Poland CTIS Part II Patient Information and Consent Requirements

Polish language requirements for the PIS and ICF

Mandatory. The current European Commission CTR Q&A Annex II marks Poland as requiring national-language translated patient-facing documents in Part II. The PIS, ICF and other participant-facing material used for informed consent in Poland should therefore be submitted in Polish.

Do not submit an English ICF and plan to translate it only before site initiation. Translation is part of the Poland dossier requirement. Use controlled versions so the Polish document and any English source version remain aligned after protocol or safety updates.

The same Q&A table also marks Poland as requiring a national-language protocol synopsis and relevant CTIS application fields. This is useful for cross-document QC because participant-facing terminology should match the Polish study description used elsewhere in the application.

What the main PIS should explain

Mandatory. The information must be comprehensive, concise, clear, relevant and understandable to a layperson. Under Article 29 of the Clinical Trials Regulation, the participant or legally designated representative must be able to understand the nature and objectives of the trial, potential benefits, risks and inconveniences, participant rights, trial conditions, expected duration and treatment alternatives.

For a Poland submission, the PIS should also cover the following where applicable to the protocol:

• study purpose and why the person is being invited
• trial procedures, randomisation, blinding and placebo or comparator use where relevant
• foreseeable risks and inconveniences, including reproductive risks
• expected benefits and a clear statement when direct medical benefit is not expected
• alternatives to participation
• duration of participation and follow-up
• voluntary participation, right to refuse and right to withdraw without detriment
• what happens to care and follow-up after withdrawal
• confidentiality, personal data, access to medical records and relevant data recipients
• biological sample collection, storage and future use
• reimbursement, compensation and other participant payments
• injury compensation and insurance in Poland
• investigator and other appropriate contact details
• circumstances in which participation may be stopped by the investigator or sponsor

The PIS should describe what the protocol actually does rather than reproduce protocol wording. The Poland patient-facing QC checklist is designed for the final consistency review.

Poland Clinical Trials Compensation Fund wording

Mandatory. Information given before informed consent in Poland must explain how compensation for trial-related harm can be obtained. The Patient Rights Ombudsman states that the Polish compensation system includes the Clinical Trials Compensation Fund and that the participant must be informed about the right to seek a compensation benefit from the Fund.

The participant information must also explain the mandatory civil liability insurance of the sponsor and investigator for harm connected with the clinical trial. The Ombudsman publishes proposed participant wording and recommends including that wording in information accompanying the informed consent form.

Treat this as a Poland-specific consent-content requirement. A generic sentence saying that insurance exists is not equivalent to explaining the Polish compensation route.

Consent form structure and choices

The ICF should record the participant's decision on the trial participation described in the PIS. Keep the main participation decision separate from optional choices that are not necessary for the main study.

Optional. Consent for scientific use of data outside the protocol may be requested under Article 28(2) of the Clinical Trials Regulation. If requested, make the choice genuinely optional and distinguish it from agreement to participate in the main trial. The Poland secondary-use consent guide covers data and sample choices in more detail.

Conditional. Separate choices may also be needed for optional future sample use, optional genetic research, additional contact after the trial, or other activities that are not required for the main protocol. The PIS must make the consequence of saying no clear.

Signatures and dating

Mandatory when consent is obtained. Article 29 of the Clinical Trials Regulation requires informed consent to be written, dated and signed by the person performing the consent interview and by the participant or, where the participant cannot give informed consent, the legally designated representative.

The PIS and ICF submitted in CTIS are blank controlled documents. The participant does not sign the dossier copy at Part II submission. Signatures are obtained on the approved version before the participant is enrolled or undergoes trial-specific procedures, unless the narrowly defined emergency pathway under Article 35 applies.

Provide the participant or legally designated representative with a copy of the document or record by which informed consent was given.

Participant who cannot write

Conditional. A participant who is able to decide but unable to write does not automatically need a legal representative. The Clinical Trials Regulation allows consent to be given and recorded by appropriate alternative means in the presence of at least one impartial witness. The witness then signs and dates the informed consent document.

