Research Governance Office and Contract Information

In addition to ethical approval, Research Governance or Site Specific Assessment (SSA) authorisation is required prior to commencing research within a NSW Health Public Health Facility. Information regarding Research Governance in NNSW LHD can be obtained from:

Contact Details:

Northern NSW Research Governance Officer:
02 6672 0269
 

Clinical Trial Research Agreement Information:

Site Details
  • Institution: Northern NSW Local Health District
  • Name: (Principal Investigator)
  • Address: Lismore Base Hospital, 70 – 72 Hunter Street, Lismore NSW 2480
  • ABN: 67 284 856 520
  • Contact for notices: Research Governance Office, 60 Uralba Street, Lismore NSW 2480
  • Fax for notices: +61 (0) 2 6672 0299
  • Phone for notices: +61 (0) 2 6672 0269

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 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

Lismore Base Hospital utilises an external pharmacy provider located at St. Vincents Hospital, Lismore. Therefore, two site detail (page 5) and approving authority (page 9) pages are required:

Site Details

North Coast Cancer Institute
Lismore Base Hospital
70 – 72 Hunter Street
Lismore NSW 2480

APHS Pharmacy Lismore (Cathie Reid Pty Ltd)
Suite 1, Level 1
K.G. Lawrence Building
20 Dalley Street
Lismore NSW 2480

Approving Authority Details:

Northern NSW Local Health District
60 Uralba Street
Lismore NSW 2480

APHS Pharmacy Lismore (Cathie Reid Pty Ltd)
Suite 1, Level 1
K.G. Lawnrence Building
20 Dalley Street
Lismore NSW 2480

 

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.
  • Indemnity must be provided for APHS Pharmacy for sponsored studies
 

Clinical Trial Payments (exc. RGO fees)

All requests for invoices to be emailed to the Research Nurse looking after the study with appropriate details as attachments.

Payment by electronic transfer is preferred. Bank details can be obtained from the Clinical Trials’ site staff.

 

 

Additional Information:

A separate pharmacy contract and budget is preferred.