Trial safety and regulations
Every clinical trial involving patients in Ireland must be approved by the Health Products Regulatory Authority (HPRA) and by a recognised ethics committee. The authority makes sure that the trial meets Irish, EU and international standards for clinical research.
The ethics committee ensures that the rights and wellbeing of the patients who are taking part in the trial are looked after. For new medicines, the Department of Health supervises this process.
If the trial application is approved by the HPRA and the ethics committee, the researchers can begin the trial. Once the trial has started it will be checked regularly to make sure the regulations are being followed and everything is being done correctly.
The HPRA can also make an official inspection of the trial at any time to make sure it is being carried out properly, with patient safety in mind.
For more information
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