Committed to Research

The role of the Clinical Research Support Unit (CRSU) is to provide overarching support and governance for Clinical Research activities.


As a team the CRSU:
  • Ensures that WSLHD grows, maintains, and effectively manages clinical research capacity and capability.
  • Develops and maintains partnerships to promote WSLHD as a clinical trials provider. This includes the development of service partnership agreements.

CRSU provides support to researchers to enable them to have the resources and confidence for the life span of research. From the conceptual idea, approval process, implementation, reporting, and publication.
This includes:
  • Assistance with protocol writing and type of applications required.  
  • Navigating research approval pathway including assistance with preparing HREC/Research Governance applications using REGIS. 
  • Providing Pharmaceutical industry partners key contacts with WSLHD to conduct clinical trials. 
  • Provides learning opportunities through ICH GCP training for researchers to understand their roles and responsibilities in conducting research.  
  • Provides support on financial management of clinical research such as budget negotiation.  
  • Strong links with NSW Health OHMR. 
  • Interpreter bookings for Culturally and Linguistically Diverse (CALD) research patients are available.

How to navigate these pages
  • Each heading has links to forms, policies, and procedures.
  • There are guides for ethics and governance tasks, so you can easily find the information you need.
  • You will find some forms and templates on more than one page, so they are at your fingertips when you are ready to use them.
  • Information about Pre-Submission meetings and how to book can be found on the Ethics page

 

Clinical Research Support Unit Contacts

Sharon Lee
WSLHD Clinical Research Manager
P: 8890 9942
E: [email protected]
E: [email protected]

Haleh Shahidipour
Clinical Research Facility Centre Manager
P: 8890 9945
E: [email protected]

Allison Sigmund
WSLHD Clinical Research Support Manager
P: 8890 4318
E: [email protected]

Ashley Bali
Administration Officer
P: 8890 4336
E: [email protected]

Jack Giannini
Clinical Trials Management Systems Administrator
P: 8890 4336
E: [email protected]

Kate Park
Clinical Trials Manager
P: 8890 6570
E: [email protected]

Lijun Mao
Clinical Trials Research Nurse
P: 8890 6278
E: [email protected]

Narae Kim
Clinical Trials Manager
P: 8890 7491
E: [email protected]

Jessica Kim
Clinical Trials Manager
P: 8890 3413
E: [email protected]

 

Clinical Trial Speciality Groups

WSLHD specialises in Clinical Trials and Research in the following groups:
  • Allied Health
  • Anaesthetics & Surgery 
  • Breast Cancer 
  • Cardiology 
  • Dermatology 
  • Diabetes & Endocrine Disorders 
  • Emergency 
  • Gastrointestinal & Liver Disorders 
  • Genetics Medicine 
  • Gynaecological Oncology 
   • Haematology 
  • Immunology 
  • Infectious Diseases 
  • Intensive Care 
  • Medical Oncology 
  • Mental Health 
  • Midwifery & Nursing 
  • Neurology 
  • Orthopaedics 
  • Palliative Care 
  • Radiation Oncology 
  • Renal 
  • Respiratory & Sleep Disorders 
  • Rheumatology 
  • Women & Newborn Health 

 

Sponsor Clinical Trial Onsite Monitoring

The WSLHD has ultimate responsibility for ensuring, via its research governance arrangements, that all its approved research is monitored. To ensure obligations are met, CRSU administers an authorisation and booking system.

Coordinators are to follow the below link to submit your monitors privacy agreement, photo ID and patient list. Please also see below for the link to the monitoring rooms booking page.

 

Clinical Research and Trials Standard Operating Procedures (SOP)

Standard Operating Procedures (SOP) are uniformly written procedures, with detailed instructions to record routine operations, processes and practices followed within an organisation. In clinical research, SOPs help define the group’s (e.g. unit, division, department, institution, etc.) standard practices and daily processes conducted to assure execution of research tasks in accordance with institutional and ICH-GCP guidelines.

You can access the Clinical Research and Trials Standard Operating Procedures here.

 

Interpreters

Health care interpreters are to be engaged in all clinical trial and research situations where communication is essential for patients/clients who are not fluent in English, including people who are deaf.
Working with health care interpreters allows health professionals to fulfil their duty of care and ensures that the quality of communication is the best it can be when a language other than English is involved.
If it is established that a NSW Health Care Interpreter Service (HCIS) will be required to undertake discussion regarding the clinical trial/research an interpreter must be booked through the Clinical Research Support Unit (CRSU) WSLHD. For Pharmaceutical Sponsored Clinical Trials and Research HCIS are provided on a fee basis. More information on booking of HCIS can be found in the CRSU Use of Health Care Interpreter Service for Clinical Trials/Research SOP 
The CRSU will contact the HCIS and coordinate the booking. Confirmation of the booking will provided by CRSU to the research team via email.

