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NHMRC Grants Administration

Pilot of the National Clinical

Trials Governance Framework

Conjoint Research Positions

Legal Manager & Legal Officer Clinical Trials

Consultant Clinical Trials Governance

Research Ethics and

Governance

SLHD RESEARCH

Director of Research

2018-2023 SLHD Research Strategic Plan

SLHD Intellectual

Property Committee

Executive Research Manager

Research Coordinator

Network Meetings

Clinical Research

Centre

SLHD Clinical Trials Steering

Committee

Research Coordinator

Shared Network Drive

REDCap

Research Promotion and

Media

Links to Key Resources and

Partners

Clinics and Departments

Research Committees

Clinical Trials Pharmacies

Education and Training

Libraries

Accellion Secure File

Transfer (SFT)

ACTA Full Membership

Sydney Local Health District (SLHD) Research Support and Infrastructure Directory

Sydney Health Economics

Collaborative

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1. Clinical Research Centre (CRC)

The Clinical Research Centre (CRC) was established to implement the aims of the Sydney Local Health District’s Research Strategic Plan, which called for increased research capacity, quality, translation and access to skills in data management, statistics and business support in a clinical setting. The CRC’s focus is on “making quality research, easier” whilst strengthening capacity for sustainable, relevant translational research within the health service. A free, consultancy and support unit has been adopted as a model to build capacity and remove barriers to research. Researchers have access to experienced staff including:

• Research Business Manager • Statistician • Data Manager • Clinical Trials Business Manager

These staff members have been appointed to provide statistical, data management and business advice, tools and education.

DON’T KNOW WHERE TO START? GET IN TOUCH WITH US

Clinical Research Centre SLHD-Research@health.nsw.gov.au Louise Ford, Research Business Manager Louise.ford@health.nsw.gov.au Ph: 9515 7966 Akila Dharmendar, Clinical Trials Business Manager Akila.dharmendar@health.nsw.gov.au Ph: 9515 6355 Yelena Fridgant, Research Data Manager and REDCap Administrator SLHD-REDCap@health.nsw.gov.au Ph: 9515 6359 Lindy Masya, Research Data Manager and REDCap Administrator SLHD-REDCap@health.nsw.gov.au Ph: 9767 6365 Request a consultation: https://redcap.sswahs.nsw.gov.au/surveys/?s=E4CWTTLKXE

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2. Research Ethics and Governance Offices

There are two research ethics and governance offices within Sydney Local Health District; one at RPA Hospital; the other at Concord Hospital. Both offices provide a major service in human research ethics governance and animal ethics governance for the District and a number of the affiliated MRIs. The offices co-ordinate and support all administrative and regulatory aspects of research at SLHD assisting with applications for research, providing support to committees and ensuring appropriate ethical review and authorisation is received for research to be conducted. Significant resources are available for clinical triallists and researchers on both the RPAH and Concord Research Ethics and Governance websites. These websites have been developed (and continue to be updated) to provide researchers with a comprehensive resource with as much help as possible to navigate through the Ethics and Governance landscape. The websites include:

• Updates on issues / changes that may impact researchers within the District • Guides on how to apply for research and governance authorisations • Clinical Trial resources including protocol templates (SPIRIT), participant information sheets

and consent forms • Post approval guidelines • Forms and templates • Grants and funding links • FAQs • Contact details for ethics and governance staff members

