Please noteAll in person course dates are provisional and subject to numbers. You will be contacted by the course coordinator once a date is confirmed. This course is also now available to complete online – you can apply at any time and complete the course material in your own time and at your own pace.
Offered in partnership with the RCSI School of Postgraduate Studies, this one-day course (six hours) is relevant to principal investigators, research nurses/midwives, monitors and research site personnel who have not undertaken GCP training within the previous two years.
Content is based on ICH E6 (R2) 2016, and includes the key requirements of the Clinical Trial Regulations (536/2014) and national legislation. The following content is included:
- Introduction to drug development and clinical research
- Clinical research governance and principles of good clinical practice
- Investigator responsibilities
- Quality and safety issues
The course has Category 1 Approval from the Nursing & Midwifery Board of Ireland (NMBI). It also meets the minimum criteria for ICH GCP investigator site personnel training identified by TransCelerate Biopharma as necessary to enable mutual recognition of GCP training by trial sponsors.