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Accelerating Clinical Trials in the EU

Initiatives in Ireland

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Support mechanisms for non-commercial clinical trials  Level
National EU Level (Multinational) Global
Dedicated webpage        
Training courses        
Scientific advice  The National Competent Authority (NCA), HPRA, supports scientific advice with no fee/reduced fee.    X  
Helpdesk, regulatory, CTIS and ethics support Regulatory and ethics requirement: Available from the NCA (HPRA) and ethics committees (NO-NREC).   X  
Other services by National Competent Authority 

NCA: Effective as of 1 January 2024, non-commercial sponsors are no longer required to pay Clinical Trial Application fees in Ireland. For more information: HPRA fee guide.

Inspection fee: The HPRA supports inspection fee reduction/waiver. For more information: HPRA fee guide.

Scientific support: For example: HRB TMRN (HRB Trials Methodology Research Network).

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Services by ethics committee

Effective as of 1 January 2024, non-commercial sponsors are no longer required to pay Clinical Trial Application fees in Ireland.

For more information: Fees - NREC (nrecoffice.ie)

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Public GCP support        
Public research office For example: HRB NCTO (HRB National Clinical Trials Office) X    
National funding

The HRB (Health Research Board) operates a funding scheme called Definitive Intervention and Feasibility Awards (DIFA). DIFA supports researchers and research teams to conduct high-quality definitive intervention trials and feasibility studies.

For more information: Funding schemes (hrb.ie)

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Funding coordination and navigation of research infrastructure        
Support identifying research networks For example: HRB NCTO (HRB National Clinical Trials Office) X    
Other support mechanisms

The HRB NCTO is an independent, integrated, national clinical research network, which provides centralised support in conducting multi-centre clinical trials and investigations across Ireland.

For academic studies, NCTO offers guidance on all aspects of delivering the study within Ireland, such as on regulatory pathways, site identification and feasibility assessments, and introduces the academic PI to the local experts at seven clinical research facilities/centres in Ireland. The local CRF/C can provide the services necessary to carry out a clinical study/trial, including clinical research nursing, data management, statistics etc. 

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