EU-wide CTIS resources
Apply the CTCG title structure, section prefixes, country and language details, metadata rules and copy-ready examples.
Classify a change, choose the correct CTIS route, and distinguish substantial modifications from Article 81(9) and other non-substantial changes.
Identify what can become public, protect personal data and CCI, and prepare the correct document versions before upload.
Prepare an ASR, assign the correct safety roles, choose the reporting scope, submit and handle assessment RFIs.
Choose the correct lifecycle event for starts, recruitment, temporary halts, restarts, early termination and trial end.
Connect end-of-trial notifications with final results, layperson summaries, publication checks and Clinical Study Reports.
Then check the Member State requirements
EU rules do not replace national Part II requirements. Use the CTIS country hubs for participant documents, sites, investigators, insurance, privacy and other Member State-specific requirements.
Official sources and resources
- EMA Clinical Trials Information System.
- European Commission EudraLex Volume 10.
- Clinical Trials Coordination Group key documents.
Last reviewed: 23 September 2026