Good Clinical Practice training

GCP training is delivered by independent education providers and meets the TransCelerate Mutual Recognition program. NSW Health is not responsible for the delivery or any content provided. Any questions regarding training content should be directed to the training provider.

See information about the training and the providers below and please contact the providers for more information.

Guidelines for Good Clinical Practice

Good Clinical Practice (GCP) is an internationally accepted standard for designing, conducting, recording and reporting of clinical trials. GCP training meeting the TransCelerate Mutual Recognition program are delivered by independent education providers.

This 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.

Further details about providers can be found below. NSW Health is not responsible for the delivery or any content provided. Any questions regarding training content should be directed to the training provider.

National Clinical Trials Governance Framework

Staff engaged in clinical trials require GCP certification. It ensures staff conducting clinical trials are working to international best practice. It is also required for accreditation under the National Clinical Trials Governance Framework. For further information on GCP requirements in Australia visit the Australian Government site, Australian Clinical Trials.

Facilitators

This is a list of facilitators offering GCP training in Australia, which may incur a cost. Please note it is not an exhaustive list and other providers are available. Click here to check whether a GCP training course meets the standard of the Transcelerate Mutual Recognition program.

Australian Clinical Trials Education Centre (A-CTEC)

A-CTEC is a not-for-profit, Australia-wide education centre, with a dedicated Learning Management System (LMS) hosting a suite of evidence-based, interactive clinical trials education opportunities suitable for a range of learning needs. A-CTEC was originally developed in Victoria and expanded nationally in early 2023.

They provide online training modules including a Comprehensive Course Package for Clinical Trial Investigators and Study team, as well as a shorter Good Clinical Practice = Good Research Practice course.

These courses are currently available free of charge and are mutually recognised and listed by TransCelerate as meeting the minimum requirements of ICH E6 (R2) GCP.

Find out more about the courses offered by A-CTEC

ARCS Australia

ARCS Australia is a national, membership-based organisation focused on the development and growth of the healthcare sector.

ARCS provides education, career pathways, professional development and advocacy to the healthcare sector.

Through its members ARCS has a broad and effective reach throughout the healthcare sector, and provides a neutral forum to develop, agree and implement aligned policies and initiatives.

ARCS and its members are dedicated to improving the quality of life of healthcare consumers.

Find out more on ARCS at their website.

Genesis Research Services

Genesis Research Services is a multiservice clinical research company focussed on trial management, recruitment, education and investigator support services.

They bring a range of clinical trial opportunities to their community, including world-first studies for pain management and healthy volunteer studies.

Genesis Research Services provides pharmaceutical, biotechnology and clinical research organisations with a dedicated team of professionals and a purpose-built facility designed around the needs and requirements for conducting clinical trials.

Visit the Genesis Research Services website to learn more.

PRAXIS Australia in partnership with Sophie Mepham GCP

PRAXIS Australia is a not for profit, registered charity created by members in 2015.

Their purpose is to enhance access to high quality, relevant and accessible education and training that can be used by individuals or organisations across the broader research and clinical trials eco-system in Australia and internationally.

They believe that education is the key to their broader purpose – to enhance the welfare of research participants and the quality and effectiveness of research.

Find out more about PRAXIS Australia and their services.