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).
| Registries at a Glance | |||||
| Registry | PHUSE Categorization | Information to be Entered By | Route of Data in Registry | Study Type | Language |
| 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 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
- September 2021: EU CTIS Webinar - European Medicines Agency updated about the upcoming Clinical Trials Information System- Webinar for small and medium-sized enterprises (SMEs) and academia over the What’s New Section on September 10, 2021: The webinar will be conducted on November 29, 2021, for the small and medium-sized enterprises (SMEs) and academic sponsors of clinical trials. The agenda of the … Continue reading "September 2021: EU CTIS Webinar"
- September 2021: CTIS Training Update - European Medicines Agency updated the page Clinical trials information system (CTIS): online modular training programme by adding a PDF in Module 19: Quick guide – Introduction: CTIS for SMEs and Academia on September 07, 2021. The document consists of a brief introduction to CTIS and its timeline. It also explains in detail about clinical trial … Continue reading "September 2021: CTIS Training Update"
- September 2021: CTIS Training Updates - European Medicines Agency updated the page name of Clinical Trials Information System: training programme to Clinical trials information system (CTIS): online modular training programme, on September 03, 2021. The below documents were also updated in CTIS Training Module 03 (User access management) and new versions of documents were added in Module 19 (CTIS for SMEs and … Continue reading "September 2021: CTIS Training Updates"
References
- Clinical Trial Application Form. European Clinical Trials Database. https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/application-form_en.pdf. Published November 28, 2019. Accessed November 28, 2019.