Slovenia CTIS Part II Document Checklist

Required Slovenia CTIS Part II documents

Recruitment and informed consent procedure

Mandatory. Submit a description of recruitment and the informed consent procedure under Recruitment Arrangements. Use the current European Commission template. Version 2.0 becomes applicable to all new Part II submissions on 1 September 2026. On this guide's review date, the transition period ends the next day, so a submission made on or after that date should use version 2.0.

The document may be in Slovenian or English because it is an administrative assessment document rather than participant-facing content. It is not signed by future participants. The current EU template does not require a Slovenian national signature form.

Conditional. Upload each recruitment advertisement, invitation, social-media text, video script, call-centre script, or other material that participants will see or hear. The Slovenian version is required. Submit final-form text or a sufficiently complete representation of non-print content. These materials are not signed at application submission.

Patient Information Sheet and Informed Consent Form

Mandatory. Submit the trial-specific Slovenian Patient Information Sheet and Informed Consent Form under Subject Information and Informed Consent Form. Upload the blank version, with a version number and date. It is not signed by the participant, legal representative, witness, or investigator at CTIS submission.

When consent is later obtained, the participant or legally designated representative and the person conducting the consent interview sign and date the consent record. KME RS guidance asks for signing in the investigator's presence and two copies, one for the participant and one for the trial archive. The main Slovenia consent guide covers the required content and consent process.

Population-specific information and consent documents

Conditional. Add separate or adapted Slovenian documents whenever the protocol includes a consent pathway not adequately covered by the main adult PIS and ICF. Common triggers include healthy volunteers, minors, adults unable to consent, emergency enrollment, a participant unable to write, pregnancy follow-up, or optional future use of data and samples.

These are blank application documents and are signed only when the applicable consent is obtained. Use the minor guide, limited-capacity guide, emergency guide, and impartial witness guide for the relevant pathways.

Other participant-facing materials

Conditional. Submit Slovenian participant cards, dosing instructions, device instructions, diaries, questionnaires, interview guides, educational sheets, pregnancy alerts, and similar materials when used. Keep protocol-driven outcome instruments aligned with the English version used for common scientific assessment. Upload the Slovenian participant version in the appropriate Part II category according to current CTIS guidance.

The Slovenia patient-facing document QC checklist covers cross-document consistency and version control.

Investigator Curriculum Vitae

Mandatory. Submit a current Curriculum Vitae for the principal investigator at each Slovenian site under Suitability of the Investigator. It may be in Slovenian or English. It should show education, professional registration, relevant experience, and clinical-trial competence.

Slovenian law requires one principal investigator at each site. The principal investigator must be a licensed physician or licensed doctor of dental medicine and trained to conduct trials according to Good Clinical Practice. The Clinical Trials Regulation does not require a signature on the CV at CTIS submission, and no additional Slovenian CTIS signature rule for the CV was identified. Do not create an unsupported signature requirement.

Declaration of Interest

Mandatory. Submit a declaration describing financial interests and institutional affiliations that could affect impartiality under Suitability of the Investigator. It may be in Slovenian or English. Use the EudraLex template or a document containing the same required information.

The current EU Questions and Answers states that signatures on investigator CVs and declarations of interest are not application requirements under the Clinical Trials Regulation. Slovenia has not published a contrary CTIS-specific rule. Keep the document current and attributable to the investigator without presenting a signature as mandatory.

Site suitability statement

Mandatory. Submit a site suitability statement for every Slovenian trial site under Suitability of the Facilities. It may be in Slovenian or English. The statement should identify the site, principal investigator, facilities, equipment, staffing, pharmacy and sample pathways, emergency support, participant population, and ability to perform the protocol safely.

KME RS guidance expects the responsible institutional management to confirm that the research is permitted after ethics approval, qualified staff and safety arrangements are available, research-only costs do not burden compulsory health insurance, and ordinary patient access will not be reduced. Use the current EudraLex site suitability form and obtain the date and signature of the person authorised to confirm the institution's suitability. Site-suitability signatures are governed by the Member State's system.

Proof of insurance or indemnification

Mandatory. Submit proof under Proof of Insurance Cover or Indemnification. Slovenian law requires insurance or another guarantee covering both sponsor liability and investigator liability for damage a participant suffers because of participation in a trial conducted in Slovenia. Coverage must be in place before trial conduct starts.

