Czechia CTIS Part II Patient Information and Consent Requirements

Czech language requirements

Mandatory. Submit the Czech PIS/ICF. SÚKL says the original English version should not be submitted because it will not be reviewed or approved. Standard bilingual versions are not permitted.

Conditional. If a foreign national is enrolled, provide the PIS/ICF in a language that the participant demonstrably understands, preferably the participant's native language. SÚKL requires a certified translation of the approved Czech version. Submit that translated document through CTIS as a non-substantial amendment. A bilingual version is permitted in this specific situation.

Other participant-facing materials such as diaries and participant cards should also be in Czech. An English questionnaire is acceptable only when it is completed together with the participant by the investigator, subject to the SÚKL conditions described in the patient-facing QC checklist.

Readability and presentation

SÚKL recommends KLH-22 Version 5 when drafting participant information. It is guidance, not a mandatory template.

Recommended. Use clear, understandable language and avoid unnecessary specialist terminology and abbreviations. KLH-22 recommends language review before submission and asks sponsors to adapt style and length to the participant population.

For adult participants and parents or guardians, KLH-22 recommends a concise document, normally no more than about eight pages and in specific cases ten pages, using a standard readable font. Shorter information and larger type may be appropriate where the target population has reduced ability to read or understand long documents.

Number the pages and show the document version, date and trial identification consistently. The participant should be able to distinguish research procedures from routine care and understand what is optional.

Main content to cover

The PIS/ICF should explain the trial in enough detail for a participant to make an informed decision. The exact content must follow the protocol and the participant's situation.

Study identity and purpose

Explain that the activity is a clinical trial and identify the sponsor. State the full clinical trial title and EU CT Number in every Czech PIS/ICF version, as required by SÚKL. Explain the study objective and the investigational treatment in participant-friendly language.

Where relevant, explain randomisation, the probability of receiving placebo or another treatment, the expected treatment period, trial visits, procedures and tests, and which procedures differ from normal care.

Risks, benefits and alternatives

Describe reasonably foreseeable risks and burdens, including risks associated with the investigational treatment and trial procedures. Present expected benefits without promising benefit. Explain appropriate alternatives to trial participation where relevant.

For pregnancy-related risks, explain known or potential fetal and breastfeeding risks and the contraception requirements that actually apply under the protocol. The pregnancy follow-up guide covers follow-up documents and partner situations.

Data access and privacy

Mandatory. SÚKL requires consent wording that permits access to source documentation such as medical records by monitors, auditors, regulatory authorities or medicines agencies, ethics committee members and study-team members as applicable.

Explain confidentiality, coding or pseudonymisation and the relevant data-processing arrangements in plain language. The sponsor also submits the separate national personal-data declaration in Part II. Do not use the participant's trial consent as a substitute for the sponsor's regulatory data-protection documentation.

Biological samples

Explain protocol-required sample collection, testing, storage and destruction or retention. If optional future research use is requested, separate the choice from mandatory trial participation.

Mandatory when future use is requested. SÚKL allows future-sample consent inside the PIS/ICF only if that consent has its own separate signature. Alternatively, use a separate signed future-use document. State the storage period, whether samples remain pseudonymised or become fully anonymised and the main intended research purpose. See the Czechia secondary-use consent guide.

Insurance, compensation and reimbursement

Explain trial-related injury arrangements and participant compensation or reimbursement that applies. The Part II dossier separately contains the Czech or bilingual insurance policy and terms and the financial-arrangements information.

If remuneration is offered, describe it accurately. KLH-22 recommends remuneration to trial participants only in Phase I, bioequivalence and pharmacokinetic studies and states that vulnerable participants should not receive remuneration. Expense reimbursement is a separate concept and may still apply.

Withdrawal and contacts

Explain that participation is voluntary and that the participant may withdraw without detriment, while accurately describing what happens to data and samples already collected.

Mandatory. Include the ethics committee contact email required by SÚKL. Use eticka.komise@sukl.gov.cz or the email of the specific Ethics Committee that reviewed and oversees the trial. SÚKL says not to provide an ethics committee telephone number in the PIS/ICF.

Mandatory. State that trial results will be available on the EMA clinical trials website. Do not direct participants to an obsolete national clinical-trial register for this purpose.

Consent and signature logic

The blank PIS/ICF is submitted in CTIS. The actual signatures are obtained later during trial conduct when informed consent is given.

Under Article 29 of Regulation (EU) No 536/2014, consent is normally written, dated and signed by the participant or legally designated representative and by the person who conducted the consent interview. The participant or representative receives a copy.

SÚKL's KLH-22 states that the consent process is conducted by the investigator and that the participant should have enough time to consider participation and ask questions. The Czech form should state that one dated and signed copy is given to the participant and one remains at the trial site.

Electronic PIS/ICF and electronic signatures

Optional. SÚKL permits electronic versions of the PIS/ICF.

When the consent record is signed electronically, SÚKL accepts a qualified electronic signature, a recognized or guaranteed electronic signature, or a dynamic biometric signature such as the national examples listed in KLH-CTIS-01. A sponsor-created electronic signature that does not meet the stated criteria is not acceptable.

The technology does not change the informed-consent requirements. The participant still needs understandable information, opportunity for discussion and a copy of the executed consent.

Population-specific variations

The main PIS/ICF should not be stretched to cover every population with generic wording. Use a separate or adapted document when the consent pathway changes.

• For children and adolescents, use the Czechia minor consent and assent guide.
• For adults with limited decision-making capacity and legal representatives, use the limited-capacity consent guide.
• For Article 35 emergency enrollment, use the emergency enrollment guide.
• When an independent witness is needed because the participant cannot read or write, use the impartial witness guide.
• For healthy volunteers, use the healthy volunteer consent guide.
• For pregnancy data collection, use the pregnancy follow-up guide.
• For optional future research or sample use, use the secondary-use consent guide.