Italy CTIS guides and Part II requirements

Italy regulatory snapshot

The Italian Medicines Agency, AIFA, acts for Italy in the authorisation and supervision of medicinal-product trials. Ethical review is performed through the competent Territorial Ethics Committee, known as a CET. Italy also has AIFA-based National Ethics Committees for paediatric trials and advanced therapy medicinal products. The applicable committee depends on the trial and is assigned within the national system. Its Part II opinion applies nationally.

The National Coordination Centre of Territorial Ethics Committees, CCNCE, publishes national models and guidance. The most important current materials include the 27 May 2026 informed-consent guidance and model forms, the 10 June 2026 FAQ, the privacy information and consent model announced on 13 August 2026, the principal-investigator declaration-of-interests model, the reimbursement and allowance model, the biological-samples model and version 3 of the national clinical trial agreement.

Documents intended for participants must be in Italian for trial conduct and ethics review. Non-participant Part II documents can generally be submitted in English. A narrow emergency arrangement may permit initial English patient documents during an officially recognised public-health emergency, but Italian information and consent are still required before enrolment begins. Do not treat that exception as a routine submission route.

Guide directory

1. Italy CTIS Part II document checklist: Use it to identify document status, language, template, signature and CTIS filing requirements.
2. Patient information and consent requirements: Use it to draft the main Italian participant information and informed-consent form.
3. Patient-facing document QC checklist: Use it to reconcile consent, privacy, recruitment, sample and population documents before upload.
4. Healthy-volunteer consent requirements: Use it for non-therapeutic, Phase I and first-in-human volunteer trials.
5. Minor consent and assent requirements: Use it for parent or guardian consent, adolescent assent, child information and re-consent at 18.
6. Limited-capacity and legal-representative consent requirements: Use it when an adult cannot independently provide valid trial consent.
7. Emergency-enrolment consent requirements: Use it only for an Article 35 deferred-consent pathway in a qualifying emergency.
8. Impartial-witness consent requirements: Use it when a capable participant understands the trial but cannot write.
9. Pregnancy follow-up requirements: Use it to separate follow-up for a pregnant participant from follow-up for a participant's pregnant partner.
10. Secondary-use consent requirements: Use it for optional future data use, genetics, biobanking and residual-sample research.

Other language versions

This deliverable contains the English Italy hub and guides. No other Italy language edition is included, so this hub does not link to an unpublished translation.

How Part II works in Italy

The sponsor submits the application through CTIS. Italy evaluates the national Part II package through the competent ethics committee. Requests for information are also exchanged in CTIS. A complete initial package reduces the risk of a short response deadline, but CTIS permits some Part II elements to be submitted after Part I in the circumstances allowed by the Regulation.

Prepare one national core set of participant documents and add only genuine site variables, such as the principal investigator, hospital, contact details, local reimbursement logistics and emergency contacts. The June 2026 CCNCE FAQ states that authorised informed-consent forms are nationally valid and must not be changed locally. Any post-authorisation change must be handled by the sponsor and submitted as a modification when required.

Use the EU templates that Italy designates as mandatory, including the principal-investigator curriculum vitae and site-suitability form. Use the Italian national models where required, including the principal-investigator declaration of interests and the financial reimbursement and allowance document. Check the CCNCE page immediately before filing because AIFA labels the May 2024 Article 7 evaluation guide as under revision.

Participant information and consent

The CCNCE describes consent as an ongoing communication process, not merely a signature. Information must be concise, relevant, complete, understandable and free of coercion or undue financial influence. It should be adapted to the participant's health literacy, age, capacity, language and disability. Participants must have time to ask questions and receive a copy of the signed documents.

The current Italian models use a layered structure. A short key-information section is followed by more detailed information and the consent statements. The principal study information and consent form should be accompanied by separate documents where applicable, including the privacy notice and consent, sample collection and future-use consent, optional sub-study consent and population-specific forms.

The main patient information and consent guide connects to the following population and situation guides:

• Healthy volunteers
• Minors and assent
• Adults with limited decision-making capacity
• Emergency enrolment
• Impartial witnesses
• Pregnancy follow-up
• Secondary use of data and samples

Important 2026 checks

Use the consent models dated 27 May 2026 rather than an older Italian form. Keep the privacy notice and data-processing consent distinct from the clinical-trial informed-consent form. The CCNCE published a dedicated privacy model on 13 August 2026.

The EU recruitment and informed-consent procedure template version 2.0 is already the preferred form and becomes the replacement template on 1 September 2026. For a submission close to that date, use version 2.0 and confirm the transition note on EudraLex Volume 10.