Cancer Clinical Trials – Mid North Coast Cancer Institute Port Macquarie

Welcome to the Clinical Research Unit at the MNCCI. Our aim is to provide patients with the latest treatment in Medical Oncology, Radiation Oncology and Haematology while focusing on quality management of clinical trials in a cost efficient environment.

The Clinical Research Unit is a centre of excellence located on the Mid North Coast of NSW at Port Macquarie Base Hospital – an Academic Teaching facility with an exceptional reputation in conducting clinical trials with both pharmaceutical and university based research groups.

We offer a dedicated team of experienced investigators and senior study coordinators proficient in the conduct of single or multicentre clinical trials. We have a vast experience with lead site responsibilities in short time frames.

Our patient recruitment strategy: patients are seen in the Public Hospital Clinic and Private Rooms. Patients are referred from local GPs, other specialists and Multi-Disciplinary Team meetings.

Medical Oncology Investigator details

Dr. Stephen Begbie – Medical Oncologist

Director Clinical Cancer Research Northern NSW & Mid North Coast LHD
Mid North Coast Cancer Institute
Port Macquarie Base Hospital
Wrights Road
Port Macquarie NSW 2444

Phone 02 6581 4053
Fax 02 6580 1775

Stephen.Begbie@ncahs.health.nsw.gov.au

  • Trials Experience: since 1996
  • Institution: Mid North Coast Cancer Institute, Port Macquarie
  • Specialty Area/Board Certification: Medical Oncology, FRACP
  • Medical Oncology Co-Investigators: Medical Registrars / Advanced Trainees as appropriate

Dr. Baerin Houghton – Medical Oncologist

Mid North Coast Cancer Institute
Port Macquarie Base Hospital
Wrights Road
Port Macquarie NSW 2444

Phone 02 6584 9805
Fax 02 6580 1775

bh@htss.com.au

  • Trials Experience: since 2010
  • Institution: Mid North Coast Cancer Institute, Port Macquarie
  • Specialty Area/Board Certification: Medical Oncology, FRACP, Respiratory and Sleep Medicine, FRACP
  • Medical Oncology Co-Investigators: Medical Registrars / Advanced Trainees as appropriate
Radiation Oncology Investigator Details

Dr. Jacques Hill – Staff Specialist Radiation Oncologist

Mid North Coast Cancer Institute
Port Macquarie Base Hospital
Wrights Road
Port Macquarie NSW 2444

Phone 02 6580 1824
Fax 02 6580 1760

Jacques.Hill@ncahs.health.nsw.gov.au

  • Trials Experience: since 2005
  • Institution: Mid North Coast Cancer Institute, Port Macquarie
  • Specialty Area/Board Certification: Radiation Oncology, FRANZCR
  • Radiation Oncology Co-Investigators: Associate Professor Tom Shakespeare, Medical Registrars / Advanced Trainees as appropriate

Assoc. Professor Andrew Last – Staff Specialist Radiation Oncologist

Mid North Coast Cancer Institute
Port Macquarie Base Hospital
Wrights Road
Port Macquarie NSW 2444

Phone 02 6580 1823
Fax 02 6580 1760

Andrew.Last@ncahs.health.nsw.gov.au

  • Trials Experience: since 1995
  • Institution: Mid North Coast Cancer Institute, Port Macquarie
  • Specialty Area/Board Certification: Radiation Oncology, FRCR, MRCP (UK)
  • Radiation Oncology Co-Investigators: Associate Professor Tom Shakespeare, Medical Registrars / Advanced Trainees as appropriate

Dr. Carmen Hansen – Staff Specialist Radiation Oncologist

Mid North Coast Cancer Institute
Port Macquarie Base Hospital
Wrights Road
Port Macquarie NSW 2444

Phone 02 6580 1868
Fax 02 6580 1760

Carmen.Hansen@ncahs.health.nsw.gov.au

  • Trials Experience: since 2008; Clinical Research Fellowship at Peter McCallum
  • Institution: Mid North Coast Cancer Institute, Port Macquarie
  • Specialty Area/Board Certification: Radiation Oncology, MBBS (Qld), FRANZCR
  • Radiation Oncology Co-Investigators: Associate Professor Tom Shakespeare, Medical Registrars / Advanced Trainees as appropriate
Oncology Clinical Trial Unit details and experience

The Port Macquarie Oncology Clinical Trial Unit has experienced Senior Clinical Trial Coordinators (Clinical Nurse Specialists) dedicated to clinical research. The unit also has an experienced Ethics/Research Governance and Finance administrator.

