National Clinical Trials Coordination Programme 2020
The purpose of this call is to;
- Provide a primary access point for multicentre clinical trials in Ireland to signpost and promote the value of clinical trials to Ireland and Internationally,
- Provide services to streamline processes for the conduct of high quality multicentre clinical trials such as the national feasibility programme, ethical and regulatory advice etc.,
- Collate and provide an accurate overview of clinical trial activity within the system,
- Enhance collaboration across the clinical trial infrastructures, supporting a national approach to improve clinical trial performance (excellence) by identifying and addressing bottlenecks or operational issues that impact trial conduct/performance, and
- Provide Irish investigators access to trial support services available through the European Clinical Research Infrastructures Network (ECRIN) and contribute to 'infrastructure development' projects with additional European and international partners.
- Details of the scheme
Investment is intended to build on the positive achievements of our previous investment in coordination and future investments in national clinical trials infrastructures. The main remit of the national clinical trials coordination programme is to serve Ireland and ensure it is an attractive location for the conduct of high-quality multicentre trials.
The national clinical trials coordination programme will not provide services for the operational implementation of clinical trials as this is the function of clinical research facilities and centres in conjunction with researchers and their clinical trial networks.
The national clinical trials coordination programme may enhance clinical trial activity in Ireland through the following core activities;
- Signposting (Business intelligence) - Primary point of contact for multi-centre clinical trials, facilitating both industry and academia. Consultation on ethical and regulatory pathways and provision of advice on conduct of clinical trials in all fields.
- Promotion - Ambassadors for Irish clinical trials, nationally and internationally by promoting high quality, nationally harmonised and internationally standardised clinical trials in Ireland. Sharing good practice and highlighting training and education opportunities on offer throughout the clinical trials infrastructures to support and grow the workforce,
- Direct contact point to ECRIN -Host the National Correspondent for the European Clinical Research Infrastructures Network (ECRIN) to contribute to 'infrastructure development' projects with additional European and international partners and provide Irish investigators access to trial support services.
- Specialists/Investigator identification - Identification of relevant specialists and clinical researchers providing access to established clinical specialty groups and or national networks within oncology, critical care, stroke etc.,
- National feasibility programme - An expedited feasibilityprocess managed through a streamlined mechanism with coordination and oversight, through the national clinical trials coordination programme and dedicated resources in the CRF/Cs to navigate local systems and engage with Investigators, leading to identification of sites within a defined number of days,
- Reporting national trial activity – An overview of clinical trial activity within the Irish system organised through an agreed efficient reporting process in the clinical trials infrastructures, with coordination and oversight through the national clinical trials coordination programme, aligned with the National Office for Research Ethics Committees and Health Product Regulation Authority, and
- Facilitate collaboration across the clinical trial infrastructures, supporting a national approach to improve clinical trial performance through prioritised Working Groups and programmes of work
- Who can apply?
Applications must be submitted on behalf of a team, with one Lead Applicant, who must be a Clinical Research Facility/Centre Director with a previous track record of providing services and supports for the coordination of multi-centre clinical trials in Ireland.
The Host Institution (HI) for the HRB awardmust be a HRB recognised host institution. It is normally that of the Lead Applicant, but it may be another organisation/institution designated by the applicant team, where it is clearly justified. An up to date list of HRB recognised host institutions can be found at all times at: https://www.hrb.ie/funding/funding-schemes/before-you-apply/all-grant-policies/hrb-policy-on-approval-of-host-institutions/
The application must be submitted through a recognised HRB Host Institution in partnership with the following Clinical Research Facility/Centres in Ireland;
- Wellcome Trust-HRB-CRF at St. James Hospital in Dublin (hosted by Trinity College Dublin)
- HRB-CRF Cork at the Mercy Hospital and Cork University Hospital (hosted by University College Cork)
- HRB-CRF Galway at University College Hospital Galway (hosted by the National University of Ireland Galway)
- UCD CRCs at The Mater Misericordiae University Hospital and St Vincent’s University Hospital (hosted by University College Dublin)
- Royal College of Surgeons in Ireland CRC at Beaumont Hospital (hosted by RCSI)
- The Health Research Institute Clinical Research Support Unit at Limerick University Hospital (hosted by University of Limerick) and
- Children’s Health Ireland (various hosting partners).
- How to apply
Applications must be completed and submitted through the HRB online Grant E-Management System (GEMS) https://grants.hrb.ie.
The application must have been reviewed and approved by the signatory approver at the research office (or equivalent) in the host institution before it is submitted to the HRB. Therefore, applicants should ensure that they give the signatory approver enough time before the call closing date to review the application and approve it on GEMS. Please note that many host institutions specify internal deadlines for this procedure.
Conflict of interest rules are applied rigorously. Where a conflict of interest exists, the reviewer is requested to inform the HRB immediately so that an alternative reviewer may be appointed. International peer reviewers will not provide comments or scores on any application on which they have a conflict of interest.
Reviewers must adhere to high standards of integrity during the peer review process. They must respect the intellectual property of applicants and may not appropriate and use as their own, or disclose to any third party, ideas, concepts or data contained in the applications they review.Close
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Health Research Board