Clinical Trials Community of Practice Meeting
2024
February
Dr Alex Stephens, Director of Research, Northern NSW Local Health District
Presentation: A brief overview of the NNSWLHD Research Office approach to accreditation and walk through the evidence bank.
Jeanette Upton, Quality Manager, Calvary Mater Newcastle
Presentation: A brief overview of the Calvary Mater Newcastle organisational approach to accreditation and their strategy to maintain their evidence bank.
Dr Katherine Bolton and Yin Wang, Research Manager and Research Governance Officer, Central Coast Local Health District
Presentation: CCLHD Research Office learnings from the NCTGF Gap Analysis and preparation for the National Clinical Trials Governance Framework accreditation
Recording link: https://uonewcastle.zoom.us/rec/share/ln7W6bqbdabPOrqMTkoFDiQ99KCKmQxcl6AIn17AZJFaXdByNRBnYlJminJKjc4G.YlQq9xZ7IXAkK8Qv
Passcode: YzC98&Dw
March
Topic: The Rural, Regional and Remote clinical trial enabling program: An update on the Northern Cluster R3 (Rural Regional and Remote) Clinical Trial Support Unit
Guest Speaker: Joan Torony, Manager, Norther Cluster Clinical Trial Support Unit
Topic: ClinicaltrialsNSW Projects update
Guest Speakers: Kristy Morris, HNE research Governance Manager, HNELHD and Katherine Bolton, Research Manager, CCLHD
Recording link: https://uonewcastle.zoom.us/rec/share/wtbI8W3XiXlIzhN_pruFE4cm9Zy_RvcyC6DAZhI3TTtMXDWkLGd6eDlN8zJDKzjE.3QgqCaYdP4sNQnqt
Passcode: uGJ8+cMt
Further information:
- Disclosure of unit record data by Local Health Districts for research or contractor services
- Privacy Manual for Health Information
- TGA Good Clinical Practice (GCP) Inspection Program
- National One stop shop
- Watch the ACTA webinar on the National Clinical Trials Governance Framework
April
Topic: Overview of the revised National Statement on Ethical Conduct in Human Research 2023 and Non-research checklist for ethical risks
Guest Speaker: Sarah Moberley, Manager, Research Ethics, HNELHD
Topic: ClinicaltrialsNSW Projects update
Guest Speaker: Catherine Johnson, NSWRHP clinical Trials Network Officer
Topic: Q&A for the NSW CTMS, eREG and CCText.
Guest speaker: Anna Edgar, Project Officer, NSW Health Statewide CTMS Project from the Office for Health and Medical Research
Recording link: https://uonewcastle.zoom.us/rec/share/rxVRGVzMEzp2Ws4yH7Qtkg9MXQHemZk_G8PokHeHug1mxCkR6Ge7nb1gGzs6cSs6.uQV9mdzm5mP2dYqu?startTime=1713244930000
Passcode: 85fCWL=H
Further information:
- The National Statement on Ethical Conduct in Human Research 2023
- HNELHD Checklist for ethical review Non Research Activities
- https://nswhealth.sharepoint.com/sites/NSWH-CTMS/SitePages/eReg.aspx
- https://nswhealth.sharepoint.com/sites/NSWH-CTMS/SitePages/CCText.aspx
- https://nswhealth.sharepoint.com/sites/NSWH-CTMS/SitePages/Minimum-data-set.aspx?csf=1&web=1&e=Rup3Cp
2023
February
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
March
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
April
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.
Passcode: 1%*8RP4%
Resources:
- Research Ethics Presentation
- Research Governance Presentation
- ‘Ethics and Governance Application Process’ and safety reporting is available in the Australian Clinical Trials Education Centre platform
June
Topic: TGA GCP Inspection Program: A HNE Experience
Guest speaker: Rosemary Carroll, Clinical Nurse Consultant- Surgery Research, Surgical Services John Hunter Hospital
Passcode: @June!23
Resources:
- Good Clinical Practice (GCP) inspection program | Therapeutic Goods Administration (TGA)
- CCLHD standard operating procedure Research – Internal Monitoring of Clinical Trials
- Listen: Clinical Trials in Focus podcast on Spotify
July
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)
Passcode: CJuoLPy@23
Resources:
- Good Clinical Practice Inspection Program metrics report July 2022 – December 2022
- G Mason ARCS Highlights
- ICH E6 Revision Session Summary
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.