Global contact details for the unit (preferred option):

Phone: +61 (0) 2 5524 2077 or  +61 (0) 439 345 715

Fax: +61 (0) 2 6580 1760

Email:

Individual contact details:

Name Phone Name Phone
Kiran Buckley +61 (0) 2 6580 1820 Suzzanna Fettell +61 (0) 2 6580 1822
Cheryl Rine +61 (0) 2 6580 1818 Kylie Newton +61 (0) 2 6580 1833
Victoria Miller +61 (0) 2 6580 1831  Nicole Allen +61 (0) 2 6580 1822

Mirella Baker – Clinical Trials Administrator +61 (0) 2 6580 1819

Site Training, Equipment and Experience

Standard Operating Procedures

A standard set of operating procedures has been developed for the MNC LHD Oncology Trial Unit. These may be obtained from the unit.

GCP

All 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 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 experience with Ethics Submissions as a lead site for large and small site numbers and experience with cognition testing, mini-mentals, (MMSE) central ECG transferral, quality of life site pad (for on line QOL recording).

Clinical Trial experience with the following disease types:

  • Bladder
  • Brain
  • Breast
  • Colorectal
  • Gastric
  • Head and Neck
  • Lung
  • Melanoma
  • Ovarian / Gynaecological
  • Prostate
  • Renal

ECGs

Staff have access to and experience with performing ECGs

Electronic CRFs

  • Inform
  • RAVE
  • Medidata
  • Oracle
  • ClinPhone
  • Vista
  • OpenClinica

IXRS

All staff have experience with IVRS & IWRS

Audits

MNCCI @ Port Macquarie has not been audited by any regulatory bodies, however have undergone sponsor audits with favourable results.

Mosaiq TM

MNCCI @ Port Macquarie 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 -70oC freezers
  • ECG machine
  • Spirometer

Archiving

Off-site archiving is preferred and organised by the sponsor; however the unit can supply the sponsor with a quotation if required.

Ethics and Research Governance

Human Research Ethics Committee

MNCCI @ Port Macquarie utilises the services of St Vincent’s Hospital (Sydney) HREC or Hunter New England HREC for the review of sponsored clinical trials. All required information can be obtained from their websites.

St Vincent’s Hospital HREC (Sydney)

Hunter New England HREC

Research Governance Office:

Fees:

Site Specific Assessment approval fees are governed as per the NSW Health Policy PD2008_030.

In summary, fees are charged as follows:

  • Full Industry sponsorship: $3,740
  • Collaborative sponsorship: NIL
  • Amendments and addition of sub-studies: NIL

Clinical Trial Research Agreement Information:

Site Details
  • Institution: Mid North Coast Local Health District trading as Port Macquarie Base Hospital
  • Name: (Principal Investigator)
  • Address: Mid North Coast Cancer Institute, Wrights Road, Port Macquarie NSW 2444
  • ABN: 57 946 356 658
  • Contact for notices: The Study Coordinator looking after the trial.
  • Fax for notices: +61 (0) 2 6580 1775
  • Phone for notices: as per Study Coordinator’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 Coorperative 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 preferred that the CRTA be signed by the sponsor prior to site approval and signature. If this is not possible then the CRTA should be submitted early in the process so that it may be reviewed, signed and returned to the sponsor for signing in time for submission 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 Port Macquarie Base Hospital – Wrights Road, Port Macquarie NSW 2444

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<Trial Unit

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

Ensure that it is to the attention of PORT MACQUARIE Clinical Trials Account 722216-3401

Please ensure that the unit is notified via email when a payment has been made so that accounts can be reconciled.

When making a direct payment, as well as notifying the Study coordinator.

If payment is by cheque, please make payment to:

  • Mid North Coast Local Health District
  • Clinical Trials Accounts 722216 -3401

Post cheque to:

Cancer Clinical Research Unit – MNCCI, Port Macquarie
Port Macquarie Base Hospital
Wrights Road,
Port Macquarie NSW 2444

Additional Information:

A separate Pharmacy Contract is to be used, please contact the study coordinator for further details