Greece Patient Information and Consent Requirements

Language and document format

Mandatory. Submit every main and population-specific Informed Consent Form in Greek. Other participant or caregiver information given before or at consent, including education leaflets and patient cards, must also be in Greek.

Conditional. If a potential participant does not understand Greek, provide information in a language the person understands and submit a valid or certified translation in CTIS. A later translation should be based on the approved Greek form.

The Greek National Ethics Committee expects the information and consent text to form a continuously paginated document. Identify every page with the document type, protocol code or acronym, version and date. Show the total page count. Keep wording accurate, complete and understandable without relying on the oral discussion to repair omissions.

Content of the Greek participant information

The main form should explain:

• the trial title, sponsor, EU trial number, investigator, Greek site and contact details
• the condition and investigational medicinal product
• why the person is invited and the trial's purpose
• treatments, randomization, placebo or comparator, assignment probability and rescue treatment
• alternatives outside the trial
• visits, procedures, tests, sample collection and participant duration
• foreseeable risks, side effects, interactions, restrictions and lifestyle precautions
• expected benefits and the possibility of no personal benefit
• pregnancy prevention, contraception, pregnancy reporting, breastfeeding and other reproductive precautions
• costs, expense reimbursement, insurance and compensation for trial-related injury
• voluntary participation, withdrawal and the effect of withdrawal on data or samples already collected
• optional substudies and optional future use of data or samples
• privacy, data controllers and processors, recipients, retention, international transfers, rights and complaint route
• direct access to medical records by authorized sponsor representatives, EOF, the National Ethics Committee and other competent inspectors
• public trial registration and availability of a lay summary of results
• new information that may affect willingness to continue
• whom to contact for trial, injury, rights, privacy or ethics questions

Greek guidance states that participants and their public or private insurers must not bear trial-specific costs for investigational or auxiliary products, examinations, procedures or treatment of trial-related injury. Include that assurance in the participant information.

Consent choices and optional activities

Keep consent to the main trial distinct from optional activities. If genetic research, pharmacokinetic work, long-term sample storage or future use is optional, describe it in a separate focused form or clearly separate optional choice. Refusal must not prevent participation in the main trial when the optional activity is not necessary for the trial.

The Greece secondary-use consent guide explains data and sample choices. The pregnancy follow-up guide covers separate maternal, pregnancy-outcome and infant permissions.

Consent discussion, signatures and dates

Consent is obtained during a prior interview by a qualified investigator or authorized study-team member. The person must be able to ask questions and must receive enough time to decide. The information must be in language the person can understand.

Greek National Ethics Committee guidance describes physical presence and a paper form. The participant and the investigator or authorized team member sign and enter the complete date. The signatures are obtained as part of the same consent encounter. The participant receives a signed copy and the site keeps the original in its records.

The blank form submitted in CTIS is not signed. It must already contain all signature and date fields that could apply. Add fields for the legally designated representative and witnesses only where the protocol could use those pathways. The Greece impartial witness guide explains the national one-witness and two-witness rules.

Population-specific forms

Do not force every participant through one generic form.

• For participants under 18, prepare age-appropriate information, written assent from age 10, and joint parental or guardian consent. See the Greece minor consent and assent guide.
• For adults under court-appointed support, prepare participant information suited to their understanding and a legal-representative form. See the Greece limited-capacity consent guide.
• For an Article 35 emergency trial, explain the initial enrollment route and prompt later consent. See the Greece emergency enrollment guide.
• For healthy volunteers, adapt risk, benefit, payment and pregnancy language to a person without the target condition. See the Greece healthy volunteer guide.

Privacy section

Place the required privacy information together in one clear section. Identify the sponsor or relevant entity as controller, give the controller's and Data Protection Officer's contacts, state purposes and legal bases, list recipients, explain third-country transfers and safeguards, give the retention period or criteria, and describe the person's applicable data rights.

Explain the right to complain to the Hellenic Data Protection Authority. If automated decision-making or profiling applies, describe its logic and expected effect. Avoid promising deletion where CTR safety, scientific integrity or record-retention duties lawfully limit that right.

Modifications and re-consent

For an ICF modification, submit the final Greek clean version and a tracked-change version against the previously approved form. Update the consent promptly when new information could affect willingness to continue. Define which enrolled participants must be re-consented and when.

When a minor turns 18 or an adult regains capacity to consent, move to the ordinary adult consent pathway promptly. Keep the new form and process consistent with the approved protocol and the person's current status.

The Greece patient-facing QC checklist can be used for the final review. Return to the Greece CTIS guide hub for the full set of population guides.