Lithuanian trials are authorised in parallel by the State Medicines Control Agency and the Bioethics Committee, with Part II documents in Lithuanian and regional committees for other biomedical research. Capture gives Lithuanian teams EU-hosted data capture and consent, free to try.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Study region
Lithuania
Key points for studies in Lithuania
Regulation
Lithuania applies the EU Clinical Trials Regulation, so a sponsor submits one application in CTIS and does not file separately with local bodies. Under the national Law on Ethics of Biomedical Research the scientific assessment and authorisation sit with VVKT under the Ministry of Health, while the Lithuanian Bioethics Committee provides the ethics conclusion. Both work in parallel, and the authorisation depends on the Agency's assessment and on the ethics opinion. Older sources describe a legal maximum of about 60 days, with approvals commonly taking several weeks in practice; check the agencies' current timelines before you plan site activation.
The language requirement is the practical hurdle. Part II covers the national side of the dossier: the participant information, consent form, recruitment arrangements and site and investigator suitability, and in Lithuania those documents are submitted in Lithuanian. Budget time for translation and for back-translation checks of anything participant-facing, and make sure the version in your data system is the version approved.
Biomedical research outside the CTR, such as observational studies and device studies, is reviewed by regional biomedical research ethics committees, with the competent committee determined by where the study takes place. Confirm the route with the Bioethics Committee. 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.
Consent and language
Capture eConsent records 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 PDF exports with signature data, timestamps and audit trail. What participants read is the text you provide: have the Lithuanian version approved first, then load it. Some sites also serve Russian- or Polish-speaking participants; if your study needs several participant languages, talk to us before designing the forms rather than assuming support.
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, add edit checks, and test consent and data entry before anything goes live.
Data protection
Personal data in Lithuanian trials falls under GDPR, applied with the national Law on Legal Protection of Personal Data, and the State Data Protection Inspectorate supervises it. Health information of research participants is also governed by the Law on Ethics of Biomedical Research, so your data protection impact assessment should cover both. Detailed national rules on research exemptions were not confirmed for this guide, so take advice from your data protection officer rather than relying on a general guide.
On the technical side, Capture hosts study data in the EU (Frankfurt) with AES-256 encryption at rest and TLS in transit, separates identities from coded data by role, and keeps an append-only, hash-chained audit trail with timestamp, user, old value, new value and reason for change. See GDPR compliant clinical trial software and, for how a validated use of the system is documented, computer system validation.
EU (Frankfurt)
Default for EU-sponsored studies
US (N. Virginia)
Default for US-sponsored studies
Lithuanian research
Lithuania's clinical research is concentrated around the university hospitals in Vilnius and Kaunas, and the country is regularly included in multinational trials for its recruitment potential and experienced investigators. Sponsors usually plan it with Latvia and Estonia: one CTIS application, national assessments, sites activated in parallel and one study database with site-level access, so each hospital sees only its own participants and the sponsor sees all countries on one dashboard. The regional overview is in clinical trial software for the Baltics; the neighbours are Latvia and Estonia.
Academic and investigator-initiated teams carry the full sponsor load on a grant. Capture has no setup fee and no per-site fee, a free sandbox with every feature, and charges only when the study goes live, and the AI study builder drafts visits and forms from an uploaded protocol for review. See EDC for investigator-initiated trials.
Before you start
One submission for VVKT and the Bioethics Committee, with Part II in Lithuanian.
Confirm the competent regional biomedical research ethics committee.
Consent, participant information and participant-facing questionnaires, with official translations of validated instruments.
Covering GDPR and the biomedical research law, with hosting and pseudonymisation described.
Run acceptance testing in the free sandbox with sample data before go-live.
Site and sponsor roles set, training recorded for every user.
The State Medicines Control Agency (VVKT) carries out the scientific assessment and authorisation, and the Lithuanian Bioethics Committee provides the ethics opinion, both through the CTIS process under the EU Clinical Trials Regulation.
Part II documents must be submitted in Lithuanian. Capture shows the text you provide; it does not translate for you.
Regional biomedical research ethics committees, such as those in Vilnius and Kaunas, with the competent one depending on where the study takes place. Confirm with the Bioethics Committee.
The State Data Protection Inspectorate, under GDPR and the national personal data protection law. Participants' health information is also covered by the Law on Ethics of Biomedical Research.
In the EU (Frankfurt), chosen at study setup. Capture does not host inside Lithuania.
Yes. One study can hold sites in all three countries with site-level access and by-site exports.
Yes. The free sandbox has every feature with no credit card and no time limit.
Keep exploring
EU-hosted EDC, eCRF and eConsent for Lithuanian studies. Free sandbox, no credit card.