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.
The HNELHD Rural Research Committee invited the National Rural Health Commissioner Adjunct Professor Ruth Stewart to deliver a virtual presentation and participate in an open discussion.
Topic: ‘Can rural health be improved through research?’
As Rural Health Commissioner, Prof Ruth has the large task of advising the federal government on how to improve rural health services and is closely involved with the current NSW Parliament Rural Health Inquiry.
For nearly 30 years she has worked as a clinician across small country towns, farming districts and with Aboriginal and Torres Strait Islander communities and her message about improving rural health outcomes is refreshing.
Ruth promotes the strengths (rather than disadvantages) of rural communities and in particular the important gains from both health research and education of all health professionals.
To access this recording, please click here.
James Murray-Parkes is the Chief Scientist at Technotia Laboratories, part of the world renowned Brookfield Asset Management team out of New York. The Technotia team is a multidisciplinary group of mathematicians, scientists and inventors. By taking inspiration from the natural world, James is widely regarded as a world leader in high-end problem solving, innovation and design. His unique design capabilities have influenced over 1170 projects in the finance, health, construction, energy and defence sectors. To James and his team, their physical world provides an endless resource for visual study and exploration, that can be used to develop a unique and yet organic approach to finding efficient solutions. Inspiration comes from the smells to the colour, textures, shapes, sounds, structures and anatomy of natural structures, which has been a consistent element for James in his career - it’s what is often referred to as biomimicry.
James shared what it means to define 'finger-on-the-pulse' innovative research which not only uses the physical world to find inspiration for the solution to problems, but more importantly, to find problems in the first place.
The University Of Newcastle's Research Advantage program aims to connect and empower by providing a range of events and support resources.
Research Advantage / Professional development / Research support / Research / The University of Newcastle, Australia
HMRI hosts and facilities a wide range of research seminars, workshops, training sessions, trade displays and events to support the work of Hunter researchers. The preeminent event is the HMRI Seminar Series - featuring national and international research and industry leaders at HMRI.
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 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.
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.
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.
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.
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.
Australian Clinical Trial Alliance (ACTA) hosted a Implementability Super-Webinar presented by Deputy Chair of ACTA, Prof Steve Webb on 11 February 2020.
The presentation was on a new concept: Implementability and how it improves the planning, design, delivery, and reporting of clinical trials.
- The recorded super-webinar and its accompanying guidance document can be found here https://clinicaltrialsalliance.org.au/resource/implementability-super-webinar/
- The slide deck for this presentation can be found here https://clinicaltrialsalliance.org.au/resource/acta-implementability-super-webinar-slide-deck/
To add your relevant education opportunity here please send details to HNELHD-ResearchOffice@health.nsw.gov.au