Good Clinical Practice - Training Courses
Staff from Sydney Health Partners’ member organisations can access free Good Clinical Practice (GCP) accredited training courses.
What is GCP?
Good Clinical Practice (GCP) is the internationally accepted standard for designing, conducting, recording, and reporting of clinical trials involving human participants. It ensures that the rights, safety and well-being of trial participants are protected, consistent with the principles outlined in the Declaration of Helsinki. Good Clinical Practice also aims to ensure that data collected during a clinical trial is credible.
The Therapeutic Goods Administration (TGA) in Australia has adopted the ICH Good Clinical Practice guidelines and other international guidelines, which are complemented by the National Statement on Ethical Conduct in Human Research. More information on how GCP applies to clinical research can be found on the Australian Clinical Trials website.
Who needs GCP training?
All investigators and site staff working in clinical trials must undertake accredited GCP training and hold a current certificate. Certificates are generally valid for 3 years unless otherwise stated.
The Australian Commission on Safety and Quality in Health Care has implemented the National Clinical Trials Governance Framework (NCTGF) which aims to embed clinical trials into routine health care and strengthen the clinical and corporate governance arrangements for those involved in delivering clinical trials.
Under the Framework, health services conducting clinical trials will be audited and must show evidence that their site meets the required standards, including GCP training, to ensure ongoing accreditation by the Commission.
How to access GCP training
In-person
Many Sydney Health Partners partner organisations conduct regular in-person (or virtual), accredited introductory and refresher GCP training courses. These engaging and interactive small group sessions are designed to significantly enhance your learning experience and are highly recommended! Please check with your local Research Office or GCP training coordinator for more details.
Online
To support the in-person training, SHP offers our partner organisations' employees free access to online GCP course modules developed and hosted by Sophie Mepham GCP™. The following online modules are available:
Introduction to GCP complies with the standards set by TransCelerate Biopharma Inc., meets the ICH Guidelines for GCP and is CPD certified. This training has been customised to meet the Australian clinical trials environment.
This training is suitable for those who have already completed the ‘Introduction to GCP’ and need to update their certification.
These modules are designed for allied health staff who see clinical trial patients as part of routine care but do not need to be listed on the trial delegation log. The available courses include clinical, radiology, biostatistics/data management, pharmacy and pathology.