Hungary CTIS Part II Document Checklist

Recruitment arrangements

Mandatory. Submit the recruitment and informed-consent procedure information required by CTIS. The current EudraLex Volume 10 template is the standard EU structure. Hungary does not publish a separate mandatory national template for this procedure, but the national requirements still apply.

Conditional. If recruitment material will be used, submit every final participant-facing version in Hungarian. This includes final advertisements, invitations, posters, website text and similar materials used to approach potential participants. Do not upload an English-only participant advertisement for use in Hungary.

At CTIS submission, recruitment materials are final blank materials and are not signed by participants. The Hungary patient-facing document QC checklist gives a final consistency review.

Subject information and informed consent

Mandatory. Submit the final Hungarian Subject Information Sheet and Informed Consent Form for each population that will be enrolled. ETT-KFEB refers to the main document as the informed consent based on information and expects information and consent to be combined in one document.

At CTIS submission, submit the final blank consent form. The participant and the investigator or person providing the information sign and date it when consent is actually obtained, not to validate the CTIS upload. If a participant is represented by another person, the correct representative identity and signature fields must be present.

Conditional. Separate genetic information and genetic consent document or documents are required when genetic sampling or genetic research is planned. ETT-KFEB treats these separately because the Hungarian Genetics Act imposes specific informed-consent rules.

Conditional. Prepare population-specific information and consent documents for minors, legal representatives, healthy volunteers, pregnant partners, substudies or other distinct data subjects when the protocol creates a separate consent decision. Each separate document should contain the privacy information relevant to that person, or clearly refer back to the applicable main document where ETT-KFEB allows that approach.

The detailed Hungary Patient Information and Informed Consent guide covers the national content and signature rules.

Patient emergency card

Mandatory when applicable. ETT-KFEB expects the patient emergency card as an addendum to the main consent document and requires the final card in Hungarian. The committee suggests uploading it in the CTIS subject-information area.

The card should include the participant's name and date of birth, protocol identification, investigational medicinal product, relevant mechanism when the name is not informative, indication, contraindications, dangerous interactions, site address, investigator or designated physician and a 24-hour telephone number, plus other emergency information required for safe care.

The committee's specific patient-card guidance states that a patient emergency card is not necessary for Phase IV trials or bioequivalence trials. Apply that exception only where the trial genuinely falls within those categories.

The card itself is not signed at CTIS submission. If the participant's name and study code will appear together on the card, the main consent document must explain the patient-safety reason and obtain agreement to that arrangement.

Investigator suitability

Mandatory. Provide the principal investigator Curriculum Vitae using the CTEG template as modified for Hungary and published by ETT-KFEB. The current national page also asks for CVs of co-investigators using that Hungary-adapted template.

Mandatory. Provide the principal investigator Declaration of Interest using the applicable EudraLex Volume 10 structure.

Mandatory. Demonstrate Good Clinical Practice qualification. The MedEthicsEU Hungary overview states that a full reference in the CV is acceptable, so a separate certificate is not always needed when the CV adequately documents it.

Mandatory. Provide the protocol signature or acceptance pages signed by the principal investigators and co-investigators as required by ETT-KFEB. Unlike the participant consent form, this is a submission-time signature requirement.

Site suitability

Mandatory. Use the Hungary-modified site suitability template published by ETT-KFEB for each Hungarian clinical trial site. It is a national mandatory template. Complete it with the site-specific information needed to demonstrate appropriate facilities and resources.

Do not substitute the generic EU form when the current Hungary-specific template is available. The source page identifies the current Site Suitability Form as the November 2025 version.

Insurance or indemnification

Mandatory. Submit proof of insurance cover or indemnification for the clinical trial. The MedEthicsEU Hungary overview lists the insurance policy and insurance confirmation or certificate as the normal evidence.

The main Hungarian consent document must also state the insurer's name, Hungarian contact details, the contact person and telephone number, and explain how the participant can seek treatment and compensation for trial-related injury. The participant-facing wording is covered in the Hungary consent guide.

The insurance evidence is a sponsor or insurer document. Use the signature or authentication required by the issuing document itself. ETT-KFEB does not require the participant to sign it.

Financial and other arrangements

Mandatory when applicable. Describe compensation or reimbursement offered to participants. ETT-KFEB requires the main consent document to state exactly which documented cost types the sponsor will reimburse. Vague wording such as costs "may" be reimbursed is not accepted by the committee.

Mandatory. Provide financial information on compensation per participant to the site and to the principal investigator and team, including the full amount and its distribution, as reflected in the MedEthicsEU Hungary overview.

Conditional. If a third-party reimbursement service will interact with participants, the consent material must describe the essential arrangement, the data transferred and relevant fees or privacy consequences.

Conditional. If small-value gifts or retention items will be given to participants during the study, Hungary asks for a list of the items and the commercial value of each item.

Data protection

Mandatory. Address Hungarian data-protection requirements in the participant information and consent package. The MedEthicsEU overview does not identify a separate Hungary Part II data-protection document as the normal national requirement. ETT-KFEB instead expects the details to be built into the participant information and consent.

The privacy text should identify the categories of data, coding or anonymisation, recipients and access, storage period and location, international transfer safeguards, purposes, legal basis and participant rights. It should also give the Hungarian data-protection authority, NAIH, as the national contact for rights enforcement.

The Hungary patient-facing QC checklist contains the corresponding checks.

Biological samples and genetics

Mandatory when samples are collected. Describe collection, use, storage and transfer of biological samples in the participant information and consent. The MedEthicsEU Hungary overview does not identify a separate national Part II sample form as the normal requirement.

Conditional. Genetic sampling has additional Hungarian requirements. ETT-KFEB requires genetic information and consent as separate document or documents. The Genetics Act requires detailed written informed consent before genetic sample collection and allows the participant to define permitted uses and storage forms.

For optional future use, follow the Hungary secondary-use consent guide.

Hungarian national cover and document list

Mandatory. ETT-KFEB requires a Hungarian-language cover letter that lists the documents submitted for approval with their names, version numbers and issue dates.

Mandatory. Also provide a Hungarian-language list of the Part II documents to support review by the lay members of ETT-KFEB.

For substantial modifications, the Hungarian cover letter should identify modified and newly created documents with version and date. New or revised documents should be provided in clean and tracked-change form where applicable.

Submission-time signature summary

Participant information and consent forms are submitted as final blank forms. Participant, representative, investigator and witness signatures are obtained during the actual consent procedure.

Protocol acceptance or signature pages are different. Hungary expressly requires them to be signed by the relevant investigators for the Part II dossier.

For national or EU templates such as CV, Declaration of Interest and site suitability, complete every signature or declaration field contained in the current template. Do not remove national fields.

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