Poland does not have a clinical trials registry of its own. It is an EU/EEA country, it follows EU Directive 2001/20/EC for protocol registration and results posting on EudraCT. EudraCT is a World Health Organization (WHO) recognized primary registry. The clinical trial information posted on EudraCT is available for public view on European Union Clinical Trials Register (EU CTR). From 31 January 2022, European Union Clinical Trial Information System (EU CTIS) has become functional and Clinical Trials Regulation (Regulation (EU) No 536/2014) is now applicable. EU CTIS will support both protocol registration and results posting activities for clinical trials conducted in EU/EEA.
| Registries at a Glance | |||||
| Registry | PHUSE Categorization | Information to be Entered By | Route of Data in Registry | Study Type | Language |
| EU CTIS | Not Applicable | Competent authority, Sponsor | Clinical Trial Application |
Interventional (Phase 1-4) |
English |
| EU CTR | EU CTR via Clinical Trial Applications | Competent authority | Clinical Trial Application |
Interventional (Phase 1-4) |
English 
Polish |
| EU PAS | EU PAS - ENCePP (European Network of Centres for Pharmacoepidemiology and Pharmacovigilance [PASS & PAES requirements]) | Sponsor | Through a dedicated registration platform (process independent from clinical trial application) | Post-authorization Safety Efficacy Studies |
English |
| INFARMA | Academic/Patient Registries/Voluntary | Sponsor | Through a dedicated registration platform (process independent from clinical trial application) |
Interventional (Phase 1-4) |
Polish |
| Registration and Results Requirements | |||
| Registry | Activity | Legal Requirement | Timing |
| EU CTIS | Registration |
Yes |
Prior to enrollment |
| Results |
Yes |
Intermediate summary of results - within 12 months of the interim data analysis date; Final summary of results and lay person summary - within 12 months from the end of trial in EU/EEA (Non-paediatric Studies); within 6 months from the end of trial in EU/EEA (Paediatric Studies) | |
| EU CTR | Registration |
Yes |
Prior to enrollment |
| Results |
Yes |
Within 12 months of Study Completion (Non-paediatric Studies); Within 6 months of Study Completion (Paediatric Studies) | |
| EU PAS | Registration |
Yes |
Before the start of data collection |
| Results |
Yes |
Within 12 months of the end of data collection | |
| INFARMA | Registration |
Yes |
Prior to enrollment |
| Results |
No |
Within 12 months of Study Completion (Non-paediatric Studies); Within 6 months of Study Completion (Paediatric Studies) | |
Registry Updates
- November 2022: CTIS Training Update - European Medicines Agency (EMA) updated the page Clinical Trials Information System: training and support on November 30, 2022, by adding a new version of the CTIS – Sponsor handbook (v3.0). The below sections were newly added in version 3.0 of the CTIS – Sponsor handbook: Section 3.5: Marketing Authorization Holder (MAH) group of users – This section gives … Continue reading "November 2022: CTIS Training Update"
- November 2022: CTIS Update for Organization Management System (OMS) Trouble Shooting Sessions - European Medicines Agency updated the event pages Organisation Management System (OMS) Trouble Shooting Session for CTIS users- October 2022 and OMS Trouble Shooting Session for CTIS users- November 2022 on November 29, 2022, with the following information: A video recording of the session held on October 2022 was made available. A Presentation from the session … Continue reading "November 2022: CTIS Update for Organization Management System (OMS) Trouble Shooting Sessions"
- November 2022: CTIS Update - European Medicines Agency updated the event page, Clinical Trials Information System (CTIS) bitesize talk: Notifications – Part 2 over the What’s New Section on November 23, 2022: The presentation for the CTIS bitesize talk held on November 23, 2022, is now available on the event page. It explains, in brief, different kinds of circumstantial events … Continue reading "November 2022: CTIS Update"
References
- Clinical Trial Application Form. European Clinical Trials Database. https://ec.europa.eu/health/system/files/2019-11/application-form_en_0.pdf. Published November 28, 2019. Accessed November 28, 2019.
- Clinical Trials Regulation. https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-regulation#transition-period-for-clinical-trial-sponsors-section.
- Clinical Trials Information System: training and support. https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-information-system-training-support.