Clinical Trials Support Unit
2. Essential Contacts
Professor Meera Agar
Director, SWSLHD Clinical Trials Support Unit
T: +61 2 8738 9145
Manager, SWSLHD Clinical Trials Support Unit
T: +61 2 8738 8304
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
• Intensive Care
• Neuroimmunology and Multiple Sclerosis
• Respiratory and sleep disorders
• Gastrointestinal and Liver Disorders
• Diabetes and Endocrine Disorders
• 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
Handling, Processing and Shipping of Infectious Substances for Clinical Trials
Informed Consent Procedures and Writing Participant Informed Consent Forms
Appendix A. Informed Consent
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
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:
|Introduction to GCP
|GCP for supporting departments
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.
|15 May 2019
|12 June 2019
|10 July 2019
|14 August 2019
|11 September 2019
|16 October 2019
|13 November 2019
|11 December 2019
How to Register
Registration is required for courses for SWSLHD staff, please register via My Health Learning - please click here to register.
For staff employed or affiliated to UNSW, WSU or the Ingham Institute - please click here to register your interest for scheduled courses and email your completed form to Kelsey Dobell-Brown at SWSLHD-ClinicalTrialsSupportUnit@health.nsw.gov.au.
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 SWSLHD-ClinicalTrialsSupportUnit@health.nsw.gov.au for further information.