Please see below for the link for booking in an Interpreter:

 

Service Level Agreements

When research activities require the support from a commercial company (e.g. provision of investigational product, provision of radiology or pathology services), an agreement will need to be in place before that support is provided.

All agreements must be made using a WSLHD approved Service Level Agreement Template, CRSU will provide the assistance in preparing the SLA. To have this prepared please contact CRSU. Once signed by service provider it is submitted as part of the REGIS application to WSLHD Research Governance for approval.

You can access the SLA Minimum Requirements Form here.

 

Confidentiality Disclosure Agreements

If confidential information is to be exchanged with or received from and external entity, a Confidentiality Disclosure Agreement (also referred to as a non-disclosure agreement (NDA) will be necessary. This agreement obligates the external entity or individual to uphold the confidentiality of the shared information, restricting its use to the specified purposes only. In WSLHD, CDAs are signed at an institutional level by the Director of Research.

 

Clinical Trial Management System (CTMS)

WSLHD has implemented a Clinical Trial Management System (CTMS) for hospitals and health services within the district conducting clinical trials. The CTMS will manage clinical trials in maintaining and managing planning, performing and reporting functions, as well as tracking deadlines and capturing metrics and milestones. The infrastructure of CTMS will also assist clinical trial departments with increased visibility of clinical trial activity and improved financial management.

CTMS Contact
Jack Giannini
Clinical Trials Management Systems Administrator
P: 8890 4336
E: [email protected]

 

Researcher Training

ICH GCP Training
Conducting research according to International Conference on Harmonisation Good Clinical Practice (more commonly known as GCP) principles in the basis on which research involving human participants is conducted.
You can access Researcher Training resources here...

 

Dangerous Goods

The purpose of the IATA Dangerous Goods regulations is to provide consistent technical requirements for the transport of dangerous goods across Australia. If you are responsible for packing or supervising an individual who packs dangerous goods for transport by air (including enclosing the goods in packaging, marking or labelling the consignment or preparing a shipper’s declaration) then you are required by both the International Air Transport Authority (IATA) and Civil Aviation Safety Authority (CASA) to ensure that you have received the appropriate dangerous goods training on an approved course certified by CASA.
The following links are certified courses appropriate for staff members:

 

Useful Links

The Therapeutic Goods Administration Website
The Therapeutic Goods Administration (TGA) is Australia's regulatory authority for therapeutic goods. We carry out a range of assessment and monitoring activities to ensure therapeutic goods available in Australia are of an acceptable standard with the aim of ensuring that the Australian community has access, within a reasonable time, to therapeutic advances.
The Therapeutic Goods Administration (TGA) has developed a helpful tool called SME Assist to help those unfamiliar with regulation to understand their regulatory and legislative obligations.

OHMR
NSW Health is focused on providing researchers, clinicians, managers and policy makers with the tools they need to translate research into innovative policy and practice to create healthier communities and deliver better patient care.

REGIS
Research Ethics and Governance Information System (REGIS)REGIS is the portal used to manage all ethics and site governance approvals of human research projects in NSW, TAS, ACT Public Health Organisations (PHOs), Allied Health Organisations (AHOs) and local health districts (LHDs)
The system is used to help researchers submit and track the progress of their ethics and governance applications, in terms of approvals and authorisations.

REDcap
The REDCap (Research Electronic Data Capture) system is an online secure capture data collection and management tool for research use. It been provided by the Office for Health and Medical Research for the use of researchers in NSW Public Health LHDs, Networks and pillars.

NHMRC
NHMRC is the key driver of health and medical research in Australia. Aside from funding, we advise the Australian Government and facilitate networking in the research community by bringing academics and industry together. We build commercial literacy among researchers and help them protect intellectual property.

Medicines Australia Website (Clinical Trial Contracts)
Medicines Australia Clinical Trial Research Agreement and Indemnity templates

Australian Clinical Trials Website
An Australian Government website with information about clinical trials in Australia. The website includes information for clinical trial sites, sponsors and consumers.

International Federation of Pharmaceutical Manufacturers Association (IFPMA) Clinical Trials Portal
This service is provided by the IFPMA, on behalf of its Member Companies and Associations. The portal has been designed as a single entry allowing you to search for comprehensive information on on-going clinical trials (registry) or results of completed trials (database) conducted by the innovative pharmaceutical industry.

Clinical Trial Budgeting Manual
User Guide: NSW Budget Costing ToolClinical Trial Budgeting Template

SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials)
The SPIRIT 2013 Statement provides evidence-based recommendations for the minimum content of a clinical trial protocol. SPIRIT is widely endorsed as an international standard for trial protocols.

 



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