Cancer clinical trials MNCCI Port Macquarie

Dr. Stephen Begbie – Medical Oncologist
Director Clinical Cancer Research Northern NSW and Mid North Coast LHD
Mid North Coast Cancer Institute
Port Macquarie Base Hospital
Wrights Road
Port Macquarie NSW 2444

Phone: +61 2 6581 4053
Fax: +61 2 6580 1775

Email: Stephen.Begbie@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: +61 2 6581 5522
Fax: +61 2 6580 1775

Email: 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.

Dr. Georgia Ritchie
Medical Oncologist
Mid North Coast Cancer Institute
Port Macquarie Base Hospital
Wrights Road
Port Macquarie NSW 2444

Phone +61 2 6581 4053
Fax +61 26580 1775

Email: Georgia.Ritchie@health.nsw.gov.au

• Trials Experience: since 2015.
• Institution: Mid North Coast Cancer Institute, Port Macquarie.
• Specialty Area/Board Certification: Medical Oncology
• Medical Oncology Co-Investigators: Medical registrars / advanced trainees as appropriate.

Dr. Jock Simpson
Haematologist
Mid North Coast Cancer Institute
Port Macquarie Base Hospital
Wrights Road
Port Macquarie NSW 2444

Phone: +61 2 6581 4228
Fax: +61 6580 1775

Email: MNCLHD-NCCI-CRU@health.nsw.gov.au

• Trials Experience: Since 2015.
• Institution: Mid North Coast Cancer Institute, Port Macquarie.
• Specialty Area/Board Certification: Haematology.
• Haematology Co-Investigators: Medical registrars / advanced trainees as appropriate.

Dr. Jacques Hill
Staff Specialist Radiation Oncologist
Mid North Coast Cancer Institute
Port Macquarie Base Hospital
Wrights Road
Port Macquarie NSW 2444

Phone: +61 2 6580 1824
Fax: +61 2 6580 1760

Email: Jacques.Hill@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.

Professor Andrew Last
Staff Specialist Radiation Oncologist
Mid North Coast Cancer Institute
Port Macquarie Base Hospital
Wrights Road
Port Macquarie NSW 2444

Phone +61 2 6580 1823
Fax +61 2 6580 1760

Email: Andrew.Last@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 +61 2 6580 1868
Fax +61 2 6580 1760

Email: Carmen.Hansen@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.

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 2 6580 1807 or +61 (0) 439 345 715
Fax: +61 2 6580 1775
Email: MNCLHD-NCCI-CRU@health.nsw.gov.au

Rachel McBride
Clinical Trials Nursing Unit Manager  
Phone: +61 2 6580 1861

Clinical trials coordinators 

Clinical trials administration

Phone: +61 2 6580 1819

Site training, equipment and experience

Standard operating procedures

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

Good clinical practice

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 Iinfectious 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 tumour streams:

• bladder
• brain
• breast
• colorectal / rectal
• gastric
• haematology
• head and neck
• lung
• melanoma
• ovarian / gynaecological
• prostate
• renal
• solid tumour.

ECGs

Staff have access to and experience with performing ECGs.

Electronic CRFs

• Inform.
• RAVE.
• Medidata.
• Oracle.
• ClinPhone.
• myTrials.
• Vista.
• OpenClinica.
• Redcap.

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 (Mosaiq^TM). 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.
• Height and weight scales.
• Spirometer.
• Onsite Pharmacy.

Archiving

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

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

Research Governance fees are charged as shown on this link.

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 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 co-orperative 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.
Form of Indemnity

Administrative fees

Please contact the Trials Unit

Clinical Trial Payments (exc. RGO fees)

Please contact the clinical trials unit for further details.

Additional information

A separate Pharmacy Contract is to be used.  Please contact the study coordinator for further details.