Introduction to Clinical Research and Good Clinical Practice

Summary

Please note

All 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.

Date: 14 September 2023, 09:00-16:00

Venue: Tutorial Room 1, RCSI Education and Research Centre, Beaumont Hospital 

Agenda

 09:00

 Introduction to Clinical Research and Drug Development

 Lessons from the Past
 10:00  Break
 10:30

 Research Governance

 Principles of Good Clinical Practice in IMP Trials

 Investigator Responsibilities
 13:00  Break
 13:40

 Investigator Responsibilities (continued)

 Quality and Safety Issues:

  • Safety Reporting
  • Essential Documents
  • GCP Inspections
 15:30  GCP Quiz

Data Privacy: In order to record attendance, and to provide certification of attendance for future reference, your contact details will be retained on a course attendance record for a period of two years. This information will be located on the RCSI server, with authorised access only. You may receive notification of future courses or be asked to complete audit forms. If you do not wish your data to be retained, or want to have it deleted or amended at any time, this will be fully respected.

Accreditation: This ICH E6 (R2) GCP investigator site training 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 full GCP course is accredited by NMBI for six CTUs; refresher accredited for four CTUs.

For further information, please contact Deirdre Hyland at dhyland@rcsi.com.