Poland

DCT Feasibility Assessment Poland The below version control table serves to document all updates made to the guidebook. The purpose is to ensure the information is always accurate and up-to-date. Disclaimers ...

This guidebook provides an overview of the current and proposed regulatory landscape in Poland in relation to Decentralized Clinical Trials (DCT) with medicinal products. It supplements the regulations and guidance applicable to the EU and the EE...

2.1 Name of Regulatory Authority The Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products ( “the Office”/URPL ). 2.2 Name of Ethics Committee The Act provides for a new structure for the functioning ...

3.1 Provide a list of documents needed to be submitted for EC/IRB review and approval including the number of copies and/or translations as relevant.   As per Art 10 of the Act March 2023 , documents required for submission are in accord...

4.1 Provide a list of documents needed to be submitted for RA/CA review and approval including the number of copies and/or translations as relevant.  As per Art 10 of the Act of March 2023 , the documents required for submission are in ac...

5.1 Does local regulation require PI/CI to be approved/registered by any health authority (e.g., RA/EC)?   Yes , the principal investigator shall hold the “required qualifications”. See: Art 37(1 ) of the Act of March 2023   “Th...

6.1 Provide a list of documents needed for export permit relevant to biological specimen shipment. We have not been able to determine an answer to this question. Much depends on whether the biological specimens are being moved within the EU (no...

7.1  Do the country regulations allow Decentralized Clinical Trials (DCT) elements (e.g., eConsent, ePRO administration, remote investigator site, etc.)? Yes . 7.2  Is there any specific regulation/ guidance on the use of DCT ele...

8.1 What data privacy and/or technology regulations need to be complied with to run a trial in the countries of interest?   Primarily, the GDPR needs to be adhered to. According to ICH E6 (R2), the data recorded during the clinical trial...

9.1 Clinical trial subject recruitment: Are digital advertisements (including social media streams such as TikTok) allowed and, if so, what regulations govern them ? While the existing Polish regulations are silent on this matter, in recent ye...

10.1 Clinical Trial with Investigational Medicinal Product A trial application must be made via CTIS. The EU's new Clinical Trial Regulation (EU) 536/2014 came into force on 31^st January 2022.  The aim of the EU CTR is to e...

European Union 1. EU Clinical Trial Regulation (EU CTR) 536/2014 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02014R0536-20220131   2. EMA- Questions and Answers Document Regulation (EU) 536/2014 https://health.ec.euro...

None.