Ms Merela Ghazal, Executive Research Manager Merela.Ghazal@health.nsw.gov.au Ph: 9515 7176 CONCORD RESEARCH OFFICE: https://www.slhd.nsw.gov.au/concord/Ethics/default.html Ms Kate Flinders, Manager Kate.Flinders@health.nsw.gov.au Ph: 9767 5622 Ms Sarah Truong, Research Ethics & Governance Support Officer Sarah.truong@health.nsw.gov.au Ph: 9767 6233 Ms Kataraina Whitbourne, Research Ethics & Governance Support Officer Kataraina.Whitbourne@health.nsw.gov.au Ph: 9767 6233 RPAH RESEARCH ETHICS and GOVERNANCE OFFICE: Ph: 9515 6764 SLHD-RPAEthics@health.nsw.gov.au https://www.slhd.nsw.gov.au/RPA/Research/default.html Human Ethics Ms Patricia Plenge, Executive Officer - Ethics Committee Patricia.Plenge@health.nsw.gov.au Ph: 9515 6766 Ms Geetha Govender, Assistant Administrator - Ethics geetha.govender@health.nsw.gov.au Ph: 9515 6764 Ethics Clinical Trials/ Animal Welfare/ Clinical Practice

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Ms Sanaa Thomas, Executive Officer - Clinical Trials / Animal Welfare sanaa.thomas@health.nsw.gov.au Ph: 9515 8200 Ms Micaela Cirnigliaro, Assistant Administrator - Research / Animal Welfare micaela.cirnigliaro@health.nsw.gov.au Ph: 9515 7439 Ms Olivia Hu, Assistant Administrator Olivia.hu@health.nsw.gov.au Ph: 9515 8200 Research Governance/Site Specific Application Ms Maree Larkin, Research Governance Officer maree.larkin@health.nsw.gov.au Ph: 9515 7899 Biosafety Dr Gabrielle O'Sullivan , Executive Officer and Primary Contact, Royal Prince Alfred Hospital Institutional Biosafety Committee (RPAH IBC) gabrielle.osullivan@health.nsw.gov.au Ph: 9515 6772

3. NHMRC Grants Administration

NHMRC funds research through institutions that it has approved to administer NHMRC grants. The SLHD is an NHMRC Approved Administering Institution, with support provided by the RPAH Research Ethics and Governance Office. The office can assist with queries regarding: - Submission of grant applications - Chief Executive approvals for submissions involving SLHD Investigators - Administration of the grant, including agreements, reporting requirements and recruitment

Ms Merela Ghazal, Executive Research Manager Merela.Ghazal@health.nsw.gov.au Ph: 9515 7176 Ms Micaela Cirnigliaro, Assistant Administrator - Research / Animal Welfare micaela.cirnigliaro@health.nsw.gov.au Ph: 9515 7439

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4. REDCap REDCap (built by Vanderbuilt University) was launched in the Sydney Local Health District to support researchers with their data. REDCap is installed within the SLHD internal data centre, simplifying compliance and ensuring best practice is supported for confidentiality, privacy and security of data storage. REDCap can be used widely, across multiple disciplines and for all research types from clinical trials, laboratory based studies to health services research and consumer engagement projects. To date, more than 2,900 staff, students and collaborators have registered as users of the system and around 2,100 research projects have so far been created. From managing Kidney transplantation trials at RPA to the swift response of public health matters, representatives from across the research spectrum have described the benefits and efficiencies of using REDCap for their research studies.

Access REDCap: https://redcap.sswahs.nsw.gov.au/ Apply for an account: https://redcap.sswahs.nsw.gov.au/surveys/?s=DW9F3FDJMJ Contact Administrator: SLHD-REDCap@health.nsw.gov.au

5. Accellion Secure File Transfer (SFT)

SLHD employees have access to the Accellion Secure File Transfer (SFT) system. Accellion Secure File Sharing allows you to share files securely with recipients both inside and outside of the District. To obtain a user account you must fill out the Secure File Transfer (SFT) Request Form online and submit it to the Statewide Service Desk for processing. The system is accessed using the Accellion Web User Interface or Accellion Mobile Apps.

