The Quality and Regulatory Department helps to ensure that patient focused research undertaken under the supervision of the HRB CRF is conducted to the highest standards. The HRB CRF-UCC operates in accordance with a fully regulatory compliant Quality Management System and provides the full suite of Quality and Regulatory services required to support world class patient focused research.

Our team of experienced clinical research professionals regularly deliver ICH-GCP Training to investigators and study site staff, both initial GCP training (5 hours) and refresher GCP course (2.5 hours).

Good Clinical Practice Course (Full Course)

The following content is included:

• Rules & Regulations governing Clinical Research
• Principles of Good Clinical Practice
• Investigator Responsibilities

This course meets the minimum criteria for ICH GCP Investigator site personnel training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.

The course has category 1 Bord Altranais approval for Continuing Education Units (CEU). Physicians who attend are eligible for Continuing Professional Development (CPD) points from the Royal College of Physicians in Ireland (RCPI).

The course has been developed and will be delivered by HRB CRF-UCC Director of Quality and Regulatory Affairs:Dr Ruben Keane, HRB CRF-UCC Monitor: Máire McCarthy, HRB CRF-UCC Research Nurse: Jean Foley.

NOTE: Face-to-face ICH-GCP courses are currently suspended due to COVID-19. However, the CRF-UCC is now running these courses online. CPD points are not applicable for these online courses.

You can register for the courses via the link below, or if you have any further queries please do not hesitate to contact Lucy Deane

ICH-Good Clinical Practice for Investigators and Site Staff

ICH-Good Clinical Practice for Investigators and Site Staff (REFRESHER)