Poland authorises trials through the URPL, with ethics review organised by a Supreme Bioethics Committee at the Medical Research Agency. Capture is a self-serve EDC hosted in Frankfurt that Polish sites and small CROs can test free.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Study region
Poland
Key points for studies in Poland
Regulation
A sponsor files one CTIS application. For Poland, secondary sources describe a split in which the URPL assesses the regulatory and quality content and a bioethics committee, organised by the NKB at the ABM, gives the ethics opinion that the URPL decision depends on. For the EU procedure, read our EU CTIS submission guide and EU CTR clinical trial software.
The data side of the dossier is a clear description of what is collected and how it is protected. Capture produces a blank eCRF PDF with a cover page, form index, visit-by-form matrix and every approved form printed empty, which suits the protocol and ethics package. Every field change carries a timestamp, the user, the old and new value and the reason, and the trail cannot be edited through the interface. See audit trail software for clinical trials.
Sources report separate fees for the ABM and the URPL, reduced for non-commercial trials with a possible waiver for academic studies. Review deadlines in the sources came from a draft, and the final figures were not confirmed. This page states no deadline. Ask the URPL and the ABM, and read the current Act.
Blank eCRF · no subject data
Visit by form matrix
| Form | SCR | D1 | W2 | W4 | W8 | EOS |
|---|---|---|---|---|---|---|
| Demographics | X | |||||
| Vital signs | X | X | X | X | X | X |
| Laboratory | X | X | X | |||
| ECG | X | X |
3. Was the ECG performed?
☐ Yes☐ No
If No, complete question 4.
Who does what
| Step | Who | What is needed | Where Capture helps |
|---|---|---|---|
| Dossier submission | Sponsor or legal representative in the EU | Protocol, IB or IMPD, consent, site and investigator details | Blank eCRF PDF of the approved forms. |
| Authorisation | URPL | Design, safety, quality, endpoints | Edit checks and derived fields documented in the form. |
| Ethics opinion | Bioethics committee appointed through the NKB | Consent, recruitment, site suitability, data protection | eConsent record with countersignature and signed PDF. |
| Site start-up | Hospital or clinic, principal investigator | Agreement, delegation, training | Site accounts, roles and site-level participant numbering. |
| Ongoing oversight | Sponsor or CRO monitors, inspectors | Source verification, safety reporting, audit trail | SDV per field, queries, field-level audit trail. |
Roles summarise secondary sources. Confirm national detail with the URPL and the ABM.
Build the visit schedule, forms and checks free, hand the blank eCRF PDF to your regulatory lead, and pay only when real participants enrol.
Operations
Poland is a major recruiting country in Central and Eastern Europe, with a mix of university hospitals, specialist centres and many small CROs and site networks. Two patterns recur: a sponsor from elsewhere adding Polish sites to a multinational CTIS study, and an investigator or small CRO running a national study without enterprise tooling. In both, site-level participant numbering, a separate site coordinator portal and by-site exports let each site be reviewed on its own.
Capture suits the second pattern because a small team can build the study itself, test it free, and go live without a sales call. Read clinical trial software for regional CROs and Central and Eastern Europe, or compare neighbours: Germany, the Baltics and the Nordics.
Data protection
Trial data is personal data under the GDPR, and health data is a special category. The Polish supervisory authority (UODO) supervises. Capture hosts in the EU (Frankfurt) and the USA (N. Virginia). For a Polish-site study the Frankfurt region keeps storage inside the EU. Whether access from a third country by a CRO or monitor amounts to a transfer is a question for your data protection officer.
In Capture, site coordinators see participant names while researchers see coded IDs, and row-level security enforces that at the database. Data is encrypted with AES-256 at rest and TLS in transit. Read GDPR compliant clinical trial software.
EU (Frankfurt)
Default for EU-sponsored studies
US (N. Virginia)
Default for US-sponsored studies
Consent
Because a negative ethical opinion cannot be appealed, the consent submitted should be the one you intend to use. Capture eConsent takes the participant on-screen signature, confirmed by a one-time email code, then the investigator countersigns with password re-authentication. Witness and legally authorised representative signatures are supported, and each signature is hashed to the exact document content. Language support is not claimed here, so confirm what is available before planning Polish-language screens.
Meaning of signature
I have reviewed this adverse event and confirm the assessment of seriousness, severity and causality.
Signer
Dr. A. Ozola, PI
Password
••••••••••
Before you start
Confirm which state is reporting member state and that Poland is a concerned state in the dossier.
Find out which committee the NKB will appoint and what it needs, since a negative opinion cannot be appealed.
Confirm ABM and URPL fees and whether a non-commercial reduction or waiver applies.
Approved Polish-language consent text and participant information, and how each is delivered.
Processor agreement, records of processing, transfer analysis for any non-EU access.
Audit trail description, role matrix and hosting region for your vendor assessment.
Medicinal product trials run under EU Regulation 536/2014 and the Polish Act of 9 March 2023. Secondary sources name the URPL as authorising body and the Supreme Bioethics Committee at the Medical Research Agency as the organiser of ethics review. Confirm current procedures with them.
For medicinal product trials under the EU regulation, yes. Sources report CTIS use has been mandatory in Poland since 1 January 2023.
Sources say neither EU nor Polish law allows an appeal against a negative ethical opinion of the bioethics committee. Confirm with counsel and prepare the first submission carefully.
No. Capture is hosted in the EU (Frankfurt) and the USA (N. Virginia). For a Polish study the Frankfurt region keeps data in the EU. Capture has no Polish data centre or office.
No regulator approves EDC software in that way. Capture provides an audit trail, e-signatures and role-based access, and your validated use is what an inspector looks at.
This page does not claim multilingual participant materials. Contact us about current language support before you commit to Polish-language screens.
Yes. The free sandbox has every feature, with no credit card and no time limit. You pay only when you go live with real participants.
Keep exploring
Clinical trial software in Central and Eastern Europe
The wider regional view.
Clinical trial software in Germany
Western neighbour.
Clinical trial software in the Baltics
Northern neighbours.
Clinical trial software in the Nordics
Across the Baltic Sea.
Clinical trial software for regional CROs
Small CRO workflows.
EU CTIS submission guide
How the EU portal works.
Pricing
Free sandbox, pay at go-live.
Build, test and share the blank eCRF PDF before any fee. You pay only when real participants enrol.