France CTIS Part II Guides

France guide directory

Part II document checklist

Use this checklist to identify the national documents, language, signatures, templates and CTIS sections required for a France submission.

https://trialagents.com/ctis/france/en/part-ii-document-checklist

Patient information and consent requirements

Use the main consent guide to prepare the standard French participant information sheet and informed consent form, including France-specific privacy, transfer, genetics and signature content.

https://trialagents.com/ctis/france/en/patient-information-consent-requirements

Patient-facing document QC checklist

Use this quality-control guide to compare the protocol, consent logic, population documents, privacy text, samples, signatures and version details before submission.

https://trialagents.com/ctis/france/en/patient-facing-document-qc-checklist

Healthy volunteer consent requirements

Use this guide when the France cohort includes healthy volunteers and the documents must cover compensation, exclusion periods and the national healthy-volunteer register.

https://trialagents.com/ctis/france/en/healthy-volunteer-consent-requirements

Minor consent and assent requirements

Use this guide for children and adolescents, parent authorization, age-adapted information, assent or personal adherence, refusal and re-consent at adulthood.

https://trialagents.com/ctis/france/en/minor-consent-assent-requirements

Limited-capacity participant and legal representative consent requirements

Use this guide to determine the correct French consent route for adults under curatorship, guardianship or another protective measure, and for adults unable to consent without a formal measure.

https://trialagents.com/ctis/france/en/limited-capacity-legal-representative-consent-requirements

Emergency enrollment consent requirements

Use this guide where the protocol proposes enrollment before prior consent in a sudden life-threatening or other serious emergency covered by Article 35 of the Clinical Trials Regulation.

https://trialagents.com/ctis/france/en/emergency-enrollment-consent-requirements

Impartial witness consent requirements

Use this guide when a capable participant can consent but cannot write, so the alternative consent process must be witnessed and properly documented.

https://trialagents.com/ctis/france/en/impartial-witness-consent-requirements

Pregnancy follow-up requirements

Use this guide for follow-up of a pregnant trial participant or the pregnant partner of a participant, including separate consent, medical-record access and infant data.

https://trialagents.com/ctis/france/en/pregnancy-follow-up-requirements

Secondary-use consent requirements

Use this guide for optional scientific use of data or biological samples outside the main protocol, including future use, transfer, genetics and withdrawal choices.

https://trialagents.com/ctis/france/en/secondary-use-consent-requirements

Main France differences

Language and participant documents

The France Part II dossier is prepared in French. The standard participant information and consent document must be clear, concise, fair and understandable to a lay reader. Recruitment materials, diaries, questionnaires and other materials intended for participants also need a French version. France does not impose a national template for the standard participant information and consent document, but its content and signature logic must meet EU and French requirements. The France patient information and consent guide explains the required content.

The harmonised EU recruitment and informed consent procedure template version 2.0 entered a transition period in June 2026. It is strongly recommended during the transition and becomes applicable to new Part II applications from 1 September 2026. Sponsors preparing an application for submission on or after that date should use version 2.0 and confirm the current implementation note on EudraLex Volume 10.

Authority and ethics roles

ANSM assesses the scientific and technical Part I dossier for France. The allocated CPP assesses the ethical Part II dossier, including recruitment, participant information and consent, investigator and site suitability, insurance, financial arrangements, data protection and biological samples. Questions about Part II are handled through CTIS and responses are normally filed in French. A question about an investigator CV or declaration of interest may be answered in the same permitted language as that document.

National forms and evidence

The Additional France application document is mandatory. It records matters such as any exclusion period, sponsor-investigator financial arrangements and the sponsor's MR-001 position. It is dated and signed by the CTIS applicant, whether that applicant is the sponsor or a contracted organisation.

For data processing that strictly complies with MR-001, the controller files a declaration of conformity with CNIL and retains the receipt. The receipt is included in the CTIS data-protection section. If the processing does not comply, the sponsor declares this in the Additional France document and obtains CNIL authorization after the CPP opinion. The France Part II document checklist gives the submission status for each item.

Population and use-case consent

French law adds specific routes for minors, adults under legal protection and adults unable to consent. A capable participant who cannot write follows a different witnessed process. Emergency enrollment is permitted only when every condition in Article 35 of the Clinical Trials Regulation is met. Use the population guides above to map the correct information sheets, signatures and later re-consent steps.

Sites, insurance and samples

France requires a site list, investigator CVs and declarations of interest, a site-suitability statement for each site, insurance evidence, financial-arrangement information and an EU biological-sample compliance document. An Agence régionale de santé authorization is conditional. It is needed only where the research requires acts that the site does not usually perform within the meaning of Article L1121-13 of the Public Health Code. France charges no clinical trial application fee under the current CTIS pathway.

Other language versions

No other language version of the France hub is included in this publication set.