Lithuania CTIS Patient-Facing Document QC Checklist

1. Trial content checks

Confirm that the participant information correctly states:

• trial purpose and research nature
• investigational treatment and comparator
• randomisation and blinding where applicable
• number and timing of visits
• invasive and burdensome procedures
• treatment duration and follow-up
• prohibited and required concomitant treatments
• reproductive precautions
• safety monitoring
• withdrawal and early discontinuation procedures

Do not accept a polished ICF if it describes a different visit schedule, dose, comparator or follow-up period from the protocol.

2. Protocol-to-participant-document consistency

Check every participant-facing statement that can be traced to the protocol.

Match:

• eligibility-related participant obligations
• procedures and assessments
• sample collection volumes and frequency
• imaging and radiation where applicable
• questionnaires, diaries and digital tools
• home visits or decentralised elements
• pregnancy testing and contraception
• optional substudies
• data and sample retention
• follow-up after treatment discontinuation

Where home visits are planned, current Lithuanian Bioethics Committee guidance treats them as exceptional and expects the arrangement to be described in the protocol and consent documentation, especially where the home visit is optional.

3. Consent logic checks

Confirm that the document clearly separates:

Mandatory. Consent needed to join and remain in the main trial.

Optional. Choices that are not necessary for main-trial participation, such as future research use of samples or coded data.

Check that refusing an optional activity does not read as if it disqualifies the person from the main trial unless the protocol genuinely makes that activity essential.

For the standard adult pathway, use the Lithuania patient information and consent requirements.

4. Population and document coverage

Map each protocol population to the correct information and consent documents.

Healthy volunteers

Confirm that the document does not imply therapeutic benefit and that payment, reimbursement, risks and free trial procedures are clearly explained. Use the Lithuania healthy volunteer guide.

Minors

Check the child's age group, parental signature logic, assent and re-consent at adulthood. Lithuania distinguishes children under 12 from those aged 12 and above. Use the Lithuania minor consent and assent guide.

Limited-capacity participants

Confirm that the legally entitled consent-giver is defined under Lithuanian law, the participant receives information adapted to their understanding and dissent is addressed. Use the Lithuania limited-capacity guide.

Emergency enrollment

Confirm that the protocol meets Article 35 and that the consent procedure explains how consent to continue will be obtained without undue delay. Use the Lithuania emergency enrollment guide.

Impartial witness

If the participant cannot write, confirm the witness pathway, reason for its use and signature block. Use the Lithuania impartial witness guide.

Pregnancy follow-up

Check whether the person providing pregnancy data is the trial participant or the participant's partner. The consent and privacy logic are different. Use the Lithuania pregnancy follow-up guide.

5. Data privacy checks

Confirm that participant-facing privacy information is consistent with the sponsor's submitted GDPR statement and actual data flows.

Check:

• controller identity and contact route where required
• categories of personal and health data
• source of data
• access by sponsor, monitors, auditors and authorities
• coding or pseudonymisation
• recipients and international transfers where relevant
• storage period
• use after withdrawal
• rights and complaint routes
• special categories such as genetics, race or ethnicity when collected

The Lithuanian Bioethics Committee FAQ states that collection of race and ethnicity data is not automatically prohibited, but it must be scientifically justified and transparently explained in the informed consent information.

6. Biosample and secondary-use checks

For each sample, confirm:

• purpose in the main trial
• collection timing
• where analysis occurs
• storage and destruction plan
• whether future use is planned
• whether future use is optional
• whether withdrawal from future use is explained

For future research, Lithuania recommends a separate ICF or a separate opt-in choice rather than burying consent inside the main trial agreement. Use the Lithuania secondary-use guide.

7. Lithuania-specific regulatory checks

Confirm that:

• the relevant Part II documents are in Lithuanian
• the recruitment and consent procedure covers the actual consent pathway
• any advertisements are submitted with the supporting explanation expected by the Lithuanian Bioethics Committee
• reimbursement and compensation wording agrees with the financial submission
• the participant information explains free IMP and trial health checks where applicable
• contraception costs are handled consistently where contraception is required specifically because of the trial
• biological-sample compliance information is included when applicable

8. Signature, version and administrative checks

Before CTIS upload, confirm:

• the ICF version number and date match the document register
• the Lithuanian version corresponds to the intended master version
• all signature blocks are appropriate for the population
• representative basis is captured when someone else gives consent
• witness fields exist only where the pathway may be used
• the participant and interviewer have not pre-signed an initial submission ICF
• documents that do require submission-time signatures, such as principal investigator declarations of interest and site suitability statements, are signed
• filenames and document titles distinguish population and use case clearly

9. Readability and translation checks

Read the Lithuanian text as a participant would, not as a translator would.

Check that:

• sentences are short enough to follow
• technical terms are explained
• risks use consistent plain-language wording
• optional choices are visibly separate
• headings make the document easy to scan
• the document does not contradict itself about withdrawal, data or samples
• the translation preserves the regulatory meaning of the source without sounding literal

Final release check

A participant-facing document is ready for Lithuania only when the protocol, consent pathway, Lithuanian wording, privacy statements, optional choices, signatures and version control all agree.

The Lithuania Part II document checklist should be used as the final package-level check after the patient-facing review is complete.