Italy CTIS Part II document checklist

Before using this checklist

“Mandatory” means the document or information is normally required for the relevant Italy Part II application. “Conditional” means it is required only when the related activity or population is present. “Recommended” means current Italian guidance expects or encourages it even though it may not be a standalone CTIS upload.

Participant-facing content must be in Italian. Non-participant documents can generally be in English. Upload clean, blank, version-controlled participant templates. The participant, legal representative, investigator and witness sign during the consent process, not before CTIS submission.

Recruitment and informed-consent procedure

Mandatory. Describe how potential participants are identified, approached, informed, given time to decide and enrolled. Include the role of each person involved and the safeguards for vulnerable populations. If recruitment procedures are fully described in the protocol, avoid contradictory duplication.

Template and timing: Use the latest EU recruitment and informed-consent procedure template or provide equivalent complete information in the designated CTIS category. Version 2.0 is preferred as of this review and replaces the previous form on 1 September 2026. Sponsor signature is not normally required because submission through CTIS authenticates the sponsor's filing.

CTIS category and submission signature: File recruitment information under Recruitment arrangements and consent-process information under Subject information, informed-consent form and informed-consent procedure, as applicable. No participant, investigator or sponsor signature is required on this procedural upload at submission.

Recruitment materials

Conditional. Submit advertisements, posters, social-media copy, letters, scripts, brochures and other materials that will be used to recruit participants. A statement that no recruitment material will be used is appropriate when true.

Language and signatures: Participant-facing recruitment material must be in Italian, clear and non-coercive. It must not promise benefit or overemphasise payments. No participant signature is required. Paediatric materials need age-appropriate design and language. The June 2026 CCNCE FAQ confirms that recruitment materials require ethics review.

CTIS category and submission signature: File the material under Recruitment arrangements. Submit a clean, versioned template. It is not signed at submission.

See the patient-facing document QC checklist for wording, consistency and version checks.

Main participant information and informed-consent form

Mandatory. Prepare a form for every participant population and consent pathway. Use the CCNCE guidance and model dated 27 May 2026 as the current national benchmark. The models are structured guidance and facsimiles, so adapt them to the trial without deleting required information.

Language, version and signature: Submit the Italian version with a title, date and version that match the footer and CTIS file name. The submitted document is blank. At enrolment, the participant and the doctor or investigator who provided the information and obtained consent sign and date the form. Record the time where the model requires it. Give the participant a signed copy.

CTIS category and submission signature: File it under Subject information, informed-consent form and informed-consent procedure. It is not signed at submission. The relevant participant, representative, parent, investigator and witness signatures are obtained only during the approved consent process.

Prepare separate or adapted forms for healthy volunteers, minors, adults unable to provide valid consent, emergency enrolment and witness-assisted consent. Link optional choices to distinct signature or initial fields so refusal of an optional activity does not prevent participation in the main trial.

Use the detailed patient information and consent requirements and the connected population guides before finalisation.

Separate privacy information and data-processing consent

Mandatory. The June 2026 CCNCE FAQ requires a separate privacy information notice, distinct from the clinical-trial informed-consent form. The CCNCE announced a dedicated model on 13 August 2026.

Language and signature: Submit the Italian, study-specific privacy document. Identify controllers, legal bases and purposes, data categories, recipients and transfers, retention, safeguards, rights, contacts and limits on withdrawal where lawfully collected research data must be retained. Use signature and choice fields that match the current model. Do not copy privacy language into the clinical-consent signature block as a substitute for the separate document.

The sponsor must also provide the mandatory Part II statement describing compliance with EU data-protection rules. AIFA states that there is no separate national template for that Annex I statement.

CTIS category and submission signature: File the privacy material and compliance statement in the designated Compliance with applicable rules for personal data protection category. The participant-facing template is blank at submission. Its consent fields are completed during the approved privacy process. The sponsor's CTIS filing replaces an additional sponsor signature on the compliance statement.

