Research and Ethics Office

Clinical Trials Support Unit







1. Updates

Early Phase Clinical Trial Requirements

As of April 2018, The Office for Health and Medical Research - NSW Health mandated that Early Phase Clinical Trials (EPCTs) must be submitted and reviewed to Sydney Children’s Health Network (SCHN) for paediatric studies or Bellberry Limited for adult studies. The South Western Sydney Local Health District Human Research Ethics Committee is not able to provide ethics approval for EPCTs. Please click here to view the document.


2. Essential Contacts 

Professor Meera Agar
Director, SWSLHD Clinical Trials Support Unit
T: +61 2 8738 9145

Kelsey Dobell-Brown
Manager, SWSLHD Clinical Trials Support Unit
T: +61 2 8738 8304

Faysal Ahmed
Clinical Trials Finance Officer, SWSLHD Clinical Trials Support Unit
T: +61 2 8738 8318

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
Communication with HREC, Trial Sponsor and Insurer
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
Investigator Site File and Essential Documents
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
Site Initiation and Close Out
Sponsor Responsibilities in Investigator Driven Studies - Under review by the OHMR

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:  

Course Cost
Introduction to GCP $150
Refresher Course $50
GCP for supporting departments No cost

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
14 August 2019 Refresher 9.00 - 11.00 TRMEC Conference Room 1
11 September 2019 Introduction 8.45 - 12.30 TRMEC Seminar Room 3
16 October 2019 Refresher 9.00 - 11.00 TRMEC Seminar Room 5
13 November 2019 Introduction

8.45 - 12.30

TRMEC Seminar Room 3
4 February 2020 Refresher 9.00 - 11.00 Liverpool
7 April 2020 Introduction 8.45 - 12.30 Liverpool
22 June 2020 Refresher 9.00 - 11.00 Campbelltown
4 August 2020 Refresher 9.00 - 11.00 Liverpool
8 October 2020 Introduction 8.45 - 12.30 Campbelltown
3 November 2020 Refresher 9.00 - 11.00 Liverpool

How to Register

For more information please contact Kelsey Dobell-Brown via

6b)  Orientation program for new clinical trial staff

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  for further information.

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