Slovenia CTIS Patient-Facing Document QC Checklist

Trial identity and content checks

• Confirm the protocol number, EU trial number, sponsor, full title, short title, investigational product, comparator, and study population are consistent across every document.
• Confirm each patient-facing file is in Slovenian and uses correct clinical terminology rather than an unreviewed literal translation.
• Verify every document has a clear title, population, version number, and date.
• Check that randomisation, blinding, placebo or comparator use, treatment assignment, and rescue treatment are explained accurately.
• Match visit counts, treatment duration, follow-up, sample volumes, imaging, questionnaires, device use, contraception, and participant responsibilities to the protocol and schedule of activities.
• Remove procedures that were deleted from the protocol and add procedures that participants will experience.
• Distinguish research-only procedures from standard care.

Protocol-to-patient consistency checks

• Compare inclusion and exclusion points that participants must understand, especially contraception, prohibited medicines, washout, donation restrictions, driving, fasting, and lifestyle requirements.
• Check that foreseeable risks match the current Investigator's Brochure, protocol, product information, and approved risk controls.
• Confirm stopping rules and reasons the investigator or sponsor may end participation.
• Align participant withdrawal text with protocol safety follow-up and data-handling plans.
• Ensure compensation, expense reimbursement, and treatment for injury match the financial and insurance documents.
• Verify site contact names, roles, addresses, and telephone numbers against the current site file.
• Confirm the Slovenian protocol synopsis covers the nationally required content and does not contradict the PIS.

Consent logic checks

• Confirm the main participation consent is distinct from optional future research, optional genetic testing, optional contact, and pregnancy-partner follow-up.
• Ensure refusing an optional activity does not appear to prevent main-trial participation when the activity is not required.
• State who signs each document and when.
• Keep application-stage blank forms free of participant, legal-representative, witness, and interviewer signatures.
• Include space for participant or representative name, signature, and date and for the person conducting the consent interview.
• Where an impartial witness may be used, include the witness statement, name, signature, and date in the approved form.
• Confirm the person receives adequate time, an opportunity to ask questions, and a signed and dated copy.
• Verify re-consent triggers for material new information, adulthood, regained capacity, and newly proposed optional use.

Population and document coverage checks

• Confirm the package covers every population in the protocol and CTIS application.
• For healthy volunteers, explain the absence or uncertainty of therapeutic benefit, payment, burden, confinement, restrictions, and reproductive risk. Use the Slovenia healthy volunteer guide.
• For minors, provide parent or legal-representative information and consent plus age-appropriate information and assent. Account for the Slovenian 15-year threshold and re-consent at adulthood. Use the Slovenia minor guide.
• For adults unable to consent, provide legal-representative documents and information suited to the participant's capacity. Use the Slovenia limited-capacity guide.
• For emergency enrollment, confirm the protocol and Part II documents address every Article 35 condition and the subsequent consent process. Use the Slovenia emergency enrollment guide.
• For a participant able to consent but unable to write, distinguish interpreter support from the impartial-witness procedure. Use the Slovenia impartial witness guide.
• For pregnancy follow-up, separate the pregnant participant from a pregnant partner who is not a trial participant. Use the Slovenia pregnancy follow-up guide.
• For optional future use, separate main-trial data and samples from secondary purposes. Use the Slovenia secondary-use guide.

Data privacy checks

• Identify the controller or joint-controller arrangement accurately.
• Do not equate informed consent to participate with the GDPR legal basis for every processing operation.
• Explain data categories, purposes, recipients, access to source records, coding, transfers, safeguards, retention, and participant rights.
• State which authorities, monitors, auditors, and ethics bodies may inspect records and why.
• Check that international transfer wording matches actual destinations and safeguards.
• Avoid promising complete anonymity when data remain coded or pseudonymised.
• Avoid promising deletion when legally required safety and trial-integrity records must remain.
• Align withdrawal wording with the data-protection statement and protocol.
• Give optional future processing its own clear legal and consent analysis.

Biological sample and secondary-use checks

• List required and optional sample collections separately.
• Match sample type, volume, frequency, analysis, genetic testing, storage, location, transfers, retention, and destruction to the protocol and laboratory plan.
• State whether samples are identified, coded, pseudonymised, or irreversibly anonymised.
• Explain whether individual or incidental findings may be returned.
• Give future research a defined scope that a person can understand.
• Provide a separate refusal and withdrawal route for optional future use.
• Do not promise destruction of material already used, anonymised, or included in completed analyses when that cannot be achieved.
• Align the participant text with the CTIS biological-sample compliance document.

Slovenia national requirement checks

• Confirm the cover letter is in Slovenian.
• Confirm the protocol synopsis is in Slovenian and contains the items listed in Article 10 of the national implementing regulation.
• Confirm every participant-facing item is in Slovenian.
• Verify the PIS is short, clear, respectful, empathetic, and understandable to a lay reader as requested by KME RS guidance.
• Include procedures, duration, benefits, risks, privacy, data access and retention, results availability, voluntariness, withdrawal, alternatives, safety, and local contacts.
• Describe insurance for trial-related injury consistently with the proof of sponsor and investigator liability cover.
• Include the relevant investigator and national participant-rights contact routes using current official details.
• Where teratogenic risk exists, include written pregnancy and fetal-risk information, contraception instructions, and the applicable signed acknowledgment.
• For minors aged 15 or older, include their own agreement in addition to legal-representative consent.

Signature, version, and administrative checks

• Confirm that the PIS, ICF, assent, partner consent, and optional-use forms submitted in CTIS are blank.
• Verify signature blocks match the approved consent pathway and do not add an inappropriate signer.
• Include printed names, roles, signatures, and dates where required during conduct.
• Provide two signed copies of the consent form during conduct, one for the participant and one for the trial archive, in line with KME RS guidance.
• Match version and date in the filename, footer, CTIS record, document list, and translated file.
• Remove tracked changes, comments, hidden text, unresolved fields, and drafting notes from clean files.
• Preserve a traceable translation and review record.
• Confirm every cross-reference points to the correct document and section.

Readability and design checks

• Use headings that answer participant questions.
• Keep paragraphs and sentences short.
• Use lists only where they make procedures or risks easier to understand.
• Define clinical, genetic, and data-protection terms.
• Check font size, spacing, contrast, page breaks, tables, and signature-page legibility.
• Explain probabilities in plain language and use consistent denominators.
• Avoid coercive, reassuring, promotional, or liability-waiving language.
• Check that the Slovenian text has been reviewed by a competent native-language clinical reviewer.

Final upload check

The Part II application should contain only the versions intended for assessment, in the correct CTIS categories. Keep the English scientific version of endpoint-related patient-facing documents aligned with the Slovenian translation according to the current EU Questions and Answers. Use the current version 2.0 recruitment and informed consent procedure template for new Part II submissions from 1 September 2026.

The Slovenia Part II document checklist provides the full administrative package map.