Application for Clinical Trial of an Investigational Medical Product (CTIMP)

18 May 2008 (updated: 14 August 2023)

Clinical Trials is defined in the European Union Directive on Clinical Trials as follows: "Any investigation in human subjects, other that a non-interventional trial intended:

with the object of ascertaining the safety or efficacy of such products, or both"

Application Process

Please revert to this NREC link provided for research proposals in specifically defined areas: currently these are limited to clinical trials of investigational medicinal products, clinical investigations of medical devices and performance studies of in vitro diagnostic medical devices. If you are planning to carry out research in Ireland in an area under an NREC's remit, you should submit your application to the NREC in question.