The insurance evidence may be in Slovenian or English because it is not addressed to participants. It should allow KME RS to connect the cover to the sponsor, protocol, Slovenian conduct, covered liabilities, period, and any material exclusions. A certificate issued by the insurer does not require a separate applicant signature. If the certificate omits essential terms, include the relevant policy wording or an explanatory guarantee.

The Slovenian PIS and ICF must describe damage cover and the route for obtaining information or making a claim. Do not confuse proof uploaded at submission with the participant signatures obtained later.

Financial and other arrangements

Mandatory information. Submit a clear description under Financial and Other Arrangements. Cover trial financing, payments to investigators or sites, participant expense reimbursement, compensation, any other benefits, and arrangements that could influence recruitment or conduct. The document may be in Slovenian or English and normally does not need a participant signature at submission.

When participants will receive payment or reimbursement, state the amount, basis, schedule, conditions, and treatment after early withdrawal in the Slovenian PIS. KME RS guidance supports reimbursement of participation-related direct costs and warns that the amount must not induce participation. The institution conducting the research, rather than the sponsor directly, should contract with participants for compensation under the published KME RS guidance.

Compliance with national data-protection requirements

Mandatory. Submit the statement or supporting document required in the CTIS data-protection category. It may be in Slovenian or English. Identify the controller arrangements, legal basis, purposes, recipients, transfers, safeguards, retention, participant rights, and compliance with the General Data Protection Regulation and Slovenian law.

The Slovenian participant information must explain privacy and confidentiality in Slovenian, including who can access identifiable or coded data and how long it will be kept. Trial participation consent is not automatically consent for personal-data processing. Slovenia's Information Commissioner requires the controller to identify the proper legal basis for the actual processing operations.

Compliance with rules for biological samples

Conditional. When the trial collects, exports, stores, genetically analyses, or reuses human biological samples, submit a completed biological-sample compliance document in the CTIS category Compliance with Use of Biological Samples. The EudraLex template may be used. The assessment document may be in Slovenian or English.

Participant-facing sample information and choices must be in Slovenian. Separate the samples required for the trial from optional future use. Explain purpose, tests, coding, storage location and duration, transfers, destruction or anonymisation, return of findings where applicable, and what withdrawal can still achieve. The Slovenia secondary-use consent guide explains optional future-use consent.

Slovenian cover letter and protocol synopsis

Mandatory national language items. The cover letter and protocol synopsis are not ordinary Part II placeholders, but they are essential Slovenia application checks. The cover letter must be in Slovenian. The Slovenian synopsis is mandatory, and current EU language guidance calls for English and Slovenian synopsis versions in a multinational application. The protocol itself may be in Slovenian or English.

The Slovenian synopsis must briefly cover the purpose and scientific importance, methods including statistics, duration, participant number and ages, recruitment, inclusion and exclusion criteria, withdrawal criteria, randomisation, and ethical issues including benefits, risks, and burdens. The national implementing regulation also asks that the scientific importance be supported by essential literature, including relevant Slovenian literature.

Proof of fee payment

Mandatory administrative requirement. The sponsor pays the combined national procedure fee to JAZMP under the current JAZMP tariff. JAZMP allocates the KME RS portion. Follow the current JAZMP payment instructions for the application type and retain proof of payment. Do not make a second standalone KME RS payment for a CTIS application unless an authority instruction for the specific procedure expressly requires it.

Submission-time signature summary

• The blank PIS, ICF, assent forms, pregnancy forms, and other participant consent forms are not signed by future participants at CTIS submission.
• Recruitment materials are not signed by participants.
• The investigator CV and Declaration of Interest do not have a CTR signature requirement at submission.
• The site suitability statement should be dated and signed by the person authorised to confirm the Slovenian site's suitability.
• Insurance evidence is issued by the insurer or guarantor. It does not need an additional participant signature.
• Participant, legal-representative, witness, and interviewer signatures are obtained during the approved consent process, not during application assembly.

Slovenia submission resources

Use the national implementing regulation for the authority split, language, investigator, and insurance rules. Use the official KME RS page and its currently posted guidance for national ethics expectations. Use the March 2026 EU Questions and Answers and EudraLex Volume 10 for the current CTIS categories, templates, and signature principles.

Return to the Slovenia CTIS hub for every guide in the country cluster.