Clinical Trial Applications in Slovakia: CTIS Part II Guides

Choose the right Slovakia CTIS guide

Slovakia CTIS Part II document checklist

Use this first to identify the required, conditional and supporting documents, their CTIS locations, language rules and submission-time signatures.

Read the Slovakia CTIS Part II document checklist

Slovakia patient information and consent requirements

Use the main consent guide to prepare the standard adult Participant Information Sheet and Informed Consent Form in Slovak.

Read the Slovakia patient information and consent requirements

Slovakia patient-facing document QC checklist

Use this before submission to check protocol consistency, Slovak wording, consent choices, contacts, privacy, samples, insurance and version control.

Read the Slovakia patient-facing document QC checklist

Slovakia healthy volunteer consent requirements

Use this for Phase I, bioequivalence and other trials involving healthy volunteers, especially where there is no expected therapeutic benefit.

Read the Slovakia healthy volunteer consent requirements

Slovakia minor consent and assent requirements

Use this for participants under 18 and for the separate information, parental permission and assent materials required by age and understanding.

Read the Slovakia minor consent and assent requirements

Slovakia limited-capacity participant and legal representative consent requirements

Use this when an adult cannot provide legally valid informed consent and a legal representative must act while the participant remains involved in the decision.

Read the Slovakia limited-capacity participant and legal representative consent requirements

Slovakia emergency enrollment consent requirements

Use this only when the protocol proposes enrollment before prior informed consent under the narrow emergency conditions in Article 35 of the Clinical Trials Regulation.

Read the Slovakia emergency enrollment consent requirements

Slovakia impartial witness consent requirements

Use this when a participant or legal representative cannot read or cannot complete the ordinary written consent process and an impartial witness is needed.

Read the Slovakia impartial witness consent requirements

Slovakia pregnancy follow-up consent requirements

Use this for follow-up of a pregnant trial participant or the pregnant partner of a trial participant, with separate privacy and medical-record permissions where needed.

Read the Slovakia pregnancy follow-up consent requirements

Slovakia secondary use consent requirements

Use this when data or biological samples may be stored, shared or used for research beyond the main trial.

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Main Slovakia-specific differences

Slovak is the controlling participant language

Slovak law requires the application dossier and participant documentation to be submitted in Slovak. Translate the approved meaning, not only the words. Medical terms, withdrawal language, data-protection rights and contact information must remain understandable to the intended population. The Slovakia patient information and consent guide explains the expected content and consent process.

One national Ethics Committee assesses Part II

The Ethics Committee established by the Ministry of Health assesses Part II for CTIS medicinal-product trials. Separate institutional ethics review may still be relevant to local governance, but it does not replace the national CTIS Part II assessment.

Slovakia uses a defined national document set

The package normally includes the recruitment and consent procedure, Slovak Participant Information Sheet and Informed Consent Form, principal investigator curriculum vitae and declaration of interest, a list of Slovak sites and investigators, a site suitability form for each site, insurance evidence, financial information, data-protection compliance and biological-sample information. The Slovakia Part II document checklist maps these items to CTIS.

Current EU limits apply to extra patient-facing materials

The March 2026 European Commission Q&A states that Member States should not request documents that the Clinical Trials Regulation does not include in the application dossier. Do not upload every diary, card, questionnaire or instruction merely because a participant sees it. Submit the materials required by Annex I and follow the specific rule for endpoint-related patient-facing documents. Any Slovak version that will be used with participants still needs proper translation and approved version control.

Revised recruitment and consent procedure template

EudraLex Volume 10 introduced version 2.0 of the informed consent and patient recruitment procedure template. It is strongly recommended up to 31 August 2026 and applies fully to new Part II submissions from 1 September 2026. Use version 2.0 for a package intended for submission after that date.

Other language versions

This file contains the English Slovakia series. Link to the Slovak-language hub only after the localized pages have been published and their URLs have been verified.