UK trials sit under their own regulator, data protection law and research ethics system. Capture supports UK sponsors, clinical trials units and NIHR-funded academic teams with the audit trail, signature and access controls MHRA inspectors expect.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Study region
United Kingdom
Key points for UK studies
Regulation
MHRA GCP inspections look closely at computerised systems: who can access the data, how changes are recorded, whether the audit trail is reviewed, and whether the system was fit for its intended use. The MHRA's data integrity guidance applies ALCOA+ principles to all GXP data, and inspectors expect sponsors to understand and oversee any system a vendor provides.
Capture supplies the technical controls those expectations rest on: an append-only audit trail with one row per changed field, each entry hash-chained to the one before it; electronic signatures with server-verified re-authentication and a meaning statement; role-based access with site-level separation; and server-set timestamps. Your procedures, training and system validation complete the picture. The ALCOA+ checklist maps each principle to controls.
Capture hosts study data in the EU (Frankfurt) or the US (N. Virginia), chosen when the study is set up. For UK studies the EU region is the usual choice, because UK data protection law recognises the EEA as adequate for transfers. Record the hosting location and transfer basis in your data protection impact assessment and participant information.
EU (Frankfurt)
Default for EU-sponsored studies
US (N. Virginia)
Default for US-sponsored studies
Clinical trials units
UK clinical trials units often run many investigator-led studies in parallel, each with its own funding and timelines. Capture lets a unit build each study from its protocol with the AI Study Generator, reuse configuration between studies, and keep a consistent approach to audit trails, signatures and exports across the portfolio.
Upload protocol
PDF, DOCX or DOC
Describe it
Plain-language summary
Phase 1 template
8 visits, ready to edit
NHS sites
Research nurses and coordinators at NHS trusts see only their own site's participants, enforced by row-level security. Participant names stay with the site; the CTU and sponsor see coded IDs. There is no per-site fee, so adding a trust to a portfolio study is an invitation, not a budget line.
Study owner
Builds and configures the study
Principal investigator
Oversees the site, signs off the casebook
Sub-investigator
Enters and signs clinical data
Study coordinator
Screens subjects, enters visit data
Monitor (CRA)
Verifies data, raises queries
Data manager
Reviews, freezes and locks data
Participant
Completes their own questionnaires
Upload a protocol, review the draft and export the blank eCRF for your submission.
Multinational trials
Since leaving the EU, the UK is not part of the EU Clinical Trials Regulation or its Clinical Trials Information System. A trial with sites in both the UK and EU member states therefore needs parallel applications: through CTIS for the EU part and through the UK route for UK sites, each with its own approvals and timelines. The protocol and the data system can still be shared.
Running every site in one EDC study keeps the data consistent across both regulatory regimes: the same locked forms, the same edit checks and one audit trail. Site-level access keeps each country's participants visible only to its own sites, and by-site exports support separate regulatory reporting where it is needed. Choose the hosting region with both data protection regimes in mind; EU hosting is common for combined UK and EU studies.
Many UK academic studies still run on paper CRFs or institution-hosted REDCap. For new studies that need regulated controls, ePRO or eConsent in one place, see paper CRF to eCRF conversion and how to migrate from REDCap.
Before you open recruitment
MHRA and REC approval for CTIMPs, HRA approval, and local capacity confirmation at each site.
Confirm how the updated UK clinical trials regulations apply to your study.
Hosting location, transfer basis and pseudonymisation documented.
Risk-based validation of the configured study, with records retained.
Delegation log and training acknowledgements for every user.
Who reviews audit trails, how often, and how findings are handled.
The MHRA regulates clinical trials of medicines and devices, with ethics review through the HRA's research ethics service. Trials of medicinal products use combined review.
Yes. Capture offers EU (Frankfurt) hosting, and UK data protection law recognises the EEA as adequate for transfers. Document the choice in your DPIA.
Capture provides the technical controls: audit trail, e-signatures, access control and server timestamps. Compliance also depends on your procedures, training and validation.
Yes. There are no setup or per-site fees, and the full study can be built and tested free before going live, which helps fixed grant budgets.
Yes. Each study is built separately, and configuration can be exported and imported between studies.
Yes. The free sandbox has every feature with no credit card.
Keep exploring
Clinical trial software in Ireland
Irish regulations and hosting.
Software for European universities
Academic sponsors in Europe.
GDPR compliant trial software
Data protection in depth.
ALCOA+ data integrity checklist
Data integrity principles.
Computer system validation
Proportionate validation.
What is GCP?
Good clinical practice explained.
Free sandbox with every feature. No setup or per-site fees.