Danish trials run through CTIS with a joint review by the Danish Medicines Agency and the ethics committees, and research data is handled under the Data Protection Act as well as GDPR. Capture gives Danish sponsors and investigators an EU-hosted EDC, eCRF and eConsent they can build and test free first.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Study region
Denmark
Key points for studies in Denmark
Regulation
Since the EU Clinical Trials Regulation became fully applicable, every medicinal product trial in Denmark is submitted through CTIS. The Danish Medicines Agency has a dedicated clinical trials unit that coordinates the joint assessment of Part I, which covers the scientific and safety content of the dossier. Part II, the national aspects such as informed consent, participant information, recruitment and investigator and site suitability, is assessed by the ethics committees. Ethics review is centralised through the Danish National Center for Ethics, so a sponsor deals with one national process rather than a committee per hospital.
The practical consequence is that the Part II documents are not an afterthought. The consent form, the participant information and the recruitment materials are judged by the ethics committees, and your data system has to be able to deliver exactly the version that was approved. For trials in multiple countries, Denmark is simply one member state concerned in the same CTIS application; the other countries run their own national Part II.
Not every Danish research project is a medicinal product trial. Health science research projects without a CTR scope, such as questionnaire studies, registry work and device studies, go through the research ethics system for health science projects, and some are notified rather than approved. Because the exact route depends on the design and on whether biological material or interventions are involved, confirm it with the National Center for Ethics or your regional committee early. 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
Health data is a special category under GDPR Article 9. In Denmark, section 10 of the Data Protection Act allows processing of special-category data when it is done solely for statistical or scientific studies of substantial societal importance and is necessary for them. Two consequences follow for how you design a data system. First, data processed on this basis may later be used only for scientific or statistical purposes, so clinic administration, teaching or quality-assurance reuse of identifiable data needs another legal basis. Second, section 10(3) requires prior permission from the Danish Data Protection Agency (Datatilsynet) for certain onward disclosures, including transfers outside the GDPR area and disclosures made for publication in a recognised journal.
This is why export planning belongs in the data management plan, not at database lock. Decide which pseudonymised datasets leave the study, to whom, and whether any recipient sits outside the EU, before the first participant is enrolled. Capture exports CSV and Excel files with an automatic data dictionary, filtered by site or date range, and CDISC SDTM datasets as SAS XPT files with Define-XML; see CDISC SDTM export. What you send, and under which permission, remains your decision as controller.
Capture hosts study data in the EU (Frankfurt) with AES-256 encryption at rest and TLS in transit, and offers a US region that you would not select for a Danish study. Role-based access separates identities from clinical data: site coordinators see participant names while researchers and sponsors work with coded IDs, enforced by row-level security in the database. For the wider picture, see 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.
At a glance
A quick map from the question you will be asked to the body that decides it and the Capture feature that supplies the evidence.
| Question | Decided by | Evidence from Capture |
|---|---|---|
| Is the trial scientifically and safety-wise acceptable (Part I)? | Danish Medicines Agency, jointly with other member states concerned | Blank eCRF PDF of every approved form, visit-by-form matrix |
| Is consent, recruitment and site suitability acceptable (Part II)? | Medical Research Ethics Committees via the National Center for Ethics | Consent template with version history, signed consent PDF export |
| Is health data processed lawfully for research? | You as controller, supervised by Datatilsynet | EU hosting, pseudonymised sponsor views, exportable audit trail |
| May data be disclosed outside the study? | Datatilsynet permission where section 10(3) applies | Filtered exports by site and date, data dictionary |
| Was the data entered, changed and signed by the right people? | Inspectors, monitors | Field-level audit trail with reason for change, role-based access |
This table summarises general practice, not legal advice. Confirm the route for your design with the Danish Medicines Agency and the National Center for Ethics.
Consent
Because Part II is judged on the consent materials, the record of what each participant actually saw and signed matters. Capture eConsent captures the participant's on-screen signature verified with 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 signature data, timestamps and audit trail. Participant-facing text is whatever your approved Danish materials say; plan for approved Danish wording from the start, and talk to us about how your study will handle any additional languages.
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 study, sign a test consent and export the data in the free sandbox. No credit card, every feature.
Danish research
Denmark combines university hospitals, strong life-science clusters around Copenhagen and the Øresund region, a large pharmaceutical sector and unusually complete health registries. That produces two very different kinds of sponsor: industry-backed teams who need to coordinate several countries, and academic or investigator-initiated teams who carry full sponsor obligations on a grant. Capture is built for both: there is no setup fee and no per-site fee, a full sandbox lets you build and test before any contract, and you pay only once real participants are enrolled. See EDC for investigator-initiated trials.
Many Danish teams also work across the border. A trial that includes Danish and Swedish sites is one CTIS application with separate national assessments of Part II, and a single study database keeps the forms and edit checks identical at every site while site-level access keeps each country's data separable. The neighbouring perspective is in clinical trial software in Sweden.
Sponsors are expected to show that the system fits its purpose. The sandbox has the same features as a live study, so you can run user acceptance testing against your own forms and edit checks; see EDC UAT and sandbox environment and computer system validation for clinical trial software.
Before you start
Part I for the Agency, Part II for the ethics committees, with the consent form and participant information in Danish.
Ask the National Center for Ethics or your regional committee whether approval or only notification is needed.
GDPR plus Data Protection Act section 10 where it applies, with hosting and pseudonymisation described.
Which datasets leave the study, to whom, and whether Datatilsynet permission is needed.
The exact approved wording is what participants sign.
Site coordinator, researcher and admin roles assigned, with training recorded.
The Danish Medicines Agency (Lægemiddelstyrelsen) is the competent authority for medicinal product trials, which are applied for in CTIS. The Medical Research Ethics Committees, coordinated through the Danish National Center for Ethics, assess the ethical and national aspects. Both approvals are needed before a trial starts.
GDPR and the Danish Data Protection Act, including section 10 on special-category data processed for scientific research of substantial societal importance. Datatilsynet is the supervisory authority, and some disclosures need its prior permission.
No. Capture hosts in the EU (Frankfurt) and the USA (N. Virginia). Danish studies normally choose Frankfurt at study setup. If your institution requires storage inside Denmark, check that requirement before you start.
Yes. One study can hold sites in several countries, with site-level access, site-level participant numbering and exports filtered by site.
It exports a blank eCRF PDF with a cover page, form index, visit-by-form matrix and every approved form printed empty, and consent documents export as signed PDFs. The submission itself is made by you in CTIS.
Yes. There are no setup or per-site fees, the sandbox is free with every feature, and you pay only when the study goes live.
Yes. The free sandbox has every feature with no credit card and no time limit.
EU-hosted EDC, eCRF and eConsent for Danish studies. Free sandbox, no credit card.