Account queries IT Service Desk: Ph: 9515 8877 Apply for Accellion Access: 1. Log on to the SARA portal using your network log-on and password: https://sara.health.nsw.gov.au/customerportal 2. Search for “Secure File Sharing” in the search bar or click on “Make a Request” then “Access Management” and then “Secure File Sharing/SFTP” 3. Complete the online form. Once you click on “Submit”, the form will be electronically sent to your cost centre manager. Questions on securing, storing and transferring research data: Yelena Fridgant and Lindy Masya, Research Data Managers SLHD-REDCap@health.nsw.gov.au

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6. SLHD Director of Research The SLHD Director of Research oversees the development and governance of research in the SLHD. Reporting to the Chief Executive the Director:

- Leads the development, implementation and monitoring of the Sydney Local Health District Research Strategic Plan.

- Facilitates strong and vital collaborations with key partners including the Medical Research Institutes within the boundaries of Sydney LHD, the University of Sydney and other major university partners and the Chris O’Brien Lifehouse at RPA.

- Provides leadership in scholarship and in the interface between research, policy and practice to external organisations at state, national and international level.

- Fosters excellence in research, professional activities, policy and planning development within the SLHD facilities.

- Enables research education and mentoring throughout the SLHD. - Oversees the consultation and inclusion of researchers in research policy and planning in

SLHD. - Oversees the establishment and maintenance of effective and accountable District and

hospital-based Research Governance structures. - Oversees mechanisms to report on Research performance and output including grants,

publications, clinical trials etc.

Professor Warwick Britton AO w.britton@centenary.org.au Ph: 9565 6263

7. SLHD Executive Research Manager

The SLHD Executive Research Manager is responsible for all matters relating to the effective and efficient management of research support and development functions, research ethics and research governance within the SLHD. Reporting to the Director of Research, the Executive Research Manager manages the RPAH Research Ethics and Governance Office, the CRGH Research Office and the SLHD Clinical Research Centre.

Ms Merela Ghazal, Executive Research Manager Merela.Ghazal@health.nsw.gov.au Ph: 9515 6764

8. SLHD Consultant Clinical Trials Governance

The role of the Consultant Clinical Trials Governance in the SLHD is to provide overarching support and governance for Clinical Trials activities. The Consultant: - As Chair of the Clinical Trials Steering Committee, leads the Committee to develop a

coordinated and system-wide approach to clinical trials management within the SLHD and provide strategic direction for future initiatives.

- Ensures that SLHD grows, maintains and effectively manages clinical trials capacity and capability.

- Oversees the reporting of KPIs/metrics and the use of this information to implement process improvement.

- Develops and maintains partnerships to promote the SLHD as a clinical trials provider. - Ensures quality systems are in place and maintained for the conduct and management of

clinical trials.

Dr Roy Donnelly Roy.donnelly@health.nsw.gov.au

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- Monitors the efficiency of clinical trials infrastructure to identify roadblocks and facilitate process improvements

9. Legal Manager and Legal Officer Clinical Trials

The District employs a Legal Manager and Legal Officer Clinical Trials, both of whom have a responsibility for providing assistance to researchers with the review and application of legal instruments, including (but not limited to): - Clinical Trial Research Agreements (CTRAs) - Clinical Investigation Research Agreement (CIRA) - Form of Indemnity - Material Transfer Agreements (MTAs) - Confidentiality agreements

Researchers are able to consult with the legal team regarding any legal matters or queries that may arise in the research or clinical environment.

Ms Blaise Lyons, A/Legal Manager Blaise.Lyons@health.nsw.gov.au Ph: 9515 9124 Ms Belinda McKenzie, Legal Officer Clinical Trials belinda.mckenzie@health.nsw.gov.au Ph: 9767 6706

10. Conjoint Research Positions

Conjoint research positions have been employed to strengthen Population Health, Community Health, Nursing and Allied Health Research and Clinical Trials. Conjoint appointments include:

• Conjoint Professor Cancer Nursing • Conjoint Professor Nursing and Midwifery • Conjoint Professor Allied Health (Chronic Diseases) • Conjoint Professor Allied Health (Community)

