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Clinical Trials

Published: 27 November 2019
From: Department of Health

European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004

The following Ethics Committees have been recognised under Regulation 7 of the above regulations to act for the whole State.

These committees are also recognised to provide ethical approval for clinical trials of investigational medicinal products which fall within the scope of the Ionising Radiation Regulations (SI No. 256 of 2018).

Research Ethics Committee


St. Luke's Research Ethics Committee


Site Specific Assessment (SSA) form


Clinical Trial application form - Ethics


Guidance on the Application for Recognised Ethics Committee Opinion and the Ethical Review of Clinical Trials on Medicinal Products for Human Use


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