France CTIS Part II Patient Information and Consent Requirements

Purpose and document set

The information sheet supports understanding. The consent section records the decision and the required signatures. They may be combined in one version-controlled document or presented as linked parts, provided that the participant receives the full approved information and the signature pages can be traced to it.

Prepare a distinct version whenever the information, procedures, risks, consent giver or optional choices differ. This commonly means separate versions for different cohorts and optional substudies. The France CTIS hub links the complete national guide set.

Language, readability and design

Use French that a lay reader in the intended population can understand. Keep sentences direct, define necessary medical terms and separate required procedures from optional choices. The national guidance calls for information that is clear, concise and fair. Excessive length can itself impair understanding.

Use headings, short paragraphs, readable type, sufficient spacing and clear tables only where they help comparison. Do not hide material risks, data transfers or withdrawal effects in dense legal text. Explain abbreviations on first use. Every page should carry a consistent title, version and date, and the consent page should identify the corresponding information version.

The English source version may support drafting and sponsor review, but the CPP reviews the French participant version. Translate all participant-facing appendices, diagrams, questionnaires and digital screens used to obtain or support consent.

Main information sections

Trial identity and purpose

Identify the trial, sponsor and investigational treatment in plain language. Explain the trial purpose, why the person is being invited, the planned number of participants where relevant, the randomisation or control design, and the expected duration of the person's participation.

State that the project is research, not ordinary care. Identify the favourable CPP opinion and ANSM authorization as France requires, using wording that can be finalized once the decisions are available. Include the EU trial number or CTIS number that allows the participant to identify the trial.

Procedures and practical burden

Describe screening, treatment, visits, tests, questionnaires, sample collection, remote contacts, devices and follow-up. Distinguish routine care from research-only procedures. State visit frequency, duration, travel expectations and foreseeable constraints.

Explain randomisation, blinding, placebo or treatment assignment where applicable. If samples or data may be transferred to other organisations, connect that transfer to the relevant procedure rather than leaving it only in the privacy section.

Benefits, risks and alternatives

Do not promise personal benefit. Describe expected individual benefit only where it is reasonably possible, then explain wider scientific benefit separately. Present reasonably foreseeable risks and inconveniences in a balanced order, including investigational treatment, control treatment, procedures and trial restrictions.

Describe available alternatives, including standard care and the option not to participate. Explain what care is planned when the trial ends and any follow-up or treatment access that the protocol provides.

Pregnancy, contraception and reproductive risk

Where relevant, state pregnancy or breastfeeding restrictions, contraception expectations, pregnancy testing, reproductive risks and what the participant should do if pregnancy occurs. Explain pregnancy follow-up separately from trial treatment and do not imply that one participant can consent for a pregnant partner. The France pregnancy follow-up guide covers the two consent routes.

Biological samples and genetics

List the samples, collection method, quantity or frequency, storage location, coded status, planned analyses, retention period, access, transfers, destruction or return policy and any optional future use. Keep the choices consistent with the protocol and the EU biological-sample compliance form.

If the trial includes a genetic examination, France requires express written prior consent after the participant is told the nature and purpose of the examination. The national guidance expects a separate genetic testing information and consent document rather than relying on the standard trial consent. Future or changed sample purposes may require a new consent. The France secondary-use guide explains the optional-use structure.

Personal data and confidentiality

Identify the controller and, where applicable, its representative and data-protection officer. Explain the categories and sources of data, purposes of processing, legal basis, recipients, retention, security measures at an understandable level, and the participant's rights and contact routes.

For direct collection, provide the information required by Article 13 of the General Data Protection Regulation. If information comes from another source, address Article 14 unless a lawful exception applies. Consent to participate in the trial is not automatically the legal basis for every data-processing activity, so do not describe it that way without confirming the controller's legal analysis.

France's national Part II guidance expects the participant information to list the countries to which data will be transferred, the recipients or recipient categories, the purpose of each transfer and whether the destination benefits from an adequacy decision. A vague statement such as transfer outside Europe is not enough for that national check.

Where the processing strictly complies with MR-001, the controller declares conformity to CNIL and retains the receipt for CTIS. If it does not comply, the sponsor follows the CNIL authorization route after the CPP opinion. Ensure that the participant notice matches the route declared in the Additional France application document.

Compensation, expenses, insurance and injury

Explain expense reimbursement, any constraint indemnity and the payment conditions. State that refusal or withdrawal does not create a penalty. Keep the amount and schedule consistent with the EU compensation form. Where a constraint indemnity is paid, comply with the French total cap of EUR 6,000 over twelve consecutive months and the restrictions that apply to protected populations.

Explain the mandatory insurance arrangements and the contact or procedure for a research-related injury. Do not turn the participant document into an insurance policy summary. Give the practical route for questions or claims.

Voluntary participation and withdrawal

State that participation is voluntary, refusal does not affect care or legal rights, and consent may be withdrawn without having to give a reason. Explain which new trial procedures and collections will stop, any safety follow-up the participant may choose or need to discuss, and what happens to data and samples already collected.

Under French law and the Clinical Trials Regulation, withdrawal does not automatically invalidate activities already carried out or lawful processing based on prior participation. Explain the consequences precisely and distinguish withdrawal from the trial, objection to future data processing, destruction of remaining samples where available, and withdrawal of an optional secondary-use choice.

Results and contacts

Explain when and how a summary of trial results will become available. French law also requires information about the right to receive personal health information and, after the research, the overall results under the stated conditions.

Give clear contact details for trial questions, emergencies, participant rights and data protection. Identify which contact is appropriate for each issue. Update local details before site use without creating a mismatch with the version approved by the CPP.

Consent logic and optional choices

Main participation consent must stand on its own. Do not make optional future research, genetic testing, optional imaging or another substudy a condition of entry unless the activity is genuinely part of the main protocol and ethically justified as such.

Use separate yes and no choices for optional activities. State whether an optional refusal changes any part of the main trial. Avoid bundled wording that produces one signature for unrelated permissions. Where an activity needs its own legally distinct consent, use a separate document rather than only an extra checkbox.

The recruitment and informed consent procedure should identify who presents the information, how understanding is checked, how much decision time is provided, how questions are answered and which version is signed. It should map every population pathway used by the protocol.

Signature and dating requirements

The version uploaded at submission is not signed. It must include the final signature blocks. When consent is obtained, the participant and the investigator or other person who conducts the consent interview sign and date the document. The participant receives a copy.

The consent record should identify the information version received and confirm that the participant had adequate time and an opportunity to ask questions. Do not predate signatures. Correct any error through a traceable process that preserves the original entry.

If the participant cannot write but can understand and decide, use the witnessed process described in the France impartial-witness guide. Do not substitute that route for the legal-representative process where the person lacks capacity.

Population-specific variations

Healthy adults who are not selected because of a disease need the standard core information plus clear wording on non-therapeutic purpose, restrictions, payments and the national registry where applicable. Use the France healthy-volunteer consent guide.

For a minor, provide age and maturity-adapted information, seek the minor's personal adherence, obtain authorization through the French parental route and respect refusal. Use the France minor consent and assent guide.

For an adult with limited capacity, identify the formal protective measure or other applicable status before choosing the consent giver. Continue to inform and involve the participant as far as possible. Use the France limited-capacity and legal-representative guide.

Enrollment before consent is restricted to the emergency conditions in Article 35 of the Clinical Trials Regulation. It requires a protocol-defined route and prompt later information and consent. Use the France emergency enrollment consent guide.

Before filing, run the complete set through the France patient-facing document QC checklist.