Conjoint Professor Allied Health (Chronic Diseases) Prof Jennifer Alison SLHD and Faculty of Health Sciences jennifer.alison@sydney.edu.au Ph: 9351 9371 or 0414 300 416 Conjoint Professor of Allied Health (Community Health) Prof Andrew Baillie SLHD & Faculty of Health Science andrew.baillie@sydney.edu.au Ph: 0417 449 817 Conjoint Professor Nursing and Midwifery Prof Elizabeth Denney-Wilson SLHD and Susan Wakil School of Nursing and Midwifery elizabeth.denney-wilson@sydney.edu.au Ph: 0414 985 810 Professor of Cancer Nursing Prof Kate White SLHD and Susan Wakil School of Nursing and Midwifery kate.white@sydney.edu.au Ph: 8627 1567

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11. Sydney Health Economics Collaborative

The Sydney Health Economics Collaborative can provide assistance with designing and conducting a health economics analyses for your next cohort study, clinical trial or evaluation, and partner with you on competitive grant applications. The Collaborative can help you:

• Measure the costs, health outcomes (including quality of life) and cost effectiveness of a new health program;

• Examine the longitudinal trends in, and determinants of, healthcare utilisation/health outcomes/health inequalities in individuals with a chronic condition using a range of analytical approaches, such as panel data analysis, duration analysis, and decomposition methods;

• Assess the impact of a health program implemented on a large-scale using interrupted time-series analysis; and

• Measure individual preferences (values) for different treatment options (and discover how individuals trade-off the various potential benefits and costs) using an online personalised decision support tool.

Dr Michelle Cunich, Senior Research Fellow in Health Economics, Boden Collaboration, Faculty of Medicine and Health (Central Clinical School), The University of Sydney Director, Sydney Health Economics Collaborative, SLHD Affiliate (Health Economist), Sydney Institute for Women, Children and their Families Affiliate (Health Economist), ANZAC Institute michelle.cunich@sydney.edu.au Ph: 8627 1949

12. Education and training Both the Clinical Research Centre and the Centre for Educational Workforce Development (CEWD) have developed education programmes for researchers. These include multiple courses in research methods, biostatistics, data management, clinical trial management through the CRC and a course in clinical research methods by CEWD. Researchers can access a multitude of training courses offered by CEWD in the categories of Governance; Engagement; Technical; Clinical Skills (including Venepuncture); Education and Research; Innovation; and Management and leadership.

CEWD website: https://www.slhd.nsw.gov.au/cewd/default.html CRC Training Calendar: https://www.slhd.nsw.gov.au/research/training.html

13. Clinical Trials Pharmacies Pharmacy Investigational Drugs Units are located at both RPA and Concord Hospitals. The units currently support the administration and dispensing of drug clinical trials from Phase 1 to phase 4 stages. In addition, the units are responsible for the procurement of investigational drugs under the Special Access Scheme. The Pharmacy Investigational Drugs Unit is responsible for administrative procedures associated with the setting-up of a Clinical Drug Trial. This includes drug accountability, temperature monitoring, development of randomisation schedules and aseptic reconstitution as needed.

Concord Clinical Trials Pharmacy: SLHD-ConcordPharmacyTrials@health.nsw.gov.au Ph: 9767 7035 RPA Pharmacy Trials: SLHD-RPAPharmacyTrials@health.nsw.gov.au Ph: 9515 8658 Opening hours: 8.30am to 5pm Monday to Friday Delivery times: 9am to 4pm

14. Promotion of Research and Clinical Trials

The SLHD is committed to the promotion of research and clinical trials, communicating research performance and its benefits.

• The SLHD annual Innovation and Research symposium has highlighted research and clinical trials activities across the District.

To stay connected in Sydney Local Health District: Visit Sydney Connect: slhd.nsw.gov.au/sydneyconnect Follow at: https://www.facebook.com/SydneyLHD/ YouTube: youtube.com/SydneyLHD Join the conversation on Twitter: @SydneyLHD

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• An annual Clinical Trials Showcase was introduced in 2015, profiling the achievements of clinical trials and clinical trials staff in the District.

