Greece CTIS Part II Guides

Choose the right Greece guide

1. Greece CTIS Part II document checklist Use this first to map each required or conditional Part II document to its CTIS section, language, signature and template.
2. Greece patient information and consent requirements Use this to draft the main Greek Patient Information Sheet and Informed Consent Form and its consent page.
3. Greece patient-facing document QC checklist Use this before submission to check protocol consistency, consent logic, privacy, samples, versions and document coverage.
4. Greece healthy volunteer consent requirements Use this for Phase I and other studies that enroll people without the condition under investigation.
5. Greece minor consent and assent requirements Use this for participants under 18, including the written assent rule from age 10 and joint parental consent.
6. Greece limited-capacity and legal representative consent requirements Use this when an adult is under court-appointed support and cannot provide legally effective consent alone.
7. Greece emergency enrollment consent requirements Use this when the protocol proposes enrollment before prior consent because of an urgent life-threatening or serious medical condition.
8. Greece impartial witness consent requirements Use this when a participant cannot read, write, hear or speak through the standard consent process.
9. Greece pregnancy follow-up consent requirements Use this for pregnancy, birth and infant follow-up involving a pregnant participant or a participant's pregnant partner.
10. Greece secondary-use consent requirements Use this for optional future research with coded data or human biological samples beyond the main trial.

Main national differences in Greece

Greek participant documents

The blank participant documents submitted in CTIS must be in Greek. If a Greek site expects to enroll someone who does not understand Greek, submit a valid or certified translation in that person's language. A later translation should be based on the approved Greek version and submitted through the appropriate application route. The Greece patient information and consent guide explains the national content and signature rules.

National ethics review

The National Ethics Committee reviews Part II through CTIS. Its official guidance calls for all Greek informed consent forms and participant materials, an investigator curriculum vitae and declaration of interest for each site, a principal-investigator-signed site suitability form, proof of insurance, financial information where applicable, a data-protection compliance statement and biological-sample information where applicable.

Paper consent and special signature pathways

The Greek consent guidance describes an in-person paper process in which the participant and the investigator or authorized study-team member sign and date the consent form, and the participant receives a signed copy. Greece also specifies two-parent consent for minors, court-appointed representation for adults lacking legal capacity, and one-witness or two-witness pathways for certain communication or literacy barriers. The detailed population guides show when each route applies.

Phase I documents

For Phase I trials, Greece adds declarations that the site and team meet the national requirements, Advanced Life Support certificates for the principal investigator and relevant team members, and confirmation of appropriate site equipment. These documents belong in the investigator and facility suitability sections. The Greece Part II checklist gives the upload map.

Other language versions

This package contains the English hub and English guides. Link the equivalent Greek-language hub here once that content has been verified and published.