Estonia CTIS Patient-Facing Document QC Checklist

Trial content checks

Confirm that every participant-facing statement matches the current protocol and other approved trial documents.

Check:

• trial title and EU CT number
• investigational product, comparator and randomisation
• visit schedule and study duration
• invasive procedures and sample collections
• optional procedures
• contraception and pregnancy precautions
• foreseeable risks and burdens
• expected benefits and alternatives
• withdrawal procedures
• injury, insurance and medical-care wording
• participant contacts

Do not add a procedure, benefit or risk statement that is not supported by the protocol or other source documents.

Protocol-to-document consistency

Compare the PIS/ICF directly with the protocol rather than reviewing it in isolation.

Verify that visit counts, time commitments, treatment periods, follow-up, blood volumes, imaging, biopsies, washouts, prohibited medicines and pregnancy testing all use the same logic.

If the protocol has different cohorts, dose levels or optional substudies, confirm that participants only receive information relevant to the pathway they may enter.

Use the Estonia main patient information and consent guide as the baseline for the default adult form.

Consent logic checks

Confirm that each consent choice is understandable and linked to a real activity.

The main trial consent should not be conditioned on optional future research, optional genetics, optional sample storage or optional data use unless participation genuinely requires that activity under the protocol and law.

Estonian ethics guidance recommends separate consent choices for trial participation and use of pseudonymised health data or biological samples.

For the actual consent event, confirm that the participant or legal representative and the person conducting the consent interview sign and date the consent as required by the Clinical Trials Regulation. Estonia permits digital signatures that are valid under Estonian law.

If remote consent is planned, confirm that the approved process includes video interaction, electronic identification, full opportunity for questions and a valid signature.

Population and document coverage

Map the protocol population against the actual document set.

Check whether the trial needs:

• healthy volunteer consent
• minor consent and age-appropriate information
• limited-capacity and legal representative documents
• emergency enrollment documents
• impartial witness procedure
• pregnancy follow-up documents
• secondary or future-use consent

For minors aged 7 to 17, Estonia has a specific national rule requiring consent from the minor as well as the legal representative. Confirm that the signature and information design can support that rule.

Data privacy checks

Verify that the PIS/ICF explains the actual data flow rather than using generic privacy language.

Check:

• categories of personal and health data
• who collects and controls the data
• who may access coded source data
• pseudonymisation
• transfers outside Estonia or the European Economic Area when applicable
• retention
• monitoring and audit access
• withdrawal consequences
• optional future research
• participant rights and contacts

Do not state that trial-participation consent is automatically the legal basis for all General Data Protection Regulation processing. The EU guidance distinguishes ethical consent to participate from data-processing legal bases.

If site electronic health records are used for source data, ensure the operational access wording is realistic. Ravimiamet states that sponsor representatives do not automatically gain direct access to Estonia's national Health Information System.

Biological sample checks

For every sample type, confirm:

• what is collected
• purpose
• coding status
• transport
• storage location
• retention duration in years
• destruction plan
• whether genetic analysis is involved
• whether future use is optional
• whether samples may leave Estonia or the EEA

Where applicable, the Part II package should include the EU biological-sample compliance form.

Compensation checks

Estonia requires compensation information in the ICF, not recruitment advertising.

Check that unavoidable direct trial expenses are reimbursed according to the approved plan. If compensation for time or burden is offered to a competent adult, confirm that the basis and amount are justified in the application and approved by the ethics committee.

Do not offer completion bonuses or defer a large share of payment until the end as an incentive to stay enrolled.

For incapacitated participants and their representatives, minors and their representatives, pregnant women and breastfeeding women, Estonia permits only reimbursement of direct costs, not participation compensation.

Country-specific regulatory checks

Before submission, confirm:

• Estonian participant-facing version is present
• every participant-facing item includes the EU CT number
• "participant" is used instead of "patient" where the national guidance requests it
• the national ICF template has been considered
• the current CTIS placement rule for Estonian-language patient-facing materials has been followed
• reimbursement and compensation wording follows Estonia guidance
• data protection is explained in detail
• sample handling is described when relevant

Signature, version and administrative checks

Check every document for:

• clear version number
• date
• consistent trial identifier
• consistent sponsor name
• consistent site name where site-specific
• signature blocks that match the actual consent pathway
• no pre-signed participant signature on a blank submission template
• correct language label
• no tracked changes or drafting comments in the clean submission version

For site and investigator documents, use the separate Estonia Part II document checklist.

Readability and language checks

Use plain Estonian suitable for the target participant population. The English master is not the participant document in Estonia unless English will genuinely be used with a specific participant group.

Check that headings explain the decision being made, abbreviations are defined, risks are not hidden in dense paragraphs, and optional choices are visually separate from mandatory trial participation.

For child documents, adapt information to age and maturity rather than shortening an adult form mechanically.

Return to the Estonia CTIS hub for all Estonia guides.