Sponsor information
South Eastern Sydney Local Health District (SESLHD) is strategically focussed on applied and translational research that improves the delivery of health care and the wellbeing of patients and the community.
SESLHD is committed to enabling clinical trials through its Research Support Office and dedicated trials units.
Information about Clinical Trial Research Agreements and ethics requirements can be sourced from the Research Support Office.
Information about specific trials units and supporting services is located below:
The vision of the Nelune Comprehensive Cancer Centre is to reduce the impact of cancer through research-led excellence in clinical care.
Our aim is to provide the best treatment currently available to our patients. In this way we are constantly striving to improve the treatment provided to our patients through clinical research and clinical trials.
The Oncology clinical trial unit has been active since 1990, with a dedicated team of experienced investigators. The unit is also staffed by a Trial Unit Manager, a Trial Site Set Up Specialist and several Research Nurses. The research staff are proficient in the conduct of single or multicentre clinical trials. The unit has vast experience with lead site responsibilities.
Investigators
|
Prof David Goldstein Prof Michael Leonard Friedlander Associate Prof Craig Ronald Lewis |
Dr Elizabeth Jane Hovey Dr Yeh Chen Lee Dr Siobhan O’Neill |
Medical and Radiation Oncology Tumour streams
|
Breast Colorectal - anal Gynae-oncology Head and Neck Lung Neuro-oncology |
Upper Gastrointestinal – oesophageal, gastric, g/e junction, GIST & Pancreas Genitourinary – renal, prostate, testicular & urothelial(bladder) Sarcoma Skin Supportive care Solid tumour – phase 1 studies |
Facility details
Christie Norris | Trial Unit Manager - contact for CTRA and budgets
Prince of Wales Hospital, The Bright Building, Cancer and Haematology Services
Level 1, Barker St Randwick, NSW 2031
Tel: 02 9382 5130 | Fax: 02 9382 5180 | Email: christie.norris@health.nsw.gov.au
Trial unit equipment
- Centrifuge (refrigerated)
- -20oC freezer temperature monitored with alarm
- -80oC freezer temperature monitored with essential power, and back to base alarm
- ECG machine
Electronic Medical Record Mosaiq
The Oncology Trials Unit uses an electronic Medical Record (MosaiqTM). This has been assessed to comply with the FDA code 21 CFR part 11. Clinical Research Associates performing source data verification using Mosaiq will be given personalised username and password to access read only patient data. It is to be noted that the trial unit monitors patient access of CRAs on a regular basis to ensure compliance and patient privacy.
CRA facilities for monitoring visits
Hot desks are available with access to electronic medical records. All attempts will be made to accommodate monitoring visits within two weeks of first patient on study. Otherwise CRA’s need to book monitoring visits at least 4 weeks in advance.
Pharmacy
Joanne O’Brien | Senior Pharmacist | Clinical Trials
Prince of Wales Hospital, Pharmacy Department, High Street, Randwick NSW 2031
Tel: (2 9382 2333, |Fax: 02 9382 2345 | Email: Joanne.OBrien@health.nsw.gov.au
Drug delivery: Pharmacy Department, Level 2 via Loading Dock 3, Prince of Wales Hospital
High Street, Randwick NSW 2031
Laboratory
NSW Health Pathology (SEALS), Randwick Campus, Level 4 Campus Centre, High Street, Randwick NSW 2031 Australia.
Radiology
Nuclear Medicine, Level 2, Campus Centre, Prince of Wales Hospital, Barker Street, Randwick NSW 2031 Australia
Wales CT, Medical Imaging Department, Level 0, Campus Centre, Prince of Wales Hospital, Barker Street, Randwick NSW 2031 Australia
Off site archiving
Government Records Repository, 143 O’Connell St, Kingswood NSW 2747
Tel: 02 96731788 | Fax: 02 88055306 | Email: grr.nsw@records.nsw.gov.au
NSW Health Pathology provides services in communities, hospitals and critical care settings. Labs located across SESLHD provide comprehensive diagnostics, genetic screening, HIV outreach clinics and a host of other essential pathology services.
As the largest public pathology service in Australia, NSWHP can tap into their vast network of laboratories to provide analysis and expertise to drive clinical decisions and support research. NSWHP are often one of the few providers of specialised tests not funded through the Medicare Benefits Scheme.
NSWHP operates over 60 laboratories, 200 hospital and community-based collection services across NSW. Their dedicated staff perform roughly 61 million tests each year and facilities supporting SESLHD operate 24 hours a day, seven days a week.
Investment in new technologies has improved turn-around times, increased output and enhanced quality. Many expert staff employed by NSWHP are affiliated with major universities, medical schools and research institutes.
Contact
For research project partnership enquiries, contact:
Erin Brighten
Clinical Projects Manager
(m) 0414 747 787 | (e) erin.brighten@health.nsw.gov.au