Belgium CTIS Part II Document Checklist

Core recruitment and consent documents

Recruitment and informed consent procedure

Mandatory. Submit the European Commission's combined informed-consent and patient-recruitment procedure template for every new initial application or addition of Belgium submitted after 1 January 2025. It belongs under Annex I K.59 and L.62 in Part II. Describe how potential participants are identified, approached, informed, given time to decide and consented. Include every special pathway, such as minors, legal representatives, emergencies, witnesses or electronic consent. The procedure is an application document, not a participant-signed form.

Advertising and recruitment material

Conditional. Submit every advertisement or recruitment item that will be used. Upload it under K.60 in Part II in at least the official language or languages of the region where it will be used. The submitted version should show the final wording and presentation. Material must not be promotional or exert undue influence. If no advertising or recruitment material will be used, no item is required under this heading.

Patient Information Sheet and Informed Consent Form

Mandatory. Submit each blank Patient Information Sheet and Informed Consent Form, including the main adult form and every applicable population or use-case variation, under L.61 and L.63. Provide at least the official language or languages of each trial region. Participants, legal representatives and the person conducting the consent interview sign and date the approved form later, when consent is obtained, not at CTIS submission.

For new initial interventional medicinal-product trials submitted from 1 August 2025, use the current CT-College template for adult patients or adult healthy volunteers. Preserve the standard text and translate only study-specific content. If the required template is not used or mandatory wording is adapted, include the sponsor statement from the template package with a justification. The vaccine healthy-volunteer template is currently recommended rather than mandatory because it is under revision. The Belgium patient information and consent guide explains the main form, and the Belgium healthy-volunteer guide covers the healthy-volunteer variation.

Special-population consent documents

Conditional. Add separate or adapted information and consent documents whenever the trial includes a population that cannot use the standard adult-patient form without modification. This may include minors, adults lacking capacity, emergency enrolment, a participant who cannot write, pregnancy follow-up or optional future use. Language follows the same regional rule as the main ICF. The Belgium minor consent guide, limited-capacity guide and emergency-enrolment guide explain the principal pathways.

Other patient-facing documents

Conditional. Submit Part II materials that may influence a person's decision to participate but are not recruitment advertisements or the main information sheet. Endpoint-related instruments belong with the protocol in Part I. Under the 2026 FAMHP list, multinational trials submit only the English endpoint-related version in Part I. Other participant-facing documents are placed in Part II when ethics review is needed.

BAREC lists examples that do not normally need ethics review, including patient identification cards, basic device instructions, dosing diaries, welcome letters, thank-you cards, travel policies and payment-portal instructions. The sponsor remains responsible for deciding whether a specific item influences participation. Incentives and compensation must still be disclosed.

Investigator and site documents

Principal investigator CV and declaration of interest

Mandatory. Provide a CV and declaration of interest for the principal investigator at each Belgian site under M.65 and M.66. The Belgian CV template is strongly recommended. Another format may be accepted if it contains the same information. Use the Belgian addendum when required information is missing from the CV. Document Good Clinical Practice training in the CV or a certificate, name the training organisation and ensure it is no more than three years old at the initial submission or appointment of a new principal investigator.

FAMHP prefers unsigned CVs to limit personal data in CTIS. Use the European Commission declaration-of-interest template. Do not upload a separate list of planned sites and participant numbers because the planned number for each site is entered in the site suitability statement.

Site suitability statement

Mandatory. Submit one statement for each site under N. Use the Belgian template or the EU template and include the site's facilities, equipment, staff and planned recruitment. For a hospital, use the three-digit Belgian hospital recognition number, not the CTIS organisation ID. If procedures occur at another facility, identify the facility and the planned agreement.

The statement must be signed at submission by the head of the institution or a person with delegated authority. The delegation should be covered by the institution's internal procedures. The sponsor normally prepares enough trial-specific information for that signatory to make a meaningful assessment.

Insurance and financial documents

Proof of insurance

Mandatory. Submit an insurance certificate under O. It must specify the insured amount and refer to applicable national legislation. Belgium imposes no-fault sponsor liability and requires insurance before the trial begins. FAMHP does not require the certificate to cite Article 12 of the Law of 7 May 2017 expressly, but the coverage must be suitable for the Belgian trial.

Statement on financing

Mandatory. Use the Belgian Statement on financing of a clinical trial for new initial applications, additions of Belgium and substantial modifications adding new sites submitted after 1 January 2025. Upload it under P.69. Complete the current national form rather than replacing it with a narrative.

Financial transactions, participant compensation and agreements

Conditional. Under P.70 and P.71, provide the applicable information on payments to participants and sites, investigator compensation and other agreements. A draft site-sponsor contract with draft amounts is accepted. The Belgian financing statement can also be used where it supplies the required information. Describe participant reimbursement or compensation with the EU template where applicable. Amounts and payment conditions must match the ICF. Contact Belgian clinical trial centres early because financial review can affect site readiness.

Privacy and biological-sample documents

GDPR statement

Conditional. If the ICF contains the required confirmation that collection and processing comply with the General Data Protection Regulation and national implementing law, Belgium does not currently require a separate Part II statement. If the ICF lacks it, upload a separate statement under R. Participant-facing privacy information must be available in the same regional languages as the ICF. The Belgium patient-facing QC checklist covers the content review.

Collection, storage and future use of human biological samples

Conditional. When the trial collects, stores or proposes future use of human biological material, submit the current EU template under S. The template is mandatory in Belgium for new initial applications and additions of Belgium submitted after 1 January 2025. Add the Belgian text required in section 5.1 and select the appropriate scope box.

The Belgian addition distinguishes research limited to the same disease, treatment or drug described in the protocol from research beyond that scope. Material used beyond the clinical-trial exemption falls under Belgian biobank legislation and must be registered in a Belgian biobank. Optional future use and sample anonymisation also need clear participant choices. The Belgium secondary-use consent guide explains the consent logic.

Items not required as separate Belgium documents

Do not add a separate planned-site list when the required information is in each site suitability statement. Do not add proof of fee payment at CTIS submission. Belgium invoices applicable safety follow-up and inspection fees separately. Avoid uploading patient cards and purely operational instructions solely because participants will see them, unless their content could affect the decision to participate or another rule makes ethics review necessary.

Final submission checks

• Confirm that every Belgian site has the correct regional participant-language set.
• Use the current CT-College ICF template and include the sponsor statement if required.
• Confirm that blank ICFs are unsigned and site suitability statements are signed by the correct institutional signatory.
• Match participant numbers, payments, procedures and sample plans across CTIS, the protocol, site statements and ICFs.
• Enter version numbers and dates in CTIS structured data. FAMHP recommends putting the Annex I letter and document language in the filename.
• Provide tracked-change versions with responses to requests for information and with substantial modifications.