Clinical Trials refer to Health Products Regulatory Authority (HPRA) regulated trials of investigational medicinal products (CT-IMP), on human participants under EC Directive (and transposed in Irish law).
They are intended to:
- Discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more investigational medicinal products, or
- Identify any adverse reactions to one or more such investigational medicinal products, or
- Study absorption, distribution, metabolism and excretion of one or more such investigational medicinal products, or
- 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.
The Clinical Trials Regulation, 2014 will replace the Directive and is planned for 2020. This new regulation requires national implementation via statutory instrument.
HPRA regulated clinical trials are also subject to the guidance of International Conference on Harmonisation – Good Clinical Practice, and the Declaration of Helsinki.
CT-IMP need only seek approval from one recognised REC even if the trial is multi-centred.