Study Start-Up Service

Contact: Maeve Kelsey

Site Management and Operations Manager

The HRB CRF-UCC provide the necessary supports to optimise study start-up activities, for both regulated clinical trials and other collaborations with commercial partners, including central coordination and dedicated resources. These supports accelerate all aspects of the study start up process at the site level including facilitating:

• Ethics Committee approval
  • Local for academic or single site study
  • Approval from one recognised ethics committee for multi-site study of IMP (See www.ucc.ie/en/crec/)
• Health Products Regulatory Authority  (HPRA) approval
  • For trials of IMP and some device trials
• Contracts approvals
  • with HSE hospitals
  • University College Cork (i.e. UCC Research Support Service and Office of Corporate and Legal Affairs)
• Clinical Trial Insurance approvals, risk and legal approval.
• Financial set up, budget approval, etc.

For commercial regulated clinical trials in Cork University Hospital please contact Maeve Kelsey, Site Management and Operations Manager

For regulated clinical trials, clinical investigations and other commercial clinical research collaborations with HRB CRF-UCC and UCC please contact our Academic Coordinator at academic-coordinator@ucc.ie