• Research and clinical trials are regularly profiled in District publications – HealthMatters has at least 2 Research articles per edition; research reports; and at annual Research Award meetings at RPA and Concord hospitals.

• Symposia for research on Allied Health; Mental Health; Nursing and Midwifery; and Community Health have been held to increase the profile of research and clinical trials in these areas.

Patient Recruitment ClinTrial Refer App provides a platform to increase cross-referral and recruitment to clinical trials. The app was developed collaboratively by staff working in the SLHD and SESLHD and has been utilised to improve recruitment to Haematological clinical trials. All District trial units now have access to list their trials on the Sydney Health Partners version of ClinTrial Refer App to assist with the recruitment of patients to their trials.

SLHD Strategic Relations and Communications Team: SLHD-SRC@health.nsw.gov.au Ph: 9515 9513. Media Unit: SLHD-Media@health.nsw.gov.au Ph: 9515 9607 ClinTrial Refer App queries: https://www.clintrial.org.au/

15. Libraries Within the Sydney Local Health District there are four libraries available for researchers. They are located at Balmain Hospital, Concord Hospital (incorporating the Mental Health Library), and Royal Prince Alfred Hospital. Libraries offer support in the following areas:

• Literature search service: staff can request literature searches by contacting libraries directly by telephone or email; or via intranet/internet sites. Literature searches can be carried out on the topics requested using multiple databases and search results can be emailed in a variety of formats. Contact your hospital library for further information.

• EndNote assistance/training: EndNote is reference management software used to collect and manage references and associated files. It is also used to prepare bibliographies in specific styles for research publications. Assistance and training is available at Concord Hospital Library and RPA Hospital Library.

• Training on database searching: the libraries provide one to one and group training on database searching for staff engaged in research. In some cases training may also be conducted in your department.

• Access to point of care tools: some hospitals have subscriptions to point of care information tools such as UpToDate or Dynamed; and BMJ Best Practice is available on CIAP. Contact your hospital library for further information.

You can find out what material is held by using your Library's online catalogue on the intranet, or contacting the library directly: Balmain Hospital: email: SLHD-BalmainLibrary@health.nsw.gov.au Concord Hospital Geoff Marel Library (Incorporating Mental Health Library): Website: https://www.slhd.nsw.gov.au/concord/Library/default.html email: SLHD-Concordlibrary@health.nsw.gov.au Royal Prince Alfred Hospital Susman Library: Website: http://slhd-intranet.sswahs.nsw.gov.au/RPA/susman/default.htm email: SLHD-RPAsusmanlibrary@health.nsw.gov.au Ph: 951 58997

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• Supply of journal articles and books: libraries provide Inter-library loan services to obtain articles and books not available in the libraries or on CIAP. Contact your hospital library to find the best way to request material.

• Electronic library resources: some libraries have individual collections of electronic journals/resources that supplement CIAP resources. Contact your hospital library for more information on how to access these resources.

• Book and journal print collections: each library has individual collections of print books and journals.

16. Clinics/ Departments The SLHD is committed to a culture that incorporates and supports research in all departments. As

such, all departments throughout the District are considered research departments. Research and clinical trials can be conducted with collaborations between a multitude of departments throughout the District, including but not limited to:

• Radiology • Pathology • Infusion Centres • Medical records • Pharmacy • PET/Nuclear medicine • Cell and Molecular Therapies- includes the development, manufacture, clinical evaluation

and implementation of cell and gene therapies. • RPA Institute of Academic Surgery (IAS) – includes processes and support for surgical

clinical trials. • Institute for Musculoskeletal Health

Information on research conducted by departments throughout the District can be found on the SLHD Research website: https://www.slhd.nsw.gov.au/research/departmentsList.html

17. SLHD Clinical Trials Steering Committee

The SLHD established a Clinical Trials Steering Committee to achieve the following objectives: • To maintain and improve access by patients of the SLHD to developing technologies and

therapies for the treatment and prevention of disease, as well as contribute to leading edge clinical research, through participation in quality clinical trials;

• To escalate issues for the operation of clinical trials which require resolution at the SLHD Executive level.

