Clinical trials contribute significantly to advances in medical treatment. A new EU Clinical Trial Regulation (Regulation No 536/2014, hereafter ‘CTR’), was adopted on 16 April 2014 and became applicable on 31 January 2022.
The CTR is designed to benefit patients and medical research in Europe by streamlining the approval of clinical trials across the Member States.
Key features of the new CTR include:
Single submission and approval of mono national and multinational clinical trial applications through an EU clinical trial portal and database known as the Clinical Trial Information System (CTIS), hosted by the European Medicines Agency (EMA)
A single fee per Member State
Identical rules for conducting clinical trials throughout the European Union (EU)
Strictly defined timelines for assessment - Increased efficiency of the approval process for clinical trials
These features will assist the CTR in achieving its aim of creating a favorable environment for conducting trials in the EU while also ensuring that the highest standards of safety for participants are maintained.
In this guide, we describe the conduct of clinical trials under the CTR in Ireland. It should be read in conjunction with EU and national legislation, and EC and EMA guidelines.
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