Release Date: 9 July 2025
Reference: EMA/186412/2021 v6.0
I am genuinely delighted and grateful that the EMA has consolidated so much guidance into this single handbook. Version 6.0 represents a significant advance in clarity, efficiency and compliance for sponsors navigating the Clinical Trials Information System (CTIS) under Regulation (EU) 536/2014 (CTR).
A Streamlined, Clickable Handbook
Handbook v6.0 begins with a fully clickable table of contents that takes you directly to topics from organisation and user setup through dossier compilation, safety reporting under Articles 40–44 CTR and public disclosure of results. Embedded “bite-size” video tutorials allow you to view five-minute demos on responding to an RFI or submitting a substantial modification without leaving the PDF Download here. Section 6.1 functions as a Release Notes hub and will be updated alongside every CTIS technical release so you can bookmark it and remain current.
Real-Time Dashboards and Self-Service Analytics
Sponsors have been asking via LinkedIn polls and ACT-EU forums for greater visibility of trial metrics. Handbook v6.0 delivers an in-depth guide to the revamped Sponsor Dashboard, where submission status, query backlogs and projected timelines are displayed at a glance. Detailed instructions explain how to use the CTIS REST API to schedule nightly exports of CTIS trial reference numbers, RFI histories and audit logs into your business-intelligence tool, automating custom reports and eliminating manual data pulls.
Mobile-First Tips and Interactive Troubleshooting
Many colleagues now access CTIS from tablets or smartphones. Version 6.0 offers concise advice on optimising the mobile interface, downloading PDF snapshots of pending queries for offline review and queuing responses for when connectivity is restored. An interactive decision tree addresses the most common CTIS error codes and links directly to the EMA Service Desk and ACT-EU Q&A logs for immediate assistance.
Alignment with ICH GCP, GDPR and MDR
This handbook does more than explain CTIS workflows; it maps each to the relevant regulatory frameworks. Cross-references to ICH E6(R2) cover risk-based monitoring and data integrity, accompanied by a quadrant model for prioritising critical-to-quality factors. The GDPR section provides DPIA templates and guidance on EU–US transfer safeguards for cloud-hosted trial data, while the transparency chapter explains early-redaction workflows under Article 81 CTR without compromising public-domain requirements. For device or combination-product studies, side-by-side notes on MDR 2017/745 Annex XXII ensure compliance with both CTR and device regulations.
Annexes, Trainer Insights and Case Study
Annex I offers a CTR-aligned glossary of acronyms and definitions. Annex II curates Q&As, EudraLex Volume 10 excerpts and CTIS release notes. Annex III details ethics-committee requirements across the EU/EEA—language-specific forms in France, the Netherlands and Spain; insurance-wording variations in Sweden and Italy; dossier-ordering conventions in Belgium and Finland. Annex IV shares Master Trainer’s Top Ten Tips drawn from two decades of regulatory-affairs leadership and EMA CTIS training sessions. A brief case study demonstrates how one sponsor reduced RFI turnaround times by 30 percent by using the new API workflows and interactive flowcharts to shave five days off their review cycle.
Conclusion
CTIS Sponsor Handbook v6.0 serves as our community’s comprehensive guide to efficient, transparent and risk-based trial management. Explore every section and implement these best practices in your next submission.