• To streamline financial processes for clinical trials within SLHD; • To develop improved systems for reporting of clinical trials activity within SLHD, including

both clinical activities and resource utilisation; • To provide strategic direction on the human resource processes that support timely

recruitment to clinical trial positions;

Chair: Dr Roy Donnelly Roy.donnelly@health.nsw.gov.au Executive Officer: Ms Akila Dharmendar SLHD-ClinicalTrials@health.nsw.gov.au Ph: 9515 6355

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• To review, and where required improve overall infrastructure support for Clinical Trials activities within SLHD; and

• To improve the efficiency of the above processes where possible, to encourage sustainable and high quality clinical trial activity within SLHD in line within the mission and vision of the District.

• To monitor the performance of clinical trials across the SLHD, tracking this performance against standard KPIs.

18. SLHD Intellectual Property Committee

The role of the SLHD Intellectual Property Committee (in accordance with NSW Health Policy Directive PD2005_370) is to receipt, consider and examine all intellectual property matters, arising from health research under paragraph 5.2 of the policy directive, and make appropriate recommendations to the Chief Executive. Notifications and questions should be directed to the Executive Officer, Ms Louise Ford.

Chair: Professor Warwick Britton AO w.britton@centenary.org.au Ph: 9515 5210 Executive Officer: Ms Louise Ford SLHD-Research@health.nsw.gov.au Ph: 9515 7966 Website: Coming Soon

19. Allied Health Research Committee

The Allied Health Research Committee was established to assist in building research capacity within and across disciplines of allied health. The role of the Committee is to: • Promote and support evidence-based practice and research within disciplines of allied health

across the SLHD • Facilitate mentoring and the development of research skills in allied health professionals across

the SLHD • Provide support to allied health staff conducting research • Support opportunities for allied health staff to engage in research • Examine opportunities for multidisciplinary allied health research • Raise the profile of allied health research • Assist networking of various allied health disciplines and to provide opportunities to engage

with other key stakeholders • Support the work of the Allied Health Professorial unit in terms of the Allied Health Research

and Education Partnership Strategic Plan

Co-Chairs: Professor Jennifer Alison jennifer.alison@sydney.edu.au Ph: 9351 9371 or 0414 300 416 Professor Andrew Baillie andrew.baillie@sydney.edu.au Ph: 0417 449 817 Executive Officer: Ling-Ling Tsai ling-ling.tsai@sydney.edu.au

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20. Research Committees The Research Committees at both CRGH and RPAH have been established to advise the General Manager, Clinical Council and District Education and Research Committee on strategies to promote and support research, including implementing the District Research Strategic Plan. The Committees’ roles include: • Overseeing the implementation of the SLHD Research Strategic Plan • Promotion of high quality research including:

o Clinical Research Training o Biostatistician Support o Research Prizes

• Responding to external research issues • Considering and identifying funding opportunities for research in SLHD • Promote links between and support for, the Research Institutes closely associated with the

facilities.

CRGH RESEARCH COMMITTEE Chair: Professor Vasi Nagananthan vasi.naganathan@sydney.edu.au Ph: 9767 7274 Executive Officer: Ms Kate Flinders Kate.flinders@health.nsw.gov.au Ph: 9767 5622 RPAH RESEARCH COMMITTEE Chair: Prof Warwick Britton w.britton@centenary.org.au Ph: 9565 6263 Executive Officer: Ms Louise Ford SLHD-Research@health.nsw.gov.au Ph: 9515 7966

21. SLHD Education and Research Committee

The SLHD Education and Research Committee was established to advise the Chief Executive and Board on strategies to promote and support education and research in Sydney Local Health District. The Committees’ roles include:

• Report to the Board (quarterly) on SLHD’s performance against the Research Strategic Plan and the Education Strategic Plan

• Oversee the monitoring and reporting of implementation of the Research Strategic Plan and the Education Strategic Plan,

• Oversee SLHD in meeting its Commonwealth and State governance reporting requirements in relation to education and research

• Oversee the governance of clinical trials including quality, patient safety and risk management

• To consider new strategic partnerships that enable growth in research capabilities • Together with strategic partners, promote initiatives of Sydney Research

consistent with the SLHD Strategic Plan • Contribute to the development of key messages in relation to education and

research • Promote key initiatives in education and research in line with the SLHD Strategic

Plan • Note the activities of the Ethics Committees.

