Clinical trial sponsorship

The RCSI Sponsorship Office supports clinical researchers by facilitating research compliance through advice, support, guidance and training. The office is responsible for ensuring clinical research involving RCSI clinical investigators is compliant with the Clinical Trial Directive and Clinical Trial Regulation (as applicable), ICH Good Clinical Practice E6 (GCP) and the Health Research Regulations.

Our role

The role of the RCSI Sponsorship Office is to:

  • Review and authorise sponsorship of clinical research when it involves: patients, resources, staff, data or facilities; tissue samples that will be collected and/or stored; and administration of a drug.
  • Classify the study as regulated or unregulated and advise if the study requires HPRA notification.
  • Record, facilitate and oversee clinical research carried out within the University and ensure that the University is compliant with relevant legislation and regulations.
  • Liaise with RCSI insurers to seek protocol insurance, once the Sponsorship Officer has confirmed the study can be sponsored by RCSI.
  • Work with University researchers to enable high-quality design and conduct of clinical research.
  • Guide researchers in writing protocols, participant information leaflets and informed consent forms prior to research ethics committee submission and Health Products Regulatory Authority (HPRA) approval submissions.
  • Provide training and guidance in good clinical practice and research governance.
  • Monitor and/or audit clinical research sponsored/hosted by the University.
  • Coordinate safety reporting.

Please contact the Sponsorship Office as early as possible when planning a clinical research project. Direct all enquiries to sponsorship@rcsi.ie in the first instance.

The team