Croatia CTIS Part II document checklist

Required and conditional Part II documents

Recruitment and informed-consent procedure

Mandatory. Submit a description of how potential participants will be identified, approached, informed, and consented. Use the current EudraLex Volume 10 informed-consent and patient-recruitment procedure template. Version 2.0 becomes fully implemented for new Part II submissions on 1 September 2026 after the published transition period. Complete the Croatia-specific parts and describe who conducts the interview. Croatian law restricts that interview role to a physician or dentist who is the principal investigator or a delegated investigator. Upload it under Recruitment arrangements. The procedure document is not signed unless the selected template includes a declaration requiring signature.

Conditional. Submit each advertisement, invitation, social-media item, poster, telephone script, letter, or other recruitment material that will be seen or heard by potential participants. Participant-facing material must be in Croatian and should carry a version and date. Upload final proposed materials under Recruitment arrangements. The Central Ethics Committee evaluates advertising case by case.

Main participant information and informed consent

Mandatory. Submit the blank Croatian informed consent document for each participant population. Current Central Ethics Committee guidance treats the participant information and signature content as one unified informed consent document rather than a general information sheet plus a separate signature-only form. It must be professionally translated, proofread, locally adapted, versioned, and dated. It is not signed at submission. When consent is obtained, the participant and the physician or dentist conducting the interview sign and date it. Upload it under Subject information and informed consent form. The Croatia patient information and consent guide explains the required content and Croatian presentation rules.

Conditional. Submit separate Croatian documents for each materially different population or use case, including healthy volunteers, minors and their parent or guardian, adults lacking capacity and their legal representative, emergency enrollment, pregnancy follow-up, optional genetic research, optional biological-sample donation, a required caregiver or study partner, an emergency contact who provides personal information, home delivery of investigational medicines, and any other third party whose data will be collected. Use the relevant detailed guide in this Croatia collection.

Conditional. If participant questionnaires, rating scales, diaries, instructions, cards, or other materials are used, submit the Croatian versions. Participant-completed rating scales must be validated and translated into Croatian. If a scale, questionnaire, or survey is not scientifically validated, Central Ethics Committee guidance asks for the English original and Croatian translation. Upload according to the closest participant-facing CTIS category.

Investigator suitability

Mandatory. Submit a current curriculum vitae for each principal investigator. Central Ethics Committee guidance requests the Croatian HALMED CV format, in Croatian, signed and dated, and no more than six months old for the application. It should identify relevant trial experience and active recruiting studies. Include a signed good clinical practice training certificate from the authorised provider. Upload under Suitability of the investigator.

Mandatory. Submit the investigator declaration of interest using the applicable EudraLex Volume 10 template. It is signed and dated by the investigator at submission and uploaded under Suitability of the investigator.

Conditional. If the proposed investigator lacks the experience expected by the Central Ethics Committee, submit mentor documentation. The guidance calls for a signed mentor acceptance statement, the mentor's CV, and evidence of good clinical practice training. This is assessed case by case under Suitability of the investigator.

Suitability of the trial site

Mandatory. Submit a site suitability form for every Croatian site using the current EudraLex Volume 10 template, completed with the site's facilities, staff, equipment, emergency arrangements, and ability to conduct the protocol. The authorised site representative signs and dates it at submission. Upload under Suitability of the facilities.

Conditional. If a non-hospital site may need to hospitalise a participant because of a serious adverse reaction or complication, Central Ethics Committee guidance requires a signed agreement with the receiving hospital. The agreement must identify who pays the hospitalisation costs. Include it with the site-suitability evidence.

Insurance or indemnification

Mandatory. Provide the local insurance policy, certificate of insurance, and relevant policy terms and clauses. Central Ethics Committee guidance asks the policy to identify the trial, institutions, principal investigators, and planned number of participants. The policy must be signed by the insurer and policyholder. Valid policies from insurers established in the European Union are accepted. Upload under Proof of insurance cover or indemnification.

The insurance must be in place before the trial starts and cover liability connected with trial-related injury, death, or treatment. If final executed coverage is not available at initial submission, confirm with the Ministry and Central Ethics Committee what interim evidence is acceptable. Do not state that a draft alone is sufficient without written confirmation.

Financial and other arrangements

Mandatory. Submit a clear description of trial financing, payments to investigators and sites, participant reimbursement, and any other financial arrangement. State that the sponsor bears all protocol-related trial costs. Central Ethics Committee guidance asks for the maximum net amount, in euros, for travel and other participant expenses. Upload under Financial and other arrangements. The EU compensation template may be used where appropriate.

Mandatory before site initiation. A signed agreement between the sponsor and each trial site is required before that site starts. The agreement must state the total cost of the trial and the costs borne by the sponsor, including medical services and payments to investigators and participants. If it is not an application document in the specific CTIS procedure, retain evidence that it will be executed before activation and provide it if requested.

Data protection compliance

Mandatory. Complete the CTIS statement confirming compliance with Regulation (EU) 2016/679 and applicable Croatian data-protection rules. Use the EudraLex Volume 10 template in the CTIS Form section. A separate Part II document is needed only if the national information is not fully covered there or the authority requests one.

Participant documents must explain the controller, purposes, data categories, recipients, transfers, retention, safeguards, participant rights, and contacts. Central Ethics Committee guidance asks the consent to include a route to the Croatian Personal Data Protection Agency, AZOP. The Croatia patient-facing document QC checklist covers privacy consistency.

Biological samples and genetic research

Conditional. When samples are collected, submit the EudraLex Volume 10 biological-samples compliance template. Describe collection, responsible parties, processing, storage location, storage period, permitted use, transfers, end-of-trial handling, withdrawal, and disposal. Upload under Compliance with applicable rules for biological samples.

Conditional. Prepare a separate Croatian informed consent for optional substudies, donation to a repository or biobank, optional future use, and genetic or genome or exome analysis where required by the Croatian guidance. Research outside the approved protocol needs prior Central Ethics Committee review. The Croatia secondary use consent guide explains when the main consent is enough and when a separate document is expected.

Population-specific documents

Conditional. For minors, submit a parent, guardian, or legal-representative consent document plus separate age-appropriate assent statements for applicable Croatian age bands: 4 to 7, 8 to 11, 12 to 14, and 15 to 17 years. The Croatia minor consent and assent guide covers font, illustration, assent, signature, and re-consent rules.

Conditional. For an adult who cannot provide valid consent, submit information for the participant at the level they can understand and consent documentation for the legally appointed representative. Croatia also has restrictive guidance for trials involving people with mental disorders. Review the Croatia legal representative consent guide before including this population.

Conditional. If the protocol relies on enrollment before consent in a sudden life-threatening or similarly serious condition, describe and justify every Article 35 condition and submit the later consent documents. The Croatia emergency enrollment guide explains the local decision hierarchy and deferred process.

Conditional. Submit separate pregnancy follow-up consent for a pregnant participant and a different consent for a participant's pregnant partner. If infant follow-up is planned, include it in the relevant document. The Croatia pregnancy follow-up guide explains the Croatian restrictions on obtaining information from healthcare professionals.

Submission language and version control

The cover letter and participant-related documentation must be in Croatian. Other documentation may be in Croatian or English. Every document used in the trial that is not a scientifically validated instrument with a reference should carry a version and date. Submit only the current version in CTIS and keep document names, versions, dates, populations, and sites consistent across the dossier.

Do not submit signed participant consent pages in the application. Submit clean, blank versions for assessment. Signatures needed during conduct must be described in the procedure and shown with correctly labelled signature and date fields in the approved document.