Executive Officer: Walter Towney Walter.towney@health.nsw.gov.au

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22. Research Coordinator Network Meetings

Bimonthly research coordinator network meetings are held with aim to: • Allow for the exchange of information and ideas • Facilitate discussion and resolution of common issues or queries • Develop relationships and provide support amongst colleagues located across various

facilities across the SLHD New participants are always welcome to join the group.

For more information: Ms Akila Dharmendar, Clinical Trials Business Manager, CRC SLHD-Research@health.nsw.gov.au Ph: 9515 6355

23. Research Coordinator Shared Network Drive

A shared network drive has been established to centrally store resources for researchers in SLHD. The shared drive is managed by the CRC. Content includes:

• Budget guidelines including templates for clinical trials and research studies • Research Coordinator contact list • eMR - Clinical Trials Alert and compliance documentation • Ethics and Governance templates/tools • Finance process documents and templates • GCP useful documents • Head of Department contact list • HR/Recruitment – list of previously approved research and clinical trials position

descriptions • Maps • OHMR Metric guidelines • PowerTrials software presentation information • Standard operating procedures • Useful information and links

Apply for access: https://redcap.sswahs.nsw.gov.au/surveys/?s=ED3CA78TEP Queries can be directed to: SLHD-Research@health.nsw.gov.au Ph: 9515 6355

24. SLHD Research Strategic Plan 2018-2023

The Plan will place the District at the forefront of developing and implementing the robust evidence base which drives innovation in care by delivering on the Sydney Local Health District Research Plan 2018-2023 Strategic Directions:

1. To invest in and sustain our research capacity across all Sydney Local Health District facilities, professions and disciplines

2. To create knowledge by leading quality biomedical, clinical, health services and population health research

3. To implement knowledge by rapidly translating research into best practice and policy.

View the plan here: https://www.slhd.nsw.gov.au/pdfs/slhd-research-strategic-plan-2018-2023.pdf

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25. Pilot of the National Clinical Trials Governance Framework

SLHD has been selected as one of 14 national primary pilot sites. The purpose of the pilot is to assist health service organisations assess their capacity to meet the actions in the National Safety and Quality Health Service (NSQHS) Standards 1 and 2 for clinical trial services as provided in the Governance Framework, and to identify additional resources that may be required to support national implementation.

Liaison Point: Ms Merela Ghazal, Executive Research Manager Ph: 9515 7176 Merela.Ghazal@health.nsw.gov.au

26. ACTA Full Membership SLHD holds Full Membership with the Australian Clinical Trials Alliance (ACTA). Staff members can access discounted prices for conference registrations and training.

Please direct questions to: Sydney Research SLHD-SydneyResearch@health.nsw.gov.au Or Clinical Research Centre SLHD-Research@health.nsw.gov.au

27. Links to Key Resources and Partners

SLHD Research Partnerships and Collaborations • Sydney Health Partners (SHP) • Sydney Research

• The ANZAC Research Institute • The Asbestos Disease Research Institute • The Baird Institute • Brain and Mind Centre • Brainstorm • The Centre for Education and Research in Ageing • The Centenary Institute of Cancer and Cell Biology • The NHMRC Clinical Trials Centre (CTC) • Concord Centre for Cardiometabolic Health in Psychosis (ccCHiP) • The Chris O'Brien Lifehouse at RPA • The Heart Research Institute • Institute of Musculoskeletal Health • RPA Institute of Academic Surgery (RPAIAS) • The Woolcock Institute of Medical Research • The Surgical Outcomes Research Centre (SOuRCe) • Sydney Institute for Women, Children and their Families • The University of Sydney

