Clinical Trials in Poland: CTIS Part II Guide Hub

How the Poland assessment works

URPL is the Polish competent authority for medicinal clinical trials. New applications are submitted through CTIS. The Polish Clinical Trials Act of 9 March 2023 supplements the directly applicable EU Clinical Trials Regulation and sets the national procedure, ethics structure, insurance rules, fees and Clinical Trials Compensation Fund.

The ethical assessment covers relevant Part I ethical aspects and the Part II aspects assigned to Member States under the Clinical Trials Regulation. The ethics assessment forms part of the basis for the decision issued by the President of URPL.

For the CTIS dossier itself, use the current European Commission and EMA templates and operational guidance. As of 24 August 2026, the European Commission's Recruitment and informed consent procedure template v2.0 is highly recommended for new Part II submissions. The stated transition period ends with full implementation on 1 September 2026.

Poland CTIS Part II guide directory

Poland CTIS Part II Document Checklist

Use this first to identify the standard and conditional Part II documents, Polish-language items, submission-time signatures and Poland-specific supporting evidence.

https://trialagents.com/ctis/poland/en/part-ii-document-checklist

Poland Patient Information and Consent Requirements

Use this for the main adult Patient Information Sheet and Informed Consent Form, Polish language, compensation information, consent process, signatures and population variations.

https://trialagents.com/ctis/poland/en/patient-information-consent-requirements

Poland Patient-Facing Document QC Checklist

Use this before submission to check protocol consistency, consent logic, translations, privacy, compensation, signatures and population coverage.

https://trialagents.com/ctis/poland/en/patient-facing-document-qc-checklist

Poland Healthy Volunteer Consent Requirements

Use this when healthy adults are enrolled and the participant documents need to explain non-therapeutic participation, restrictions, risks and payments or reimbursements.

https://trialagents.com/ctis/poland/en/healthy-volunteer-consent-requirements

Poland Minor Consent and Assent Requirements

Use this for children and adolescents, including the Polish 13-year consent threshold, parent decision logic, age-specific documents and re-consent at adulthood.

https://trialagents.com/ctis/poland/en/minor-consent-assent-requirements

Poland Limited-Capacity Participant and Legal Representative Consent Requirements

Use this when an adult cannot provide legally valid informed consent and a legally designated representative may need to act.

https://trialagents.com/ctis/poland/en/limited-capacity-legal-representative-consent-requirements

Poland Emergency Enrollment Consent Requirements

Use this when the protocol relies on the Clinical Trials Regulation emergency pathway and consent cannot be obtained before the first trial intervention.

https://trialagents.com/ctis/poland/en/emergency-enrollment-consent-requirements

Poland Impartial Witness Consent Requirements

Use this when a participant can consent but cannot write. Current NKB guidance confirms that one impartial witness is sufficient for a medicinal clinical trial under the EU rule.

https://trialagents.com/ctis/poland/en/impartial-witness-consent-requirements

Poland Pregnancy Follow-Up Consent Requirements

Use this when a trial collects pregnancy, pregnancy outcome or infant follow-up information from a participant or a pregnant partner.

https://trialagents.com/ctis/poland/en/pregnancy-follow-up-requirements

Poland Secondary Use Consent Requirements

Use this for optional scientific use outside the trial protocol and for future use of data or biological samples.

https://trialagents.com/ctis/poland/en/secondary-use-consent-requirements

Main national differences to plan for

Polish participant documents

Mandatory. Patient-facing documents used in Poland must be available in Polish. The European Commission language table specifically marks translated patient-facing documents in Part II as requiring a national-language version for Poland. Build translation and linguistic QC into the submission schedule rather than treating translation as a site-start activity.

The Poland patient information and consent guide explains the main Polish ICF requirements and links to the population-specific variations.

Compensation and insurance information

Polish participant information must explain the compensation system for trial-related harm. Poland operates the Clinical Trials Compensation Fund through the Patient Rights Ombudsman. The Ombudsman states that information provided before informed consent must include the participant's right to seek a benefit from the Fund and information on the mandatory civil liability insurance of the sponsor and investigator.

The Polish Clinical Trials Act also requires sponsor and investigator civil liability insurance for clinical trials, subject to the statutory exception for the sponsor in low-intervention trials. Proof of insurance and proof of the required payment to the Clinical Trials Compensation Fund are attached to the clinical trial application.

Minors and witnesses

Poland applies a national consent threshold for minors. Current NKB good practice states that for a child under 13 the legal representative gives consent. From the 13th birthday until age 18, consent is required from both the minor and the legal representative. Where both parents hold parental authority, NKB expects the decision to be a joint parental decision and gives two acceptable documentation routes.

For a participant who can consent but cannot write, current NKB good practice follows Article 29 of the Clinical Trials Regulation. Consent may be recorded by an appropriate alternative means in the presence of at least one impartial witness. The witness signs and dates the informed consent document. The NKB guidance expressly explains that the two-witness rule used for certain non-clinical medical experiments does not apply to medicinal clinical trials under the Clinical Trials Regulation.

Other language versions

This publication set contains the English Poland hub and English guides. Link only to a Polish-language hub once that localized set has been published.