Greece Healthy Volunteer Consent Requirements

Documents to prepare

Mandatory. Submit a blank Greek healthy-volunteer information and consent form in the CTIS Subject Information and Informed Consent Form section. It is not signed at submission. It must contain future signature and full-date fields for the volunteer and the investigator or authorized study-team member.

Conditional. Submit any Greek recruitment advertisement, prescreening material, payment explanation, participant card or study instructions that will be shown to volunteers. Describe the recruitment and consent process in the current EU Recruitment and Informed Consent Procedure template.

Conditional for Phase I. In addition to the participant documents, Greece requires a principal investigator declaration that the site and team meet Article 7 of Government Gazette B 4131/2016, current Advanced Life Support certificates for the principal investigator and relevant team members, and evidence of appropriate site equipment. These are uploaded under investigator and facility suitability, not inside the ICF.

What changes from the standard patient form

Do not write as if the volunteer is receiving treatment for an illness. State clearly that the person is healthy for the study's purposes, the investigational product is being studied, and participation is not expected to provide therapeutic benefit.

Explain the scientific purpose, dose escalation or cohort progression, randomization and placebo use in plain terms. Describe sentinel dosing, stopping rules, inpatient stays, fasting, confinement, activity restrictions and washout periods when applicable. Explain invasive procedures, blood volume, cannulation, biopsies, lumbar puncture, radiation exposure or challenge agents with the detail needed for a voluntary decision.

For a first-in-human or early-phase study, distinguish known human evidence from animal or laboratory findings. Avoid converting uncertainty into reassurance. Explain foreseeable risks, unknown risks, emergency arrangements and follow-up after dosing.

Payment, expenses and undue influence

Conditional. If volunteers are paid or reimbursed, state the amount, basis, schedule, tax handling where relevant, and what happens after early withdrawal or investigator-directed discontinuation. Payment may compensate time, inconvenience and documented expenses. It must not be tied to completing unsafe procedures or be so high that it undermines a free decision.

Greece recommends the EU Compensation for Trial Participants template in English when compensation is planned. The Greek ICF must match that document. Trial-specific products, tests and procedures must not be charged to the volunteer or the volunteer's public or private insurer.

Reproductive precautions

Explain pregnancy testing, contraception, sperm or egg donation restrictions, breastfeeding restrictions and the required precaution period. State what happens if a pregnancy occurs and whether the protocol requests pregnancy, birth or infant follow-up.

The Greek insurance certificate must contain the required pregnancy clause. If follow-up information will be collected from a pregnant volunteer, a volunteer's pregnant partner or a child after birth, prepare the appropriate separate forms described in the Greece pregnancy follow-up guide.

Consent and withdrawal

The ordinary Greek in-person paper-consent process applies. A qualified investigator or authorized team member conducts the prior interview, allows questions and enough decision time, then signs and dates the form with the volunteer. Give the volunteer a signed copy.

Explain the right to leave without penalty and the medical follow-up that may still be recommended for safety. Distinguish withdrawal from further intervention, withdrawal from active follow-up and limits on removing data already collected for safety or regulatory purposes.

Recruitment exclusions and safeguards

Check that recruitment does not include groups whom the Greek implementing decision excludes from clinical trials, including people performing compulsory military service, people serving a custodial sentence, people barred by court decision and people living in institutions.

Describe screening privacy, repeat-enrollment controls and any registry checks. Keep advertisements factual. They should not promise benefit, imply that the product is safe or approved, or emphasize payment in a way that could distort the decision.

Return to the Greece CTIS guide hub or use the Greece patient-facing QC checklist before submission.