Population-specific information and consent documents

Conditional. Required when the population or situation applies.

• Healthy volunteers: adapt the adult form to state the non-therapeutic purpose and realistic lack of direct benefit. See the healthy-volunteer consent guide.
• Minors: prepare the parent or legal-guardian form, the 12-to-17-year mature-minor information and assent form, and the 6-to-11-year child information sheet as applicable. See the minor consent and assent guide.
• Limited capacity: prepare the legal-representative route and adapted participant information. See the limited-capacity consent guide.
• Emergency enrolment: describe the deferred-consent process only when every condition in Article 35 is met. See the emergency-enrolment consent guide.
• Impartial witness: include a witness attestation where a capable participant cannot write. See the impartial-witness guide.
• Pregnancy follow-up: prepare the participant or partner-facing follow-up information required by the protocol. See the pregnancy follow-up guide.

CTIS category and submission signature: File these forms with the subject information and consent material, or in the currently designated patient-document category when CTIS implementation requires it. They are blank at submission. Signatures are obtained from the applicable participant, parent, representative, investigator or witness during use.

Biological-sample compliance and participant consent

Conditional. When the trial collects, stores, transfers or uses human biological samples, submit the required Part II compliance information using the latest applicable EU or Italian model. Describe national-law compliance, custodianship, coding, storage location, access, transfer, retention and destruction.

Prepare a separate Italian participant information and consent document for sample collection, storage and future use where applicable. It must distinguish protocol-required analysis from optional future research. Genetic testing, optional sub-studies and future secondary use may need distinct choices. See the secondary-use consent guide.

CTIS category and submission signature: File the dossier statement under Compliance with applicable rules for collection, storage and future use of human biological samples. A separate sponsor signature is not required where CTIS filing supplies it. File the blank participant sample-consent document with the subject information and consent materials. Participant signatures are collected later.

Principal-investigator curriculum vitae

Mandatory. For each site. Use the current EU principal-investigator CV template. Provide a concise, current record of education, clinical-trial experience, relevant therapeutic expertise and GCP training. Italy's guidance asks for the principal investigator's CV rather than CVs for the whole site team.

Language and signature: English is acceptable. Complete all required fields and retain the source record. Do not add a site signature requirement that is not present in the current EU form. Upload it in the CTIS investigator-suitability category with a file name that identifies the investigator and site without exposing unnecessary personal data.

CTIS category and submission signature: File it under Suitability of the investigator. Under current Italian guidance, the sponsor's upload attests that the copy conforms to the PI-prepared original. No additional sponsor signature is required on the uploaded copy.

Principal-investigator declaration of interests

Mandatory. For each site. Use the current CCNCE national declaration-of-interests model, version 4 dated 21 April 2024 at the time of this review. Declare financial, institutional and other interests that could affect impartial conduct of the trial.

Language and completion: The Italian and English versions can be used as provided by AIFA. Complete and date the form for the site principal investigator. Keep the document consistent with the CV, site name and CTIS site record. Do not invent a “coordinating centre” merely to satisfy a legacy label. The June 2026 FAQ confirms that a formal coordinating centre is not required for CTIS trials.

CTIS category and submission signature: File it under Suitability of the investigator. The current version 4 model contains a date field and no separate signature line. The PI completes and dates the original, and the sponsor's CTIS upload attests conformity to that original.

Site-suitability form

Mandatory. For each trial site. Use the current EU site-suitability template. Describe the facilities, equipment, staffing, patient population, pharmacy, laboratories and other resources needed to conduct the protocol safely.

Signature: The institution's legal representative or an authorised delegate signs using PAdES or an equivalent digital-signature method accepted in Italy. The delegation must exist before signature and should be retained, but it is not uploaded merely because the delegate signed. A separate Italy-specific site number is not mandatory. A principal-investigator change normally requires updated investigator documents, not a new site-suitability form solely for that reason.

CTIS category and submission signature: File it under Suitability of the facilities. This document is signed at submission by the institution's legal representative or properly authorised delegate.

