Greece CTIS Part II Document Checklist

Documents to prepare

Trial sites

Mandatory. Complete the CTIS Part II Trial Sites structured data for every Greek site. A clinical trial site in Greece must be a public hospital or private clinic with suitable infrastructure. No separate signature applies to the structured data at submission.

Recruitment arrangements

Mandatory. Upload the completed EU Recruitment and Informed Consent Procedure template in the CTIS Recruitment Arrangements section. Greece recommends completion in English. Version 2.0 is the current harmonized template and becomes fully implemented for new Part II submissions on 1 September 2026. Upload final Greek recruitment advertisements or participant-facing recruitment material when used. Blank recruitment materials are not signed at submission unless their own format requires approval or attestation.

Participant information and informed consent forms

Mandatory. Upload every applicable blank Greek Patient Information Sheet and Informed Consent Form in Subject Information and Informed Consent Form. Include separate versions for adults, minors, parents or guardians, legal representatives, pregnancy follow-up, optional substudies or other populations when the protocol requires them. Other patient or caregiver leaflets provided before or at consent also belong here in Greek.

The blank forms are not signed at CTIS submission. They must contain the correct future signature and full-date fields for the participant, both parents where applicable, the legally designated representative where applicable, the investigator or authorized study-team member, and witnesses where the national rules require them. The Greece main consent guide explains the core form. The minor guide, limited-capacity guide and witness guide cover special signature routes.

Conditional. If participants at a Greek site do not understand Greek, upload a valid or certified translation in the language they understand. A later translation should follow the approved Greek form and be submitted through the applicable CTIS route.

Conditional. Endpoint-related questionnaires and patient-reported outcome instruments are handled with the protocol in Part I under the EU rules, not duplicated as ordinary Part II participant material. Other educational or information material given before or during consent remains in Part II.

Suitability of the investigator

Mandatory. For each Greek site, upload a short curriculum vitae for the principal investigator that states relevant qualifications, experience and current Good Clinical Practice training. Greece recommends the EU Investigator Curriculum Vitae template or a similar document, completed in English. Upload a declaration of interest for each principal investigator using the EU template or a similar document, also normally in English.

The Greek Part II Q&A directs signature questions to the EU CTR Q&A. Do not add signatures to CVs or declarations solely by habit. Use the current template instructions and any explicit National Ethics Committee request.

Conditional for Phase I. Upload a signed declaration by the principal investigator that the site and research team meet Article 7 of Government Gazette B 4131/2016. Also upload current Advanced Life Support certificates for the principal investigator and relevant research-team members.

Suitability of the facilities

Mandatory. Upload one Site Suitability Form for each Greek site in Suitability of the Facilities. Greece recommends the EU template completed in English. The form must be signed by the principal investigator at submission.

Conditional for Phase I. Add the principal investigator's declaration that the site and team meet Article 7 and provide the required evidence of appropriate equipment and emergency capability.

Proof of insurance cover or indemnification

Mandatory. Upload the insurance certificate in Proof of Insurance Cover or Indemnification. The Greek National Ethics Committee accepts the certificate in Greek or English. The certificate must identify the trial and coverage and must contain the required pregnancy clause. The insurance arrangement must comply with the Greek implementing decision and CTR requirements. A blank certificate is not enough if the proof of cover must be executed by the insurer.

Financial and other arrangements

Conditional. The fully signed financial agreement between sponsor and principal investigator is no longer required in CTIS. Where financial details are provided for ethics review, the Greek Part II Q&A allows the applicable annexes from Government Gazette B 230/22.01.2026, including the per-participant fee analysis, project-team list and project budget. The sponsor and investigator do not need to sign those annexes for CTIS submission.

Conditional. If participants receive reimbursement or compensation, Greece recommends the EU Compensation for Trial Participants template in English. State what is paid, why, when and how, and ensure that the amount does not exert undue influence. Trial-specific medicines, procedures and examinations must not be charged to participants or their public or private insurer.

Data-protection compliance

Mandatory. Complete the CTIS Form statement on compliance with Regulation (EU) 2016/679 and any transfer of personal data to third countries. Greece recommends the EudraLex GDPR compliance template in English. The 2026 Member State overview identifies no additional Greece-specific standalone Part II document beyond this statement. Participant-facing privacy information must still appear in the Greek consent material.

Biological samples

Conditional. When the trial collects, stores or proposes future use of human biological samples, upload the completed EU Compliance with Member State Applicable Rules for Biological Samples template in English under Compliance with Use of Biological Samples. Add separate optional Greek consent material when sample use is not necessary for the main trial. The Greece secondary-use guide explains the consent structure.

Version and submission checks

• Use the same trial title, protocol code, site, department and principal investigator details throughout CTIS and every document.
• Put the document type, protocol code or acronym, version and date in the header or footer of every participant-facing page.
• Use continuous pagination and show the total number of pages.
• Upload clean and tracked-change Greek consent forms for a modification.
• Remove personal data and confidential information from any document version intended for publication under the current CTIS transparency rules.
• Do not upload obsolete national forms used under the former Clinical Trials Directive unless the current CTR guidance expressly retains the relevant content or annex.

The Greece patient-facing QC checklist provides a final document-level review.