Lithuania CTIS Part II Document Checklist

Required Lithuania CTIS Part II documents

Recruitment and informed consent procedure

Mandatory. Submit a description of the subject recruitment and informed consent procedure. The document should explain how, when and where potential participants are approached, how privacy is protected, how much time they receive to decide, how understanding is checked and how withdrawal is handled. It should also cover any special consent pathway used in the protocol, such as minors, limited-capacity participants, impartial witnesses or emergency enrollment.

The document is submitted in Lithuanian. It is normally a procedural sponsor or site document rather than a participant-signed document, so participant signatures are not required at CTIS submission. Use the Lithuanian national recommendation or the current EU Part II recruitment and informed consent procedure template as the structure, while retaining Lithuania-specific information.

The Lithuania patient information and consent guide explains how the procedure should align with the actual consent form.

Recruitment advertisements

Conditional. If advertisements, posters, flyers, email invitations, audio, video or similar recruitment materials will be used, submit the relevant copies or recordings. Lithuanian Bioethics Committee guidance also expects an explanation of why advertising is needed, where it will be placed, what happens to respondents who are not eligible, reimbursement arrangements and how respondent personal data will be handled when data are collected.

Recruitment materials intended for participants should be in Lithuanian for the Lithuania submission. They are not signed by participants at submission.

Participant information and Informed Consent Form

Mandatory. Submit the written participant information and Informed Consent Form that will be used before a person decides whether to participate. It must be understandable and cover the trial purpose, procedures, risks and burdens, possible benefits, alternatives where relevant, withdrawal, insurance and compensation, confidentiality, data processing, samples where applicable, contacts and the consent statements needed for the protocol.

The blank submission version is not signed by the participant at CTIS submission. The participant or legally designated representative and the person conducting the consent interview sign and date the consent record when informed consent is actually obtained. Lithuania's national ICF recommendations also provide space for names, signatures, date, time and the basis of representation where applicable.

Use the Lithuania patient information and consent requirements for the standard document and the population-specific guides when a different consent pathway applies.

Other information given before the participation decision

Conditional. Submit other information that forms part of the pre-participation decision package when it falls within the participant information required by Annex I of the Clinical Trials Regulation. Lithuania lists other subject information, such as a subject card, in its national Part II list, but current Lithuanian Bioethics Committee FAQ guidance recommends limiting additional patient-facing submissions to the documents required by the relevant Annex I sections unless another document is needed.

Do not automatically upload every operational patient-facing document. First determine whether it is part of recruitment, consent or information needed before the participation decision.

Lithuania site list and principal investigators

Mandatory. Submit the list of planned clinical trial sites in Lithuania, naming the principal investigator at each site, the investigator's position and the expected number of participants. This is a submission document and does not require participant signatures.

Investigator qualification description

Mandatory. Submit documentation showing that the investigators are suitably qualified. Lithuania asks for a description of investigator qualifications and a sponsor statement that those qualifications comply with the Clinical Trials Regulation and Lithuanian requirements.

The current Lithuanian Bioethics Committee FAQ states that all investigators should complete training on ICH E6(R3). Investigators without medicinal-product clinical trial investigator experience in the previous five years need a GCP training certificate. Experienced investigators still need documented E6(R3) training, even when a new certificate is not required.

Principal investigator CV

Mandatory. Submit a current curriculum vitae for each principal investigator. The national recommendations provide a sample form, but the form itself is recommended rather than mandatory.

Principal investigator declaration of interest

Mandatory. Submit a completed declaration of interest for each principal investigator. The Lithuanian national Part II list explicitly requires each declaration to be signed. This signature is therefore required at submission.

Site suitability statement

Mandatory. Submit a written suitability statement for each Lithuanian clinical trial site. Lithuania specifies that it is issued by the head of the clinic or institution at the trial site, or by that person's delegate. The national sample form includes signature and date fields, so prepare the signed site statement before CTIS submission.

Civil liability insurance or other proof of indemnification

Mandatory. Submit the civil liability insurance certificate or policy, or other proof of indemnification that demonstrates the applicable cover. Check that the policy corresponds to the Lithuanian trial, sponsor, investigators and covered activities before upload.

Participant reimbursement

Mandatory when reimbursement applies. Submit a description of the reimbursement of participant costs for trial participation. Lithuania also regulates compensation for time spent in biomedical research. The Lithuanian Bioethics Committee recommends stating an approximate hourly compensation amount in the ICF when compensation for time is paid.

The Lithuania healthy volunteer guide explains why reimbursement and compensation wording deserves particular attention in non-patient studies.

Trial financing and financial arrangements

Mandatory. Submit information on trial financing, financial transactions, compensation paid to participants and the investigator or site, and other relevant financial agreements with the site. Keep this consistent with the ICF so that participant reimbursement described to participants matches the submitted financial information.

Proof of payment

Mandatory. Submit proof that the applicable Lithuanian state fee has been paid. The national authority states that a fixed state fee applies to authorisation of a clinical trial and to a substantial modification.

GDPR compliance statement

Mandatory. Submit the sponsor statement that trial data will be collected and processed in accordance with the General Data Protection Regulation. This administrative statement does not replace participant-facing privacy information in the ICF.

The Lithuania patient-facing QC checklist includes a practical privacy consistency check.

Biological sample compliance information

Conditional. If the trial involves collection, storage or future use of biological samples, submit information showing compliance with Lithuanian rules for those activities. Lithuania's national recommendations include a specific sample form for this purpose.

If samples or coded data may be retained for research beyond the main trial, the Lithuania secondary-use consent guide explains the separate optional-consent approach recommended by the Lithuanian Bioethics Committee.

Which documents should be signed at CTIS submission?

Do not confuse a document that contains future signature fields with a document that must already be signed when uploaded.

At submission, the clearest signature requirements in Lithuania are the signed declaration of interest for each principal investigator and the signed site suitability statement. Other institution or sponsor forms should be signed when the applicable form or legal requirement calls for it.

The participant ICF is submitted as the version that will be used to obtain consent. The participant and interviewer sign it later, when consent is actually obtained. A consent form already signed by a participant should not be part of an initial CTIS application dossier.

Current EU Part II template transition

Recommended. EudraLex Volume 10 now provides version 2.0 of the harmonised recruitment and informed consent procedure template. The European Commission states that it is highly recommended for new Part II submissions during the transition period and is intended for full implementation from 1 September 2026. Lithuania's national sample forms remain useful for the Lithuania-specific content that must be captured.