Lithuania CTIS Part II Submission Guides

Lithuania CTIS guide directory

Lithuania CTIS Part II Document Checklist

Use this guide to identify the main Part II documents, when each applies, the Lithuanian language rule and which documents require signatures at submission.

Read the Lithuania CTIS Part II Document Checklist guide

Lithuania Patient Information and Consent Requirements

Start here for the standard Participant Information Sheet and Informed Consent Form, including content, signatures, readability, data protection and Lithuania-specific consent expectations.

Read the Lithuania Patient Information and Consent Requirements guide

Lithuania Patient-Facing Document QC Checklist

Use this before submission to check protocol consistency, consent logic, population coverage, privacy, biosamples, versions, signatures and Lithuanian localisation.

Read the Lithuania Patient-Facing Document QC Checklist guide

Lithuania Healthy Volunteer Consent Requirements

Use this when the trial recruits healthy volunteers and the standard consent package must be adapted for non-patient participants, risk communication and reimbursement.

Read the Lithuania Healthy Volunteer Consent Requirements guide

Lithuania Minor Consent and Assent Requirements

Use this for children and adolescents. It explains Lithuania's under-12 and age-12-plus information approach, parental consent and assent.

Read the Lithuania Minor Consent and Assent Requirements guide

Lithuania Limited-Capacity and Legal Representative Consent Requirements

Use this when an adult cannot reasonably assess their own interests or when a guardian, curator or another legally entitled person may need to consent.

Read the Lithuania Limited-Capacity and Legal Representative Consent Requirements guide

Lithuania Emergency Enrollment Consent Requirements

Use this for trials relying on the emergency consent pathway in Article 35 of the Clinical Trials Regulation, including subsequent consent after the emergency intervention.

Read the Lithuania Emergency Enrollment Consent Requirements guide

Lithuania Impartial Witness Consent Requirements

Use this when a participant cannot write and consent may need to be recorded through an alternative method in the presence of an impartial witness.

Read the Lithuania Impartial Witness Consent Requirements guide

Lithuania Pregnancy Follow-Up Consent Requirements

Use this when the protocol requires pregnancy follow-up for a trial participant or for the pregnant partner of a trial participant.

Read the Lithuania Pregnancy Follow-Up Consent Requirements guide

Lithuania Secondary Use Consent Requirements

Use this when biological samples or coded data may be kept or used for research beyond the main trial. Lithuania gives specific guidance on keeping this consent separate and optional.

Read the Lithuania Secondary Use Consent Requirements guide

Main Lithuania-specific differences

Lithuanian is the working language for the national Part II package

The Lithuanian Bioethics Committee states that the Part II documents in its national recommendations must be submitted in Lithuanian. This is especially important for participant-facing information and consent documents, recruitment materials and national Part II forms. English source documents can still be useful for global drafting, but the Lithuania submission package should be built around the Lithuanian versions required for Part II. The Lithuania Part II document checklist maps the national document set.

Lithuania publishes a national Part II list and sample forms

The Lithuanian Bioethics Committee's national recommendations cover recruitment and informed consent procedures, participant information, investigator suitability, declarations of interest, site suitability, insurance, financial arrangements, proof of payment, GDPR compliance and biological samples. The sample forms in the national recommendations are described as recommended rather than mandatory, so a different format can be acceptable if it fully covers the required information.

Minors have specific national consent and assent rules

Lithuania normally requires consent from both parents for a child's participation, subject to defined exceptions. National Part II guidance also distinguishes children under 12 from those aged 12 and above. From age 12, the child should receive information orally and in writing and, when capable of understanding it, sign an assent form. The Lithuania minor consent and assent guide explains the practical document set.

Secondary and future use should remain optional

The Lithuanian Bioethics Committee recommends either a separate informed consent form for future use of biological samples and coded data or a separate opt-in choice in the consent section. Future use should not be presented as a condition of joining the main trial. The Lithuania secondary-use consent guide covers the recommended structure.