Training and Education Opportunities
Good Clinical Practice (GCP)
Good Clinical Practice (GCP) is an internationally accepted standard for the designing, conducting, recording and reporting of clinical trials.
The principles of GCP help assure the safety, integrity, and quality of clinical trials by addressing elements related to the design, conduct, and reporting of clinical trials.
More specifically, GCP training aims to ensure that:
* The rights, safety, and well-being of human subjects are protected.
* Clinical trials are conducted in accordance with approved plans with rigor and integrity.
* Data derived from clinical trials are reliable.
Health staff engaged in clinical trials require GCP certification. It ensures staff conducting clinical trials are working to international best practice.
Evidence of CGP certification is to be uploaded with HNE Site Specific Application / HNE Site Amendment.
GCP is also required for accreditation under the upcoming National Clinical Trials Governance Framework.
Clinical trials of medicines and biologicals regulated under the CTN or CTA schemes are subject to the TGA's Good Clinical Practice (GCP) Inspection Program.
GCP Training is delivered by a number of independent education providers.
Please see below for links to providers and training.
Clinical Trials Community of Practice Meeting
PRAXIS Australia
Human Research Ethics Committee (HREC) Essentials
This course provides HREC Executives, Managers, Researchers and Committee Members with a deeper understanding of the purpose and function of HRECs and their role within them. HREC Essentials includes many downloadable resources, videos, short activities, and case studies written by industry experts.
It is the ideal training solution for anyone new to Research Ethics or those wishing to upskill and increase their knowledge in this unique area of practice.
Research Essentials - Developing Excellence in Research Design and Practice
Research Essentials is a world class, competency based clinical trials and research training program composed of over 65 distinct online modules and electives. It has been designed to meet the unique and lifelong training needs of all those involved in research and clinical trials.
Research Essentials was created to build capacity and capability across the research and clinical trials sector and to support high quality, reliable, ethical research, that can change people’s lives now and into the future. Research Essentials is used by individuals wishing to upskill – and by organisations and institutions who want to build their own educational programs or platforms.
https://praxisaustralia.com.au/services/research-essentials/
In Person Workshops
PRAXIS facilitates a diverse menu of face to face workshops across Australia that cover a range of new and emerging areas of interest in research, research ethics and clinical trials.
https://praxisaustralia.com.au/services/in-person-workshops/
Virtual Workshops
As a result of the Covid19 pandemic, PRAXIS have transitioned some of the regular In Person Workshops to shorter, fully virtual formats. These sessions allow participants to gain an understanding of the principles and critical considerations of each topic.
https://praxisaustralia.com.au/services/virtual-workshops/
Webinars
PRAXIS is currently offering a series of FREE webinars, designed to support our HREC and Clinical Trials sector as they prepare to emerge from the impacts of the COVID19 pandemic.
https://praxisaustralia.com.au/services/webinars/
Intensive Research Ethics Retreat
PRAXIS, in collaboration with The Center for Ethics in Medicine and Society and Sydney Health Ethics , offers a highly regarded Intensive Research Ethics Course that is convened by PRAXIS Directors Paul Komesaroff , Ian Kerridge and Dr Kandy White, along with a team of guest presenters that are recognised as some of Australia’s leading research ethics experts.
This intensive course is conducted as a five day retreat and is designed to assist researchers, ethics committee members and others involved in the conduct and assessment of research to understand and clarify the issues arising in relation to research of all kinds involving human participants. It provides an opportunity for members of the research and research ethics communities to come together to discuss the issues they face and share their experiences.
https://praxisaustralia.com.au/services/intensive-research-ethics-retreat/
Australian Clinical Trials Education Centre (A-CTEC)
A-CTEC is a not-for-profit, Victorian developed, 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 is supported by the Victorian Research Translation Centres Collaborative (VRTCC).
A-CTEC builds the capacity and capability of the clinical trials workforce in Australia through easy access to world-class education and training opportunities, at no cost to the end user.
Target Audience
All staff involved in clinical trials in health service settings across Australia, regardless of role or site. The audience will include: study coordinators, research nurses and clinical trial assistants, investigators, clinical trial pharmacists, HREC and governance officers, clinical and non-clinical research staff, general staff in departments that interact with clinical trials, employees involved in clinical trials from hospitals, community health settings, universities, and any location where clinical trial research is undertaken.