A Finnish medicinal product trial is assessed jointly by Fimea and the national medical research ethics committee Tukija, inside the EU Clinical Trials Regulation. Capture gives Finnish sponsors and hospital investigators an EU-hosted EDC, ePRO and eConsent with an audit trail they can show to either body.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Study region
Finland
Key points for studies in Finland
Regulation
Since the EU Clinical Trials Regulation became fully applicable, a medicinal product trial in Finland starts with a CTIS application. Fimea's guidance describes the split plainly: both Fimea and Tukija assess trials in CTIS and coordinate where needed, and Part II, which holds the national documents, is processed only by the authorities of the country concerned. In Finland those are Fimea and Tukija. A sponsor may submit Part I first and Part II afterwards, but Part II can only go in once the authorities have processed Part I, so most sponsors submit the full dossier together.
The Act on Clinical Trials (983/2021) assigns Fimea the assessment of the aspects in Article 6(1) of the Regulation, while the National Committee on Medical Research Ethics evaluates the aspects in point (b) of that article and issues its opinion. For a data manager the consequence is concrete: the consent form, participant information and recruitment materials are judged by an ethics body, so the system that collects consent must be able to deliver exactly the version that was approved, with proof of who saw which version.
Not every Finnish project is a CTR trial. Device investigations follow the EU Medical Device Regulation and their own national routes; see EU MDR clinical investigation guide and EDC for medical device clinical trials. Non-interventional and questionnaire studies in health care usually need an ethics statement from the relevant ethics committee under the Medical Research Act. Because the route turns on the design, confirm it with Tukija, the hospital district research office or local counsel before you build.
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 map from the question you will be asked to the body that decides it and the Capture feature that produces the evidence. The legal allocation is simplified; confirm details with Fimea, Tukija or local counsel.
| Question | Decided by | Evidence from Capture |
|---|---|---|
| Is the trial scientifically and safety-wise acceptable? | Fimea, with the other member states concerned for Part I | Blank eCRF PDF of every approved form, visit-by-form matrix |
| Are consent, recruitment and investigator suitability acceptable? | Fimea and Tukija for Finnish Part II | Consent template with versions, signed consent PDF export |
| May this research use the participant's health data? | You as controller under GDPR and the Data Protection Act | Pseudonymised sponsor views, role-based access, EU hosting |
| May trial data be linked to national registers? | Findata permit for secondary use of social and health data | Filtered exports by site and date, data dictionary |
| Were data entered and changed by the right people? | Inspectors, monitors | Field-level audit trail with reason for change |
| Were serious events handled on time? | Sponsor, with Fimea oversight | Adverse event and SAE forms with timestamps and sign-off |
Data protection
Health data is special-category data under GDPR Article 9. Finland's Data Protection Act (1050/2018) provides the national supplement, including conditions for processing in scientific research, and the Data Protection Ombudsman supervises. A university or hospital sponsor typically documents its lawful basis, a data protection impact assessment and the retention period in the protocol and the privacy notice. Wording differs between sponsors; the point for the data system is that the notice and the technical measures must match what you actually do.
Finland also has an unusual national structure for reusing health data. The Act on the Secondary Use of Health and Social Data (552/2019) created Findata, which grants permits and provides pseudonymised data to a secure remote environment for research, statistics and similar purposes. Findata's own materials describe an opt-out principle for register-based research. That does not transfer to a prospective trial, where participants consent, but it is the route a Finnish team will use if it wants to link its trial cohort to registry follow-up. Plan that linkage in the protocol, with a coded participant ID you can supply to the permitted party, and see clinical trial data ownership and portability.
Capture stores EU studies in Frankfurt with AES-256 encryption at rest and TLS in transit. Site coordinators see participant names, while researchers and sponsors work with coded IDs, enforced by row-level security at the database layer. Exports are CSV or Excel with an automatic data dictionary, and CDISC SDTM datasets as SAS XPT files with Define-XML; see CDISC SDTM export. The wider GDPR picture is in GDPR compliant clinical trial software.
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.
Finnish research setting
Much Finnish clinical research runs through the university hospital districts and the medical faculties around them, alongside industry-sponsored multinational studies. For academic sponsors the practical issue is cost and speed: no setup fee, no per-site fee, a sandbox in which the whole study is built and tested before any contract, and payment only when real participants are enrolled.
Sites
3 of 4 ready
Forms approved
11 / 11
Draft the forms from your protocol, test the checks, sign a test consent and export the blank eCRF for your ethics file. Free, with every feature.
Multinational trials
Finnish sites regularly join studies run across the Nordic countries, where populations are small and registries are strong. Under the Regulation that is one CTIS application with each member state concerned assessing its national Part II. The data system should therefore be one database for the whole trial, one set of forms and checks, and country-specific differences handled in configuration, such as a Finnish consent version attached to Finnish sites. Neighbouring guides cover Sweden, Denmark and Norway, and the EU-wide submission process is in the EU CTIS submission guide.
Language is the one point to settle early. Participant-facing consent and questionnaires need approved Finnish (and for some sites Swedish) versions, and validated instruments should use the developers' official translations. Capture does not claim multilingual support, so tell us which languages your forms need before the build and we can say what is practical.
Getting started
Upload the protocol or describe the forms. Review every AI-drafted visit and form, then approve the forms you want live.
Generate the PDF with cover page, form index and visit-by-form matrix for the ethics and authority file.
Load the consent version in the dossier so the electronic version matches the approved text.
Decide any registry linkage, exports and onward sharing before enrolment, and record them in the data management plan.
Give each hospital its own site, add the team and record training before the first participant.
Move to a paid plan only when you enrol real participants. Sandbox work carries over.
Before you start
Part I and the Finnish Part II documents, submitted to Fimea and Tukija through CTIS.
The electronic consent matches the approved text and version.
Under GDPR and the Data Protection Act, consistent with the privacy notice.
Any Findata permit route identified and the coded ID plan written down.
Roles, signatures and audit export tested in the sandbox.
Who enters and signs adverse events; see SAE reporting timelines.
Fimea, the Finnish Medicines Agency, together with Tukija, the National Committee on Medical Research Ethics, assess trials under the EU Clinical Trials Regulation and the Finnish Act on Clinical Trials (983/2021). Confirm current procedure on the Fimea site.
Medicinal product trials fall under it and are submitted through CTIS. Device investigations and non-interventional studies follow other routes, so confirm the right one with Tukija or local counsel.
The Finnish Social and Health Data Permit Authority, which grants permits for secondary use of health and social data under Act 552/2019. It is relevant if you plan registry linkage, not for ordinary trial data capture.
In the EU (Frankfurt), chosen at study setup. Capture does not host inside Finland, so check whether your institution requires in-country storage.
No. Support is by email, typically answered within 24 hours, and enterprise plans add training and implementation assistance.
Yes. One study can hold sites in several countries with site-level access and by-site exports, and a consent version can be attached per site.
Yes. It supports Phase 1, 2 and 3, with an audit trail, e-signatures, edit checks, 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 with real participants.
Keep exploring
EDC, ePRO and eConsent with an audit trail. Free sandbox, no credit card.