In early 2017, Irish academic institutions and research funders came together under the Corporate Enabling of Clinical Research (CECR) initiative to identify and address the challenges of managing and sponsoring clinical research studies.
To address the key challenges, an action plan was immediately developed by an overarching steering group and delivered by six working groups, each with a particular focus on one of the following key areas: governance and leadership, sponsorship and quality, insurance, contracts and legal, resourcing of sponsorship, and clinical engagement and support.
Over the course of the following two years a process of intensive, collaborative engagement was undertaken by all stakeholders with the coordination of Clinical Research Development Ireland. During this time, recommendations were proposed to many of the issues identified as well as next steps. These are all outlined in the Report of the CECR. With the objective of creating standardisation and harmonisation across the Irish clinical research system, the report also contains sample operational tools, methodologies and guidelines for use and reference by those involved in the conduct and support of clinical research.
The rationale for the CECR initiative was the belief that the difficulties experienced would be better addressed in a cooperative manner and with input from all stakeholders across the health sector, academia, funding and regulatory bodies.
The CECR initiative builds on the excellent work conducted over a number of years by CRDI’s partner institutions. Furthermore, it brought together the complementary expertise and experience of 67 colleagues from a wide range of stakeholder bodies including NUI Galway, Trinity College Dublin, Royal College of Surgeons in Ireland, University College Cork, University College Dublin, University of Limerick, Health Research Board, CRDI, HRB-Clinical Research Coordination Ireland, Maynooth University, Enterprise Ireland, Cancer Trials Ireland, Mercy University Hospital, Beaumont Hospital, State Claims Agency and the Health Service Executive.
The initiative, including the Steering Committee and the Governance and Leadership Working Group, was co-chaired by Dr Paola Della Porta of RCSI, Nora Geary of UCC and Professor Pat O’ Mahony of CRDI. Gemma Leacy was employed as CECR Project Manager.
Professor O’Mahony said, “I would like to thank all those who contributed to the substantial work conducted for the CECR initiative which has culminated in the production of this seminal report”.