Czechia CTIS Part II Guide

Czechia CTIS Part II guide directory

CTIS Part II document checklist

Use this checklist to identify the national Part II documents, templates, language rules, submission-time signatures and CTIS categories that apply in Czechia.

Read the CTIS Part II document checklist

Patient information and consent requirements

Use the main consent guide when preparing the Czech PIS/ICF, including required content, language, consent execution and SÚKL drafting expectations.

Read the Patient information and consent requirements

Patient-facing document QC checklist

Use this before submission to check protocol consistency, Czech-language content, consent logic, population coverage, privacy, samples, versioning and administrative details.

Read the Patient-facing document QC checklist

Healthy volunteer consent requirements

Use this when the study recruits healthy volunteers and the main PIS/ICF must be adapted for healthy-volunteer risks, procedures and compensation.

Read the Healthy volunteer consent requirements

Minor consent and assent requirements

Use this for children and adolescents, including Czech age bands, parent consent, minor signatures and re-consent as the participant gets older.

Read the Minor consent and assent requirements

Limited-capacity participant and legal representative consent requirements

Use this when an adult cannot give legally valid consent or needs information adapted to reduced decision-making capacity.

Read the Limited-capacity participant and legal representative consent requirements

Emergency enrollment consent requirements

Use this when the protocol relies on the emergency provisions of Article 35 of the Clinical Trials Regulation and prior consent cannot be obtained within the therapeutic window.

Read the Emergency enrollment consent requirements

Impartial witness consent requirements

Use this when a participant cannot write or cannot read and an independent witness is needed to document the consent procedure.

Read the Impartial witness consent requirements

Pregnancy follow-up consent requirements

Use this for pregnancy follow-up information and consent, including the distinction between a pregnant trial participant and the pregnant partner of a participant.

Read the Pregnancy follow-up consent requirements

Secondary and future use consent requirements

Use this when the study asks for optional future research use of biological samples or other research activities beyond the main protocol participation.

Read the Secondary and future use consent requirements

Main Czechia Part II differences

Czech participant documents

Mandatory. SÚKL requires the Czech version of the PIS/ICF. The original English PIS/ICF should not be submitted because it is not reviewed or approved. Standard bilingual versions are not permitted. A foreign-language PIS/ICF may be used for a foreign national who demonstrably understands that language, but it must be a certified translation of the approved Czech version and is submitted through CTIS as a non-substantial amendment. The Czechia patient information and consent guide explains the drafting and consent rules.

National templates

Mandatory. SÚKL's January 2026 Part II guideline states that use of its templates is mandatory. The national set includes the recruitment and informed consent procedure, investigator CV, declaration of investigator interest, site suitability, sponsor declaration on personal data processing, participant compensation information and the biological-sample compliance form. Some templates have their own signature requirements, so they should not be treated as interchangeable EU administrative forms. The Czechia Part II document checklist maps each document to its preparation rule.

Minors and other consent variations

For minors, SÚKL requires written age-specific information for ages 12 to 14 and 15 to 17. The national guidance also addresses children under 12, one-parent consent for CTIS studies, re-consent as age changes, reduced capacity, emergency situations and impartial witnesses. Use the relevant population guide rather than adapting the adult form without a documented consent pathway.

Insurance, data and biological samples

Czechia requires the insurance certificate and complete policy including terms and conditions in Czech or bilingual form. SÚKL also requires its sponsor-signed personal-data declaration. When human biological samples are collected, Template 7 is used to describe collection, storage and future use. Optional future use of samples requires a distinct consent choice with a separate signature or a separate signed document.

Ethics fee timing

Do not pay the Part II assessment fee at the initial CTIS submission. SÚKL designates the Ethics Committee during validation and provides payment instructions. Evidence of payment is then required within the national assessment process. The detailed checklist explains the timing so the payment proof is not prepared against the wrong committee.

Other language versions

This package currently contains the English Czechia hub and English guide set. A Czech-language hub should be added only when the corresponding Czech guides have been translated, localized and verified so that no English guide URL is presented as a Czech resource.