Europe (EMA)

DCT Feasibility Assessment EMA 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 applicable in the EU/EEA in relation to Decentralized Clinical Trials (“DCT”) through the European Medicines Agency (“EMA”) and the Clinical Trials Regulation ...

2.1 Name of Regulatory Authority European Medicines Agency (EMA) 2.2 Name of Ethics Committee Multiple ethics committees exist in the 27 EU Member States, plus those of Norway, Iceland, and Liechtenstein (the European Econ...

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.  Under the EU CTR, the initial application for a clinical trial is divided into two parts...

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.  Under the EU CTR, the initial application for a clinical trial is divided into two parts:...

5.1 Does local regulation require PI/CI to be approved/registered by any health authority (e.g., RA/EC)?   The investigator/principal investigator must meet national requirements – see Art 49 of the Clinical Trial Regulation (EU) 536/20...

6.1 Provide a list of documents needed for export permit relevant to biological specimen shipment. Much depends on whether the biological specimens are being moved within the EU (not within the EEA) or from/to outside the EU, in which (latter) ...

7.1 eConsent/Remote Consent  This is possible, but subject to national laws. The EMA “ Recommendation paper on decentralized elements in clinical trials ” includes an overview of national provisions for specific decentralized clinical tri...

8.1 What data privacy and/or technology regulations need to be complied with in order to run a trial in the countries of interest?   Clinical Trial Regulation (EU) 536/2014 , Art 94 states: “ Data protection Member States shall app...

9.1 Clinical trial subject recruitment: Are digital advertisements (including social media streams such as TikTok) allowed and, if so, what regulations govern them  (including the language/claims used and whether or not the mention of open-...

10.1 Clinical Trial with Investigational Medicinal Product The submission process using CTIS (see Annex I for details on how to get started using the CTIS itself) is described in more detail below this flowchart/roadmap: The EU's new Clinica...

Regulations EU Clinical Trial Regulation 2014/536: https://health.ec.europa.eu/system/files/2016-11/reg_2014_536_en_0.pdf General Data Protection Regulation (GDPR): https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32016R0679...

Compliance with applicable rules for biological samples: https://health.ec.europa.eu/latest-updates/new-template-compliance-applicable-rules-biological-samples-2022-02-01_en   Declaration of Interest: https://health.ec.europa.eu/system/file...