Croatia patient information and informed consent requirements

Purpose and CTIS submission format

Mandatory. The document must allow the potential participant to understand why they are invited, what participation involves, what could happen, how their information and samples will be used, and that participation is voluntary. Upload the clean Croatian version under Subject information and informed consent form. Do not upload a participant-signed copy with the application.

Use a clear document title that includes the Croatian term Informirani pristanak. Central Ethics Committee guidance says the title and text should not use vague labels such as information, form, or document instead of that term. Put the basic trial and sponsor details in a first-page header. Translate the header and footer into Croatian.

Croatian language, readability, and presentation

Mandatory. Use professionally translated and proofread Croatian. Do not submit a literal translation of a global English template. Replace country-neutral wording with Croatia-specific authority, cost, insurance, privacy, and contact information. Explain medical terms in language the intended participant can understand.

Keep the document complete but not unnecessarily long. Avoid large blank spaces, inconsistent margins, small text, or signature pages that appear detached from the information. Address the participant directly. Croatian guidance asks for the formal pronoun Vi and its forms to begin with a capital letter, while avoiding excessive repetition.

State visits and weeks with ordinal numbers in Croatian. Use Croatian wording rather than phrases such as "in your country" or "in some countries." Each question asking the participant to make an optional choice should provide both DA and NE response options.

Participant-completed questionnaires and rating scales must be validated and translated into Croatian. When an instrument is not scientifically validated, submit the English original and Croatian translation for ethics assessment.

Core information to include

The main informed consent should cover the following in an order a participant can follow:

• The trial title, sponsor, purpose, phase where useful, and why the person is being invited.
• The planned number of participants globally and in Croatia.
• The voluntary nature of participation and the right to refuse or withdraw without adverse consequences or loss of ordinary care.
• The trial design, treatment groups, randomisation, blinding, investigational medicine, comparator, and a plain explanation that placebo is not an active medicine where applicable.
• Every screening, treatment, sampling, imaging, diary, questionnaire, genetic, digital, home, and follow-up procedure relevant to that participant.
• Expected duration, visit schedule, practical restrictions, hospital stays, and what happens after treatment stops.
• Foreseeable risks, discomforts, burdens, reproductive risks, and important unknowns.
• Expected benefit, including a clear statement when direct medical benefit is not expected.
• Other treatment options available outside the trial.
• Pregnancy testing and contraception. Where the medicine's reproductive effects are unknown or potentially harmful, Croatian national specifics expect both partners to use reliable contraception, for example hormonal contraception plus condoms.
• What happens if the participant or a participant's partner becomes pregnant. If follow-up is planned, state that a separate consent will be offered.
• Collection, testing, storage location, storage period, permitted use, transfer, withdrawal, return of results, and final handling of biological samples.
• Personal-data processing, coding, access, recipients, international transfers, retention, safeguards, rights, and complaint routes.
• Sponsor responsibility for all protocol-related trial costs, including treatment, procedures, tests, visits, and treatment of trial-related injury.
• Participant travel and other expense reimbursement, with the maximum net amount stated in euros where required by the arrangement.
• Trial insurance and the process for reporting and seeking help for a trial-related injury.
• Contacts for medical questions, emergencies, participant rights, data protection, and complaints.
• New information, suspension, early termination, withdrawal, and circumstances in which the investigator may stop participation.

The only Central Ethics Committee information normally needed in the document is its role, the fact that it approved the trial once approval has been obtained, and its address for written questions about participant rights. The document should first direct trial questions to the investigator and then the trial lead. It should also provide a route to the Croatian Personal Data Protection Agency, AZOP, for data-protection rights.

Consent choices and optional activities

The main decision to join the trial must be distinct from optional activities. A refusal to join an optional substudy, donate samples for future research, or permit another optional use must not be presented as preventing participation in the main trial unless that activity is genuinely required by the protocol.

Use a separate Croatian informed consent for an optional pharmacogenetic or other optional substudy. If genetic or another analysis is a required and integral part of the trial, explain it inside the unified main consent. The Croatia secondary use consent guide explains sample repositories, future research, genetics, and withdrawal.

Conditional. If a caregiver or study partner must help the participant and provide information to the trial team, the participant should name that person and the caregiver or study partner must complete their own consent process. If the caregiver withdraws and another person replaces them, the replacement must also consent.

Conditional. If the site may lose contact with a participant, the main consent may ask the participant to name an emergency contact. The named person must provide separate consent for the processing of their details. Croatian guidance does not permit use of a tracing agency or disclosure of participant data to an outside party for tracing.

Conditional. Home delivery of investigational medicines requires a separate consent identifying the delivery company, delivery controls, replacement procedure, return of packaging or unused medicine, and personal-data handling. Home nursing, participant transport, and third-party reimbursement providers must also be identified with their privacy arrangements where used.

Signature and dating requirements during consent

Mandatory when consent is obtained. The participant and the person conducting the consent interview sign and date the informed consent. Under Croatian law, the interviewer must be a physician or dentist. The interviewer may be the principal investigator or a delegated investigator. Ensure the delegation is documented before the person performs the activity.

The consent conversation and signature take place before any trial-specific procedure. The participant receives a copy of the signed document. Keep the signed original according to the approved process and clinical-trial records requirements.

Current Central Ethics Committee guidance does not permit routine electronic informed consent in Croatia. Consent is obtained in person on paper from the participant or parent, guardian, or legal representative. Exceptional electronic consent does not replace the need to obtain paper consent in person as soon as possible.

If a participant can consent but cannot write, use the impartial-witness pathway rather than treating the person as lacking capacity. The Croatia impartial witness consent guide explains that process.

Access to medical information

Croatian national specifics state that trial health and medical information should be obtained from the participant or legal representative. The sponsor or investigator should not ask for the family physician's contact details or contact other healthcare professionals to obtain the participant's health information.

Participants should be encouraged to tell their family physician that they are in the trial and offered a physician letter about the study. The decision and communication remain with the participant. Review protocol data flows carefully because a global clause authorising unrestricted direct access to outside physicians would conflict with the published Croatian position.

Population-specific consent variations

Prepare separate documents where the information, decision-maker, or signature process changes:

• The Croatia healthy volunteer consent guide covers non-therapeutic participation and practical restrictions.
• The Croatia minor consent and assent guide covers four age-specific assent bands and parent or guardian consent.
• The Croatia legal representative consent guide covers adults unable to provide valid consent.
• The Croatia emergency enrollment guide covers the Article 35 exception and later consent.
• The Croatia pregnancy follow-up guide covers pregnant participants, pregnant partners, and infant follow-up.

Final review before submission

Check the Croatian document against the final protocol, schedule of activities, investigator's brochure, insurance, data plan, sample plan, and financial arrangements. Confirm that every optional choice has DA and NE boxes, all contacts are current, each document carries the correct version and date, and the signature logic matches the population.

Use the Croatia patient-facing document QC checklist for a structured protocol-to-consent review and return to the Croatia CTIS hub for the full guide collection.