Belgium assigns each trial to an ethics committee through an independent College and has the FAMHP and the committee assess it jointly. Capture is a self-serve EDC hosted in Frankfurt that Belgian sites can test free before go-live.
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Study region
Belgium
Key points for studies in Belgium
Regulation
A sponsor files one CTIS application. Belgium assesses its national items in a combined step: the FAMHP and the committee assigned by the College conclude jointly, and the Minister, acting through the FAMHP, takes the admission decision. For the EU procedure, read our EU CTIS submission guide and EU CTR clinical trial software.
What the dossier and the committee need from a data system is a clear description of what is collected and how it is protected. Capture produces a blank eCRF PDF with a cover page, form index, visit-by-form matrix and every approved form printed empty, which suits the protocol and ethics package. Every field change carries a timestamp, the user, the old and new value and the reason, and the trail cannot be edited through the interface. See audit trail software for clinical trials.
Belgian guidance describes extra requirements for committees that review phase I trials, including a healthy volunteer with prior phase I experience among their members. Belgium also keeps an older 2004 law for experiments on human beings that fall outside the medicinal products law; a 2018 presentation called it due for revision, so check its current status if your study is not a medicinal product trial.
Blank eCRF · no subject data
Visit by form matrix
| Form | SCR | D1 | W2 | W4 | W8 | EOS |
|---|---|---|---|---|---|---|
| Demographics | X | |||||
| Vital signs | X | X | X | X | X | X |
| Laboratory | X | X | X | |||
| ECG | X | X |
3. Was the ECG performed?
☐ Yes☐ No
If No, complete question 4.
Who does what
| Step | Who | What is needed | Where Capture helps |
|---|---|---|---|
| Dossier submission | Sponsor or legal representative in the EU | Protocol, IB or IMPD, consent, site and investigator details | Blank eCRF PDF of the approved forms. |
| Committee assignment | The College | Application routed to an accredited committee | Nothing to configure; plan the timeline around the assignment. |
| Joint assessment | FAMHP and the evaluating ethics committee | Design, safety, consent, site suitability | Edit checks documented; eConsent record with countersignature and signed PDF. |
| Site start-up | Hospital, principal investigator | Agreement, delegation, training | Site accounts, roles and site-level participant numbering. |
| Ongoing oversight | Sponsor monitors, inspectors | Source verification, safety reporting, audit trail | SDV per field, queries, field-level audit trail. |
Roles summarise secondary sources. Confirm national detail with the FAMHP and the College.
Build the visit schedule, forms and checks free, hand the blank eCRF PDF to your regulatory lead, and pay only when real participants enrol.
Data protection
Trial data is personal data under the GDPR, and health data is a special category. The Belgian Data Protection Authority supervises. Capture hosts in the EU (Frankfurt) and the USA (N. Virginia). For a Belgian-site study the Frankfurt region keeps storage inside the EU. Whether access from a third country by a CRO or monitor amounts to a transfer is a question for your data protection officer.
In Capture, site coordinators see participant names while researchers see coded IDs, and row-level security enforces that at the database. Data is encrypted with AES-256 at rest and TLS in transit. Read GDPR compliant clinical trial software and the GDPR DPIA template for clinical trials.
EU (Frankfurt)
Default for EU-sponsored studies
US (N. Virginia)
Default for US-sponsored studies
Consent
Belgium has three official languages and consent text is usually needed in the participant's language. Capture eConsent takes the participant on-screen signature, confirmed by a one-time email code, then the investigator countersigns with password re-authentication. Witness and legally authorised representative signatures are supported, and each signature is hashed to the exact document content. Language support is not claimed here, so confirm what is available before planning Dutch, French or German screens.
Meaning of signature
I have reviewed this adverse event and confirm the assessment of seriousness, severity and causality.
Signer
Dr. A. Ozola, PI
Password
••••••••••
Research landscape
Belgium is a compact, dense research country with university hospitals in Leuven, Ghent, Brussels, Antwerp and Liege, and it often appears in multinational programmes alongside its neighbours. Site-level participant numbering and by-site exports keep Belgian data separate for review and reconciliation.
For nearby markets see the Netherlands, France, Germany and Spain. For running sites across borders, read multi-site clinical trial management.
Before you start
Confirm which state is reporting member state and that Belgium is a concerned state in the dossier.
Ask the College how and when the committee will be assigned and what it needs for early-phase studies.
Approved consent text in each language you need, and how each version is delivered.
Processor agreement, records of processing, transfer analysis for any non-EU access.
If the study falls outside the 2017 law, check the 2004 law status with the FAMHP.
Audit trail description, role matrix and hosting region for your vendor assessment.
Medicinal product trials run under EU Regulation 536/2014 and the Belgian Law of 7 May 2017. The FAMHP is the national contact point and, with an ethics committee chosen by the College, assesses the trial. Confirm current procedures with them.
Sources say the College decides which committee advises on each trial. Ask the College how the assignment works for your study.
For medicinal product trials under the EU regulation, yes. A Belgian presentation says the regulation applied from 31 January 2022.
No. Capture is hosted in the EU (Frankfurt) and the USA (N. Virginia). For a Belgian study the Frankfurt region keeps data in the EU. Capture has no Belgian data centre or office.
No regulator approves EDC software in that way. Capture provides an audit trail, e-signatures and role-based access, and your validated use is what an inspector looks at.
This page does not claim multilingual participant materials. Contact us about current language support before you commit to local-language screens.
Yes. The free sandbox has every feature, with no credit card and no time limit. You pay only when you go live with real participants.
Keep exploring
Clinical trial software in the Netherlands
Northern neighbour.
Clinical trial software in France
Southern neighbour.
Clinical trial software in Germany
Eastern neighbour.
Clinical trial software in Spain
AEMPS and CEIm.
EU CTIS submission guide
How the EU portal works.
GDPR compliant clinical trial software
Processor and hosting questions.
Pricing
Free sandbox, pay at go-live.
Build, test and share the blank eCRF PDF before any fee. You pay only when real participants enrol.