Irish trials combine the EU Clinical Trials Regulation with national rules on consent for health research that go further than GDPR alone. Capture hosts data in the EU and gives investigators signed, auditable consent and data records.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Study region
Ireland
Key points for studies in Ireland
Regulation
For medicinal product trials, Ireland applies the EU Clinical Trials Regulation directly. Sponsors submit through CTIS, the HPRA assesses the Part I aspects with other member states where the trial is multinational, and a National Research Ethics Committee provides the ethics opinion. Device investigations follow the EU Medical Device Regulation, with their own national ethics committee route.
Where Ireland differs from many EU countries is in how it treats personal data in health research. The Health Research Regulations 2018 require explicit consent as a safeguard for processing personal data for health research, in addition to the lawful basis under GDPR, unless a consent declaration is granted by the Health Research Consent Declaration Committee. For most prospective trials this simply means consent must be explicit, informed and well documented.
You need to be able to show, for each participant, the consent they gave, the version they saw and when they signed. Capture's eConsent records the participant's on-screen signature, verified with a one-time email code, followed by the investigator's countersignature with password re-authentication. Each signature is cryptographically linked to the exact document content, and the signed consent exports as a PDF with embedded signature data, timestamps and audit trail.
Meaning of signature
I have reviewed this adverse event and confirm the assessment of seriousness, severity and causality.
Signer
Dr. A. Ozola, PI
Password
••••••••••
Hosting
EU studies are hosted in Frankfurt, with encryption at rest and in transit, and participant identities visible only to site coordinators. That keeps the data protection impact assessment simple and avoids international transfer questions for the core study data.
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.
Irish research
Irish clinical research spans university hospitals, academic research centres and a large medtech and pharma sector. Capture's self-serve model suits all three: no setup fee, no per-site fee, and a full sandbox to build and test before any contract.
Pre-launch readiness
1 site activated
1 form not yet approved
Sign a test consent as participant and investigator, then export the signed PDF.
Multinational trials
Ireland participates fully in the EU Clinical Trials Regulation, so an Irish site in a multinational EU trial is covered by the same CTIS application as sites in other member states. The coordinated assessment of the scientific parts (Part I) is shared between the member states concerned, while national aspects (Part II), such as site suitability and local consent arrangements, are assessed nationally. For global trials with UK or US sites as well, the UK and US parts follow their own routes.
For the data system, the practical question is consistency: the same forms, checks and consent process at every site, with country-specific requirements handled in configuration rather than separate builds. Capture runs every site in one study with site-level access, and a consent template can be adapted per country where local requirements differ.
Clinical investigations of medical devices in Ireland follow the EU Medical Device Regulation rather than the CTR, with their own notification and ethics routes. The data requirements are similar; see EDC for medical device clinical trials.
Before you start
For medicinal product trials under the EU CTR.
National Research Ethics Committee for the trial type.
Consent covers data processing for the research, consistent with the Health Research Regulations.
Hosting, pseudonymisation and retention documented.
Signed consent PDFs with signatures, timestamps and audit trail.
Proportionate system validation and user training recorded.
The Health Products Regulatory Authority (HPRA) is the national competent authority. Medicinal product trials follow the EU Clinical Trials Regulation through CTIS.
Ireland's National Research Ethics Committees, coordinated by the National Office for Research Ethics Committees.
Irish regulations that require explicit consent as a safeguard for processing personal data in health research, with a consent declaration process for exceptions.
In the EU (Frankfurt), chosen at study setup.
With an on-screen participant signature verified by email one-time code, investigator countersignature with re-authentication, and a signed PDF export with the audit trail.
Yes. The free sandbox has every feature with no credit card.
Keep exploring
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Academic sponsors.
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Another EU country guide.
What is an IRB or ethics committee?
Ethics review explained.
EU-hosted eConsent and EDC. Free sandbox, no credit card.