A clinical trial is a type of health research. These types of studies prospectively assign human participants to one or more health-related interventions to evaluate the effects on health outcomes. Interventions include, but are not restricted to, drugs, cells, and other biological products, surgical procedures, radiological procedures, devices, behavioral treatments, process-of-care changes, or preventive care.
The term ‘clinical trial’ in the HSE National Framework for the Governance, Management, and Support of Health Research (RGMS Framework) includes regulated and non-regulated trials as well as clinical investigations of medical devices.
- Regulated vs non Regulated clinical trials
- Regulatory and ethical oversight: HPRA and NREC
- Clinical Research Infrastructure
- What is a clinical trial sponsor and what are their responsibilities?
- HSE-approved Clinical Trial agreement templates
Regulated vs Non-Regulated clinical trials
Non-Regulated Clinical Trials refer to studies that meet the definition of a Clinical Trial (see above) but are not subject to regulation by the Health Products Regulatory Authority (HPRA).
Regulated Clinical Trials refer to
- Regulated Clinical Trial of an Investigational Medicinal Products (CTIMP)
- Regulated Clinical Investigation of a Medical Device
Before they can start Regulated Clinical Trials need approval from both the HPRA and the applicable National Research Ethics Committee (NREC).
Clinical Trials regulatory and ethical oversight: HPRA and NREC
Health Products Regulatory Authority (HPRA)
The Health Products Regulatory Authority (HPRA) regulates medicines and devices for the benefit of people and animals in Ireland. Their remit and regulatory functions include human and veterinary medicines, clinical trials, medical devices, controlled drugs, blood and blood components, tissues and cells, and cosmetic products. The HPRA is the National Competent Authority for the Republic of Ireland.
For further information about regulated clinical trials with investigational medicinal products and investigations with medical devices visit the HPRA website.
National Research Ethics Committee (NREC)
In Ireland, the National Office for Research Ethics Committees is an independent office that hosts National Research Ethics Committees (NRECs). The NREC system has the mandate to return ethics decisions that are respected nationally (‘single national ethics opinion’).
Applications related to Clinical Trials of Investigational Medicinal Products (CTIMPs) are under the remit of The National Research Ethics Committee for Clinical Trials (NREC-CT). This includes interventional studies and low-interventional studies involving medicinal products for human use.
Applications related to Clinical Investigations of Medical Devices are under the remit of the National Research Ethics Committee for Clinical Investigations of Medical Devices (NREC-MD).
Clinical Research Infrastructure
- National Clinical Trials Office and other Clinical Research Networks
- Clinical Trial Networks (CTNs)
- Clinical Research Facilities
What is a Clinical Trial Sponsor and what are their responsibilities?
The definition, roles, and responsibilities of Sponsors are outlined in the HSE National Framework for the Governance, Management, and Support of Research.
HSE-approved Clinical Trial Agreement Templates
The HSE has two approved Clinical Trial Agreement Templates: 1) a bipartite one where the clinical trial involves a Commercial Sponsor and a Hospital(s) and 2) a tripartite one where the clinical trial involves a Commercial Sponsor, Contract Research Organisation and a Hospital(s). Both CTAs have been developed in collaboration with the Irish Pharmaceutical Healthcare Association.
1. Bipartite Model Clinical Trial Agreement (Bipartite, Commercial Sponsor and Hospital) (Word docx / 179KB)
This model Clinical Trial Agreement (CTA) is mandatory and effective from 11.11.22 for CTAs. However, where negotiations have commenced, the CTA that is already the subject of the negotiations may continue to be used in the clinical trial. The HSE model CTA guide for public hospitals hosting regulated clinical trials can be requested by emailing Research.LegalDataprotection@hse.ie
2. Tripartite Model Clinical Trial Agreement (Tripartite, Commercial Sponsor, Clinical Research Organisation and Hospital) (Word docx / 192KB)
This model Clinical Trial Agreement (CTA) is mandatory and effective from 20.05.2024 for tripartite engagements involving a Commercial Sponsor, Contract Research Organisation and Hospital(s). However, where negotiations commenced before 20.05.24, the CTA that is already the subject of the negotiations may continue to be used for that specific clinical trial.
Work has commenced on the creation of a model CTA for quadripartite engagements involving a Commercial Sponsor, Contract Research Organisation, Academic Partner and Hospital(s) and we hope to be in a position to release this template shortly.
updated 16/05/24