Research and Ethics Office

Clinical Trials Support Unit

1.  UPDATES
2.  ESSENTIAL CONTACTS
3.  CLINICAL TRIAL SPECIALITY GROUPS
4.  USEFUL LINKS
5.  CLINICAL TRIALS STANDARD OPERATING PROCEDURES (SOP)
6.  TRAINING 

1. Updates

COVID-19:  Guidance on clinical trials for institutions, HRECs, researchers and sponsors is now available on the NHMRC's website at:  www.nhmrc.gov.au/research-policy/COVID-19-impacts

This guidance reflects the shared views of all state and territory Departments of Health, the Clinical Trials Project Reference Group (CTPRG), NHMRC and the Therapeutic Goods Administration (TGA). This is also reflective in our contingency plan.  South Western Sydney Local Health District (SWSLHD) is taking every precaution for the safety and health of our clinical trial participants and staff.  Due to the evolving situation with COVID-19 we are continually assessing how to approach each individual clinical trial using the below criteria:

  1. Business as usual:  protocol requirements remain unchanged and participants will have all assessments with the clinic/hospital as planned.
  2. Participants will be seen in an alternative location:  there may be a need to see participants in a different hospital or one of the SWSLHD community centres.  You will be informed of this prior to this occurring and of any impact on the protocol requirements will be communicated.  Onsite monitoring will cease and ongoing discussions with sponsors regarding remote monitoring will take place.
  3. Remote visits:  in the event participants cannot attend their scheduled visits, a telephone or tele-health visit may be conducted.  You will be informed of this prior to this occurring.  The SWSLHD clinical trials team will discuss with you the supply of investigation product and logistics of administering the protocol requirements.
  4. Withdrawal from the clinical trial and investigation product:  there may be circumstances where it is in the best interest of the participant to withdraw from the clinical trial and your SWSLHD clinical trials team will notify you of this.

Thank you to everyone for working to identify the risks for each clinical trial and making decisions on continuing or stopping recruitment.  It is important that we can support the continuance of our clinical trials in accordance with good clinical practice while we safeguard the health and well-being of participants and our teams.

2. Essential Contacts 

Meg Ford
Executive Director of Clinical Trials
T: +61 2 8738 3920

E: megan.ford@health.nsw.gov.au
E: SWSLHD-ClinicalTrialsSupportUnit@health.nsw.gov.au  

Kelsey Dobell-Brown
Manager, SWSLHD Clinical Trials Support Unit
T: +61 2 8738 8304
E: SWSLHD-ClinicalTrialsSupportUnit@health.nsw.gov.au  

Faysal Ahmed
Clinical Trials Finance Officer, SWSLHD Clinical Trials Support Unit
T: +61 2 8738 8318
E: SWSLHD-ClinicalTrialsSupportUnit@health.nsw.gov.au

3. Clinical Trial Speciality Groups

          • Medical Oncology
          • Radiation Oncology
          • Palliative Care
          • Haematology
          • Intensive Care 
          • Emergency 
          • Neurovascular
          • Neuroimmunology and Multiple Sclerosis 
          • Respiratory and sleep disorders
          • Cardiology 
          • Gastrointestinal and Liver Disorders
          • Renal 
          • Diabetes and Endocrine Disorders 
          • Rheumatology
          • Immunology
          • Orthopaedics
          • Mental Health 

4.  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.

Clinical Trial Budgeting Manual - User Guide: NSW Budget Costing Tool
Clinical Trial Budgeting Template

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.

5.  Clinical Trials Standard Operating Procedures (SOP) 

Standard Operating Procedures (SOPs) 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.

Case Report Forms, Source Documents, Record Keeping and Archiving
Documentation of Investigational Site Qualifications Adequacy of Resources and Training Records 
     Appendix a) training log
     Appendix b) Delegation log
Electronic Filing
Handling, Processing and Shipping of Infectious Substances for Clinical Trials
Informed Consent Procedures and Writing Participant Informed Consent Forms 
     Appendix A. Informed Consent
Investigator Responsibilities
Management of Safety Reporting for Clinical Trials Sites
Non Compliance Reporting
     Non Compliance Form
     Corrective and Preventive Action Form
Preparing for a Regulatory Inspection
     Clinical Trial Unit Self Audit form
     Corrective and Preventative Action Form (CAPA)
Protocol and Investigational Brochure Content, Design, Amendments and Compliance
Receipt and Handling of Investigational Product 
Sponsor Responsibilities in Investigator Driven Studies - Under review by the OHMR

SOP_CTSU_01 Risk Assessment for Clinical Trials
SOP_CTSU_02 Investigator Responsibilities
SOP_CTSU_03 Communication with Human Research Ethics Committee, Trial Sponsor and Insurer
SOP_CTSU_04 Clinical Trial Start Up
SOP_CTSU_05 Budgets and Contracts
SOP_CTSU_06 Financial Management; billing compliance, invoicing, financial conflict for interest
SOP_CTSU_07 Identifying and Contracting Suppliers and Sub-contractors
SOP_CTSU_08 Documentation of Training and Clinical Handover
SOP_CTSU_09 Investigator Site File and Essential Documents
 

 



6.  Training

6a)  Good Clinical Practice (GCP) training for SWSLHD, Ingham Institute, UNSW and WSU staff

The Clinical Trials Support Unit (CTSU) offers onsite internationally accredited GCP programs. These programs are tailored to all staff involved in clinical research and their supporting departments such as Pathology, Nursing and Pharmacy.

The course content promotes a depth of understanding about conducting research involving humans within south western Sydney and the Australian environment, through interactive scenarios and discussion.

All Researchers are ethically responsible to conduct clinical research of the highest quality. This includes the collection of high quality, credible data that contributes to the answering of specific scientific questions, while protecting the rights, safety and well-being of clinical trial participants. These principles have their origin in the World Medical Association’s Declaration of Helsinki.

GCP standards exist to provide a benchmark of clinical research quality that can be relied upon throughout the world.

As endorsed by SWSLHD Chief Executive, in collaboration with the Research Director and Research and Ethics Manager, GCP training is a mandatory requirement for all staff involved in clinical trials in South Western Sydney. The Course can be offered to all SWSLHD, Ingham Institute, Western Sydney University and University of NSW staff and students.

The SWSLHD Clinical Trials Support Unit offers the following courses:  

All GCP training sessions have been cancelled until further notice.

Training Dates

GCP course are held on a monthly basis as per the table below.  In-services on request are also provided to supporting departments such as Nursing, Pharmacy and Radiology to gain an understanding of clinical trials.

Dates Workshop Time Venue
7 April 2020 Introduction 8.45 - 12.30 Liverpool - Cancelled
22 June 2020 Refresher 9.00 - 11.00 Campbelltown - Cancelled
4 August 2020 Refresher 9.00 - 11.00 Liverpool - TBC
8 October 2020 Introduction 8.45 - 12.30 Campbelltown - TBC
3 November 2020 Refresher 9.00 - 11.00 Liverpool - TBC

How to Register

6b)  Orientation program for new clinical trial staff

Orientation for new coordinators is available online.  This program is designed to assist new clinical staff in adjusting to their jobs and work environment and to in-still a positive work attitude and motivation at the onset.  Please contact the Clinical Trials Support Unit (CTSU) at SWSLHD-ClinicalTrialsSupportUnit@health.nsw.gov.au  for further information.

© 2016 South Western Sydney Local Health District
Last Updated: 19 May, 2016
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