Belgium CTIS Part II Guides

Choose the right Belgium CTIS guide

Belgium CTIS Part II document checklist

Use this guide to identify the Part II documents, conditional triggers, language rules, submission-time signatures and Belgian forms for an initial application.

Belgium CTIS Part II document checklist

Belgium patient information and consent requirements

Start here when drafting the main Patient Information Sheet and Informed Consent Form for adult patients, including the Belgian template, required content and consent process.

Belgium patient information and consent requirements

Belgium patient-facing document QC checklist

Use this checklist before submission to compare the protocol, consent forms, recruitment materials and special-population documents and to confirm the correct CTIS placement.

Belgium patient-facing document QC checklist

Belgium healthy-volunteer consent requirements

Use this variation for trials involving healthy adults, including early-phase trials and the mandatory Belgian healthy-volunteer ICF template.

Belgium healthy-volunteer consent requirements

Belgium minor consent and assent requirements

Use this guide for children and adolescents. It explains parental authority, the two-parent signature approach, age-adapted information, assent, dissent and adult re-consent.

Belgium minor consent and assent requirements

Belgium limited-capacity participant requirements

Use this variation when an adult cannot provide valid consent. It explains Belgium's legally designated representative hierarchy and the participant's continuing role.

Belgium limited-capacity participant and legal representative requirements

Belgium emergency-enrolment consent requirements

Use this guide only where the protocol proposes enrolment in an emergency before prior consent can be obtained and the strict conditions in the EU Clinical Trials Regulation are met.

Belgium emergency-enrolment consent requirements

Belgium impartial-witness consent requirements

Use this variation when a participant can consent but cannot write. It separates the witness role from legal representation and explains the procedure that must be documented.

Belgium impartial-witness consent requirements

Belgium pregnancy follow-up requirements

Use this guide for pregnancy in a participant or a participant's partner. It reflects the CT-College and BAREC Q&A endorsed in July 2026.

Belgium pregnancy follow-up requirements

Belgium secondary-use consent requirements

Use this guide when data or human biological material may be used outside the main protocol, including Belgian biobank and sample-anonymisation rules.

Belgium secondary-use consent requirements

Main national differences in Belgium

Participant documents follow the participant's language, not simply the dossier language. For a trial in Flanders this normally means Dutch. In Wallonia it normally means French, with German required for participants recruited in the German-speaking region. Brussels sites may need French and Dutch according to the intended population. The sponsor is responsible for accurate translations, even though the assigned ethics committee reviews the ICF in one language. The Belgium patient information and consent guide explains the document set.

For new initial applications submitted from 1 August 2025, Belgium requires the CT-College ICF template for interventional medicinal-product trials in adult patients and adult healthy volunteers. Standard text should be preserved and only study-specific content translated. If the template is not used or mandatory text is changed, a sponsor statement must justify the approach. The vaccine healthy-volunteer template remains recommended while it is under revision.

Belgium requires no-fault trial insurance. The Part II certificate must state the insured amount and refer to applicable national legislation. Site suitability must be signed by the head of the institution or a properly delegated person. The Belgian financing statement is mandatory for new initial applications, additions of Belgium and substantial modifications adding sites submitted after 1 January 2025. The Belgium Part II checklist maps these requirements.

For paediatric trials, Belgium does not use a single statutory assent age. The child's understanding is assessed case by case. The current national advice recommends two parent signature lines and active documentation of the minor's assent or dissent. The Belgium minor consent and assent guide explains the exceptions.