An external facility performing part of the investigational treatment may need to be treated as a trial site with its own form and local principal investigator. A facility performing only routine tests for a site that lacks local capacity is not automatically a trial site. Document the arrangement, quality controls, contract and insurance implications.

Proof of insurance or indemnification

Mandatory. Provide a study-specific certificate that satisfies the Italian Ministerial Decree of 14 July 2009. The certificate must cover the sponsor's and investigators' civil liability for trial-related injury and must apply for the whole trial.

Language and signature: The certificate must be in Italian and signed by the insurer. Check the insured parties, protocol identifier, sites or territorial scope, policy dates, limits, exclusions and post-trial claim period against the study. For minors and certain advanced treatments, the decree requires an extended post-trial period. Include policy terms when needed to demonstrate that the certificate provides the required cover.

CTIS category and submission signature: File it under Proof of insurance cover or indemnification. The insurer signs the certificate before submission. No participant, investigator or sponsor signature substitutes for the insurer's signature.

Financial arrangements, reimbursements and allowances

Mandatory. Submit the current national reimbursement and allowance model and disclose all participant payments, reimbursements and documented loss-of-income arrangements. Describe amounts, eligible costs, payment method, timing and the party administering payment. The competent ethics committee must be able to assess whether the proposal creates undue influence.

Use reimbursement of actual, documented trial-related costs rather than promotional language about payment. Apply the current Italian rules for vulnerable participants and healthy volunteers. Do not assume that a payment category is acceptable merely because it appears in another country's materials.

The current national clinical-trial agreement, version 3 dated 28 January 2026, is the minimum model for commercial trials. The non-commercial version 3 is dated 22 July 2026. Submit the applicable contractual information and execute the site agreement before activation in accordance with the national process. The sponsor's CTIS submission replaces a separate sponsor signature on documents where current guidance expressly allows that route. It does not replace signatures needed to execute the final contract.

CTIS category and submission signature: File participant financial arrangements and the applicable agreement material under Financial and other arrangements. The reimbursement model does not need a separate sponsor signature at submission because CTIS filing replaces it. The final clinical-trial agreement is signed by the contracting parties when executed.

Data-protection compliance statement

Mandatory. Provide the statement required by Annex I, section R, of the Clinical Trials Regulation. Cover lawful processing, security, confidentiality, data-subject information, rights, transfers, retention and the handling of coded data. Italy has not prescribed a separate national form for this statement.

This dossier statement is not the participant privacy notice. Submit both. Align them with the protocol, data-management plan, contracts, vendor flows and the separate Italian privacy document.

CTIS category and submission signature: File the statement under Compliance with applicable rules for personal data protection. It does not require a separate sponsor signature at submission.

Other patient-facing operational materials

Conditional. Diaries, questionnaires, cards, device instructions and other participant tools must be available in an appropriate language for conduct. Their CTIS location depends on purpose. Materials that define endpoint collection may belong with Part I protocol material. Current EU guidance does not create a blanket Part II upload requirement for every operational patient document. Recruitment materials and consent documents remain subject to the specific Part II rules above.

Recommended documents that are not routine standalone uploads

Prepare the CCNCE general-practitioner or paediatrician letter dated 7 January 2026 when communication with the participant's doctor is relevant. The June 2026 FAQ says the letter is recommended for the participant but is not a mandatory CTIS or ethics-review document.

Maintain delegation records, training evidence, staff CVs, original signed source documents and site implementation records in the trial master file or investigator site file as applicable. Do not upload them to CTIS unless requested or required in the designated category.

Final filing check

Confirm that every site, investigator and population in CTIS has the corresponding document. Match protocol number, EU trial number, sponsor, study title, version, date and language across the package. Remove tracked changes, comments, hidden text and completed participant data. Use descriptive CTIS file names with document type, country or language, version and date. Keep the visible document version identical to the file name.

Before filing, run the patient-facing QC checklist and return to the Italy CTIS guide hub for every connected requirement.