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

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What Is a Clinical Trial?

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

  • a) to discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more investigational medicinal products, or
  • b) to identify any adverse reactions to one or more such investigational medicinal products, or
  • c) to study absorption, distribution, metabolism and excretion of one or more such investigational medicinal products, or
  • d) to discover, verify, identify or study any combination of the matters referred to at subparagraphs a), b) and c).

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

Application Process

Please visit NREC 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.