In Sweden the Medical Products Agency and the Ethical Review Authority assess a CTIS application in parallel, Part II must be in Swedish, and biobank samples add a further opinion. Capture gives Swedish teams EU-hosted, auditable data capture and consent that they can test free first.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Study region
Sweden
Key points for studies in Sweden
Regulation
Since 31 January 2023 all new trials of medicinal products in Sweden are registered and authorised through CTIS. Once the application is submitted, Läkemedelsverket and Etikprövningsmyndigheten work in parallel, and either can send a request for information that the sponsor answers in the portal. For a trial with sites in several countries, Sweden is a member state concerned in the shared application and issues its own national decision on Part II.
Two Swedish particulars shape the data work. The first is language: Part II covers national items such as the site, recruitment arrangements, the informed consent form and the suitability of the investigator, and it should be in Swedish. The second is biobanking. If your study collects human biological material and the Biobank Act applies, the regional biobank centre gives an opinion to the Ethical Review Authority on consent and subject information and to the Agency on other issues, and the Agency then records a national decision in CTIS. Your consent template and your specimen records both need to match what was approved.
Many Swedish clinical studies are not CTR trials: observational studies, questionnaire studies, quality registries and device studies. They still fall under the Ethical Review Act when they involve people, sensitive personal data or biological material, and need approval from the Ethical Review Authority before the first participant is recruited. Registration in a recognised registry is expected for clinical studies. Medical device investigations follow the EU Medical Device Regulation; see EDC for medical device 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.
Data protection
Sweden has a population-wide personal identity number (personnummer) that is used throughout healthcare, which makes it tempting to type it into a research database. As a design practice, give each participant a coded study ID instead and keep identifying details in the access-restricted site view. In Capture, site coordinators see participant names while researchers and sponsors see coded IDs, enforced by row-level security at the database layer, and study data is hosted in the EU (Frankfurt) with AES-256 encryption at rest and TLS in transit. Which identifiers you collect at all is a decision for your data protection impact assessment, not a platform default.
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 and language
Capture eConsent records the participant's on-screen signature, verified with a one-time email code, followed by the investigator's countersignature with password re-authentication; the signature is hashed to the exact document content, and the signed PDF includes signature data, timestamps and audit trail. That gives you a traceable record of which version each participant saw. See eConsent software for clinical trials.
Two honest limits apply. Capture does not use BankID or any national electronic identity to sign; verification is the email code plus the countersignature. And participant-facing text is whatever your approved materials say: the Swedish consent and questionnaires must be translated and approved by you and the ethics authority, and validated instruments should use their developers' official translations. If you plan a study with more than one participant language, talk to us before you design the forms.
Meaning of signature
I have reviewed this adverse event and confirm the assessment of seriousness, severity and causality.
Signer
Dr. A. Ozola, PI
Password
••••••••••
Draft forms from your protocol with the AI study builder, review every field, then test consent and data entry.
Which route
| Study type | Regulatory route | Data system focus |
|---|---|---|
| Medicinal product trial | CTIS; Läkemedelsverket and Etikprövningsmyndigheten in parallel; Part II in Swedish | Approved forms locked, audit trail, signed consent, SDTM export for submission |
| Trial with biobank samples | As above plus a regional biobank centre opinion under the Biobank Act | Consent template matches the approved sample consent, specimen forms |
| Non-interventional clinical study | Ethical approval before recruitment; registry registration | Lean eCRFs, coded IDs, ePRO diaries |
| Device clinical investigation | EU MDR route and ethics review | Device and incident forms, safety reporting |
Summary of general practice. Confirm the route for your study with the agencies; the web pages used for this guide were last checked on 2026-10-10.
Swedish research
Swedish healthcare is organised by regions, with university hospitals tied to several medical universities, a strong tradition of academic clinical research and a well-developed life-science sector. Much of the clinical research is investigator-initiated, run by clinical departments with grant funding, where the sponsor obligations are the same as for industry but the budget is not. With no setup fee, no per-site fee and payment only at go-live, Capture suits that profile. See clinical trial software for European universities.
Swedish teams also run joint studies with Denmark, Finland and Norway. In an EU trial, each EU member state is assessed nationally for Part II, while the study database stays one: the same forms, edit checks and auto-queries at every site, with site-level filtering for national reporting. For the Danish perspective, read clinical trial software in Denmark. Before go-live, use the sandbox for acceptance testing; see EDC UAT and sandbox environment.
Before you start
Consent form, participant information and recruitment materials in Swedish.
If samples are stored or used, confirm whether the Biobank Act applies and plan the regional biobank centre opinion.
Coded study IDs in the database; decide in the DPIA which identifiers are collected at all.
Obtained before the first participant is recruited.
CTIS for trials; a recognised registry for other clinical studies.
UAT results, training records and role assignments in the trial master file.
The Medical Products Agency (Läkemedelsverket) and the Swedish Ethical Review Authority (Etikprövningsmyndigheten) review a CTIS application in parallel. Decisions are delivered through CTIS.
Part II documents, which include the informed consent form, should be written in Swedish. Capture shows the text you provide; it does not translate for you.
If the Biobank Act (2023:38) applies, a regional biobank centre also gives an opinion on consent and subject information and on other issues, and the Agency records a national decision in CTIS.
No. Capture verifies the participant's signature with a one-time email code and the investigator countersigns with password re-authentication. It has no BankID or national eID integration.
In the EU (Frankfurt), chosen at study setup. Capture does not host inside Sweden.
Generally yes: studies involving people, sensitive personal data or biological material need ethical approval before recruiting. Confirm your design with the Ethical Review Authority.
Yes. The free sandbox has every feature with no credit card and no time limit.
EU-hosted EDC, eCRF and eConsent for Swedish studies. Free sandbox, no credit card.