIS.

Preparing for CTIS

Learn how to effectively adopt CTIS and leverage the EMA’s training materials.

Assessing the Impact of EU CTR

Learn how the regulation affects study start-up and TMF operations.

Organizational Changes due to CTR

Get an overview of CTR benefits, timelines, and expected changes.

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Processes & Technology

How are the new EU CTRs shaking up the established system?

Learn how the industry is reacting to EU CTR, its impact on clinical trials disclosure, and the role of technology.

Q&A with Novo Nordisk: Orchestrating Your Company’s Response to EU CTR

Novo Nordisk shares how to address some of the major process changes required by the EU CTR.

EU CTR Challenges Sponsors and CROs To Get Their Houses in Order

EMA’s vision of a single source of truth for clinical trial information forces a major shift in how companies collect and store trial data and documents.

Best Practices for EU CTR Compliance using Veeva Vault

Get practical tips on how to manage EU CTR processes in Vault.

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CTIS Sponsor Handbook

Get key guidance, technical information, recommendations, and references to get ready to use CTIS.

Guidebook: Modeling for CTIS

Read tips for how to organise CTIS and configure access based on study roles and responsibilities.