Greece Patient-Facing Document QC Checklist

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

Other language versions

Read this guide in Greek.