Norway is in the EEA but not the EU, and its trial approvals are decided jointly by the Norwegian Medical Products Agency and the ethics committee REK KULMU. Capture gives Norwegian investigators and sponsors an EU-hosted EDC, ePRO and eConsent with a field-level audit trail.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Study region
Norway
Key points for studies in Norway
Regulation
DMP's guidance for sponsors is direct: clinical trials of medicines must be approved by the agency and by the ethics committee REK KULMU, who coordinate a single decision for Norway, and the application is made through the common European portal, CTIS. CTIS then carries the trial through its whole life, including substantial modifications and notifications. Trials that began under the older Directive framework had to move to the new system, and the regulator's pages explain the transition.
The EEA position is what makes Norway different from, say, Denmark or Sweden. Because Norway is part of the single market through the EEA Agreement rather than the EU, EU rules reach it by incorporation, and Norwegian law implements the Regulation's detail through the Medicinal Products Regulation. For a sponsor this rarely changes the dossier, but it does mean that the authoritative statement of national procedure is the DMP and Lovdata text, not an EU member-state guide. Confirm with DMP or local counsel before relying on any summary, including this one.
Health research that is not a CTR trial, such as a questionnaire study, a biobank project or a device study, follows the Health Research Act and needs prior approval from the relevant regional REK committee before recruitment starts. Institutions such as Oslo University Hospital add that the project must also have a documented legal basis for processing and cannot begin until approvals and that basis are in place. Device investigations in the EEA follow the EU Medical Device Regulation; see EU MDR clinical investigation guide.
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.
At a glance
A simplified comparison of the usual routes. Treat it as a starting question list, not legal advice.
| Study type | Typical route | What your data system should produce |
|---|---|---|
| Drug trial, Phase 1 to 3 | CTIS application, joint DMP and REK KULMU decision | Blank eCRF PDF, consent versions, audit trail export |
| Investigator-initiated drug trial | Same CTIS route, often with a non-commercial sponsor | Low-cost build, site-level access, exportable records |
| Medical device investigation | EU MDR route plus ethics review | Device accountability and adverse event forms |
| Questionnaire or registry-linked health study | Regional REK approval under the Health Research Act | Consent record, pseudonymised exports |
| ePRO or wearable add-on to a trial | Part of the trial's approved protocol and consent | Participant diary schedule, sync status, audit trail |
| Non-health personal data project | Notification and assessment of data processing through the institution | Documented lawful basis and retention |
Data protection
GDPR applies in Norway through the Personal Data Act, and the national supervisory authority is Datatilsynet. Health data is a special category, so a Norwegian project needs two things in place at once: ethics approval and a documented legal basis for processing under GDPR Articles 6 and 9. University hospitals and research institutions generally have a data protection officer and a process for this; involve them before you finalise the data management plan, not at database lock.
Because Norway is in the EEA, a Frankfurt-hosted study keeps data inside the EU/EEA. That simplifies the transfer analysis for core study data, although it does not remove the need to document processors, roles and retention. If you want to share data with a collaborator outside the EEA, or to use a US region, you need a separate transfer assessment; see EU-US data privacy framework for clinical research and GDPR compliant clinical trial software.
In Capture, site coordinators see participant names while researchers and sponsors see coded IDs, enforced by row-level security at the database layer. Combined with AES-256 encryption at rest and TLS in transit, that gives a documented technical measure to cite in the data protection assessment. Retention and archiving are covered in clinical trial data archiving and retention.
Site coordinator
Jane Peterson
DOB: 04-Mar-1978
Subject 01-004
Sees direct identifiersResearcher
Subject 01-004
DOB: withheld
Coded ID only
Sees coded ID onlySame record, two roles. Row-level security enforces the split.
Consent
Norwegian ethics approval covers a specific consent text. Capture's eConsent records the participant's on-screen signature, verified by a one-time email code, then the investigator's countersignature with password re-authentication. Each signature is hashed to the exact document content at signing, and the signed consent exports as a PDF with embedded signature data, timestamps and audit trail.
Meaning of signature
I have reviewed this adverse event and confirm the assessment of seriousness, severity and causality.
Signer
Dr. A. Ozola, PI
Password
••••••••••
Build the forms, export the blank eCRF for your REK submission and sign a test consent. Free, no credit card.
Research setting
Norwegian clinical research is concentrated in the regional health authorities and their university hospitals, with university faculties and research institutes alongside. Many studies are investigator-initiated, funded by grants, and sit in Nordic or European consortia. For those teams the usual pain is not the regulation but the toolchain: spreadsheets and email for data capture, then a scramble at inspection time. A single system with an audit trail, edit checks and queries replaces that.
For a Norwegian site in a multinational trial, the sponsor runs one CTIS application and Norway issues its own national decision. Keep one database for the whole study, one set of forms and checks, and handle country differences in configuration. Neighbouring guides cover Sweden, Denmark and Finland. Safety reporting follows the trial's approved procedure; see SAE reporting timelines.
Consent and questionnaires for Norwegian participants will need approved Norwegian text. Capture does not claim multilingual support, so tell us your language needs before you build and we can say what is practical. Validated instruments should use the developer's official translation.
Before you start
CTIS for medicinal product trials; REK under the Health Research Act for other health research.
GDPR Articles 6 and 9 recorded alongside ethics approval, with the data protection officer involved.
Electronic consent version identical to the approved document.
PDF with form index and visit matrix for the submission.
Site, researcher and admin roles checked in the sandbox.
Retention period and export format agreed before the first visit.
The Norwegian Medical Products Agency (DMP) and the ethics committee REK KULMU coordinate a joint decision, with the application made through CTIS. Confirm current procedure on dmp.no.
DMP states that trials in the EU and EEA area are applied for through CTIS, and Norway applies the Regulation through the EEA Agreement and national implementing rules. Check DMP's legislation page or local counsel for exact detail.
The Regional Committees for Medical and Health Research Ethics, which approve medical and health research under the Health Research Act. REK KULMU handles medicinal product trials alongside DMP.
Capture hosts in the EU (Frankfurt) or the USA. Frankfurt is inside the EU/EEA, but it is not inside Norway, so check whether your institution requires in-country storage.
No. Support is by email, typically answered within 24 hours. Capture does not claim multilingual support, so discuss your language needs before building.
Yes. One study can hold sites in several countries with site-level access, by-site exports and per-site consent versions.
Yes. Capture suits Phase 1, 2 and 3 with audit trail, e-signatures, queries and role-based access.
Yes. The free sandbox has every feature with no credit card and no time limit. You pay only when you go live.
Keep exploring
EU CTR clinical trial software
The regulation in detail.
GDPR compliant trial software
Data protection in depth.
Clinical trial software in Sweden
A Nordic neighbour.
Clinical trial software in Denmark
Another Nordic guide.
Clinical trial software in Finland
Fimea and Tukija.
What is an IRB or ethics committee?
Ethics review explained.
EU-hosted EDC, ePRO and eConsent. Free sandbox, no credit card.