The creation of ICRIN is part of an ambitious project which will attempt to fill all remaining gaps (human capital, physical infrastructure and information systems) needed to create a world class clinical research capacity in Ireland.

The structural changes taking place within the Health Service coupled with sustained research funding provide an ideal opportunity to place biomedical research at the heart of Ireland’s healthcare delivery system and will provide the impetus to establish a world-class clinical research infrastructure.

Engaging in the initial steps towards creating a harmonised and coordinated clinical research infrastructure in Ireland ICRIN has been created under a Memorandum of Understanding between University College Dublin ( UCD ), The University of Dublin, Trinity College, Dublin (TCD ), The Royal College of Surgeons in Ireland ( RCSI ), University College Cork ( UCC ), The National University of Ireland, Galway ( NUIG ) and Dublin Molecular Medicine Centre ( DMMC ).

ICRIN is Ireland’s representative within the European ECRIN
 

Objectives of ICRIN:

• To engage with the constituent teaching hospitals to develop a national clinical research infrastructure in Ireland to perform cutting edge clinical research in a safe and regulated environment so that patients benefit from the best interventions carried out under the best international standards of ethics and GCP.
• To provide a framework for the harmonisation of different operating norms into a common, European connectable system ( ICRIN is Ireland’s representative within ECRIN )
• To ensure that education and training programmes are put in place for clinical and nursing staff that allow standards to be updated and constantly improved
• To allow Irish academic and non-academic clinical investigators to participate in multi-centred clinical studies
• To drive a standardised approach to biobanking at all sites
• To drive harmonisation of procedures with respect to Informed Consent, Ethical Review, Data Monitoring, Adverse Event Reporting etc.

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Initial Steps:

ICRIN will allow the coordination of all of the complex activities involved in clinical research across the country and in the first instance will draw up a detailed situation analysis of clinical research infrastructure in this country addressing key items laid down by ECRIN that describe trial support infrastructures and the Irish landscape for the organisation of clinical trials :

1. Centres, the national network, and their institutional partners
2. Partners of projects: funding and sponsorship
3. Ethical review
4. Legislation, regulatory authorities, good clinical practice, insurance
5. Pharmacovigilance, drug dispensing
6. Methodology, data management and analysis, data monitoring
7. Quality control, audits and evaluation
8. Communication with patients, with investigators and the scientific community, with industry
9. Trial registers
10. Education and careers.

This will result in a national report and in a comparative analysis with what has already been done in Europe. This will help to define priorities regarding networking activities required to promote harmonisation of training, tools, practice, and to define which high-quality services should be proposed to support sponsors in clinical studies in Ireland.

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Initial Goals & Outputs:

This initial programme of work will ultimately result in :

• An in-depth description of gaps and bottlenecks hampering Clinical Research in Ireland, taking into account changes brought to national regulations
• Proposals and recommendations directed to national stakeholders and regulators - aimed at reducing such gaps, bottlenecks and fragmentation in Clinical Research in Ireland
• Proposals and recommendations to harmonise quality and data management systems and Standard Operating Procedures in light of adopted or evolving international standards and practise.
• The development of competencies allowing ICRIN to support, at the next step, the role of sponsors (or investigator-sponsors) in multinational studies.

Harmonisation and compatibility in quality and data management systems is a prerequisite for the conduct of trans-national studies. In addition, shared Standard Operating Procedure principles will spread the best practice, improve the quality of the conduct of studies (national and trans-national) performed within the network, and avoid duplication of efforts for both centres conducting the study and sponsors of the trial.