Bulgaria CTIS Part II Patient-Facing Document QC Checklist

Trial content checks

• Confirm the study title, protocol number, investigational treatment and study purpose match the current protocol.
• Check treatment arms, randomisation and placebo descriptions against the protocol.
• Confirm the visit schedule and participant procedures are described accurately at a level a participant can understand.
• Check invasive procedures, optional procedures and remote or digital activities against the current protocol.
• Confirm the expected duration of participation and any follow-up period.
• Check the approximate participant number where it appears in the PIS or ICF.
• Ensure foreseeable risks and inconveniences reflect the current safety information and protocol procedures.
• If direct clinical benefit is not expected, state that clearly rather than implying benefit.

The Bulgaria patient information and consent guide explains the baseline content expected in the standard PIS and ICF.

Protocol-to-patient-document consistency checks

• Match every participant procedure in the PIS to the protocol schedule of activities.
• Confirm optional procedures are not described as mandatory participation requirements.
• Check that contraception, pregnancy testing and pregnancy follow-up wording matches the protocol.
• Match biological sample types, volumes, purposes, storage and future-use statements.
• Confirm reimbursement and payment descriptions agree with the financial-arrangements document.
• Check trial-related injury and insurance wording against the Bulgaria insurance documents.
• Confirm withdrawal language does not promise destruction of data or samples when the protocol or applicable law provides otherwise.
• Verify local contacts and emergency contacts are current and suitable for Bulgaria.

Consent logic checks

Mandatory. The standard adult consent pathway must require written informed consent before enrollment unless the protocol lawfully uses the emergency exception in Article 35 of Regulation (EU) No 536/2014.

Check that the participant or legally designated representative and the person conducting the consent interview have the correct signature and date fields. Do not add a witness signature to every ICF. A witness is used only when the applicable witness pathway is triggered.

Optional choices should be distinguishable from the main decision to enter the trial. If future data or sample use is optional, the participant must be able to refuse that use without being treated as refusing the main study. The Bulgaria secondary use consent guide explains the separation.

Population and document coverage checks

Compare the protocol population with the actual document set.

Conditional. For healthy-volunteer trials, check that the participant documents do not imply therapeutic need or expected treatment benefit and that payment or reimbursement wording agrees with the Part II financial arrangements. Use the Bulgaria healthy-volunteer consent guide.

Conditional. For minors, Bulgaria distinguishes children under 14 from participants aged 14 to 17. Check both parent or guardian logic and the young person's own role. The ICF for a participant aged 14 to 17 must contain a signature field for the minor. Use the Bulgaria minor consent and assent guide.

Conditional. For adults who cannot legally consent, check the legally designated representative document, participant information adapted to the person's understanding, objection or dissent wording and re-consent if capacity returns. Use the Bulgaria limited-capacity participant guide.

Conditional. If emergency enrollment is planned, the protocol and patient-facing documents must reflect the Article 35 conditions and the requirement to seek consent without undue delay after the first intervention. Use the Bulgaria emergency enrollment guide.

Conditional. If the participant or legal representative cannot read or cannot write, verify the appropriate independent witness process. Use the Bulgaria impartial witness guide.

Conditional. If pregnancy follow-up is planned, check whether the participant's existing consent clearly covers it and whether a pregnant partner needs a separate information and consent process. Use the Bulgaria pregnancy follow-up guide.

Data privacy checks

• Make the participant-facing privacy explanation consistent with the sponsor's GDPR compliance declaration.
• Explain who handles trial data and the practical categories of recipients where needed.
• Describe access to source medical records for authorised monitors, auditors, ethics reviewers and regulators in a way consistent with Good Clinical Practice.
• Avoid presenting trial participation consent as the only possible GDPR legal basis for all trial data processing.
• Check international transfers and central laboratories against the protocol and privacy documentation when relevant.
• Confirm withdrawal language distinguishes stopping trial participation from the handling of data already lawfully collected.

Biosample and secondary-use checks

Conditional. If samples are collected, verify the PIS and ICF state the purpose, sample type, storage and relevant transfer or future-use conditions. The Part II dossier must also include the required declaration on compliance with applicable rules for collection, storage and future use of human biological samples when applicable.

If the protocol contains optional future research, use a separate optional choice or clearly separated consent section. Check that refusal does not affect main-study participation and that withdrawal wording explains what can and cannot be retrieved after anonymisation or use, based on the actual sample plan.

Bulgaria-specific regulatory checks

• Bulgarian PIS and ICF present.
• Corresponding Bulgaria English version present.
• Recruitment arrangements and advertisements in Bulgarian.
• Participant compensation wording consistent with the Part II financial-arrangements information.
• Insurance wording consistent with the current Bulgaria insurance documentation.
• Minor consent logic matches Article 97 of the Bulgarian Medicinal Products in Human Medicine Act.
• Site and participant numbers agree across CTIS, site list and insurance documentation.
• Current EudraLex recruitment and informed-consent procedure template used where applicable. Version 2.0 is highly recommended now and fully implemented from 1 September 2026.

Signature, version and administrative checks

• Check document title, version and date on every patient-facing document.
• Ensure Bulgarian and English Bulgaria versions identify the same content version.
• Confirm the signature blocks match the population and consent pathway.
• Check that participant-facing documents uploaded for review do not contain completed participant signatures.
• Confirm the final site-use document matches the version authorised through CTIS.
• For substantial modifications, control clean and tracked-change versions in line with the BDA's national instructions.

Readability and document-design checks

Bulgarian Good Clinical Practice requires consent information to be free of medical jargon and sufficiently understandable. Read the Bulgarian text as a participant document, not as a protocol translation.

• Define medical and regulatory terms when they cannot be avoided.
• Keep sentences short and use direct wording.
• Separate main-study requirements from optional choices.
• Use headings that help a participant find risks, visits, alternatives, withdrawal, contacts and compensation.
• Avoid dense blocks copied from the protocol.
• Check that translated terminology is consistent throughout the PIS, ICF and supporting materials.

For the complete country guide library, return to the Bulgaria CTIS hub.