Denmark, Sweden, Norway, Finland and Iceland share the EU trial regulation and the GDPR, yet each keeps its own agency and ethics route. Capture is a self-serve EDC hosted in Frankfurt that a Nordic team can build and test free.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Study region
Nordic countries
Key points for a multi-country Nordic study
Regulation
Medicinal product trials in the region are filed through CTIS. A reporting member state leads the shared scientific assessment, and each concerned country assesses its national and ethical items. For the EU procedure itself, read our EU CTIS submission guide and EU CTR clinical trial software. For the Nordic picture the practical point is that the dossier is common while consent wording, site suitability and ethics timing are national.
Capture supports the dossier from the data side. It produces a blank eCRF PDF with a cover page, form index, visit-by-form matrix and every approved form printed empty, and each field change is recorded with a timestamp, the user, the old and new value and the reason. The record cannot be changed through the interface. See audit trail software for clinical trials.
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.
Country map
| Country | Status in the EU trial system | Bodies to confirm | Where Capture helps |
|---|---|---|---|
| Denmark | EU member state | Danish Medicines Agency, national research ethics committee | Country guide linked above; site numbering and by-site exports. |
| Sweden | EU member state | Swedish Medical Products Agency, Swedish Ethical Review Authority | Country guide linked above; eConsent record for the ethics file. |
| Norway | EEA member, takes part through the EEA agreement | Norwegian Medical Products Agency, regional committees for medical and health research ethics | Blank eCRF PDF and audit trail for the national ethics part. |
| Finland | EU member state | Finnish Medicines Agency Fimea, national and regional medical research ethics bodies | Edit checks and queries documented in each form. |
| Iceland | EEA member; CTIS route live from 31 January 2022 per Icelandic sources | Icelandic Medicines Agency, National Bioethics Committee | Small-site numbering and one study record across countries. |
Agency and ethics body names are summarised from public sources and general knowledge. Confirm each with the national authority before filing.
Set up the visits, forms and checks in the free sandbox, share the blank eCRF PDF with each national ethics body, and pay only when real participants enrol.
Data protection
The GDPR applies in all five countries, in the EEA through incorporation, and each has its own supervisory authority and national health-data and biobank rules on top. Capture hosts in the EU (Frankfurt) and the USA (N. Virginia). For a Nordic study the Frankfurt region keeps storage inside the EU. Whether access by a CRO, monitor or analyst outside the EU and EEA counts as 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 EU-US data privacy framework note for what a processor agreement should cover.
EU (Frankfurt)
Default for EU-sponsored studies
US (N. Virginia)
Default for US-sponsored studies
Consent
Each country has its own approved consent text, so each carries its own version. 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 with us what is available before planning Danish, Swedish, Norwegian, Finnish or Icelandic 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
••••••••••
Set-up
The AI study builder drafts visits and forms. Your team reviews every one before it is saved.
Use site-level participant numbering so Danish, Swedish, Norwegian, Finnish and Icelandic data stay separable.
Edit checks raise auto-queries; site coordinators and researchers see different identity data.
Enter sample participants, test e-signatures and the audit trail, and send the blank eCRF PDF to each ethics body.
Activate sites as each national approval arrives. Filter and export by site at any time.
Before you start
Decide which state leads Part I and confirm Norway and Iceland participation mechanics.
Name the ethics body for each country and plan for the slowest, since one pending approval can stall the dossier.
Approved text per country, and a decision on how each is delivered to participants.
Processor agreement, records of processing, transfer analysis for any non-EU access.
Check national health-data and biobank rules with local counsel.
Audit trail description, role matrix and hosting region for your vendor assessment.
There is one CTIS application for a medicinal product trial, but each country assesses its national part and has its own ethics route. Plan separate timelines and confirm each with the national authority.
Both are in the EEA and take part in the EU system. Icelandic sources say the EEA-wide CTIS route went live on 31 January 2022. Confirm the mechanics for your study with the Norwegian and Icelandic agencies.
No. Capture is hosted in the EU (Frankfurt) and the USA (N. Virginia). Capture has no Nordic 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.
They are separate pages: clinical trial software for Denmark and for Sweden. This regional page links both and adds Norway, Finland and Iceland in the country table.
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 Denmark
Danish agency and ethics route.
Clinical trial software in Sweden
Swedish agency and ethics route.
Clinical trial software in the Baltics
The neighbouring region.
Clinical trial software in Poland
Southern Baltic Sea neighbour.
EU CTIS submission guide
How the EU portal works.
Multi-site clinical trial management
Running sites across borders.
Pricing
Free sandbox, pay at go-live.
Build, test and share the blank eCRF PDF with every national ethics body before any fee. You pay only when real participants enrol.