When a university sponsors a trial in Europe, it takes on the same data obligations as a pharmaceutical company, usually on a grant budget. Capture gives academic teams EU-hosted data, GDPR-ready pseudonymisation and Part 11 and Annex 11-aligned controls, with no setup fee.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Study region
European Union
Key points for academic sponsors in Europe
Regulation
The EU Clinical Trials Regulation applies to every clinical trial of a medicinal product in the EU, whoever sponsors it. Since the end of its transition period in January 2025, all ongoing trials have been expected to run under it, with applications and documents managed through the Clinical Trials Information System (CTIS). For universities, that means formal sponsor responsibilities for the data system: it must be fit for purpose, access must be controlled, changes must be traceable, and the sponsor must be able to show oversight of any vendor that hosts trial data.
The EMA's guideline on computerised systems and electronic data in clinical trials spells out what that means in practice, from audit trail review to user management and validation. It does not distinguish between academic and commercial sponsors, though a proportionate, risk-based approach is expected. The EU CTR guide covers the regulation in more detail.
Capture provides the technical controls behind these expectations: an append-only, hash-chained audit trail recording user, time, old and new values and reasons; electronic signatures with server-verified re-authentication and meaning statements; role-based access with site-level separation; and server-set timestamps. Your procedures, training and validation complete the picture; the computer system validation guide explains a proportionate approach.
Weight changed 68.0 to 68.5 kg
Site coordinator · Reason: Transcription error
Query Q-0014 answered on Weight
Site coordinator · Reason: Source checked
Vital signs form locked
Data manager · Reason: Visit cleaned
Data protection
Site coordinators see participant names so they can run visits; researchers, monitors and statisticians see coded IDs. The separation is enforced by row-level security in the database. Data for EU studies is hosted in Frankfurt, encrypted at rest and in transit.
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.
Consortia
European academic trials are often run by consortia of universities and hospitals across several countries. Every partner site joins the same study with the same locked forms, its own coordinator portal and site-level participant numbering, and there is no per-site fee to budget for each partner.
Randomized
166 / 240
Open queries
24
Fields verified
84%
3 open queries · 92% SDV
7 open queries · 85% SDV
14 open queries · 61% SDV
0 open queries · 100% SDV
Site risk
Site 03 query backlog
Data lock
Site 04 ready to lock
Free, with every feature. Budget for live use only once the study starts.
Study types
| Study type | Typical needs | In Capture |
|---|---|---|
| Investigator-initiated drug trials | CTR sponsor duties, randomisation, safety reporting | Part 11 and Annex 11-aligned controls, randomisation and supply, AE and SAE workflow |
| Device and digital health studies | Performance data, ePRO, usability | Site forms, ePRO on participant phones |
| Observational and registry studies | Long follow-up, questionnaires, consent | Recurring ePRO, eConsent, long schedules |
| Student and early-career research | Low budget, fast set-up, supervision | Free sandbox, AI study builder |
| Pragmatic and health services trials | Simple forms, many sites, routine care | No per-site fee, QR enrolment |
Grant budgets
Grant applications are often written a year or more before the first participant, with software costs estimated from a vendor quote that may not survive procurement. Budgets built on setup fees, per-site charges and change orders are particularly exposed: the number of sites and amendments is rarely known at application stage.
A pay-when-live model reduces that risk. The study can be designed, built and tested in the sandbox while ethics and regulatory approvals are pending, at no cost, and adding a consortium partner does not change the price. The clinical trial budget template helps estimate the rest of the site budget, and the EDC cost calculator gives typical ranges for comparison.
Funders increasingly expect trial data to be shared after publication. Exports with a code and a label per field, a data dictionary and an annotated CRF make a dataset understandable to others, and pseudonymised exports keep it within the consent participants gave.
Academic sponsors
Who in the university holds data management, safety and vendor oversight duties.
EU hosting chosen and the data protection impact assessment completed.
Assessment of the data system and ongoing oversight, as the EMA guideline expects; see the vendor security questionnaire.
Risk-based validation of the configured study, with records kept.
Ethics approval, contract, initiation visit and delegation log per partner.
Export formats and pseudonymisation agreed with the funder's requirements.
Yes. The EU Clinical Trials Regulation applies to all clinical trials of medicinal products in the EU, including those sponsored by universities.
In the EU (Frankfurt), chosen at study setup, with AES-256 encryption at rest and TLS in transit.
Capture is GDPR ready: EU hosting, pseudonymisation between site and research roles, and configurable data minimisation. GDPR compliance also depends on your lawful basis, DPIA and procedures.
Yes. Export your REDCap data dictionary and let the AI form builder draft the forms. Most teams start new studies in Capture rather than switching mid-study.
No. Adding a site means inviting a coordinator and sharing an enrolment link.
Yes. The free sandbox needs no credit card and no contract.
Keep exploring
For academia
Capture for academic research.
EU CTR clinical trial software
The regulation in detail.
Clinical research software for universities
University research teams.
Clinical trial software in Ireland
Irish regulations and hosting.
Clinical trial software in Latvia
From our Riga office.
EDC for investigator-initiated trials
IIT-specific needs.
EU-hosted, GDPR ready and free to build. No credit card.