Greece Secondary Use Consent Requirements

When separate consent is needed

Conditional. Use a separate Greek consent form or clearly separate optional module when the sponsor proposes an activity that is not necessary for the main trial, including:

• future research with coded trial data beyond the approved primary study purposes
• long-term storage or future use of biological samples
• genetic or genomic research that is optional
• optional pharmacokinetic or biomarker substudies
• sharing data or samples with additional researchers or repositories for a new research purpose

Do not repeat the whole main ICF. Explain the optional activity in focused detail and cross-reference the main study only where needed.

If processing or sample use is necessary for the main trial, explain it in the main ICF and avoid presenting it as an optional choice that the protocol cannot honor.

Data-related content

Explain what data will be used, whether it is coded or anonymized, who holds the code, the research scope, recipients, countries of access, retention and security. State whether data may be linked with other sources and whether individual findings or general results will be returned.

Keep the participant-facing wording consistent with the CTIS GDPR compliance statement. Identify the controller, Data Protection Officer, purposes, legal bases, recipients, third-country safeguards, retention and applicable rights. Consent to trial participation and the legal basis for data processing are related but not interchangeable. Do not state that all regulated processing stops automatically when trial consent is withdrawn.

Biological-sample content

Describe the sample type, collection volume, storage location, coding, access, transfer, duration and planned research. State whether samples may be used only for a similar scientific purpose or for a broader defined field. Greek guidance describes further use as related to a similar scientific purpose and subject to competent-authority approval.

Explain whether samples may be sent outside Greece or the European Economic Area, used by commercial partners, used for genetic analysis, transformed into cell lines, or used in research that may lead to intellectual property. State whether samples will be destroyed, returned, anonymized or retained when the person withdraws.

Complete the EudraLex Compliance with Member State Applicable Rules for Biological Samples template in English for the CTIS Part II section. The Greek consent form remains participant-facing and is submitted in Greek.

Separate and optional choice

Use a clear yes or no choice for each genuinely separable activity. Refusal of optional future use must not affect eligibility for the main trial, treatment, ordinary care or reimbursement.

Avoid one bundled signature covering unrelated data use, genetics, long-term sample storage and recontact if participants can reasonably choose among them. Keep choices operationally manageable and align them with the database and sample-management plan.

For minors, obtain the age-appropriate agreement and parental permission required in Greece. Plan what happens when the child reaches 18. See the Greece minor consent guide.

For adults under court-appointed support, obtain the participant's own agreement to the extent possible and the judicial supporter's consent. Optional research involving a vulnerable person needs the same refusal protections as the main trial. See the Greece limited-capacity guide.

Withdrawal and recontact

Explain how a person can withdraw from optional future use and whom to contact. Distinguish:

• stopping new collection
• stopping future identifiable or coded use when still feasible
• destruction of remaining identifiable samples when feasible and lawful
• retention of results already generated
• data or samples already anonymized or already shared in a way that cannot be reversed

If future projects may require new consent, explain how recontact will occur and keep recontact permission separate where appropriate.

Submission and signature checks

At CTIS submission, upload the blank Greek optional-use form in Subject Information and Informed Consent Form and the English biological-sample compliance template in its Part II section. The blank consent is not signed at submission.

During conduct, apply the Greek in-person paper-consent process. The participant and investigator or authorized team member sign and enter full dates. Give the participant a signed copy. Use the Greece impartial witness guide when the ordinary written route cannot be used.

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