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:
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.