Animal Ethics

• Animal Ethics Infolink

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Australian Government departments and agencies • Department of Industry, Innovation and Science • National Health and Medical Research Council (NHMRC) • Office of the Gene Technology Regulator • Therapeutics Goods Administration (TGA)

Authorised Prescriber Scheme • Guidance for Medical Practitioners, Human Research Ethics Committees, Specialist Colleges and Sponsors, Version 3.0, July 2017

Clinical trial resources

• Australian Cancer Trials • Australian Clinical Trials Alliance (ACTA) • Australian Clinical Trials Official Site • Australian New Zealand Clinical Trials Registry (ANZCTR) • Clinical Trials Action Committee • Clinical Trial Research Agreements for Use in NSW Public Health Organisations • Clinical Trials – Insurance and Indemnity • Consumers Health Forum of Australia (CHFA) • Human Research Ethics Committees: Standards for Scientific Review of Clinical Trials • ISO 14155:2011 - Clinical investigation of medical devices for human subjects -- Good clinical practice • Medicines Australia

o Medicines Australia indemnity form and compensation guidelines o Medicines Australia clinical trial research agreements

• NHMRC – Safety monitoring and reporting in clinical trials involving therapeutic goods, November 2016 • NSW Clinical Trials Budget Costing Tool • Therapeutics Goods Administration (TGA)

o Access to unapproved therapeutic goods (TGA) o The Australian Clinical Trial Handbook o Clinical Trial Notification (CTN) and Clinical Trial Exemption forms (TGA) o Note for guidance on good clinical practice (TGA)

• Understanding Clinical Trials (Clinicaltrials.gov) Data Management (courtesy of the Australian Research Data Commons (ARDC))

• 10 medical and health research data Things • ARDC Guide: De-identification • ARDC Guide: Publishing and sharing sensitive data • ARDC Webinars: Health and medical data webinar series

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Details: Contacts and Links:

Human research resources and ethics guidelines

• Australian Code for the Responsible Conduct of Research (under review in 2017) • Ethical Guidelines on the use of Assisted Reproductive Technology in clinical practice and research (2007) (ART Guidelines). • HREC and Research Governance: Fee Policy for Review of Commercially Sponsored Research • Human Research Ethics Committees: Ethical Review for External Entities • Human Research Ethics Committees: Quality Improvement & Ethical Review: A Practice Guide for NSW • Human Tissue – Requirements of the Human Tissue Act 1983 in relation to research & use of tissue • Keeping Research on Track: A guide for Aboriginal and Torres Strait Islander Peoples about health research ethics • List of Institutions with Certified Ethical Review Processes • National Approach to Single Ethical Review • National Statement on Ethical Conduct in Human Research 2007 — updatedMarch2014 • NHMRC – Ethical Considerations in Quality Assurance and Evaluation Activities • Overview of Human Research Ethics Committees • Research – Ethical & Scientific Review of Human Research in NSW Public Health Organisations • Understanding Consent in Research Involving Children: The Ethical Issues — A Handbook for Human Research Ethics Committees and Researchers • Values and Ethics: Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research

NSW Health Agencies

• NSW Health Statewide Biobank • NSW Office for Health and Medical Research

Privacy

• Health Records and Information Privacy Act 2002 (NSW) – Statutory Guidelines on Research • Health Records and Information Privacy Act 2002 (NSW) – Statutory Guidelines on the collection of health information from a third party • Health research privacy framework • Guidelines approved under Section 95 of the Privacy Act 1988 • Guidelines approved under Section 95A of the Privacy Act 1988 • Guidelines approved under Section 95AA of the Privacy Act 1988 (Cth) • Office of the Australian Information Commissioner: Australian Privacy Principles – Privacy fact sheet 17 (January 2014)