Other 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.
National Rural Health Commissioner Presentation
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.
Clinical Trials Community of Practice Meeting
Topic: InFORMed Project: Redesigning Consent to Research
Meeting Recording: https://uonewcastle.zoom.us/rec/share/RNz28rTSRM0D8yIZPwqEs40F_VT17Q-xpQAO8QmC0ES4XGUfJpvosKBDIlWMfoHR.SxwJ7nrMP164AKm7
Guest speaker: Sonia Harvey, Project Manager, CT:IQ and the CT:IQ InFORMed Project Team
Topic: ‘Injury in Clinical Trials: Can we do this better?’
Meeting Recording: https://uonewcastle.zoom.us/rec/share/lpH2pw2xFc1iqnqvZWQmNvcQycxeAfQtJHjeFM3klwN8KbX9ecuIu3_OdmjHkvuq.L1D1TeuJj43stiFP
Speakers: Sophie Mepham, Executive Manager Research Global, Icon Group and Dianne Sheehan, clinical trial participant.
Topic: Teletrials: The Victorian Experience and Key Operational Considerations for Sites and Staff.
Date: 25 August 2022
Meeting recording: https://uonewcastle.zoom.us/rec/share/X6jpJqJDmiAqK2bpRtlsRkPuRrYcvKxhna2kd8mPqAEutV7qYYsQ0-y_xzaqJ-QA.ZMk55onbYViR1KOU
Access Passcode: @ugust22
Topic: Data sharing and linkage in clinical trials and research
Date: 28 July 2022
Meeting Recording: https://uonewcastle.zoom.us/rec/share/XfxI92nd0K0usQDuzjbC2Tz22tm6LxC0C9-pyFx_TGCG3XgrSFv7fOq8kq-B2zub.YcecQDFdpzgaSDft
Access Passcode: CoP_July@22
Topic: NSW Regional Health Partners Clinical Trials Community of Practice- ARCS Conference Highlights held 23 June 2022
Date: June 23,2022
Access the meeting recording here: Access Passcode: @June22!
Topic: New Clinical Trials Resources and Spotlight on John Hunter Hospital Intensive Care Unit Clinical Trials Unit
Access the meeting recording here, Access Passcode: 2022M@y!
Topic: Navigating Clinical Trial Research Agreements
Date: April 28,2022
Access the meeting recording here, Access Passcode: April@22!
Topic: General Clinical Trials Update
Date: March 2022
Access the meeting recording here, Access Passcode: M@rch22!
Topic: Involving and engaging consumers in research and clinical trials
Date: 24 February 2022
Access the meeting recording here, Access Passcode: Febru@ry22!
Topic: Grant Writing
Date: January 2022
Access the meeting recording here, Access Passcode: Janu@ry22
Topic: Difficult Conversations: Skills for clinical trials staff
Date: November 25, 2021
Access the meeting recording here, Access Passcode: 21N@vember
Topic: Managing Clinical Trials Workloads and Workforce Models
Date: October 28, 2021
Access the meeting recording here, Access Passcode: 21@ctober
Topic: What Pharmacy can do to support clinical trials and research teams.
Date: September 23, 2021
Access the meeting recording here, Access Passcode: 21@eptember
Date: August 26, 2021
Access the meeting recording here, Access Passcode: 21@ugust
Date: July 2, 2021
Please note: There is no recording for this session.
Resources: Here is the link to the 2021 ARCS presentations - ARCS Australia
Topic: Audits, Monitoring and Site update- Port Macquarie Mid North Coast Cancer Institute
Date: June 24, 2021
Access the meeting recording here, Access Passcode: Audits1$
Resources: You can access information about the clinicaltrialsNSW Standard operating procedure ‘Hosting an audit or regulatory inspection’ here
Topic: National Clinical Trials Governance Framework
Date: May 27, 2021
Resources: You can access further information about the National Clinical Trials Governance Framework here
Topic: Clinical Trials Quality Management: Standard Operating Procedures
Date: Apr 22, 2021 03:24 PM Canberra, Melbourne, Sydney
Here are the presentations by Dr Ashika Kumar and Rosemary Carroll FYI.
Key resources referred to throughout the presentations yesterday included:
Innovation Seminar - James Murray-Parkes
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.
To access this recording please click here.
Research Advantage Program
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 Seminar Series
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.
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.
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.
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.
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.
Implementability Super Webinar
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