EU CTR, Regulation (EU) No 536/2014, replaced the old Clinical Trials Directive and now covers every clinical trial in the EU, submitted and tracked through CTIS, the Clinical Trials Information System. This page explains what actually changed and where Capture already fits: EU-hosted data, a field-level audit trail, and verified e-signatures.
Free sandbox · No credit card · 21 CFR Part 11 aligned
EU (Frankfurt)
Default for EU-sponsored studies
US (N. Virginia)
Default for US-sponsored studies
EU
hosting region available (Frankfurt) for EU-sponsored studies
Field-level
audit trail, exportable to support what you submit in CTIS
2
e-signature steps: participant sign, then countersign
0
setup fee to start building a study
The regulation
Regulation (EU) No 536/2014 replaced the old Clinical Trials Directive. Every EU member state involved in a trial now assesses it through one harmonised procedure in CTIS, instead of separate national submissions, and sponsors report through a single EU-wide portal for the life of the trial. The regulation itself does not certify software; it sets requirements for how trial data and safety information are managed and reported.
Stage 1
DraftBuild and edit freely
Stage 2
ApprovedLocked for live use
Stage 3
In the casebookOnly approved forms
SDV requirement changed on Systolic BP
Data manager · Reason: critical safety value
Form approved: Vital Signs (VS) v2
Study owner · Locked for live use
Answer changed: Weight 68.0 to 68.5 kg
Site coordinator · Reason: transcription error
What to check
None of this is CTIS itself. It is what supports a clean submission and an inspection-ready record afterward.
Field-level history on every record, timestamped and attributable.
A Frankfurt hosting region you can select at setup.
OTP-verified participant signature plus investigator countersignature.
Protocol and form changes tracked through the same audit trail.
CSV and Excel exports with an automatic data dictionary.
Amendments
EU CTR amendments still need to be tracked cleanly across every affected site. Capture lets you amend forms and the visit schedule yourself, with the change captured in the same audit trail as everything else, so nothing about the update depends on a change-order ticket to a vendor.
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.
The difference
Before you switch
EU hosting, the audit trail and e-signatures are part of every plan, including the free sandbox.
Capture does not submit to CTIS. It gives you the records and exports you need to support what you submit there yourself.
Pick your EU hosting region at study setup. No separate infrastructure to provision.
Bring an ongoing EU trial in without losing its audit history.
Email support, typically under 24 hours, plus documentation on Enterprise.
Free sandbox with every feature. No credit card, no sales call.
EU CTR, Regulation (EU) No 536/2014, is the regulation that replaced the old EU Clinical Trials Directive. It harmonises trial assessment across EU member states and requires submissions through CTIS, the Clinical Trials Information System.
No. Capture does not connect to or submit through CTIS. It gives you the audit trail, exports and e-signatures you need to support what your team submits there.
EU CTR does not itself mandate a hosting location, though many EU sponsors choose EU-based hosting alongside their GDPR obligations. Capture’s Frankfurt region is available for that.
No. The controls EU CTR asks for, an audit trail, verified signatures, and secure hosting, are the same ones a well-run trial needs regardless of the regulation.
Yes. Forms and the visit schedule can be amended directly, with the change tracked in the audit trail.
Yes. The free sandbox includes EU hosting, the audit trail and e-signatures with sample data, no credit card required.
Keep exploring
GDPR-compliant clinical trial software
The data protection side of running an EU study.
Protocol amendments without change orders
How amendments stay tracked across every site.
ICH E6(R3) guide
The GCP guidance running alongside EU CTR.
21 CFR Part 11 compliance checklist
The audit trail and signature controls, in FDA terms.
eConsent software
Verified signatures for EU-based participants.
Features
Every module the audit trail runs across.
Free sandbox with every feature. No credit card, no sales call.