Croatia patient-facing document QC checklist

Trial content checks

• Confirm that the trial title, EU trial number where available, sponsor, investigational medicines, comparator, indication, phase, and participant group match the final application.
• Confirm that the purpose and reason for invitation are understandable and do not promise benefit.
• Confirm that global and Croatian target enrollment figures match the approved planning data.
• Check the explanation of randomisation, blinding, placebo, rescue treatment, and treatment assignment against the protocol.
• Check trial duration, treatment duration, follow-up, visit frequency, inpatient stays, remote contacts, and end-of-trial arrangements.
• Confirm that foreseeable risks, unknown risks, expected benefits, lack of expected direct benefit, and alternative treatments match the latest investigator's brochure and protocol.
• Check that emergency contacts and medical advice are appropriate for Croatia and the participating site.

Protocol-to-participant-document consistency

• Compare every procedure with the schedule of activities. Include screening, washout, dosing, blood draws, imaging, biopsies, questionnaires, devices, diaries, recordings, home visits, and long-term follow-up.
• Compare blood and tissue volumes, sample frequency, fasting, contraception, pregnancy testing, and prohibited medicines with the protocol.
• Confirm that optional activities are identified as optional. Do not make optional sample donation, genetics, future research, or recordings appear required for main-trial participation.
• Confirm that the document explains foreseeable burdens such as travel, waiting time, overnight stays, device use, dietary limits, and return of unused medicine.
• Check that withdrawal language distinguishes stopping trial treatment, withdrawing from follow-up, withdrawing an optional consent, and requesting action on stored samples where applicable.
• Confirm that the sponsor's planned home delivery, home nursing, transport, payment provider, recording, wearable, or digital platform appears in both the participant document and the application.

Consent logic checks

• Confirm that the main decision to join the trial has clear signature and date fields.
• Confirm that every optional choice offers both DA and NE and that neither answer affects main-trial participation unless scientifically necessary and stated in the protocol.
• Confirm that the participant and the physician or dentist conducting the consent interview sign and date the document when consent is obtained.
• Confirm that no participant signature is requested at CTIS submission. The submitted version must be blank.
• Confirm that consent occurs before any trial-specific procedure and that the participant receives a signed copy.
• Confirm that routine electronic consent is not proposed. Current Croatian guidance requires in-person paper consent, with only narrow exceptional use of electronic consent followed by paper consent.
• Confirm that an inability to write uses an impartial witness and is not confused with an inability to understand or decide.
• Confirm that refusal, dissent, and later withdrawal are respected without adverse consequences.

Population and document coverage

• Prepare the main competent-adult informed consent as a unified information and signature document.
• For healthy volunteers, explain the absence of therapeutic intent, practical restrictions, confinement where applicable, payment, and reproductive precautions. Use the Croatia healthy volunteer consent guide.
• For minors, cover every recruited age band with the correct assent statement and provide parent or guardian consent. Use the Croatia minor consent and assent guide.
• For adults lacking capacity, provide understandable participant information and a legal-representative document. Use the Croatia legal representative consent guide.
• For Article 35 emergency enrollment, provide the approved initial process and later participant or representative consent. Use the Croatia emergency enrollment guide.
• For a participant who cannot write, add an impartial-witness pathway and attestation. Use the Croatia impartial witness guide.
• For pregnancy follow-up, use separate documents for a pregnant participant and a participant's pregnant partner. Add minor and representative versions where relevant. Use the Croatia pregnancy follow-up guide.
• For optional genetics, biobanking, or future use, use a separate consent where Croatian guidance requires it. Use the Croatia secondary use consent guide.
• Add separate consent for a required caregiver or study partner, a named contact person whose personal details are collected, and home delivery of investigational medicine.

