Slovenia CTIS Part II Guides

Choose the right Slovenia guide

Slovenia CTIS Part II Document Checklist

Use this page to identify the standard and conditional Part II documents, their language, CTIS category, and submission-time signature status.

Read the CTIS Part II Document Checklist guide

Slovenia Patient Information and Consent Requirements

Start here when preparing the main Slovenian Patient Information Sheet and Informed Consent Form for adults able to consent.

Read the Patient Information and Consent Requirements guide

Slovenia Patient-Facing Document QC Checklist

Use this final review before uploading Slovenian participant materials, consent forms, recruitment content, diaries, questionnaires, and use-case variations.

Read the Patient-Facing Document QC Checklist guide

Slovenia Healthy Volunteer Consent Requirements

Use this variation when the trial recruits healthy volunteers and the information must explain non-therapeutic participation, payment, burden, and reproductive risk clearly.

Read the Healthy Volunteer Consent Requirements guide

Slovenia Minor Consent and Assent Requirements

Use this guide for parent or guardian consent, age-appropriate information, assent, Slovenia's 15-year threshold, dissent, and re-consent at adulthood.

Read the Minor Consent and Assent Requirements guide

Slovenia Limited-Capacity and Legal Representative Consent Requirements

Use this guide when an adult cannot provide legally valid consent and a legal representative must act while the participant remains involved as far as possible.

Read the Limited-Capacity and Legal Representative Consent Requirements guide

Slovenia Emergency Enrollment Consent Requirements

Use this guide only for a protocol designed to rely on the narrow emergency pathway in Article 35 of the Clinical Trials Regulation.

Read the Emergency Enrollment Consent Requirements guide

Slovenia Impartial Witness Consent Requirements

Use this guide when a participant or legal representative can consent but cannot write, making an impartial witness necessary for the consent record.

Read the Impartial Witness Consent Requirements guide

Slovenia Pregnancy Follow-Up Requirements

Use this guide for pregnancy-risk language, pregnant participants, pregnant partners, follow-up data, medical-record access, and separate consent decisions.

Read the Pregnancy Follow-Up Requirements guide

Slovenia Secondary Use Consent Requirements

Use this guide when optional future research will use identifiable or pseudonymised data, stored biological samples, or material beyond the main trial purpose.

Read the Secondary Use Consent Requirements guide

Main Slovenia differences to plan for

Slovenian is mandatory for key documents

The national implementing regulation allows the application dossier in Slovenian or English, but makes three exceptions. The cover letter must be in Slovenian. A Slovenian protocol synopsis with the nationally specified short description is mandatory, and current EU language guidance calls for both English and Slovenian synopsis versions in a multinational application. Documents intended for participants must also be in Slovenian. This includes the Patient Information Sheet, Informed Consent Form, recruitment materials, participant cards, instructions, questionnaires completed by participants, and population-specific consent documents. The Slovenia Part II document checklist maps these language rules to the CTIS upload categories.

National ethics review is centralised

KME RS is the competent ethics committee for the Clinical Trials Regulation in Slovenia and prepares the Part II assessment. JAZMP performs validation, the scientific assessment, national coordination, and notification of the decision. A separate pre-submission ethics opinion is not a substitute for the CTIS assessment.

Slovenian participant information has national content expectations

KME RS expects clear, short, respectful, and lay-friendly information. Its published guidance asks for procedures, duration, benefits, risks, confidentiality, data access and retention, results availability, alternatives, withdrawal, insurance, and a named investigator contact. The consent form is signed when consent is obtained, not by future participants at CTIS submission. KME RS also publishes a short model consent form, but the model does not replace a trial-specific information and consent package. The main Slovenia patient information and consent guide explains the content and signature process.

Insurance must cover sponsor and investigator liability

Before the trial starts in Slovenia, insurance or another guarantee must cover both the sponsor's liability and the investigator's liability for damage suffered because of trial participation. The proof belongs in the Part II insurance category and should be aligned with the trial, Slovenian sites, participants, and planned conduct period.

Slovenia applies a 15-year consent-capacity presumption in healthcare

Under the Patients' Rights Act, a child younger than 15 is presumed unable to consent to healthcare unless the doctor considers the child sufficiently mature. A child aged 15 or older is presumed able unless the doctor finds otherwise. For a clinical trial, the Clinical Trials Regulation still requires consent from the legally designated representative for every participant who remains a minor. KME RS guidance also requires agreement from invited minors aged 15 or older in addition to parent or representative consent. The Slovenia minor consent and assent guide explains how the rules work together.

Trial consent and data-protection legal basis are different questions

Slovenia's Information Commissioner states that informed consent to participate in a clinical trial must not be treated automatically as consent under the General Data Protection Regulation. The controller must identify and document the correct legal basis for each processing purpose. Optional future research or sample use needs a separate, intelligible choice when consent is used. The Slovenia secondary-use guide covers that separation.

Other language versions

This package is the English version. A reciprocal link should be added here when the Slovenian-language hub and guides are published.