Belgium CTIS Patient Information and Consent Requirements

Select the correct Belgian language set

The application dossier may be in Dutch, French, German or English. Participant documents are different. They must be written in the language or languages of the participants and submitted at least in the official language or languages of the region where the trial will run.

Use Dutch for participants recruited in the Dutch-speaking region, French for the French-speaking region and German for the German-speaking region. For Brussels, plan French and Dutch versions when both language groups may be recruited. A site-specific recruitment plan may justify the exact set, but the sponsor remains responsible for appropriate and matching translations.

The assigned ethics committee reviews the ICF in one language. This does not remove the sponsor's duty to ensure that every submitted language version has the same meaning. Use the current CT-College source text for each official language and avoid re-translating its standard paragraphs.

The current CT-College template package is published in Dutch, French and English, while German remains an official participant language where applicable. For recruitment in the German-speaking region, confirm the expected implementation of the mandatory template with FAMHP or the CT-College before submission and document the translation approach.

Use the mandatory CT-College template

Mandatory. Use the current Model ICF for interventional clinical trials with an investigational medicinal product on adult patients for a new initial application in this category. The page was last updated in June 2026 and its zip package includes the ICF versions and sponsor statement.

Keep the fixed text and structure. Insert the study-specific title, purpose, design, procedures, visits, investigational treatment, risks, reproductive precautions, benefits, alternatives, costs, compensation, insurance, privacy, samples and contacts where directed. If a required topic does not apply, follow the template instruction rather than silently deleting fixed safeguards.

The healthy-volunteer template is a separate mandatory form. The vaccine healthy-volunteer template remains recommended while a new version is prepared. The Belgium healthy-volunteer consent guide explains those routes.

Main information the participant must receive

The final information should let an adult decide without consulting the protocol. Cover, in clear participant language:

• why the trial is being done and why the person is invited
• the investigational medicinal product, randomisation, placebo and blinding where applicable
• visits, tests, procedures, treatment duration and follow-up
• foreseeable risks, discomforts and burdens, including unknown risks
• expected benefit, the absence of guaranteed benefit and treatment alternatives
• pregnancy, contraception, breastfeeding and partner precautions where relevant
• what samples and data are collected, who receives them and how long they are retained
• optional genetic testing, future research, sample storage or anonymisation as separate choices
• confidentiality, coded data, access by monitors, auditors, authorities and ethics reviewers
• reimbursement, compensation, trial-related injury and Belgian no-fault insurance
• voluntary participation, withdrawal, consequences of withdrawal and continued safety follow-up where legally required
• who to contact for trial questions, urgent medical issues, participant rights and data protection

Information about compensation and reimbursement must match the financial documents. Sample wording must match the protocol and the mandatory EU biological-sample form. Privacy wording must distinguish the informed consent to participate from the legal basis for processing data.

Readability and presentation

Write for the intended participant, not for the assessor. Define medical terms, explain probabilities in a form the population can understand and use short sections. Keep risks specific to the intervention and avoid copying investigator-facing lists without context.

For electronic informed consent, the electronic presentation must contain at least the same information as the paper ICF. Submit the screens, logos, images, videos and process as participants will see them, together with a printable PDF. Participants must be able to refuse the electronic route and request a physical process with a paper ICF.

Electronic advance information does not replace the consent interview. Belgium permits the interview in person or by video conference, not by telephone alone. The ICF must state which format is used. A trial site may refuse electronic information or signing.

Consent interview, signatures and dating

Submit blank, version-controlled ICFs in CTIS. Participant signatures are obtained only after authorisation, before any trial-specific procedure and after the participant has received information, had time to consider and had questions answered.

Under Belgian law, the team member conducting the interview required by Article 29 of the Clinical Trials Regulation must be a physician. A dentist may conduct it for a dental trial. That professional may delegate nursing activities used to support the process, but remains responsible and in control.

The participant and the person who conducted the consent interview sign and date the approved form. For electronic consent, the interview occurs first and the investigator signs last. After both parties sign, lock the electronic document, preserve the audit trail and give the participant a printed or locked electronic copy.

If the participant cannot write but can decide, use the Belgium impartial-witness consent pathway. If an adult lacks decision-making capacity, use the Belgium legal representative pathway. Do not use a witness as a substitute for a legally designated representative.

Population and use-case variations

Prepare a separate or clearly adapted document set whenever the consent logic changes:

• The minor consent and assent guide covers parents, guardians, age-adapted information, assent and re-consent at adulthood.
• The emergency-enrolment guide covers the narrow deferred-consent conditions in Article 35.
• The pregnancy follow-up guide separates pregnant participants, pregnant partners and infant follow-up.
• The secondary-use guide covers optional research with data and samples outside the main protocol.

Do not bury an optional choice in the signature for the main trial. Refusing optional future use, genetic testing or child follow-up must not automatically exclude someone from the main trial unless the protocol provides a scientifically and ethically justified reason.

Submission checks for the main ICF

• Confirm that the CT-College template version is current on the day of submission.
• Preserve mandatory standard wording and include the sponsor statement when required.
• Match title, EU trial number, treatment arms, visits, sample volumes, risks and contraception with the protocol.
• Match payments, reimbursement and insurance with the Part II finance and insurance documents.
• Include the required GDPR confirmation in the ICF or submit a separate Part II statement.
• Submit every regional language and every special-population variation.
• Keep the submission forms unsigned, with clear version and date metadata in CTIS.

The Belgium patient-facing document QC checklist provides a final cross-document review, and the Belgium CTIS hub links the complete guide set.