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Dementia Trials Ireland: Feasibility

Dementia Trials Ireland (DTI) endeavours to support clinical trials sponsors (or their Clinical Research Organisation) to identify potential investigator sites and establish their suitability to conduct the proposed clinical trial.DTI collaborates with HRB National Clinical Trials Office (NCTO) to streamline the site identification and study feasibility process nationally.

Feasibility aims to connect academic and industry sponsors with potential investigators. HRB NCTO act as the channel through which study feasibility assessments can be distributed and completed efficiently.

Through their Investigator Membership Database and direct links to the national Clinical Research Facility/Centre (CRF/C) network time taken to identify investigator sites and to assess study feasibility is significantly reduced.

Feasibility: pre-application considerations

The programme is actively managed via the HRB NCTO Trial Platform Lead with the aim of providing feedback within two weeks of initial receipt of a feasibility request. Study feasibility assessment is free of charge. Please submit feasibility enquiries to: info@dementiatrials.ie

Before submitting a feasibility request we request, where possible, the following information and documents:

  • Protocol synopsis
  • Study feasibility questionnaire (if available)
  • Study timelines, including accrual timelines (local and international)
  • Any trial related questions critical to evaluating feasibility (e.g. Standard treatments, study assessments etc.)
  • Confirm location: is it definitely being placed in Ireland, or if the applicant is currently bidding for the study
  • Confidential disclosure agreement (if available)
  • A list of potential sites (if available) and confirmation of which sites have been approached to date

Feasibility: Clinical Participation

The HRB NCTO National Study Feasibility Programme connects academic and industry sponsors with potential investigators.

If you are a health care professional and would like to register to participate in the HRB NCTO National Study Feasibility Programme please click here.

Investigator members are promptly informed of the latest research opportunities as they arise and can complete study feasibilities for studies of interest to them within their area of clinical interest.

Additional industry related information

The HRB National Clinical Trials Office (NCTO) has a dedicated medtech expert, the Clinical Industry Liaison Officer (CILO). The CILO role is funded by Enterprise Ireland and works with medical device companies and medtech entrepreneurs to help them navigate the clinical research landscape and supports available in Ireland.

The CILO can help you with any medical device focused queries regarding clinical investigations and can give guidance relating to the Competent Authority in Ireland, Health Products Regulatory Authority (HPRA) and/or the National Research Ethics Committee for Clinical Investigations of Medical Devices and Performance Studies of In Vitro Diagnostic Medical Devices (NREC-MD).

Questions regarding clinical investigations involving medical devices in Ireland can be directed to: ncto@ucc.ie.

CTAs are one of several key documents that govern the conduct of clinical trials. They serve as a legally binding contract between a sponsor, site, and researcher, and outline each party’s responsibilities and obligations for the clinical trial.

It is imperative that researchers and sites understand the importance of CTA development, negotiation, and execution, as effectiveness in these areas will increase efficiency, protect researchers/sites and subjects, and help advance research.

Provision of a single standard clinical trial agreement (CTA) for Ireland will reduce delays, costs, increase efficiencies and enable more trials to set up on time in Ireland. To that end a standard (model) CTA, devised by the IPHA in collaboration with the HSE, was introduced and became mandatory in November ’22. The model CTA is standardised and therefore changes to the standard text in the document are not permissible. However, in cases where negotiations have commenced, the existing CTA undergoing negotiation may continue to be used in the clinical trial.

To access the CTA please use the following link: https://hseresearch.ie/clinical-trials-2/#HSE-approved-Clinical-Trial-Agreement-Templates

Note: Work to develop an agreed Model CTA for tripartite engagements (Commercial Sponsor, Hospital, Academic Partner) and CTA with academic sponsors is underway.

The National Office for Research Ethics Committees is an important component of the research environment in Ireland.  It is an independent office that hosts National Research Ethics Committees (NRECs) The NRECs work in a mixed-model system to support research ethics across the spectrum of health research in Ireland – its has the mandate to return ethics decisions that are respected nationally (‘single national ethics opinion’).

