Hungary CTIS Patient-Facing Document QC Checklist

Trial content checks

• Confirm the EU clinical trial number, protocol number and trial title are correct and identical across participant documents.
• Confirm the Hungarian site and healthcare-provider details match the submitted site package.
• Confirm investigator or information-provider names and roles are current.
• Confirm the study purpose, duration, participant numbers, procedures and visit burden match the protocol.
• Confirm alternatives to trial participation are described accurately.
• Confirm known and reasonably foreseeable risks are consistent with the protocol and current safety information.
• Confirm the document says explicitly when no direct participant benefit is expected.
• If placebo is used, confirm the probability and practical meaning of placebo assignment are explained.
• Confirm the investigational medicinal product and any necessary plain-language mechanism description are correct.

Protocol-to-document consistency checks

• Match contraception, pregnancy testing and pregnancy-reporting wording to the protocol.
• Match sample types, volumes, collection times and analyses to the protocol.
• Match data and sample retention periods to the approved plan.
• Match reimbursement and travel arrangements to the financial documents.
• Match emergency contact arrangements to the site information and patient emergency card.
• Confirm all optional substudies in the protocol have a corresponding optional consent pathway where needed.
• Confirm the protocol does not contain a participant-facing procedure that is absent from the Hungarian information.

Consent logic checks

• Confirm the participant receives information before signing.
• Confirm the participant or authorised person has the correct signature and date fields.
• Confirm the principal investigator or person providing information has the required signature field.
• Confirm each separate consent document has one coherent signature set.
• Confirm optional decisions are separated from mandatory participation decisions.
• Confirm withdrawal is described as possible without reason and without disadvantage.
• Confirm the document explains any lawful consequences of withdrawal, such as handling of data already collected.
• Confirm genetic consent is not merged into the main ICF. Hungary expects separate genetic information and consent documents.

Population and document coverage checks

• Adults with capacity have the standard Hungarian ICF.
• Healthy volunteers have wording suitable for a person with no therapeutic indication and, where relevant, transparent compensation information. See the healthy volunteer guide.
• Minors have age and maturity appropriate information plus the correct parent or legal-representative pathway. See the minor consent and assent guide.
• Adults with restricted capacity have participant and representative material appropriate to the legal situation. See the limited-capacity guide.
• Emergency-enrollment trials have a prospectively described later-information and consent pathway. See the emergency enrollment guide.
• If a participant cannot read or write, the form supports Hungary's two-witness oral-consent process. See the impartial witness guide.
• Pregnancy follow-up has separate documents for the participant or pregnant partner where the data subject and consent decision differ. See the pregnancy follow-up guide.
• Optional future use is covered by a separate or clearly separable choice. See the secondary-use guide.

Data privacy checks

• Identify the sponsor and other controllers or processors as required by the approved privacy model.
• List the categories of personal and special-category data actually collected.
• Use "coded", "pseudonymised" and "anonymous" consistently. Do not describe the same transfer as anonymous in one section and coded in another.
• Explain which parties may access source records and under what conditions.
• Explain how data leave the site and whether the code key stays at the site.
• Name recipients or recipient categories with enough specificity for the participant to understand.
• State the purpose of processing and the legal basis described in the Hungary-approved wording.
• State storage duration and location.
• Explain third-country transfers and safeguards where relevant.
• Include the participant's rights and NAIH contact information.
• If a third-party reimbursement service receives data, state exactly which data it receives and why.
• If a pregnant partner has a separate information sheet, include privacy information for that partner.
• If a substudy has a separate information sheet, include or appropriately cross-reference the privacy information for that substudy.

Biosample and secondary-use checks

• State which biological samples are taken and the primary study purpose.
• State storage duration, location, coding and transfer.
• State what happens to samples after the primary research purpose ends.
• Make future use optional when it is not required for the main study.
• For non-anonymous secondary use, check whether the future purpose was explained at the original consent. If not, ETT-KFEB requires renewed consent.
• For genetic sampling, use the separate Hungarian genetic information and consent structure and check the choices required under the Genetics Act.
• Confirm withdrawal instructions distinguish identifiable or coded material from material that has already been irreversibly anonymised.

Insurance, injury and reimbursement checks

• Name the insurer.
• Include the insurer's Hungarian contact details.
• Include the contact person's name and telephone number.
• Explain who the participant contacts after trial-related injury.
• Explain treatment and compensation rights in language consistent with Hungarian law.
• If reimbursement is offered, list exact documented cost types.
• Remove vague wording such as "may reimburse" when the sponsor has defined reimbursable costs.
• If an external reimbursement provider is used, explain its relationship with the participant and the data flows.

Patient emergency card checks

• Confirm a final Hungarian card is included for applicable trials.
• Confirm participant name and date of birth fields.
• Confirm protocol and investigational medicinal product identification.
• Add the mechanism when the product name alone does not explain the relevant safety context.
• Confirm indication, contraindications and dangerous interactions.
• Confirm site address and 24-hour medical contact.
• Confirm the ICF tells the participant to carry the card.
• If participant identity and study code appear together, confirm the patient-safety reason is explained and consented.
• Check the ETT-KFEB exception for Phase IV and bioequivalence trials before creating an unnecessary card.

Signature, version and administrative checks

• Confirm every document has a version number and date consistent with the Hungarian Part II document list.
• Confirm no participant-facing form is pre-signed for CTIS submission.
• Confirm the main ICF contains participant or authorised-person and investigator or information-provider signature fields.
• Add two witness signature fields plus witness address or contact fields when the oral-consent pathway can apply.
• Confirm genetic documents each have their own coherent signature set.
• Confirm pregnancy-partner documents are signed by the pregnant partner when her data or records are collected.
• Confirm the Hungarian cover letter and document list identify the same versions.

Hungarian language and design checks

• Use final Hungarian text for participant-facing and recruitment material.
• Have the text reviewed by a competent Hungarian-language reviewer with clinical-trial knowledge.
• Check formal address and verb forms for consistency.
• Remove literal English constructions that sound unnatural or change meaning.
• Remove foreign-law references that do not apply in Hungary.
• Use understandable explanations for medical and regulatory terms.
• Keep headings and consent choices visually clear.
• Do not place a participant study code in the ICF where ETT-KFEB expressly says it should not appear.

Back to the Hungary CTIS hub

The complete English Hungary guide cluster is at https://trialagents.com/ctis/hungary/en.