CTIS Document Naming Convention: A Practical 2026 Guide

Copy-ready examples by dossier category

Replace the capitalised placeholders with the actual trial details. These examples implement the CTCG structure; adapt them to the applicable CTIS placeholder and keep the final title under 100 characters.

Why C and Q are absent: the CTCG example structure runs from B, then D–P, R and S. Some items, including proof of fee payment and the GDPR statement in the Forms section, use other CTIS upload locations and are outside this example structure.

Details to add only when they distinguish the document

• Subtype: adult ICF, adolescent ICF, questionnaire, advertisement, addendum or CTD module.
• Country and language: use appropriate ISO codes for national versions and translations.
• Site: use the site name or site number for site-specific material.
• Product or organisation: use a concise identifier where several related documents would otherwise be ambiguous.
• Special state: identify a split-file number, public or redacted version, tracked-changes version, or summary or extract of changes.

Personal names and public disclosure

Include a person's name only when compatible with CTIS public-disclosure rules. CTCG permits the principal investigator's name in investigator-suitability documents such as a CV or Declaration of Interest because that legal-role name is public. Do not generalise that exception to other people.

Resubmissions and the Article 11 workaround

EU trial number during resubmission

CTIS changes the final two digits of the EU trial number during resubmission. CTCG accepts omitting those final two digits inside uploaded documents. If the full original number is already present, immediate correction is not expected during the ongoing procedure; it can be corrected when the document is updated in a later substantial modification. Decision letters still use the full number.

Part II placeholder title

For a Member State intended to receive Part I only under the Article 11 workaround, upload the official multilingual Part II placeholder PDF into every mandatory Part II placeholder and use this identical title:

The placeholder does not authorise the trial to start or recruit in that Member State. The actual Part II information must be submitted and authorised later.

Final naming QC

1. Correct B–S section prefix and CTIS placeholder.
2. Unique, self-explanatory title of no more than 100 characters.
3. Country, language, site, product or organisation included only when needed.
4. Version and date entered in CTIS metadata, not the title.
5. Personal name included only where disclosure permits it.
6. Clean, tracked-change, redacted or public and split-file variants clearly distinguished.
7. Uploaded filename checked for forbidden special characters.
8. National naming instructions checked in addition to the CTCG convention.

Continue with the CTIS country hubs to check the Part II requirements and source guidance for each participating country.

The core CTIS title structure

Use this order where the details apply. Omit fields that do not help distinguish the document.

• Start with the designated section prefix from B to S.
• Use a clear document type; a recognised abbreviation is acceptable.
• Add country, language, site, product or organisation only when needed.
• Identify split-file, public or redacted, tracked-change and summary-of-change variants when applicable.
• Keep the complete CTIS title unique, self-explanatory and at most 100 characters.

CTIS title versus uploaded filename

Keep version and date out of the title

Enter the version number and date only in the corresponding CTIS metadata fields. This keeps the document title stable when CTIS manages a later version.