The HRB CRF-C is established as a Department within the UCC College of Medicine and Health and it is overseen by a combined UCC HSE Management Board which meets quarterly or more often as determined by the committee chairperson, and reports annually to UMTO. The Board is advised by an independent HRB CRF-C Advisory Committee which meets 6 monthly.
Membership of the Management Board
- Head of College of Medicine & Health (Chair)
- Vice President for Research and Innovation
- Corporate Secretary
- Hospital clinician
- HSE South/South-West Hospitals’ Group representative
- Director of Research Support Services
- Clinical Research Reporting Officer
In Attendance HRB CRF-C Clinical Director
The HRB CRF-C Advisory Committee serves as an independent Advisory Committee representing both relevant national and international expertise as well as various local stakeholders in the conduct of Patient Focused Research. It reviews the work undertaken and strategy proposed by HRB CRF-C with regard to established regulatory standards and national/international benchmarking. Meetings take place on a six monthly basis and are scheduled to take place approximately 4-6 weeks in advance of scheduled Management Board meetings. The Chair of CAC forwards a summary of their deliberations and recommendations to the Management Board. The terms of reference and membership of the CAC are approved by the MB.
Membership of the HRB CRF-C Advisory Committee
- Independent Chair
- MB representative
- CEO, Mercy University Hospital or designee
- CEO Cork University Hospital or designee
- COMH Research Committee Chair or designee
- Two senior researchers/directors of an external clinical research committee
- Member with legal or bioethical expertise
- Two members with a commercial/pharmaceutical industry background
- One lay/patient representative
In Attendance: HRB CRF-C Clinical Director
Responsible for all activities that take place in all parts of the HRB CRF-C. He leads a monthly Senior Management Team and fortnightly Operations team meeting.
The Senior Management Team.
Responsible for strategic development of the HRB CRF-C, allocating resources across the HRB CRF-C constituent portfolios and ensuring conformance with objectives and targets of the approved Business Plan. The SMT comprises the
- Clinical Director
- Director Clinical Trials and Operations
- Director of Quality and Regulatory Affairs
- Senior lecturer in Education
- Centre Manager
Meets fortnightly and comprises the HRB CRF-C Portfolio leads, it is responsible for ensuring the high-quality, efficient and timely conduct of HRB CRF-C projects and identifying and responding to any issue limiting their progress.
The work of the HRB CRF-C is divided across 8 portfolios each with a designated lead responsible for the leading the conduct and development of the portfolio. The portfolios:
- Site Management & Operations
- Academic Research Coordination
- Statistics and Data Analysis
- Quality & Regulatory Affairs
- Data Management