Slovakia CTIS Patient Information and Consent Requirements

Slovak language and document format

Mandatory. Provide participant documentation in Slovak. Use familiar words, short sentences and direct explanations. Avoid unexplained protocol terminology, legal formulas and wording that asks the participant to waive rights or releases the investigator, institution or sponsor from liability.

National guidance expects submitted patient-facing documents in English and Slovak. Keep the English master and Slovak translation synchronized by version and date. If only a Slovak participant version is legally needed for a specific item, keep a certified or documented translation trail in the sponsor file.

The Participant Information Sheet may be combined with the Informed Consent Form or presented as two controlled documents. Whichever structure is used, the participant must receive the information before signing and receive a copy of the signed and dated form after consent.

Core content for the Participant Information Sheet

Trial identity and purpose

State that the activity is research. Give the full and short trial title, protocol identifier, sponsor and EU trial number where available. Explain the purpose, investigational treatment, comparator, randomization, blinding and expected length of participation in plain Slovak.

Procedures and participant responsibilities

Describe screening, treatment, visits, tests, sample collection, questionnaires, remote contacts and follow-up. Separate standard care from research-only procedures. Explain invasive procedures, optional activities, recording devices and anything that may affect daily life.

Risks, discomforts and reproductive precautions

Describe reasonably foreseeable risks and burdens, including risks to an embryo, fetus or breast-fed child where relevant. Explain contraception, pregnancy testing, prohibited medicines and what the participant should do if pregnancy occurs. Keep these requirements consistent with the protocol and Investigator's Brochure.

Expected benefit and alternatives

Do not imply personal benefit when none is expected. Explain the possible benefit, or the absence of direct benefit, and the available alternatives to participation. For healthy volunteers, state clearly that the trial is not intended to treat them. The Slovakia healthy volunteer guide covers that variation.

Voluntary participation and withdrawal

State that participation is voluntary and refusal will not affect care or legal rights. Explain how to withdraw, what happens to treatment and safety follow-up, what data may lawfully remain in the trial record and whether unused samples can be destroyed or retained. Do not combine withdrawal from intervention, follow-up, data use and optional future research into one unclear statement.

Injury, insurance, payment and expenses

Explain trial-related injury arrangements and where to seek help. State participant payments and reimbursement of travel or other expenses, including any conditions and what happens after early withdrawal. ŠÚKL's 2025 report identified missing Ethics Committee telephone details and travel-cost information among consent deficiencies, so check both before submission.

Privacy and medical-record access

Identify the controller or controllers and explain why personal and health data are processed, who may access coded or identifiable records, where data may be transferred, how long they are retained and how the participant can exercise rights. Explain access by monitors, auditors and authorities without suggesting that confidentiality can be absolute.

The privacy explanation must be consistent with the CTIS GDPR compliance statement and the protocol. Regulation (EU) 2016/679 consent is not automatically the legal basis for every trial-processing activity, so do not make participation depend on a misleading blanket privacy consent.

Biological samples

Explain which samples are required for the trial, where they are analyzed or stored, whether they leave Slovakia or the European Economic Area, how they are coded, when they are destroyed and what happens after withdrawal. Put optional future use in a separate choice. The Slovakia secondary use guide explains that addition.

Contacts and complaints

Provide a reachable trial medical contact and a contact for participant rights or complaints. Include the national Ethics Committee contact information required by the current Slovak participant-information guidance, including the telephone route. Do not use a generic global mailbox as the only safety contact.

Consent choices and signature block

The consent section should confirm, in separate statements where useful, that the participant:

• received and understood the information
• had enough time and an opportunity to ask questions
• understands participation is voluntary
• agrees to the main trial procedures
• understands permitted source-record access
• received information about privacy, injury, reimbursement and withdrawal
• makes separate optional choices for future data or sample use, optional genetic research, recordings or other substudies

At the consent visit, the participant signs and personally dates the approved form. The person conducting the discussion also signs and dates it. If the participant can consent but cannot write, use the witnessed oral process described in the Slovakia impartial witness guide.

Do not predate forms, complete optional choices on the participant's behalf or use a later translation without ethics approval. Document the consent discussion in the source record.

Population-specific versions

Prepare a separate document pathway whenever the reader, decision-maker or data subject changes:

• participants under 18 need age-appropriate information, parental or legal-representative permission and the child's involvement, as explained in the Slovakia minor consent and assent guide
• adults unable to consent need legal-representative documents and participant information suited to their understanding, as explained in the Slovakia limited-capacity guide
• emergency enrollment requires a protocol-specific deferred-consent route and cannot be created by shortening the standard form, as explained in the Slovakia emergency enrollment guide
• pregnancy follow-up may require a separate participant or pregnant-partner form, as explained in the Slovakia pregnancy follow-up guide

CTIS submission and later use

Upload the blank controlled documents in Subject information and informed consent form. Give each filename a clear population and language label. Do not include completed participant forms or personal data in CTIS.

After authorization, use only the approved Slovak version. Submit material changes through the appropriate CTIS modification route before use. New safety information that could affect willingness to continue must be communicated promptly and may require revised information and re-consent.

Use the Slovakia patient-facing document QC checklist before final upload, and return to the Slovakia CTIS hub for the full guide series.