France CTIS Part II Patient-Facing Document QC Checklist

Trial content checks

• Confirm the trial title, short title, protocol number, EU trial number, sponsor and investigational treatment are correct and consistent.
• State why the person is invited and whether the cohort is a patient or healthy-volunteer cohort.
• Explain randomisation, blinding, placebo and treatment allocation in language that matches the protocol.
• Check the visit schedule, treatment period, follow-up, tests, procedures, devices and remote contacts against the latest protocol.
• Distinguish routine care from research-only procedures.
• Check that benefits are not promised or overstated.
• Cover foreseeable treatment, control, procedural and reproductive risks without copying a technical safety table into the participant document.
• Describe realistic alternatives to participation and planned care after the trial.
• Confirm that contact routes work for routine questions, urgent safety matters, participant rights and privacy issues.

Protocol-to-document consistency checks

• Compare every eligibility-sensitive restriction that participants must follow, including medicines, food, activity, contraception and donation restrictions.
• Match the number and timing of blood draws, biopsies, imaging procedures, questionnaires and home activities.
• Reconcile sample types, analyses, storage, transfers, retention, optional future use and destruction across the protocol, laboratory manual, consent forms and biological-sample compliance template.
• Reconcile data sources, recipients, transfers and retention across the protocol, data-management material, MR-001 analysis and participant notice.
• Match expense reimbursement and constraint indemnity to the EU compensation form and Additional France document.
• Check that the insurance description identifies the correct France route and does not conflict with the certificate.
• Confirm that pregnancy reporting and follow-up are described consistently in the protocol and participant documents.

Consent logic checks

• Separate main participation from optional substudies, future research and any other choice that may be refused without losing trial access.
• Provide a clear yes and no choice where an optional activity requires a recorded decision.
• Do not bundle genetic testing into a general signature. France requires separate information and express written prior consent for a genetic examination.
• Confirm that the recruitment and informed consent procedure identifies who informs, who consents, when consent occurs and how understanding is assessed.
• Check that the participant has adequate time to decide except where a legally valid emergency route applies.
• Explain withdrawal effects separately for trial procedures, new data collection, existing data and stored samples.
• Ensure the participant receives a signed copy of the consent record.
• Confirm that electronic or remote consent methods, if proposed, meet the same information, identity, signature, copy and record requirements and are described in the submitted procedure.

Population and document coverage checks

• Build a list of every cohort and consent pathway in the protocol, then map an information version, consent form and recruitment route to each.
• For healthy volunteers, check non-therapeutic purpose, exclusion period, payment, restrictions and national-register information. Use the France healthy-volunteer guide.
• For minors, check age-adapted information, parent authorization, personal adherence, refusal and re-consent at adulthood. Use the France minor consent and assent guide.
• For limited-capacity adults, verify the exact French protective status before selecting a legal representative or assisted-consent route. Use the France limited-capacity guide.
• For emergency enrollment, confirm that every Article 35 condition is addressed and later consent is sought without undue delay. Use the France emergency enrollment guide.
• For a capable participant who cannot write, include the correct witnessed process and attestation. Use the France impartial-witness guide.
• For pregnancy follow-up, separate a pregnant participant from a pregnant partner who is a new data subject. Use the France pregnancy follow-up guide.
• For optional future data or sample use, check separate choices, transfers, genetics and withdrawal. Use the France secondary-use guide.

Data privacy checks

• Identify the controller, any EU representative and the data-protection officer or privacy contact.
• State the processing purposes, data categories, sources, recipients, retention and participant rights in clear French.
• Distinguish direct collection under GDPR Article 13 from collection through another person or record source under Article 14.
• Confirm the selected legal bases with the privacy team. Do not equate trial consent with the GDPR legal basis by default.
• List the countries receiving data, the recipients or recipient categories, each transfer purpose and the adequacy status expected by the France guidance.
• Check the right to access, rectify, restrict or object and the right to complain to CNIL, subject to lawful research limitations.
• Explain what happens to previously collected data after withdrawal without promising deletion that law or scientific-integrity duties do not permit.
• Match the notice to the MR-001 declaration or CNIL authorization route stated in the national application.
• Check privacy text in recruitment websites, screeners, apps, diaries and pregnancy follow-up forms, not only in the main consent document.

Biosample and secondary-use checks

• Identify every sample, collection point, quantity or frequency and analysis.
• State storage location, access, coded status, retention, transfers and end-of-storage action.
• Separate protocol-defined analyses from optional future research.
• Confirm that any future purpose is specific enough to support an informed choice.
• Check that a changed sample purpose triggers a new-consent assessment before use.
• Prepare the separate French genetic-testing information and consent form where genetic examination is planned.
• Confirm that the main form, optional form and EU biological-sample compliance template use the same choices and terminology.

France-specific regulatory checks

• All participant-facing documents for France are in French.
• The main information is clear, concise, fair and not so long that it impairs understanding.
• The document identifies the CPP opinion and ANSM authorization as required by French law.
• The information explains the right to personal health information and access to overall research results.
• Any constraint indemnity aligns with French restrictions and the EUR 6,000 cap over twelve consecutive months.
• The data-transfer disclosure is exhaustive enough for the national Part II guidance.
• The separate genetics route is used where applicable.
• The recruitment procedure uses the harmonised version required on the intended submission date.

Signature, version and administrative checks

• Give each submitted file a unique, consistent title, version and date.
• Put the information-document version and date on the consent page.
• Include signature and date fields for the participant and the person conducting the consent interview.
• Add parent, representative, curator, witness or separate data-subject fields only where the applicable route requires them.
• Label each role in French and make clear whether a person signs for authorization, assistance, attestation or consent.
• Confirm that unsigned templates are uploaded at application and approved versions are signed during conduct.
• Check headers, footers, page numbers, blank pages, tracked changes, comments and hidden text.
• Make filenames intelligible in CTIS and ensure PDFs contain searchable text.
• Reconcile local contact placeholders before site use through the approved document-control process.

Readability, language and document-design checks

• Use plain French appropriate to the intended age, condition and health literacy.
• Define medical and regulatory terms at first use.
• Keep sentences and paragraphs short and use headings that help a participant find an answer.
• Use legible type, contrast, spacing and page layout.
• Explain diagrams and icons in words where needed for accessibility.
• Avoid coercive tone, sponsor marketing language and statements that could waive legal rights.
• Ask an independent French reviewer to check meaning, not only grammar.
• Test digital screens on the devices participants will use and retain the CPP-reviewed content and flow.

Final release decision

Do not release the set while any protocol fact, consent giver, optional choice, data transfer, sample purpose, payment or signature block is unresolved. Record the resolution and rerun the affected checks. Return to the France CTIS hub for the full submission series.