Data privacy checks

• Identify the data controller and relevant representatives with usable contact details.
• State the processing purposes, categories of personal and health data, recipients, coded identifiers, access, retention, transfers, safeguards, and participant rights.
• Do not equate informed consent to trial participation with consent as the legal basis for every personal-data processing operation.
• Explain which data may continue to be used after withdrawal and why, without suggesting that the participant has no data-protection rights.
• Include the sponsor or controller privacy contact and the Croatian Personal Data Protection Agency, AZOP, complaint route.
• Remove blanket clauses allowing the sponsor or investigator to contact outside healthcare professionals for health information. Croatian national specifics state that health information should be obtained from the participant or legal representative.
• If the participant is encouraged to inform a family physician, make clear that the participant chooses and performs that communication. Offer an appropriate physician letter.
• Identify each home-delivery, home-nursing, transport, reimbursement, technology, or other vendor that receives identifiable participant data and explain its role.
• If an emergency contact, caregiver, partner, or other third party provides personal data, prepare a separate notice and consent process for that person where required.

Biological samples and secondary-use checks

• State what samples are collected, why, by whom, where they are processed, where they are stored, how long they are stored, and what happens at the end of the trial.
• Distinguish protocol-required analysis from optional substudies, repository donation, future research, genetic testing, and whole-genome or whole-exome sequencing.
• Explain whether samples are coded or anonymised and avoid claiming anonymisation if a re-identification key remains.
• State how a participant withdraws permission for optional sample use and what can still be done with results or samples already used.
• For genetic analysis, identify who can see results, how they may be used, whether important findings may be returned, and the participant's option not to receive such information.
• Confirm that research outside the approved protocol will not begin without prior Central Ethics Committee review.
• Plan re-consent when a participant who donated samples as a minor becomes an adult and gains full legal capacity.

Croatia-specific regulatory checks

• The cover letter and participant-related documents are in Croatian.
• The Croatian text is professionally translated and proofread, not a literal global-template translation.
• Croatia-specific authorities, costs, insurance, contacts, privacy rights, and legal wording replace country-neutral text.
• The title and text use the Croatian term Informirani pristanak consistently.
• The main consent is one unified document, with all information before the signature section.
• The first page identifies the trial and sponsor. Headers and footers are in Croatian.
• The document states the planned number of participants globally and in Croatia.
• It explains that the sponsor bears all protocol-related costs, including treatment of trial-related injury.
• Reimbursement is described accurately, with the maximum net amount in euros where applicable.
• Croatian contraception and pregnancy follow-up wording matches the national specifics and protocol risk.
• Participant rights questions are directed first to the investigator and trial lead, with the Central Ethics Committee address for written rights questions after those routes.

Signature, version, and administrative checks

• Each document has a unique descriptive name, version, and date matching CTIS.
• Population, site, country, language, and age band are clear in the file name and document header where useful.
• The current version only is in the submission package.
• Signature labels identify participant, legal representative, parent or guardian, physician or dentist interviewer, and impartial witness correctly.
• Date and time fields are included where the protocol or emergency process requires exact sequence evidence.
• The investigator delegation log will authorise the physician or dentist who conducts consent.
• Recruitment materials, scripts, diaries, cards, questionnaires, and instructions are versioned and dated.
• Documents do not contain tracked changes, comments, placeholders, foreign contacts, or inconsistent page numbers.

Readability and document-design checks

• Medical and regulatory terms are explained in plain Croatian.
• Sentences and paragraphs are short enough for the intended population.
• Risks are grouped and prioritised without hiding serious or likely effects in dense text.
• Font, contrast, spacing, headings, tables, and page breaks support reading and printing.
• Signature pages remain visibly connected to the information and include document identity.
• For ages 4 to 7, assent uses simple illustrations, simple explanations, and font no smaller than 20.
• For ages 8 to 11, assent uses simple illustrations, simple explanations, and font no smaller than 16.
• Ages 12 to 14 and 15 to 17 have separate versions in an ordinary format with simpler language.
• Croatian diacritics, capitalization, grammar, and formal address are consistent.

Final package check

Run the Croatia Part II document checklist after the content QC. Confirm that the recruitment procedure, participant documents, investigator evidence, site evidence, insurance, financial arrangements, GDPR statement, and biological-sample statement are all present when applicable.

Return to the Croatia CTIS hub for the complete guide cluster.