Externally sponsored clinical trials, commercial and non-commercial, conducted at NSW public health organisations must be governed by a Clinical Trial Research Agreement (CTRA) or a Clinical Investigation Research Agreement (CIRA).

The CTRA and CIRA establishes the terms and conditions for the conduct of the clinical trial between the Sponsor and the NSW public health service organisations who are parties to the agreements. Two sets of agreements are approved for use by NSW Health:

• Medicines Australia Clinical Trial Research Agreements
  • Standard Medicines Australia Clinical Trial Research Agreement for Commercially Sponsored Trials (Commercially Sponsored CTRA)
  • Standard Medicines Australia Clinical Trial Research Agreement for Contract Research Organisations acting as the Local Sponsor (CRO Sponsored CTRA)
  • Standard Collaborative or Cooperative Research Groups Clinical Trial Research Agreement (CRG Sponsored CTRA)
  • Phase IV Clinical Trial Clinical Trial Research Agreement for Medicines.
• Medical Technology Association of Australia Clinical Investigation Research Agreement

The South Eastern Border States (SEBS) Review Panel has established, as far as possible, standardised CTRA and CIRA terms and conditions for medicines and devices. The SEBS Review Panel considers amendments and variations to the standard CTRA and CIRA for multi-site studies only, they do not consider sponsor specific clauses for single-site studies. Amendments to CTRA or CIRA clauses for single site studies should be referred by the site for legal review. Please discuss this with your research office. 

Who Can Help

• Calvary Mater Newcastle Research Office
• Central Coast Local Health District Research Office
• Hunter New England Local Health District Research Office
• Mid North Coast Research and Knowledge Translation Unit