Belgium CTIS Patient-Facing Document QC Checklist

Trial content checks

• Use the same official trial title, short title, EU trial number, sponsor and investigational product throughout.
• Describe the objective and treatment groups in participant language without changing their scientific meaning.
• Explain randomisation, placebo, blinding and the chance of receiving each treatment where they apply.
• Check visit numbers, visit duration, treatment period, follow-up and total participation time against the schedule of activities.
• Match all invasive procedures, imaging, questionnaires, home activities and optional substudies to the protocol.
• State foreseeable risks and burdens accurately. Do not promise benefit or describe an experimental product as safe or effective.
• Match pregnancy testing, contraception, breastfeeding and exposure precautions to the protocol and product information.

Protocol-to-document consistency checks

Compare the ICF line by line with the current protocol, not with an earlier synopsis. Confirm doses, routes, washouts, rescue treatment, hospital stays, blood volume, tissue collection and long-term follow-up.

Check whether participant-facing instruments are linked to trial endpoints. For multinational trials, FAMHP's June 2026 list says only the English endpoint-related version is submitted in Part I. For mono-national trials, a Member State language version may be submitted in Part I when no English version exists. Other documents that may influence a decision to participate belong in Part II for ethics review.

BAREC states that patient cards, simple device instructions, dosing diaries, welcome letters, travel policies and payment-portal instructions do not normally require ethics review. Reclassify an item if it contains trial claims, risk information, payment incentives or content that could affect participation.

Consent logic checks

• Make the main trial decision explicit and separate from optional choices.
• Ensure that declining optional samples, genetic analysis, future use or extra follow-up does not appear to withdraw the main-study consent.
• Identify who conducts the consent interview and when consent must occur.
• Leave participant and interviewer signature fields blank at CTIS submission.
• Include signature and date fields for every person whose consent, assent, attestation or authorisation is required.
• State how a participant withdraws and what happens to data and samples already collected.
• Explain any safety follow-up that continues under a legal obligation after withdrawal.

For electronic consent, confirm that a paper route remains available, that the interview is in person or by video rather than telephone only, and that the investigator signs last. Submit the electronic flow and visual materials as the participant will see them, plus a printable PDF. The Belgium main consent guide explains the standard process.

Population and document coverage checks

Map every population in the protocol to an information and signature pathway:

• Use the healthy-volunteer variation for adult healthy participants.
• Use the minor consent and assent variation for children, adolescents and parents or guardians.
• Use the limited-capacity and legal representative variation when an adult cannot consent personally.
• Use the emergency-enrolment variation only if every Article 35 condition is built into the protocol and procedure.
• Use the impartial-witness variation when a participant can consent but cannot write.
• Use the pregnancy follow-up variation for a pregnant participant, pregnant partner or infant follow-up.
• Use the secondary-use variation for optional use outside the protocol.

Belgium does not prescribe one numeric assent age. Check that age-adapted information reflects the actual population and that the investigator can document the minor's understanding, assent or dissent. Include two parent signature lines in the paediatric ICF unless a justified exception applies under the current national advice.

Data privacy checks

• Identify the sponsor and relevant data controllers or roles in terms the participant can understand.
• Describe what personal and health data are collected and why.
• Identify recipients and access groups, including monitors, auditors, authorities and ethics reviewers.
• Explain coding or pseudonymisation without describing coded data as anonymous.
• State relevant retention periods and international transfer safeguards.
• Explain data-subject rights and any lawful limitations caused by research integrity or legal obligations.
• Provide data protection and participant-rights contacts.

Do not treat the signature consenting to trial participation as the legal basis for every data-processing activity. Belgium accepts the GDPR compliance statement inside the ICF. If it is absent, submit the separate Part II statement required by the FAMHP list.

Biological-sample and future-use checks

Use the mandatory EU biological-sample template for applicable new initial applications and additions of Belgium. Insert the required Belgian text in section 5.1 and select whether all use remains limited to research on the same disease, treatment or drug.

If any use falls outside that scope, confirm that the material will be registered in a Belgian biobank. Separate main-protocol use from optional future use. If samples may be anonymised by lifting traceability, obtain explicit consent, explain the rights that will be lost and keep a system that prevents anonymisation when consent was refused.

Belgium-specific template checks

• Confirm the latest CT-College adult-patient or healthy-volunteer template was used where mandatory.
• Preserve fixed national text. Translate only the study-specific sections.
• Include the current sponsor statement if the template was not used or mandatory wording changed.
• Use the vaccine healthy-volunteer template as a recommendation while the revised version is pending.
• Use the mandatory EU recruitment and informed-consent procedure template.
• Confirm that compensation and insurance wording agrees with the Belgian finance statement and insurance certificate.

Signature, version and administrative checks

• Put a clear document title, population, language, version and date on every item.
• Enter version and date in CTIS structured data. FAMHP recommends omitting them from the filename.
• Add the Annex I letter and language to filenames where practical, such as L Main ICF_NL.
• Confirm that all submission ICFs are blank and the institutional site suitability statements are signed.
• Ensure tracked-change documents accompany responses to requests for information and substantial modifications.
• Remove signatures, personal addresses and other unnecessary personal data from documents intended for CTIS publication.

Readability and language checks

Read each local version independently. Check medical terminology, consistent defined terms, short sentences, clear headings and usable contact details. Confirm that risk frequencies and time periods retain the same meaning across Dutch, French, German and English versions.

For Brussels or multilingual recruitment, do not assume a single local language is enough. Align the language set with the intended participant population and recruitment material. The sponsor is responsible for translation concordance even though the ethics committee reviews one ICF language.

Return to the Belgium CTIS hub for the full guide set or use the Belgium Part II document checklist to verify non-participant documents.