Welcome to the Clinical Trials Unit at the Mid North Coast Cancer Institute (MNCCI) – Coffs Harbour. Our aim is to provide patients with the latest treatments in Medical Oncology, while focusing on quality management of clinical trials.
The Clinical Trials Unit is a centre of excellence located on the Mid North Coast of NSW at Coffs Harbour Health Campus – an Academic Teaching facility with an exceptional reputation in conducting clinical trials with both pharmaceutical and university-based research groups.
We are a small, agile, responsive unit with fast study set up timelines and offer a dedicated team of experienced investigators and study coordinators, proficient in the conduct of single and multicentre clinical trials, whilst ensuring the rights, safety and well-being of study participants are protected, and maintained
Our patient recruitment strategy: Patients are seen in the Public Hospital Outpatient Clinic, and are referred from local GPs, other specialists and Multi-Disciplinary Team meetings.
Dr. Karen Briscoe – Medical Oncologist
Mid North Coast Cancer Institute
Coffs Harbour Health Campus
345 Pacific Highway
Coffs Harbour NSW 2450
Phone +61 2 6656 5737
Fax +61 2 6656 5855
Email: MNCLHD-CHHC-NCCI-CTU@health.nsw.gov.au
- Trials Experience: since 2004 as a Principal Investigator, and since 2001 as a sub investigator
- Institution: Mid North Coast Cancer Institute, Coffs Harbour
- Specialty Area/Board Certification: VMO Medical Oncology, FRACP
- Medical Oncology Co-Investigators: Medical Registrars / Advanced Trainees as appropriate
Dr. William Fox – Medical Oncologist
Mid North Coast Cancer Institute
Coffs Harbour Health Campus
345 Pacific Highway
Coffs Harbour NSW 2450
Phone +61 2 6656 5737
Fax +61 2 6656 5855
Email: MNCLHD-CHHC-NCCI-CTU@health.nsw.gov.au
- Trials Experience: since 2014 as a Sub-Investigator and 2019 as Principal Investigator
- Institution: Mid North Coast Cancer Institute, Coffs Harbour
- Specialty Area/Board Certification: Medical Oncology, FRACP
- Medical Oncology Co-Investigators: Medical Registrars / Advanced Trainees as appropriate
Dr. Pinky Baghi – Medical Oncologist
Mid North Coast Cancer Institute
Coffs Harbour Health Campus
345 Pacific Highway
Coffs Harbour NSW 2450
Phone +61 2 6656 5737
Fax +61 2 6656 5855
Email: MNCLHD-CHHC-NCCI-CTU@health.nsw.gov.au
- Trials Experience: since 2018 as a Sub-Investigator
- Institution: Mid North Coast Cancer Institute, Coffs Harbour
- Specialty Area/Board Certification: Medical Oncology, FRACP
- Medical Oncology Co-Investigators: Medical Registrars / Advanced Trainees as appropriate
MNCCI Coffs Harbour Health Campus Oncology Clinical Trial Unit has experienced Senior Clinical Trial Coordinators dedicated to clinical research.
In addition, the unit includes an experienced study start up specialist/ finance manager (HSM1), an administration officer, and a clinical trial pharmacist
Global contact details for the unit (preferred option):
Phone: +61 2 6656 5053 or +61 (0) 429 234 338
Fax: +61 2 6656 5693
Email: MNCLHD-CHHC-NCCI-CTU@health.nsw.gov.au
Clinical Trials Unit Contact Details:
Robyn Dever (Mon, Tues, Thurs & Fri) – Clinical Trial Coordinator
Phone: +61 2 6656 5733
Fax: +61 2 6656 5693
Email: MNCLHD-CHHC-NCCI-CTU@health.nsw.gov.au
Experience: Over 15 years’ experience in clinical trials
Amber Carle (Tues, Wed, Thurs & Fri) – Clinical Trial Coordinator
Phone: +61 2 6656 5423
Fax: +61 2 6656 5693
Email: MNCLHD-CHHC-NCCI-CTU@health.nsw.gov.au
Experience: Over 10 years’ experience in clinical trials
Cassandra Simons (Mon, Tues and Wed) Health & Services Manager
Phone: +61 2 6656 5735
Fax: +61 2 6656 5693
Email: MNCLHD-CHHC-NCCI-CTU@health.nsw.gov.au
Experience: Over 2 years in clinical trial startup activities and finances as a Health Services Manager 1 (HSM1)
Nicole Morrison (Tues & Fri) Administration Officer
Phone: +61 2 6656 5592
Fax: +61 2 6656 5693
Email: MNCLHD-CHHC-NCCI-CTU@health.nsw.gov.au
Experience: Over 2 years in clinical trials administration
Jessica Andrews (One day a fortnight) Pharmacist
Phone: +61 2 6656 5053
Fax: +61 2 6656 5693
Email: MNCLHD-CHHC-NCCI-CTU@health.nsw.gov.au
Experience: This position has just been created
Site Training, Equipment and Experience
Standard Operating Procedures
A standard set of operating procedures has been developed for the MNCCI Oncology Trial Unit. These may be obtained from the unit.
Good Clinical Practice
All required research staff have attended formal GCP training and can provide a certificate on request. In addition, staff have attended numerous Investigator Meetings which include GCP Training.
Shipping
All required research staff have completed the Civil Aviation Academy Australasia – Safe Transport of Infectious Substance by Air and have extensive experience shipping blood, tumour, slides, discs (imaging) and films.
