France CTIS Part II Document Checklist

How to read the status labels

Mandatory means the document is normally required in every France Part II application. Conditional means it is required when the stated trial feature, population or site condition applies. Recommended means it is not a separate compulsory document in every case, but it is a practical way to demonstrate a required process. Optional means the sponsor may offer the choice or material without making it a condition of trial participation.

The signature field below refers to the version uploaded at initial CTIS submission. It does not remove any later requirement to sign the approved document when consent is obtained or before a site starts work.

Recruitment documents

Recruitment and informed consent procedure

Mandatory. Submit with the initial Part II application. It describes how potential participants are identified, approached, informed, given time to decide and documented as consenting. It must also cover any population-specific or emergency route in the protocol. Prepare it in French. No signature is required at CTIS submission. In CTIS, use Part II, Recruitment arrangements, section K. Use the harmonised EU Recruitment and Informed Consent Procedure Template. Version 2.0 is strongly recommended during the transition that began in June 2026 and is applicable to new Part II applications from 1 September 2026.

Related guide: The France patient information and consent guide explains how the procedure connects to the main consent document.

Recruitment materials and documentation

Mandatory. Submit every participant-facing recruitment item intended for France. This includes advertisements, posters, letters, call scripts, social-media content, video scripts or storyboards, recruitment websites and data-collection pages. Where no separate advertising is planned, make the recruitment-material position clear in the filed recruitment set. Upload material before it is used. A later new or materially changed item requires the appropriate CTIS modification route. Participant-facing content must be in French. No signature is required at CTIS submission. In CTIS, use Part II, Recruitment arrangements, section K. No mandatory national content template. Present the final wording and enough visual context for the CPP to review presentation, claims and privacy notices.

Additional France application document

Mandatory. Submit with the initial Part II application. The document records any exclusion period, financial arrangements between sponsor and investigator, and the sponsor's MR-001 compliance position. Prepare it in French. It must be signed at CTIS submission. Date and signature are required from the CTIS applicant. The signatory is the sponsor or the organisation submitting on the sponsor's behalf. In CTIS, use Part II, Recruitment arrangements, section K. Use the current CNRIPH Additional France application document published with the national Part II guidance.

Participant information and consent documents

Main participant information sheet and informed consent form

Mandatory. Submit the document for every participant group with the initial Part II application. Create separate or clearly differentiated versions where the information, consent giver, procedures or risks differ. The approved version is signed when consent is obtained, before any trial-specific procedure unless a valid emergency pathway applies. Prepare it in French. No signature is required at CTIS submission. The submitted form must contain signature and date fields for the participant and the investigator or other person who conducts the consent interview. In CTIS, use Part II, Subject information and informed consent form, section L. France has no mandatory national template for the standard document. Use the requirements in Article 29 of the Clinical Trials Regulation, the French Public Health Code and the national Part II guidance.

Related guide: Use the France patient information and consent guide for content and signature logic.

Separate genetic testing information and consent

Conditional. Required when the trial includes a genetic examination. Obtain express written consent before the genetic examination. The national guidance expects a document separate from the main trial information and consent form. Prepare it in French. No signature is required at CTIS submission. The submitted form needs signature and date fields. The participant signs before testing. In CTIS, use Part II, Subject information and informed consent form, section L. No mandatory national template. State the nature and purpose of the genetic examination and keep the choice distinct from main trial participation where the testing is optional.

Related guide: For future genetic work, also use the France secondary-use consent guide.

Other participant-facing materials

Conditional. Submit diaries, questionnaires, instruction sheets, alert cards, digital screens, wearable instructions, home-procedure materials and similar items before use. These materials may explain a task but cannot replace the main participant information and consent document or become more exhaustive than it. Prepare it in French. A signature is normally not required at CTIS submission. A separate signature is needed only if the material itself records a consent or authorization choice. In CTIS, use Part II, Subject information and informed consent form, section L, or the most specific CTIS participant-document category available. No general national template.

Related guide: Apply the France patient-facing document QC checklist across the full participant set.

Population-specific information and consent versions

Conditional. Required when the protocol includes healthy volunteers, minors, participants with limited capacity, an emergency enrollment route, an inability-to-write route, pregnancy follow-up or secondary use that is not fully and validly covered by the standard document. Submit the applicable versions before that pathway is used. Prepare it in French. No signature is required at CTIS submission. Include the correct later signature and date fields for the participant, parent, representative, witness, investigator or separate data subject as applicable. In CTIS, use Part II, Subject information and informed consent form, section L. No general French template. Use the applicable legal pathway and the relevant guide in the France CTIS guide collection.

Investigator and site documents

List of sites and principal investigators

Mandatory. Submit the complete France site and principal-investigator list with the initial application and keep it current through the relevant CTIS procedure. Prepare it in French. No signature is required at CTIS submission. A principal-investigator signature is not required on the list. In CTIS, use Part II, Suitability of the investigator, section M, using the CTIS structured site and investigator data where requested. Use the current EU or CTIS list format.

