CTIS clinical trial submissions in Croatia

Choose the right Croatia CTIS guide

1. Croatia CTIS Part II document checklist
   Use this checklist to identify the standard and conditional Part II documents, their language, submission signatures, and CTIS categories.
2. Croatia patient information and consent requirements
   Start here when preparing the main Croatian participant information and informed consent document for adults.
3. Croatia patient-facing document QC checklist
   Use this final review before submission to check protocol consistency, Croatian wording, consent choices, privacy, versions, and population coverage.
4. Croatia healthy volunteer consent requirements
   Use this variation when healthy adults are recruited and the consent must explain non-therapeutic participation, procedures, restrictions, and payments clearly.
5. Croatia minor consent and assent requirements
   Use this guide for the four Croatian assent age bands and the related parent or guardian consent document.
6. Croatia limited-capacity participant and legal representative consent requirements
   Use this guide when an adult cannot provide legally valid informed consent and a court-appointed legal representative may need to act.
7. Croatia emergency enrollment consent requirements
   Use this guide only for protocols that rely on the narrow emergency exception in Article 35 of the Clinical Trials Regulation.
8. Croatia impartial witness consent requirements
   Use this guide when a participant or legal representative can consent but cannot write, so an impartial witness must attend and sign.
9. Croatia pregnancy follow-up consent requirements
   Use this guide when the protocol collects pregnancy, birth, or infant follow-up data from a trial participant or a participant's pregnant partner.
10. Croatia secondary use consent requirements
    Use this guide for optional substudies, biobanking, genetics, and future use of samples or data outside the main protocol.

Main Croatian differences to plan for

Croatian participant documents

Participant-related documents must be in Croatian. Central Ethics Committee guidance calls for professional translation and proofreading, local adaptation rather than a literal translation, Croatian headers and footers, and language that participants can understand. The main consent should be one unified document containing the information and the signature section. The Croatia patient information and consent guide explains the required structure and local wording.

Consent must be obtained by a physician or dentist

The person conducting the informed-consent interview must be a physician or dentist. This may be the principal investigator or an investigator to whom the principal investigator has delegated the activity. The blank document submitted in CTIS is not signed. The participant or legal representative and the person conducting the interview sign and date it when consent is obtained.

Age-specific assent for minors

Croatia uses four assent-document age bands: 4 to 7, 8 to 11, 12 to 14, and 15 to 17 years. The two younger versions require simple illustrations and minimum font sizes. A child capable of forming an opinion and evaluating the information also signs, and a child's refusal must be respected. The Croatia minor consent and assent guide sets out the document and signature logic.

Separate consent for pregnancy follow-up and optional research

Separate consent is expected for pregnancy follow-up, including follow-up of a participant's pregnant partner. Separate consent is also needed for optional substudies and many forms of future sample use. Further studies outside the approved protocol need prior Central Ethics Committee review. The Croatia pregnancy follow-up guide and Croatia secondary use guide explain the distinctions.

Site start conditions

A Croatian site may start only after the site agreement has been signed, the Central Ethics Committee has issued a positive opinion, and the Ministry of Health has authorised the trial. Liability insurance connected with trial-related injury, death, or treatment must be in place before the trial starts.

Other language versions

This package contains the English Croatia hub and English guides. No Croatian-language hub is linked here until that version is published.