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
- December 2021: In Vitro Diagnostic Medical Devices Regulation Update - European Commission provided an update regarding the Progressive roll-out of the In Vitro Diagnostic Medical Devices Regulation on December 20, 2021: The update mentions that the ‘In Vitro Diagnostic (IVD) Medical Devices Regulation’ can now be progressively rolled out, after its adoption by the European Parliament and the Council to ensure there is no shortage … Continue reading "December 2021: In Vitro Diagnostic Medical Devices Regulation Update"
- December 2021: CTIS Training Update - European Medicines Agency (EMA) updated the pages Clinical Trials Information System: training and support and Clinical Trials Information System (CTIS): online modular training programme on December 16, 2021, by adding the below documents: Clinical Trial Information System (CTIS) structured data form – Annual Safety Report (ASR): This document provides guidance on the data fields Sponsors will … Continue reading "December 2021: CTIS Training Update"
- December 2021: CTIS Training Program - European Medicines Agency updated about the upcoming event Clinical Trials Information System sponsor user training program over the What’s New Section on December 16, 2021: The event page notifies about EMA’s plan to conduct six different virtual training courses as part of the training program for sponsor users and the dates on which these courses will be … Continue reading "December 2021: CTIS Training Program"
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.