Latvia Patient-Facing Document QC Checklist

Trial content and protocol consistency

• Confirm the trial title, sponsor protocol number, EU CT number, sponsor, study centre, treatment names, groups, dose schedule, randomisation ratio, placebo use, blinding, and participation period against the current protocol.
• Reconcile the visit schedule, procedures, sample volumes, imaging, questionnaires, optional procedures, follow-up, and burden with the schedule of activities.
• Match risks to the current protocol, Investigator's Brochure, product information, and risk assessment. Do not omit reproductive, genetic, radiation, procedural, privacy, or withdrawal risks that apply.
• State expected benefit accurately. Do not imply personal benefit where none is expected.
• Confirm alternatives to participation and usual-care options with the protocol and Latvian site pathway.
• Confirm that trial medicines, administration devices, protocol-required medicines, devices, and examinations are described as free to the participant where applicable under Latvian rules.

Consent logic

• Confirm that no trial-specific procedure occurs before valid consent, except within an authorised emergency pathway.
• Separate required participation statements from optional choices.
• Ensure every optional box can be answered independently and that refusal does not create an unintended exclusion.
• Match signatures and dates to the actual consent pathway. Include the participant or authorised decision-maker, the person conducting the interview, and an impartial witness only when applicable.
• State that adequate time is given, questions can be asked, and a copy of the signed consent record is provided.
• Explain withdrawal from participation separately from withdrawal of optional future-use permission.
• Explain what happens to data and samples already collected when consent is withdrawn. Avoid promising deletion where lawfully retained trial records must remain.

Population and document coverage

• Map every protocol population to a Latvian information and consent document.
• For healthy volunteers, check screening, washout, confinement, restrictions, payments, incidental findings, and medical-care wording against the Latvia healthy volunteer guide.
• For ages 0 to 13, include legal-representative consent and age-appropriate child information where the child can understand it.
• For ages 14 to 17, include both the legal representative's written consent and the minor's own written consent. Check the Latvia minor consent and assent guide.
• For adults unable to consent, verify the lawful decision-maker and participant-information pathway against the Latvia legal representative guide.
• For emergency enrollment, verify every Article 35 condition and the subsequent-consent process against the Latvia emergency enrollment guide.
• For participants unable to write, verify the alternative method and witness signatures against the Latvia impartial witness guide.
• For pregnancy follow-up, keep the participant and partner pathways separate. Check the Latvia pregnancy follow-up guide.

Privacy and medical-record access

• Identify the controller and relevant processors without confusing sponsor, site, and investigator roles.
• Describe data categories, purposes, recipients, retention, international transfers, safeguards, and applicable rights consistently with the data-protection statement.
• Include the Data State Inspectorate contact details requested by the Latvia national overview.
• Explain direct access to medical records for authorised sponsor representatives, investigators, monitors, auditors, inspectors, and authorities only to the extent applicable.
• Confirm that privacy wording does not present consent to participate as the sole legal basis for every research-processing activity.
• Keep contact details for privacy questions separate from medical-emergency contacts.

Biological samples and secondary use

• Match each sample type, volume, timing, storage location, responsible entity, transfer, retention period, analysis, and disposal plan to the protocol and laboratory manual.
• Separate protocol-required sample use from optional future or secondary research.
• Explain coding or pseudonymisation accurately. Do not call coded samples anonymous.
• State whether genetic analysis is included and whether individual or incidental findings may be returned.
• Align withdrawal wording across the consent form, biological-samples statement, protocol, and sample-management plan.
• Review optional future use against the Latvia secondary-use consent guide.

Latvia-specific administrative checks

• Confirm that participant-facing documents are in Latvian and understandable to the intended age and population.
• Confirm that participant and doctor-facing recruitment materials are in Latvian.
• Include the study-centre name and address, data-controller identity, ZVA contact, assigned ethics-committee contact, and Data State Inspectorate contact.
• Include document title, version, date, sponsor protocol number, and EU CT number.
• Reconcile reimbursement and payment wording with the mandatory participant-compensation template and draft site budget.
• Reconcile injury and insurance wording with the submitted Latvia-compliant insurance evidence.
• Confirm that the blank CTIS forms contain no participant signatures, completed personal data, tracked changes, comments, or drafting notes.

Readability and final production

• Use short sentences, familiar Latvian terms, clear headings, and sufficient space around consent choices and signatures.
• Check that risk wording is understandable without reducing medical accuracy.
• Define abbreviations at first use and remove technical detail that does not help the decision.
• Review names, telephone numbers, email addresses, after-hours contacts, and site fields.
• Confirm consistent page numbers, headers, footers, version control, and filenames.
• Perform a final native-language proofread after all content changes. Do not rely only on back-translation or automated checks.

Return to the Latvia CTIS Part II guide hub if the protocol includes a consent pathway not covered by the standard adult set.