The National Office has launched RECs in a variety of health research areas to include clinical trials of medicinal products for human use, clinical investigations of medical devices and performance studies of in vitro diagnostic medical devices. This is to ensure Ireland is meeting the obligations as an EU Member State in line with EU Regulations on clinical trials (Regulation EU 536/2014),medical devices (Regulation EU 2017/745) and in vitro diagnostic medical devices (Regulation EU 2017/746).

Queries relating to clinical trials of an investigational medicinal products, please contact: clinicaltrials@nrec.ie 

Queries relating to clinical investigations of medical devices/ performance studies of in vitro diagnostic devices, please contact: devices@nrec.ie

For all other queries, please contact: nationaloffice@nrec.ie

The National Competent Authority, Health Products Regulatory Authority (HPRA) are tasked with the regulation of medicines and devices for the benefit of people and animals.

HPRA 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.

On their industry homepage you will find product information as well as regulatory updates for the sectors, services and facilities regulated by the HPRA.

The Competent Authority in Ireland, Health Products Regulatory Authority’s (HPRA) Innovation Office provides regulatory support and advice to individuals, academics, small and medium enterprises, pharmaceutical and medical device companies, and other groups who are developing innovative health products or technologies.

What kind of support and advice is available?
The Innovation Office can advise individuals or companies directly on regulatory requirements and provide general guidance on technical or scientific issues that they need to consider during the development of their product or technology. Queries can relate to any area regulated by the HPRA including medicines, medical devices, drug-device combination products and cosmetics. Where more detailed scientific advice would be appropriate, the Innovation Office will provide information on how such advice can be obtained. The Innovation Office also publishes general updates and information about regulatory and scientific issues related to innovation.

Queries should be submitted using the online enquiry form available via the Innovation Office webpage which can be accessed through the website; or alternatively via e-mail: innovationoffice@hpra.ie.

The Data Protection Commission (DPC) is the national independent authority in Ireland responsible for upholding the fundamental right of individuals in the European Union (EU) to have their personal data protected. Accordingly, the DPC is the Irish supervisory authority responsible for monitoring the application of the General Data Protection Regulation (GDPR).

Under the GDPR, Data Protection Impact Assessments (DPIAs) are mandatory for any new high risk processing projects.

DPIAs can be used to identify and mitigate against any data protection related risks arising from a new project, which may affect an organisation or the individuals it engages with.

Click here for general guidance on data protection, DPIAs and further information on GDPR requirements.

HRB Clinical Trial Networks

In partnership with a number of HRB’s Clinical Trial Networks, DTI will support efforts to increase capacity in the national dementia trial space through the facilitation of ‘Trial Readiness’, in fostering ‘New Trial Development’ and supporting quality ‘Trial Delivery’, all its objectives and outputs are formulated to be informed and underpinned by active ‘Person and Public’ engagement.

HRB PPI Ignite

The PPI Ignite Network  promotes excellence and inspires innovation in public and patient involvement (PPI) in health and social care research in Ireland.

Public and patient involvement in research means that the public and patients are involved in planning and doing research from start to finish and help tell the public about the results of research.

PPI Ignite have devised a growing repository of PPI resources to help researchers and the public to understand PPI and to build effective partnerships as a pathway to increase the relevance and impact of research.


The HRB-Trials Methodology Research Network (HRB-TMRN) is a collaborative initiative between a number of Irish and international higher education institutes and methodology centres.

HRB-TMRN serves to strengthen the methodology and reporting of trials in health and social care in Ireland. They provide guidance to individual researchers, to CRF/Cs and other research infrastructures and to organisations. HRM-TMRN also provides training and education programs with the aim of advancing trials methodology research, research and innovation and public engagement in Ireland.  Contacthrb-tmrn@nuigalway.ie


The HRB-National Clinical Trials Office (HRB-NCTO) is a collaborative programme between HRB, Enterprise Ireland and CRF/Cs in the Republic of Ireland, hosted by University College Cork.

HRB-NCTO is the central point of contact for the national feasibility service, ECRIN, and CRFManager. It provides a number of systemic strategic supports to academic and commercial partners in support of a harmonised strategic national approach and the conduct of high-quality clinical trials in Ireland. Contactncto@ucc.ie