Poland CTIS Part II Document Checklist

Required and conditional Part II documents for Poland

Recruitment arrangements and informed consent procedure

Mandatory. Describe how potential participants are identified, the first act of recruitment, who approaches them, and how informed consent is provided and obtained. The current European Commission Recruitment and informed consent procedure template v2.0 covers standard adults, incapacitated adults, minors, impartial-witness consent and emergency enrollment. As of this review date the Commission highly recommends v2.0 for new Part II submissions, with full implementation stated for 1 September 2026.

This is a sponsor or applicant submission document. It is not signed by participants at CTIS submission. Give it a controlled sponsor version and date. Complete the Poland-specific fields where the procedure depends on national consent rules.

Recruitment materials

Conditional. Submit recruitment advertisements, letters, digital content or other materials when they will be used to recruit participants. Material shown to potential participants in Poland should be in Polish. The application should also explain how the material is used and how responses from people who are not eligible will be handled.

Recruitment materials are not participant-signed at submission. Upload the final proposed version that will be used after authorization.

Patient Information Sheet and Informed Consent Form

Mandatory. Submit the blank Patient Information Sheet (PIS), also called Subject Information Sheet in CTIS terminology, and Informed Consent Form (ICF) for the populations that will be enrolled in Poland. The Polish version is required for participant-facing documents.

The participant and the person conducting the consent interview do not sign the CTIS submission copy. They sign and date the approved version when consent is obtained. If a participant cannot write, the applicable impartial-witness procedure changes the signature record. The Poland patient information and consent guide explains the main form and signature logic.

Population-specific information and consent documents

Conditional. Add separate or adapted documents where the population or use case changes the consent pathway. This can include minors, limited-capacity adults, emergency enrollment, an impartial witness, pregnancy follow-up, and optional future or secondary use.

For minors, Poland has a national 13-year threshold for the minor's own consent in addition to the legal representative's consent. The Poland minor consent and assent guide explains the age and parent-signature rules.

Other participant-facing materials

Conditional. Submit other materials that are given to participants where they are part of the Part II participant information package. The current CTR Q&A also requires translated patient-facing documents to be submitted in Part II according to national language rules. Poland is marked as requiring a national-language version.

Use Polish for material that the participant must read or use. A document that merely records study data and is never participant-facing should not be translated solely because it exists in the trial master file.

Investigator Curriculum Vitae

Mandatory. Provide the investigator CV required to demonstrate suitability. The European Commission provides an optional harmonized CV template and states that a separate document should be completed and submitted for each site.

The CTR does not impose a general signature requirement on individual application documents. The EU CV template explicitly notes that a signature could be required only by national legislation. The current Polish sources reviewed for this guide do not establish a separate blanket signature requirement for the EU CV template. Complete the current information and date fields required by the template or chosen CV format.

Declaration of interest

Mandatory. Provide a declaration of interest for the principal or lead investigator at each site. The European Commission template asks whether economic, institutional or personal interests could influence impartiality, identifies the investigator and institution, and includes a date field.

The current EU declaration template states that the CTR does not require signing individual application documents unless national law adds that requirement. Complete and date the declaration and follow any case-specific instruction from CTIS or the Polish assessor.

Site suitability form

Mandatory. Provide the site suitability information for every Polish trial site. It should demonstrate that the site has the facilities, equipment, staffing and organisational arrangements needed for the protocol and the expected participant population.

Use the current European Commission site suitability form unless a Poland-specific instruction requires otherwise. The document is submitted before site initiation because suitability is part of the Part II assessment.

Proof of insurance or indemnification

Mandatory for the usual pathway. Polish law requires civil liability insurance for the sponsor and investigator for damage connected with the conduct of the clinical trial. The sponsor's insurance obligation has a statutory exception for a low-intervention clinical trial, but the investigator remains within the national liability framework. The proof required for the specific trial must be attached to the application before authorization.

The insurance obligation arises no later than the date the clinical trial application is submitted. The Polish Act also sets minimum guaranteed sums based on the number of participants. Use the current statutory text and insurer documentation when preparing the evidence.

Clinical Trials Compensation Fund payment evidence

Mandatory. The sponsor must make the required payment to the Clinical Trials Compensation Fund for each application for authorization and attach proof of payment. The Patient Rights Ombudsman confirms that this applies to applications submitted from 14 April 2023, including low-intervention trials.

This is application evidence rather than a participant-signed document. The participant information must separately explain the participant's right to the Polish compensation mechanism.

Financial and participant-compensation arrangements

Mandatory information. Part II must describe compensation to trial participants, investigator and site financial arrangements, and other relevant financial arrangements. Use the European Commission compensation template where appropriate and state any travel reimbursement, expense compensation or other payment that participants may receive.

For vulnerable populations, do not assume that a payment allowed for healthy adults is also permissible. The Clinical Trials Regulation restricts incentives for minors, incapacitated participants and pregnant or breastfeeding participants to compensation for expenses and loss of earnings directly related to participation.

Data-protection compliance

Mandatory. Include the CTIS statement or documentation showing compliance with applicable personal-data rules. The European Commission provides a standard GDPR compliance statement for the CTIS Form section. Participant-facing privacy information used in Poland should be in Polish and consistent with the actual data flows, recipients, retention plan and international transfers described for the trial.

Informed consent to participate in the clinical trial and the legal basis for processing personal data are related but not interchangeable. The European Commission's CTR-GDPR Q&A should be used when drafting the data section.

Compliance for biological samples

Conditional in content, standard Part II category when samples are collected, used or stored. State how biological samples will be collected, used, stored and managed under applicable rules. The European Commission provides a Part II compliance template for biological samples.

Where samples may be kept for optional future research outside the protocol, give participants a clear separate choice and make the limits of that choice understandable. The Poland secondary-use consent guide covers optional future use.

Application and ethics fees

Mandatory where applicable to the application. Poland charges a national clinical trial application fee under the Clinical Trials Act. NKB states that proof of the payment made to the Medical Research Agency account for the application is uploaded in CTIS. URPL and NKB publish the current payment instructions.

Use the current fee page rather than copying an old amount into a standing submission checklist, because payment details can change independently of the document requirements.

Poland language checks before upload

The European Commission CTR Q&A Annex II marks Poland as requiring translation into a national language for the protocol synopsis, patient-facing documents submitted in Part II, labelling, labelling for an investigational medicinal product not handed to the participant, and relevant CTIS application fields.

For the Part II document set, the practical rule is simple. Prepare the Polish participant-facing version before submission. Do not rely on a later site translation to cure the dossier. If an administrative EU template is completed in English, check whether any participant-facing content is embedded in that template and whether the Poland-specific field needs Polish.

Final Part II submission QC

Before submitting Poland Part II, confirm that:

• every Polish site has the required investigator and site-suitability evidence
• every population has the correct Polish PIS and ICF or adapted document
• the main ICF includes the Polish Clinical Trials Compensation Fund and insurance information
• minor documents follow the current NKB 13-year consent rule and joint-parent decision guidance
• any non-writing consent pathway follows the one-witness CTR and NKB rule
• the recruitment and informed consent procedure reflects the actual Polish workflow
• proof of insurance, Compensation Fund payment and required application fee payment is present
• privacy and biological-sample information matches the protocol and actual data or sample use
• document versions and dates are consistent across CTIS

The Poland patient-facing document QC checklist provides a focused review of the participant documents. Return to the Poland CTIS Part II guide hub for the full guide set.