Dutch research runs on the WMO, accredited METCs, the CCMO and, for drug trials, CTIS. Capture is a self-serve EDC hosted in Frankfurt with eConsent, ePRO and randomization in one system, free to build and test.
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Study region
The Netherlands
Key points for studies in the Netherlands
Regulation
The Dutch system is decentral. A sponsor or investigator submits to an accredited METC, usually the one linked to the hospital or university running the study, or to the CCMO for certain categories such as some higher-risk or novel interventions. The CCMO's English pages describe the primary submission routes. For drug trials in the EU process, the CCMO acts for the validation step, and ethics assessment of Part II is organised nationally.
Whichever committee reviews your study, it will read the protocol, participant information, consent and a description of data handling. Capture produces a blank eCRF PDF (cover page, form index, visit-by-form matrix and every approved form printed empty), which is useful as a protocol appendix. Consent is handled in eConsent with countersignature and a signed PDF. Read how to get IRB approval for a general view of what ethics bodies ask for, and EU CTIS submission guide for the portal.
The WMO has been evaluated by the government in recent years, covering EU law effects, participant protection and how the CCMO and METCs function. Because policy is moving, confirm current rules on ccmo.nl before relying on any summary, including this one.
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.
Route finder
| Study type | Route | Reviewer | What Capture covers |
|---|---|---|---|
| Medicinal product trial | CTIS under the CTR (and the WMO) | CCMO validation; national ethics assessment | eCRF, audit trail, safety forms, SDTM export. |
| Other WMO-subject research | Submission to an accredited METC | METC, or CCMO for some categories | Forms, ePRO, eConsent, randomization. |
| Medical device study | MDR rules plus WMO where applicable | METC / competent authority | Device-related eCRFs and AE forms. |
| Non-WMO research | Non-WMO review committee or institutional route | Local committee | Questionnaires and registries. |
Routes are a sketch from CCMO pages and legal guides. Ask the CCMO or your METC office to classify your study.
Draft forms from your protocol, test edit checks and e-signatures, and pay only when you go live.
Choosing a system
The Dutch market has home-grown research software, including Castor, which our comparison page describes as founded in the Netherlands, in our Castor comparison. Many teams will already know it, and the right choice depends on your study. What Capture offers is a self-serve, all-in-one platform: eCRF builder and EDC, ePRO, eConsent, randomization, an AI study builder and safety reporting in one system with one audit trail, a free sandbox with every feature, and payment only at go-live. We make no claims here about any other vendor's features or pricing.
If you are weighing options, read Castor EDC alternatives, the Castor vs REDCap comparison or, for existing users, how to migrate from Castor. The most reliable test is to rebuild one of your current forms in the sandbox and see how it feels.
Data protection
Health data is a special category, and the Dutch Data Protection Authority (Autoriteit Persoonsgegevens) supervises. Dutch universities and UMCs generally require a processor agreement and a data protection impact assessment for a new system, plus a data management plan. Capture hosts in Frankfurt, which keeps data inside the EU. Access from outside the EU, for example by a non-EU CRO, needs its own analysis.
In Capture, site coordinators see participant names while researchers see coded IDs, enforced by row-level security. AES-256 encrypts data at rest and TLS in transit. See GDPR compliant clinical trial software for what a processor agreement should cover.
EU (Frankfurt)
Default for EU-sponsored studies
US (N. Virginia)
Default for US-sponsored studies
Participant reporting
Many Dutch academic studies mix site visits with participant-reported outcomes. Capture runs ePRO diaries and questionnaires with reminders and a compliance view, and links participant, consent and eCRF data under the same participant ID. Questionnaire licences stay with your study documents, and Capture does not supply licensed instruments. Dutch-language screens are not claimed on this page, so ask about current language support before you plan around them.
At-risk participants
Research landscape
The Netherlands has eight university medical centres, strong investigator-initiated networks and a dense hospital landscape. A typical Dutch team is an academic group running a pragmatic or multicentre trial with limited budget, which is where EDC for academic clinical trials and EDC for investigator-initiated trials apply.
For nearby markets see Germany, Denmark and the UK. For a very different regulatory culture, compare Israel.
Accredited METCs review most research under the WMO, designated and overseen by the CCMO, which also handles certain categories directly. Drug trials under the EU regulation go through CTIS. Confirm your route with ccmo.nl.
For medicinal product trials under the EU regulation, sources say primary submissions must be made in CTIS from 31 January 2023. Other study types follow other routes.
No. Capture is hosted in the EU (Frankfurt) and the USA (N. Virginia). Frankfurt keeps data in the EU. There is no Dutch data centre.
No. Capture is self-serve with no office, partner or CRO in the Netherlands.
This page makes no claims about Castor's features or pricing. See our Castor comparison page, and test Capture on one of your forms in the free sandbox.
No. Committees review studies, not EDC software. Capture provides an audit trail, e-signatures and access controls, and your validated use is assessed.
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.
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Free sandbox with every feature. No credit card, no time limit, pay only at go-live.