Research Governance Office and Contract Information

Research Governance Officer:

Maureen Lawrence

Mobile 0428 882 170

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

Coffs Harbour

  • Institution: Mid North Coast Local Health District trading as Coffs Harbour Health Campus
  • Name: (Principal Investigator)
  • Address: Mid North Coast Cancer Institute, 345 Pacific Highway, Coffs Harbour, NSW 2450
  • ABN: 57 946 356 658
  • Contact for notices: The Study Coordinator assigned to the clinical trial
  • Fax for notices: +61  (0)2 6656 5128
  • Phone for notices: as per Study Coordinator’s contact details.

Port Macquarie

  • Institution: Mid North Coast Local Health District trading as Port Macquarie Base Hospital
  • Name: (Principal Investigator)
  • Address: Mid North Coast Cancer Institute, Port Macquarie Base Hospital, Wrights Road, Port Macquarie NSW 2444
  • ABN: 57 946 356 658
  • Contact for notices: The Study Coordinator assigned to the clinical trial 
  • Fax for notices: +61 (0)2 6580 1760
  • Phone for notices: as per the 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:  Medicines Australia.

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 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

Coffs Harbour

Coffs Harbour Health Campus – Mid North Coast Cancer Institute, 345 Pacific Highway, Coffs Harbour NSW 2450

Port Macquarie

Port Macquarie Base Hospital – Mid North Coast Cancer Institute, 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.

Clinical Trial Payments (exc. RGO fees)

All requests for invoices to be emailed to the Study Coordinator with appropriate details as attachments.

Electronic Funds Transfer is 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 Clinical Trials Account 784036.

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

Additional Information:

A separate Pharmacy Contract is to be used, please contact the Study Coordinator for further details.