Slovakia CTIS Patient-Facing Document QC Checklist

Trial content checks

Confirm that each document uses the same:

• full and short trial title
• protocol number and current version
• sponsor name
• EU trial number where available
• investigational treatment and comparator descriptions
• visit duration and overall participation period
• contact details and site information

Remove internal drafting notes, tracked changes, unresolved placeholders and references to another country.

Protocol-to-participant consistency

Check the Slovak text against the protocol schedule and safety sections. Confirm that screening tests, randomization, blinding, treatment periods, washouts, invasive procedures, imaging, sampling, genetic testing, questionnaires, contraception, pregnancy testing, prohibited medicines and long-term follow-up are described at the correct level.

Make sure standard care and research-only procedures are distinguished. Do not promise results, treatment access or medical benefit that the protocol does not provide.

Consent logic checks

Confirm that main-trial consent is not bundled with optional future research, recordings, genetic analysis or other substudies. Each optional choice should allow a clear yes or no without affecting main-trial eligibility unless the activity is scientifically required by the protocol.

Check that the form states participation is voluntary, questions are allowed, refusal does not affect care, and consent may be withdrawn. Explain separately what withdrawal means for treatment, safety follow-up, data already collected and remaining samples.

The standard signature block must allow the participant and the person conducting the consent discussion to sign and personally date the form. Add legal-representative, witness or parent blocks only to the document pathway where they apply. The main Slovakia consent guide explains the ordinary process.

Population and document coverage

Map every protocol population to an approved information and consent route:

• healthy volunteers need an explicit no-direct-benefit and payment explanation
• participants under 18 need parent or legal-representative permission and age-appropriate information
• adults unable to consent need a legal-representative route and participant involvement
• emergency enrollment needs the Article 35 pathway and subsequent consent documents
• participants or representatives unable to read need an impartial-witness procedure
• pregnancy follow-up needs the correct form for the pregnant participant or pregnant partner
• optional future data or sample use needs a separate choice

Use the Slovakia healthy volunteer guide, minor guide, limited-capacity guide, emergency guide, witness guide, pregnancy guide and secondary-use guide for the detailed variations.

Slovak language and readability

Check that all participant text is in natural Slovak and can be understood by the intended population. Expand abbreviations at first use. Replace literal translations that do not match Slovak clinical or regulatory usage. Keep defined trial terms consistent across all documents.

Compare the Slovak text sentence by sentence with the English source. Verify numbers, units, dates, probabilities, treatment names, visit frequencies, sample volumes, contraception periods and contact details. Confirm that formatting does not hide qualifications or make optional text look mandatory.

Privacy checks

Confirm that the privacy section identifies controllers, processing purposes, data categories, recipients, source-record access, international transfers, retention, participant rights and the complaint route. Check consistency with the GDPR statement submitted in CTIS and with sponsor and site privacy responsibilities.

Do not say that all data can be deleted after withdrawal. Explain which records may need to be retained for trial integrity and legal obligations. Do not use consent to the clinical trial as a blanket GDPR consent for every processing activity.

Biological sample and secondary-use checks

Confirm that the main trial sample description matches the protocol and laboratory manual. State collection, purpose, coding, analysis location, transfers, storage period, destruction and withdrawal handling.

Optional future use must be distinguishable from required trial testing. Define the scope without using an unlimited phrase such as any research forever. If genetic analysis is planned, say so directly and explain whether individual results will be returned.

Slovakia-specific regulatory checks

Confirm that:

• the Slovak version is the participant-use version
• English and Slovak versions align where both are submitted
• the current national Ethics Committee contact route, including required telephone details, appears in the Participant Information Sheet
• travel and other expense reimbursement is explained
• injury and insurance wording matches the valid Slovakia certificate
• the correct version 2.0 recruitment and consent procedure template is used for submissions from 1 September 2026
• only documents permitted by the Clinical Trials Regulation and current Commission Q&A are uploaded

ŠÚKL's 2025 annual report identified missing Ethics Committee phone details and travel-cost information as recurring deficiencies. Treat these as explicit QC points, not generic good practice.

Signature, version and administration checks

Before upload, confirm that the CTIS documents are blank and contain no participant personal data. Check version number, date, language, population and country in the filename and footer.

The participant-use form is signed only when consent is obtained. Confirm that the approved signature blocks match the planned process and that the participant receives a signed copy. Retain evidence of translation review and approval in the trial file.

Final upload review

Open every final PDF after conversion. Check page order, bookmarks if used, line breaks, special Slovak characters, signatures fields, selectable text and absence of comments or hidden content. Upload each file to the correct CTIS placeholder and apply the required publication or personal-data handling rules.

Finish by reconciling the document inventory with the Slovakia Part II document checklist. Return to the Slovakia CTIS hub for the complete series.