Researcher Training – ICH Good Clinical Practice (GCP)

January to June 2023 WSLHD ICH GCP Training

Good Clinical Practice (GCP) is an internationally accepted standard for the designing, conducting, recording and reporting of clinical trials and research. It is designed for all researchers who currently work, or who will work at site level, such as Principal Investigators, Sub Investigators, Research Nurses, Research Coordinators, Data Managers, Research Assistants, Pharmacists and all associated site roles.

WSLHD offers TransCelerate accredited GCP training that meets the minimum criteria for ICH GCP Investigator Site Personnel Training to enable mutual recognition of GCP training among trial sponsors.

There are two courses to choose from:
Introduction to GCP - designed for new researchers and staff working in clinical trials who have not completed comprehensive training previously - 4 hours face to face.
Refresher GCP - designed for experienced researchers and clinical trial staff who have previously obtained GCP certification – 1 ½ hours face to face learning.

• GCP - the background and why we need it
• Study set up, roles and responsibilities, approvals and essential documents
• Informed Consent
• Case Report Forms, source documents and source data
• Safety Reporting

If you would like to book in for a course please email: WSLHD-ClinicalTrialsSupportUnit@health.nsw.gov.au

ICH GCP Training Schedule
We hope to be able to recommence face-to-face learning in early 2023. It is likely that we will offer a hybrid utilising MS Teams and face-to-face.