Curriculum vitae for each investigator

Mandatory. Submit a CV for every investigator listed for France. It should be dated less than one year before submission and demonstrate relevant experience. The France guidance expects recent good clinical practice training, normally within three years, and the investigator's RPPS professional identifier. French or English is accepted. No signature is required at CTIS submission. In CTIS, use Part II, Suitability of the investigator, section M. Use the EU CV template.

Declaration of interest for each investigator

Mandatory. Submit a declaration for every investigator. It should be dated within one year before submission and updated if a relevant interest changes. French or English is accepted. No signature is required at CTIS submission under the current France guidance. In CTIS, use Part II, Suitability of the investigator, section M. Use the EU declaration-of-interest template.

Site suitability statement

Mandatory. This requirement applies to each site. Submit one statement for every France trial site with the application. It confirms that the facilities, equipment, staff and organisation are suitable for the protocol. Prepare it in French. It must be signed at CTIS submission. It is dated and signed by the person responsible for the site. A delegated department head may sign only when that person has visibility over the full trial activities at the site. In CTIS, use Part II, Suitability of the facilities, section N. Use the EU site-suitability template.

Regional Health Agency site authorization

Conditional. Required only when the interventional research requires acts that are not usually performed at the proposed site within Article L1121-13 of the French Public Health Code. Obtain the Agence régionale de santé decision for that site and submit it before the non-routine acts are performed. Prepare it in French. The submitted item is the official signed ARS decision. No extra sponsor signature is needed. In CTIS, use Part II, Suitability of the facilities, section N. Use the applicable ARS application and decision process.

Insurance and financial documents

Clinical trial insurance certificate

Mandatory. Submit evidence of insurance with the application. Coverage must include the France trial period from the first participant included in France through the last participant's last visit. An annual certificate can be accepted when it states the trial end date and remains continuously renewed. Prepare it in French. No extra signature is required on the uploaded certificate. It must be an issued and dated insurer document. In CTIS, use Part II, Proof of insurance or indemnification, section O. The insurer must be established in the European Union. The certificate should identify the trial and provide sponsor or legal-representative contact details.

Compensation and other financial arrangements

Mandatory. This remains required even where no participant payment is planned. Submit the EU compensation form with the application. State reimbursement, any constraint indemnity and any other participant payment. French law bars a financial advantage beyond reimbursement of expenses and the permitted indemnity for constraints. The total indemnity for one person is capped at EUR 6,000 over twelve consecutive months. Prepare it in French. No signature is required at CTIS submission. In CTIS, use Part II, Financial and other arrangements, section P. Use the EU compensation-for-trial-participants template. Put sponsor-investigator financial arrangements in the signed Additional France application document and do not duplicate inconsistent figures.

Data protection document

CNIL MR-001 declaration-of-conformity receipt or authorization

Mandatory. Evidence of the applicable route is required. Where processing strictly complies with MR-001, the controller makes one declaration of conformity to CNIL and retains the receipt. Submit that receipt in CTIS. A new receipt is not required for every study by the same controller. If the planned processing does not comply with MR-001, disclose that position in the Additional France document and obtain CNIL authorization after the CPP opinion, before non-compliant processing begins. Upload the authorization in CTIS when issued. Prepare it in French. The MR-001 receipt must be the dated document issued and signed by CNIL. No extra sponsor signature is needed. A later authorization is the official CNIL decision. In CTIS, use Part II, Compliance with national requirements on data protection. Use the dedicated CTIS data-protection subsection and do not file the receipt in the biological-sample subsection. Use the CNIL online declaration for the conformity route. There is no study-specific sponsor template for the receipt.

Biological-sample document

Compliance with rules for biological samples

Mandatory. Submit the EU biological-sample compliance template with the application, including where the protocol specifies collection, storage, transfer or future use. Keep the answers aligned with the protocol, laboratory manual and consent choices. A change of sample purpose may require new consent before the changed use begins. Prepare it in French. No signature is required at CTIS submission under the current France guidance. In CTIS, use Part II, Compliance with applicable rules for biological samples, section R. Use the EU template on compliance with national requirements for biological samples.

Related guide: The France secondary-use consent guide explains optional future-use choices.

Application fee

France does not charge a clinical trial application fee for this CTIS pathway, so no proof of fee payment is submitted in section Q.

Submission control points

• Match every France site and investigator across CTIS, the protocol, insurance and suitability documents.
• Use searchable text PDFs or editable formats accepted by CTIS. Do not upload image-only PDFs.
• Check dates against the France recency rules for CVs and declarations of interest.
• Confirm that every participant-facing item is in French and carries a clear version and date.
• Include signature fields in consent forms even though unsigned drafts are filed at submission.
• Use the procedure template version required on the intended submission date.
• Resolve contradictory statements across the protocol, recruitment procedure, consent documents, Additional France form, MR-001 materials and sample template.