Passcode: %i%5d254
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 webinar recording: The CT:IQ InFORMed Project - Building more accessible participant information and consent forms for diverse Australians.
- Running a clinical trial from start to finish. This course includes information on the process of enrolling participants in a clinical trial, including informed consent and required documentation.
- CT:IQ
- The InFORMed Project and the The InFORMed Project template
- Screen and video recording software: Loom
- Sydney Health Literacy Lab Health Literacy Editor
September
Topic: NSW Clinical Trials Management System
Guest speakers:
- Anna Edgar, Project Officer, NSW Health Statewide CTMS Project, Office for Health and Medical Research. (CTMS Update, Mandatory Use and Audit)
- Amy Kelty, Research Coordinator, Cardiology, Critical Care, Gosford Hospital (Hints and Tips for enhancing your CTMS experience), and
- Kathryn Reilly, Research Development Manager, HNE Research Office
- Melissa Gavenlock, Research Governance Officer, Calvary Mater Newcastle
- Katherine Bolton, Research Manager, CCLHD
Passcode: g@E&JU66
October
Topic: Role of a Clinical Academic Pharmacist in Supporting Clinical Trials
Guest Speaker: Prof. Beata Bajorek, Clinical Academic Pharmacist for UoN, HMRI and HNELHD
Topic: HMRI Imaging Centre and How Clinical Trials Teams can Engage with this Service
Guest Speakers: Saadallah Ramadan, HMRI Imaging Centre Manager and Shiami Luchow, Senior MRI Radiographer, HMRI Imaging Centre
Passcode: L+yqor7y
November
Topic: Aboriginal Health Research Community Panel
Guest Speaker: Yeena Thompson, Aboriginal Health Research Partner, University of Newcastle
Passcode: cg4iDk#f
Resources:
- Aboriginal Health Research Strategy / Research to influence change / Indigenous Commitment / Our Uni / The University of Newcastle, Australia
- Study Participant Feedback Questionnaire Toolkit - TransCelerate (transceleratebiopharmainc.com)
- NSW health policy_ Preparation of pharmaceutical and advanced therapeutic products: PD2023_021.pdf (nsw.gov.au).This Policy Directive includes the preparation, procurement, storage, transportation, waste disposal and guidance for outsourcing the preparation of pharmaceuticals, clinical trial investigational medicinal products (IMPs), genetically modified organism medicinal products, chimeric antigen receptor (CAR) T-cell products, antigen specific cell and bacteriophage products for human use.
2022
January
Topic: Grant Writing
Access the meeting recording here,
Passcode: Janu@ry22
February
Topic: Involving and engaging consumers in research and clinical trials
Access the meeting recording here,
Passcode: Febru@ry22!
Resources:
- New resources have been developed by the Australian Health and Research Alliance Consumer and Community Involvement working parties. There is a new handbook on Involving Consumers and Community in Health and Medical Research this is a Step-by-Step guide to moving from good intention to good practice. This resource is aimed at research organisations, researchers, consumers and funders. For more information, read here;
- In addition you will find reports on Tools for Assessing Consumer and Community Involvement in Health Research and Consumer and Community Involvement Knowledge Hub on the AHRA website: Consumer and Community Involvement - AHRA
- The Consumer and Community Involvement section of the NSWRHP website has recently been updated with a range of new information and resources. You may like to check it out here: Consumer and Community Involvement – NSW Regional Health Partners.
March
Topic: General Clinical Trials Update
Access the meeting recording here
Passcode: M@rch22!
Resources:
- The National One Stop Shop - a national platform for health-related human research | Australian Commission on Safety and Quality in Health Care
- ICHGCP: ICH_E6-R3_GCP-Principles_Draft_2021_0419.pdf and ICH Releases E8 “General Considerations for Clinical Trials” Draft Revision for Public Comment — Clinical Pathways (clinicalpathwaysresearch.com)
April
Topic: Navigating Clinical Trial Research Agreements
Access the meeting recording here
Passcode: April@22!
Resources:
- clinicaltrialsNSW: NSW Health & Medical Research | Clinical Trial Toolkit
- Hunter New England Research Office services: Hunter New England Research Office | HNE Health (nsw.gov.au)
- Activities supporting the growth of Clinical Trial Networks in Australia | Trials | Full Text (biomedcentral.com)
May
Topic: New Clinical Trials Resources and Spotlight on John Hunter Hospital Intensive Care Unit Clinical Trials Unit
Access the meeting recording here
Passcode: 2022M@y!