Current NKB good practice confirms that this one-witness CTR rule applies to medicinal clinical trials in Poland and that the separate Polish two-witness rule for certain medical experiments does not apply to these CTR clinical trials. The Poland impartial witness consent guide explains the documentation and witness role.

Minors

Conditional. Trials involving people under 18 need a minor-specific document set and consent pathway. Current NKB good practice states that for a minor under 13 the legal representative gives consent. A minor who has reached 13 also gives consent in addition to the legal representative.

When both parents have parental authority, NKB considers participation in a clinical trial an important matter that should result from a joint parental decision. NKB permits documentation by both parents signing the ICF or by one parent signing with an attestation that the decision is the result of a joint decision with the other parent.

The minor must receive information adapted to age and maturity and take part in the consent process. The investigator must respect an explicit wish of a capable minor to refuse or withdraw. If the participant reaches the age of legal competence during the trial, the Clinical Trials Regulation requires the participant's express informed consent before continuing. The Poland minor consent and assent guide sets out the full pathway.

Adults who cannot provide informed consent

Conditional. For an incapacitated adult, Article 31 of the Clinical Trials Regulation requires consent from the legally designated representative and information for the participant in a form adapted to the participant's capacity. The investigator must respect an explicit wish to refuse or withdraw when the participant is capable of forming an opinion and assessing the information.

The Poland submission should explain how the legally designated representative will be identified under Polish law and what evidence of that authority will be checked at the site. Do not use a generic family-member signature line without defining why that person is legally entitled to act. The Poland limited-capacity and legal representative guide explains the Part II documentation.

Emergency enrollment

Conditional. Article 35 of the Clinical Trials Regulation allows consent and trial information after the decision to include the participant only when every emergency condition in that article is met. This is not a general waiver of consent.

If the protocol uses emergency enrollment in Poland, describe the pathway in the Part II recruitment and informed consent procedure. Explain why prior participant consent and prior representative consent cannot be obtained within the therapeutic window, how any known prior objection is checked, and how consent for continued participation will be sought without undue delay. The Poland emergency enrollment guide gives the operational checklist.

Pregnancy and pregnancy follow-up

A trial that enrolls pregnant or breastfeeding participants must meet the additional protections in Article 33 of the Clinical Trials Regulation. Pregnancy follow-up after exposure is a separate practical issue. If the protocol collects extra pregnancy, outcome or infant information, the participant documents should describe what will be collected, for how long and from whom.

A pregnant partner is not covered by the trial participant's consent merely because the participant reports the pregnancy. Where identifiable health information or medical-record information is collected from the partner, prepare a separate partner-facing information and consent process. The Poland pregnancy follow-up guide explains the two pathways.

Data protection and medical-record access

Mandatory. Explain what personal and health data will be collected, who will receive them, how coded data are used, relevant transfers, retention and the practical rights available to the participant. The description must match the actual data flow and the CTIS GDPR compliance statement.

Do not describe the clinical-trial informed consent as if it automatically supplies the legal basis for every processing operation under the General Data Protection Regulation. The European Commission's CTR-GDPR Q&A distinguishes the ethical and regulatory informed-consent requirement from the data-protection legal basis.

If the trial requires source-data verification or medical-record access, explain who may review the records and why. Use language that is understandable to a participant, not an internal data-processing description.

Readability and document design

Polish participant information should be written for a lay reader. Use clear headings, short paragraphs, defined medical terms and a logical sequence from study purpose through procedures, risks, rights and contacts.

Avoid combining several distinct consent populations into one form if that makes the signature logic unclear. A parent document, adolescent document and adult document can share core content while still being separate controlled documents where the consent-givers differ.

Before submission

Confirm that the final Poland PIS and ICF:

• are in Polish
• match the current protocol and safety information
• contain the Polish Compensation Fund and insurance information
• distinguish main participation from optional secondary or future use
• use the correct signature route for each population
• cover all sites and contact details used in Poland
• match the recruitment and informed consent procedure submitted in Part II
• use consistent version numbers and dates

Return to the Poland CTIS Part II guide hub for the connected Poland guides.