Italy combines strong academic research centres and hospital networks with a reorganised ethics system under the EU regulation. Capture runs Italian sites in the same study as the rest of your programme, hosted in the EU.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Study region
Italy
Key points for studies in Italy
Research landscape
The 2023 reorganisation of Italian ethics committees aimed to align the system with the EU regulation's timelines. For sponsors, it means checking which committee reviews each study and planning submissions accordingly. Site contracts and local administrative steps at each hospital remain important for start-up timelines.
Once approved, Italian sites should work exactly like every other site in your study: the same locked forms, edit checks, randomisation and audit trail. Local differences, such as site-specific consent versions, belong in configuration, not a separate build. See multi-site clinical trial management.
Italian data protection rules include specific provisions for medical research where obtaining consent is not possible, particularly for retrospective studies. These usually need an ethics committee opinion and additional safeguards. Discuss the legal basis with your data protection officer early.
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
Start-up
Each site passes an activation checklist before it can enrol: ethics approval, contract, initiation visit and delegation log. Italian sites can be added and trained while approvals are pending, then activated as soon as the checklist is complete.
Pre-launch readiness
1 site activated
1 form not yet approved
Walk through the site activation checklist in the free sandbox.
Planning
| Area | What to plan |
|---|---|
| Regulatory | CTIS application with the Italian part; AIFA as competent authority |
| Ethics | Which territorial or national committee reviews the study |
| Site contracts | Hospital administrative steps and timelines |
| Data protection | Legal basis, Garante requirements, pseudonymisation |
| Materials | Italian consent and participant documents |
| Activation | Checklist complete before first enrolment |
Academic research
Italy has specific provisions for non-commercial ("no-profit") studies sponsored by hospitals, universities and research institutes, recognising that academic sponsors have different resources from industry. Many important Italian trials are investigator-led, often run across networks of public hospitals and IRCCS research institutes.
Academic sponsors need tools that are affordable and quick to set up without a vendor project. Capture's free sandbox lets investigators build and test the study before funding or approval is final, and there is no per-site fee as the network grows. See EDC for investigator-initiated trials.
Before you start
Including the Italian part.
Territorial or national committee identified.
Hospital contracts and administrative approvals.
Legal basis and safeguards documented.
Approved consent and participant documents.
Ethics approval, contract, initiation visit and delegation log.
Italy has specific provisions for non-commercial studies sponsored by hospitals, universities and research institutes.
No. Adding a site means inviting its team and activating it.
The Italian Medicines Agency (AIFA), under the EU Clinical Trials Regulation, with ethics review by territorial or national ethics committees.
In 2023 Italy reorganised its ethics committees into a smaller number of territorial committees plus national committees for specific areas.
The Garante per la protezione dei dati personali, applying the GDPR and the Italian Privacy Code.
Yes. Every site runs in the same study with the same forms, checks and audit trail.
Capture hosts study data in the EU (Frankfurt) or the US (N. Virginia), chosen at study setup, with AES-256 encryption at rest and TLS in transit. Choosing Frankfurt keeps study data in the EU.
Yes. The free sandbox has every feature with no credit card and no time limit.
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