Poland CTIS Part II Patient-Facing Document QC Checklist

Trial content checks

Confirm that each Polish participant document uses the current trial title, EU CT number where included, sponsor name and correct study population. Check that study purpose, treatment arms, randomisation, blinding, placebo or comparator use and duration match the protocol.

Verify that the description of visits, procedures, hospital stays, home activities, sampling, imaging and questionnaires is complete enough for informed consent but does not introduce procedures that are not in the protocol.

Check numerical details that participants will notice. Dose schedules, visit frequency, treatment periods, follow-up duration and approximate blood volumes should agree with the protocol and schedules.

Protocol-to-patient-document consistency

Compare the PIS against the protocol's objectives, interventions, schedule of activities, risk sections, contraception requirements, prohibited medicines, withdrawal rules and follow-up plan.

Mandatory. Risks that are material to the participant's decision must be represented in understandable language. Do not copy investigator-facing safety language without translating its practical meaning for the participant.

If an optional procedure appears in the PIS, confirm that it is genuinely optional in the protocol and that refusing it does not accidentally exclude a participant when the protocol does not require it.

Consent logic checks

Confirm that the ICF records the decisions actually described in the PIS. The main agreement to participate should be distinguishable from optional choices for future research, optional genetic work or other activities outside the core protocol.

Mandatory when consent is obtained. The signature block must support the Article 29 pathway. The participant or legally designated representative signs and dates, and the person performing the consent interview signs and dates. The blank CTIS submission version is not signed by the participant.

If the protocol can enroll people unable to write, make sure the form supports the impartial-witness pathway rather than adding a second legal representative. The Poland impartial witness guide explains the current one-witness rule.

Population and document coverage

Map every population in the protocol to a participant document. Do not assume that the adult ICF can cover every situation.

Check specifically for:

• minors and age-specific information
• adults who may lack capacity to give informed consent
• emergency enrollment
• participants who can consent but cannot write
• pregnancy follow-up for a trial participant
• pregnancy follow-up for a pregnant partner
• optional secondary or future use of data or samples
• healthy volunteers where the risk, benefit and payment explanation differs from patient trials

The Poland patient information and consent guide is the main document guide and links to each population variation.

Minor-specific QC

For a trial involving minors, confirm the age bands against current Polish rules. NKB states that a minor under 13 is represented for consent by the legal representative. A minor who has reached 13 must also consent.

Check the parent signature design. Where both parents hold parental authority, current NKB good practice treats the clinical trial decision as a joint parental matter. The documentation may use both parents' signatures or one parent's signature accompanied by an attestation that the decision is the result of a joint decision with the other parent.

Check that age-band labels are unambiguous. Current NKB good practice explains that a range written as 13-18 years means participants who have reached 13 but have not yet reached 18. The Poland minor consent and assent guide covers the full pathway.

Data privacy checks

Confirm that the Polish privacy wording matches the real data flow. Review controller identities, trial-site roles where described, categories of recipients, monitoring and audit access, international transfers, retention and contact routes for data-protection questions.

Do not make the participant believe that withdrawal from the trial automatically requires deletion of every item of lawfully collected trial data. The withdrawal explanation should match the Clinical Trials Regulation, the GDPR framework and the sponsor's actual legal basis.

If the document asks for access to medical records, explain who may access them and for what trial-related purpose. Avoid vague statements that allow unlimited access.

Biological samples and secondary-use checks

Check each planned sample against the protocol. State what is collected, why, where it may be analysed, how long it may be stored and whether any use continues after the main trial.

If the sponsor asks for scientific use outside the protocol, make the choice optional and separable from main study participation. Check that the withdrawal wording explains what can and cannot be stopped once data have already been used or samples have been anonymised, if that is factually applicable to the trial.

The Poland secondary-use consent guide provides a focused review of these choices.

Poland compensation and insurance checks

Mandatory. Confirm that the PIS explains the Polish system for compensation for trial-related harm. The Patient Rights Ombudsman states that participants must be informed about the Clinical Trials Compensation Fund and the mandatory civil liability insurance of the sponsor and investigator.

Use the current Ombudsman wording as the reference point. Do not leave a generic global insurance paragraph in the Polish version if it does not explain the Polish Fund.

If participant reimbursement is offered, make sure the amount or method described in the PIS is consistent with the Part II financial-arrangements information.

Signature, version and administrative checks

Before upload, verify:

• the correct Polish document is uploaded to the correct CTIS participant-document category
• the title identifies the intended population clearly
• version and date match the version referenced in the recruitment and consent procedure
• headers, footers and page numbers are consistent
• no tracked changes, drafting comments or translation notes remain in the clean version
• signature lines match the consent pathway and do not demand a signature from someone who is not a consent-giver
• the participant copy requirement is reflected in site procedures
• contact details are current and usable in Poland

Readability and Polish-language checks

Mandatory. Participant-facing documents for Poland must be in Polish. Review the final Polish text clinically, not only linguistically. Drug names, procedures, reproductive precautions, risks and withdrawal instructions should use terminology a Polish participant can understand.

Check that defined terms remain consistent across the PIS, ICF, recruitment materials, pregnancy forms and optional future-use forms. A translation that changes the meaning of a protocol criterion or optional consent choice is a substantive defect.

Shorten long legal passages where the legal meaning can be preserved in plain language. Keep the participant's actions visible, such as who to call, when to stop a medicine, when to report a pregnancy and how to withdraw.

Recruitment materials

If advertisements or invitations are used, confirm that they do not promise benefit, minimise risk or use payment in a way that could distort the decision to participate. The description of the target population and study purpose must match the authorised trial.

Make sure the recruitment material and the recruitment procedure tell the same story about who makes first contact and how personal data are accessed during pre-screening.

Final release check

Release the Polish patient-facing set only when the following are aligned:

1. protocol and current safety information 2. Poland PIS and ICF 3. population-specific consent documents 4. recruitment and informed consent procedure 5. recruitment materials 6. privacy wording and CTIS GDPR statement 7. biological-sample and secondary-use documentation 8. compensation, insurance and payment descriptions 9. version and date control across CTIS

Return to the Poland CTIS Part II guide hub for the document-specific guides.