Greece Patient-Facing Document QC Checklist

Trial content checks

• Confirm the exact trial title, sponsor, EU trial number, protocol code and current protocol version.
• Confirm the correct Greek site, department, principal investigator and contact information.
• State the purpose and design in plain Greek without overstating efficacy or expected benefit.
• Describe every treatment arm, randomization, placebo or comparator and assignment probability accurately.
• Include participant duration, visits, procedures and follow-up that change burden or risk.
• Explain available alternatives outside the trial.
• Distinguish trial treatment from standard care and identify any post-trial treatment arrangements.

Protocol-to-document consistency

• Match inclusion-relevant facts such as age, reproductive status and disease population.
• Match doses, administration routes, visit schedules, invasive procedures and sample volumes.
• Reconcile risks with the current protocol, Investigator's Brochure and safety information.
• Match contraception methods, duration and pregnancy testing requirements.
• Confirm that optional substudies are optional in both the protocol and consent package.
• Ensure that participant-facing endpoint questionnaires handled under Part I are not misplaced or omitted from the scientific dossier.

Consent logic

• Make voluntary participation and withdrawal clear.
• Give adequate space for questions and decision time.
• Keep main-trial consent separate from optional future research, genetic testing or long-term sample storage.
• Explain what happens to data and samples after withdrawal without promising actions that conflict with law or scientific integrity.
• State when new information may lead to re-consent.
• Confirm that the person receives a signed copy after consent.
• Ensure the approved process matches Greece's in-person paper-consent guidance unless a different approach has been expressly accepted for the trial.

The Greece main patient information and consent guide provides the baseline requirements.

Population and form coverage

• Prepare the correct adult form for the ordinary pathway.
• For healthy volunteers, remove disease-treatment assumptions and explain the absence of therapeutic intent. Use the Greece healthy volunteer guide.
• For participants under 18, include age-appropriate information, written assent from age 10 and both-parent or guardian signatures. Use the Greece minor guide.
• For adults under court-appointed support, include the participant's own information and expression of will plus the judicial supporter's consent. Use the Greece limited-capacity guide.
• For emergency enrollment, document Article 35 eligibility and the prompt later-consent route. Use the Greece emergency enrollment guide.
• For participants who cannot use the ordinary written route, add the correct witness fields and procedure. Use the Greece impartial witness guide.
• For pregnancy follow-up, separate the pregnant person's permission from later infant-data permission. Use the Greece pregnancy guide.
• For optional future use, add separate choices and withdrawal language. Use the Greece secondary-use guide.

Data privacy checks

• Identify the controller and provide its contact details.
• Provide the sponsor's or applicable controller's Data Protection Officer contact.
• State each processing purpose and legal basis accurately.
• Identify recipients or categories of recipients.
• Explain transfers outside the European Economic Area and the safeguards used.
• State the retention period or the criteria used to set it.
• Explain applicable access, correction, restriction, objection and complaint rights.
• Name the Hellenic Data Protection Authority as the national complaint authority.
• Explain automated decision-making or profiling if it applies.
• Keep privacy wording consistent with the sponsor's CTIS GDPR compliance statement.

Biological samples and secondary use

• Describe sample type, volume, collection schedule, storage location and planned retention.
• State whether samples are required for the main trial or optional.
• Separate optional future research from main-study consent.
• Define the scientific scope of future use and any transfer or sharing.
• Explain coding, who can re-identify the sample and when destruction or anonymization is possible.
• Align the Greek consent with the CTIS biological-sample compliance template.

Greece-specific regulatory checks

• Every participant-facing version is in Greek.
• A valid or certified translation exists for any expected participant who does not understand Greek.
• No participant or public or private insurer is charged for trial-specific products, tests or procedures.
• Insurance and injury-compensation information matches the certificate, including the pregnancy clause.
• The document allows direct record access by authorized sponsor representatives and competent authorities while protecting confidentiality.
• The National Ethics Committee contact is used correctly for ethics questions and is not described as the complaints authority.
• Prohibited participant groups under the Greek implementing decision have not been included.

Signatures, versions and administration

• The blank submission form contains complete date fields for every signer.
• The participant and investigator or authorized team member fields are present.
• Both-parent fields appear for minors, subject to the documented national exceptions.
• Legal-representative fields appear only for an applicable pathway.
• One-witness or two-witness fields match the planned Greek procedure.
• Pregnant-partner follow-up forms contain the nationally requested representative and two-witness fields.
• Each page shows document type, protocol code or acronym, version and date.
• Pagination is continuous and shows the total page count.
• Clean and tracked-change versions are prepared for a modification.
• CTIS publication versions have been checked for personal data and confidential information.

Readability and design

• Use plain, non-promotional Greek.
• Explain abbreviations and medical terms.
• Use short sections, readable type and enough white space.
• Present risks by likelihood and seriousness where the evidence supports it.
• Keep the consent statements close to the signature page.
• Confirm that the final PDF is searchable, selectable and correctly rendered.

Return to the Greece CTIS guide hub for the full document cluster.