Trials Experience
All staff have clinical trials experience with the following tumour streams:
- Bladder
- Brain
- Breast
- Colorectal
- Upper GIT (also doing oesophageal studies currently)
- Head and Neck
- Lung
- Melanoma
- Ovarian / Gynaecological
- Prostate
- Pancreas
ECGs
Staff have access to, and experience with performing ECGs
Electronic CRFs
- Inform
- RAVE
- Medidata
- Oracle
- ClinPhone
- myTrials
- Sirius
- ctc eCRF’s
- eClinicalos
- Macro
- Redcap
IXRS
All clinical staff have experience with IVRS & IWRS
Audits
MNCCI @ Coffs Harbour has not been audited by any regulatory bodies, however have undergone collaborative audits with favourable results.
Mosaiq TM
MNCCI @ Coffs Harbour utilises 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 are required to complete a requisition form for access to 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.
IT and Telecommunications
All study coordinators have their own desktop computer with high speed internet access and international phone lines.
Site Equipment
- Centrifuge, both refrigerated and non-refrigerated
- -20oC and -80oC freezers
- ECG machine
- Locked fridge, specific to trials
- Height and weight scales
- Fully stocked advanced resuscitation trolley
- Onsite pharmacy with the ability to do own compounding
Archiving
Off-site archiving is preferred and organised by the sponsor; however the unit can supply the sponsor with a quotation if required. Collaborative trials will be archived onsite.
Research Governance Office
Fees:
Site Specific Assessment approval fees are governed as per the https://mnclhd.health.nsw.gov.au/wp-content/uploads/MNCLHD-Research-Governance-Fees-05May2020.pdf
Clinical Trial Research Agreement Information:
Site Details
- Institution: Mid North Coast Local Health District trading as Coffs Harbour Health Campus
- Name: (Principal Investigator)
- Address: Mid North Coast Cancer Institute, 345 Pacific Hwy Coffs Harbour NSW, Australia 2450
- ABN: 57 946 356 658
- Contact for notices: HSM 1
- Fax for notices: +61 2 6656 5693
- Phone for notices: as per HSM 1’s contact details
It is NSW Health Policy that Clinical Trials conducted at NSW Public Health Organisations use the standard clinical trial research agreements which can be found on the Medicines Australia website. The governing policies can be found at the NSW Health website.
Pharmaceutical and Contract Research Organisations
Any changes to the standard agreement (except NSW Health pre-approved Schedule 7 additions) will be required to undergo legal review at the expense of the sponsor.
Collaborative or Cooperative Groups
The Public Health Organisation will need to consider legal review for non-trivial changes to the standard agreement, or if the group elects to use their own contract. In this case the sponsor will be informed as it is acknowledged that not all groups will be in a position to meet legal costs.
It is mandated that the CRTA be signed by the sponsor prior to site approval and signature as this will be submitted concurrently with the Site Specific Assessment (SSA) Application to the Research Governance Office.
Clinical Trial Notification (CTN) Site Details
Mid North Coast Local Health District trading as Coffs Harbour Health Campus, 345 Pacific Hwy Coffs Harbour NSW, Australia 2450
Certificate of Currency
Must contain the following:
- The name of the local sponsor
- The name of the particular trial, or, state that it covers all trials conducted in Australia by the sponsor
- Australian Prudential Regulatory Authority (APRA) approved or a foreign insurer with a minimum credit rating by Standard and Poors (or equivalent) of -A or higher
- Current for the duration of the trial
- Minimum coverage of AUD20M per occurrence
Form of Indemnity
Medicines Australia Form of Indemnity must be used. Site details as per the CTRA.
Administrative Fees
Please contact the Clinical Trial Unit on +61 2 6656 5053
Clinical Trial Payments (exc. RGO fees)
Invoice details are to be emailed to the study coordinator with appropriate details as an attachment.
Electronic Funds Transfer preferred.
Bank details
- Account Name: Mid North Coast Local Health District
- Bank: Westpac Banking Corporation
- Branch: 181 Miller Street, North Sydney, NSW 2060
- BSB: 032 099
- Account Number: 520 669
- Swift Account Number: WPACAU2S
- Reference: Coffs Harbour Oncology Clinical Trials 780030-3481
When making a direct payment to the unit, please ensure the unit is notified via email, to MNCLHD-CHHC-NCCI-CTU@health.nsw.gov.au, and include the Study coordinator within this communication
If payment is by cheque, please make payment to:
- Mid North Coast Local Health District
- Clinical Trials Account 780030-3481
Post cheque to:
Clinical Trials Unit
Mid North Coast Cancer Institute
Coffs Harbour Health Campus
345 Pacific Highway
Coffs Harbour NSW 2450
Site Initiation
This needs to be scheduled with the Clinical Trial Staff.
Monitoring
To facilitate monitors from each trial being able to access the site for monitoring purposes, the following guidelines are recommended:
- Monitoring visits are restricted to 2 monitoring days per visit
- The next monitoring visit should be scheduled immediately after monitoring and made directly with the study coordinator
- The site needs to be notified if more than one monitor will be visiting
- Satisfactory notification if a meeting with the Principal Investigator and/or pharmacy is required
- The Study Coordinator will be available for resolving issues/queries at designated times during the day and this can be decided at the start of each visit
- Monitoring staff will be provided with a comprehensive orientation to the clinical trials area.