EU CTIS Guides

Start with EU-wide rules that apply across Member States, then use the country hubs for national Part II requirements.

These guides cover three recurring submission tasks: naming documents consistently, choosing the correct route for post-authorisation changes, and preparing information for CTIS publication.

Scope: EU/EEA CTISLanguage: EnglishReviewed: 18 September 2026

EU-wide CTIS resources

CTIS document naming convention

Apply the CTCG title structure, section prefixes, country and language details, metadata rules and copy-ready examples.

Substantial vs non-substantial modifications in CTIS

Classify a change, choose the correct CTIS route, and distinguish substantial modifications from Article 81(9) and other non-substantial changes.

CTIS transparency and redaction guide

Identify what can become public, protect personal data and CCI, and prepare the correct document versions before upload.

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

Last reviewed: 18 September 2026

EU-wide CTIS resources

Then check the Member State requirements

Official sources and resources

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