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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.

Passcode: RuralResearch2021!

Clinical Trials Community of Practice Meeting

August 2023

Topic: Creating concise and readable patient information sheets for interventional studies in Australia

Guest speakers:  Tanya Symons, Director, T Symons Associates PTY LTD and Professor Josh Davis, School of Medicine and Public Health University of Newcastle,Staff Specialist, Infectious Diseases and General Medicine, John Hunter Hospital, Head, Infection Research Program, HMRI, Principal Research Fellow, Menzies School of Health Research, Darwin, Honorary Associate Professor, Doherty Institute for Infection and Immunity, University of Melbourne.

Recording link

Passcode: %i%5d254

Further Resources:

  • Publications:
    • Symons, Tanya & Straiton, Nicola & Gagnon, Rosie & Littleford, Roberta & Campbell, Anita & Bowen, Asha & Stewart, Adam & Tong, Steven & Davis, Joshua. (2022). Consumer perspectives on simplified, layered consent for a low risk, but complex pragmatic trial. Trials. 23. 10.1186/s13063-022-07023-z.
    • Symons, Tanya & Davis, Joshua. (2022). Creating concise and readable patient information sheets for interventional studies in Australia: are we there yet?. Trials. 23. 10.1186/s13063-022-06712-z.
  • Australian Clinical Trials Education Centre

July 2023

Topic: An overview of the best of the best from the ARCS and SCRS conferences

Guest speakers:

  • Caitlin Queripel and Yin Wang (CCLHD)
  • Sarah Lukeman (Consumer)
  • Gillian Mason and Nicole Lapachelle (HMRI)
  • Louis Ndagijimana (UoN)
  • Joan Torony, Rachel Wilks and Julianne Rose (Northern NSW R3 Cluster)

Recording link

Passcode: CJuoLPy@23

Further Resources:  

June 2023

Topic: TGA GCP Inspection Program: A HNE Experience

Guest speaker: Rosemary Carroll, Clinical Nurse Consultant- Surgery Research, Surgical Services John Hunter Hospital

Recording link

Passcode: @June!23

Further Resources:

May 2023 (rescheduled to August)

Topic: Creating concise and readable patient information sheets for interventional studies in Australia

Guest speakers: Tanya Symons, Director, T Symons Associates PTY LTD and Professor Josh Davis, School of Medicine and Public Health University of Newcastle,Staff Specialist, Infectious Diseases and General Medicine, John Hunter Hospital, Head, Infection Research Program, HMRI, Principal Research Fellow, Menzies School of Health Research, Darwin, Honorary Associate Professor, Doherty Institute for Infection and Immunity, University of Melbourne.

April 2023

Topic: Navigating Research Ethics in HNE Health: An overview and tips for a smooth approval process

Guest speakers: Sarah Moberley, Manager, HNELHD Research Ethics; Katherine Bolton, Research Manager, CCLHD; Kristy Morris, Manager Research Governance, HNELHD and Melissa Gavenlock, Research Governance Officer, Calvary Mater Newcastle.

Recording link

Passcode: 1%*8RP4%

Session Resources:

March 2023

Topic: Australian Clinical Trials Education Centre

Guest speaker: Dr Eman Naefa, Director, Australian Clinical Trials Education Centre (A-CTEC)

Meeting Recording: Clinical Trials Community of Practice - Zoom

Passcode: March!!23

February 2023

Topic: Clinical Trials Update

Guest speakers: Dr Sonya Murray, Professor Nikola Bowden and Dr Kathryn Reilly

Meeting Recording: NSW RHP Clinical Trials Community of Practice - Zoom

Passcode: Febru@ry23

December 2022

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

Passcode: 22_Dec_Consent$

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.

Passcode: 22_Dec_Injury@

August 2022

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

July 2022

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

June 2022

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!

May 2022

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!

April 2022

Topic: Navigating Clinical Trial Research Agreements 

Date: April 28,2022

Access the meeting recording here, Access Passcode: April@22!

March 2022

Topic: General Clinical Trials Update

Date: March 2022

Access the meeting recording here, Access Passcode: M@rch22!

February 2022

Topic: Involving and engaging consumers in research and clinical trials

Date: 24 February 2022

Access the meeting recording here, Access Passcode: Febru@ry22!

January 2022

Topic:  Grant Writing

Date: January 2022

Access the meeting recording here, Access Passcode: Janu@ry22

November 2021

Topic:  Difficult Conversations: Skills for clinical trials staff

Date: November 25, 2021

Access the meeting recording here, Access Passcode: 21N@vember


October 2021

Topic: Managing Clinical Trials Workloads and Workforce Models

Date: October 28, 2021

Access the meeting recording here, Access Passcode: 21@ctober


September 2021

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

August 2021


Topic: Difficult Conversations : Skills for Clinical Trials Staff

Date: August 26, 2021

Access the meeting recording here, Access Passcode: 21@ugust

Resources: 

July 2021


Topic: Highlights from the 2021 ARCS Conference

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

June 2021

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

May 2021

Topic: National Clinical Trials Governance Framework

Date: May 27, 2021
Access the meeting recording here. Access Passcode: 1Framework$

Resources: You can access further information about the National Clinical Trials Governance Framework here

April 2021

Topic: Clinical Trials Quality Management: Standard Operating Procedures

Date: Apr 22, 2021 03:24 PM Canberra, Melbourne, Sydney
Access the meeting recording here. Access Passcode: vx@#?!8!

Here are the presentations by Dr Ashika Kumar and Rosemary Carroll FYI.
OHMR presentation_NSW RHP CT CoP_22Apr21.pdf
Caroll_SOPs.pdf

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.

https://connect.hmri.org.au/user/login?destination=node/6393

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/

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