June
Topic: NSW Regional Health Partners Clinical Trials Community of Practice- ARCS Conference Highlights held 23 June 2022
Access the meeting recording here
Passcode
July
Meeting Recording: https://uonewcastle.zoom.us/rec/share/XfxI92nd0K0usQDuzjbC2Tz22tm6LxC0C9-pyFx_TGCG3XgrSFv7fOq8kq-B2zub.YcecQDFdpzgaSDft
Passcode: CoP_July@22
Resources:
- PHRN Data Linkage Webinar 1: Designing Clinical Trials using Linked Data
- https://www.youtube.com/watch?v=NL2CiARkf7M&list=PLH5JZhNGOhzZyGt8ylqadnb3W25BvYSEU&index=1
- PHRN Data Linkage Webinar 2: Accessing Linked Data https://www.youtube.com/watch?v=ApTotJ7os3E&list=PLH5JZhNGOhzZyGt8ylqadnb3W25BvYSEU&index=2
- PHRN Data Linkage Webinar 3: Ethical considerations in using Linked Data
- https://www.youtube.com/watch?v=xMzd2j0TH9s&list=PLH5JZhNGOhzZyGt8ylqadnb3W25BvYSEU&index=3
- PHRN Data Linkage Webinar 4: Accessing MBS and PBS data
- https://www.youtube.com/watch?v=6O2ZZ4f1a2s&list=PLH5JZhNGOhzZyGt8ylqadnb3W25BvYSEU&index=4
August
Meeting recording: https://uonewcastle.zoom.us/rec/share/X6jpJqJDmiAqK2bpRtlsRkPuRrYcvKxhna2kd8mPqAEutV7qYYsQ0-y_xzaqJ-QA.ZMk55onbYViR1KOU
Access Passcode: @ugust22
Resources:
- National Standard Operating Procedures for Clinical Trials, including Teletrials, in Australia: National Standard Operating Procedures for Clinical Trials | Australian Government Department of Health and Aged Care
- National Principles for Teletrials in Australia: National Principles for Teletrials in Australia | Australian Government Department of Health and Aged Care
- NSW Health & Medical Research | The Rural, Regional and Remote clinical trial enabling program
December
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@
2021
April
Topic: Clinical Trials Quality Management: Standard Operating Procedures
Access the meeting recording here.
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
Resources:
clinicaltrialsNSW Standard Operating Procedures
- The National Standard Operating Procedures for Clinical Trials, including Teletrials were recently released, they have been endorsed by all states and territories together with the TGA and the NHMRC. NSW Health has endorsed the National Teletrials Compendium and strongly encourages the use of these National SOPs to support a consistent approach to national implementation more broadly. The NSW SOPs are not mandatory but also strongly encouraged for trials. These SOPs have been written at a high level, therefore it is recommended that any local requirements/details to be added in the form of work instructions.
- National Clinical Trials Governance Framework
May
Topic: National Clinical Trials Governance Framework
Access the meeting recording here.
Passcode: 1Framework$
Resources: You can access further information about the National Clinical Trials Governance Framework here
June
Topic: Audits, Monitoring and Site update- Port Macquarie Mid North Coast Cancer Institute
Access the meeting recording here,
Passcode: Audits1$
Resources: You can access information about the clinicaltrialsNSW Standard operating procedure ‘Hosting an audit or regulatory inspection’ here
July
Topic: Highlights from the 2021 ARCS Conference
Please note: There is no recording for this session.
Resources: 2021 ARCS presentations - ARCS Australia
August
Topic: Difficult Conversations : Skills for Clinical Trials Staff
Access the meeting recording here,
Passcode: 21@ugust
Resources:
- National Platform for Health and Medical Research
- clinicaltrialsNSW Clinical Trials Training and Capability Framework: Contact details: Steve Millard, Clinical Trial Manager
September
Topic: What Pharmacy can do to support clinical trials and research teams.
Access the meeting recording here,
Passcode: 21@eptember
October
Topic: Managing Clinical Trials Workloads and Workforce Models
Access the meeting recording here,
Passcode: 21@ctober
November
Topic: Difficult Conversations: Skills for clinical trials staff
Access the meeting recording here,
Passcode: 21N@vember