Confirming UNSW Sponsor Related Responsibilities for a Clinical Trial

The trial sponsor is the company, institution, or organisation responsible for initiating, managing, or financing a clinical trial.  The definitions of grant/funding sponsor and the clinical trial sponsor differ. 

  • Grant Funding Sponsor Definition: The Grant/Funding Sponsor is the institution responsible for the administration of and governance for research funding.  
  • Clinical Trial Sponsor Definition: A Clinical Trial Sponsor is responsible for the initiation, management and oversight of the clinical trial following the requirements of ICH Good Clinical Practice.

UNSWs role as the Grant/Funding Sponsor does not confirm Clinical Trial responsibilities. The process outlined on this page must be followed for all clinical trials where UNSW will be the trial sponsor.

Criteria for Confirming Sponsor Responsibilities
  • A UNSW employee or an academic with a current appointment initiates the clinical trial and is the principal coordinating investigator. 

  • The clinical trial protocol has been developed using one of the UNSW protocol templates. When UNSW is the local in-country sponsor for international trials, the protocol must comply with Good Clinical Practice and include the following sections of information in the UNSW template. In addition, the delegation of trial duties, safety monitoring, non-compliance, protocol deviation and serious breaches of good clinical practice, data ownership, the clinical trial delegation log, corrective and preventative action form are included or attached as appendices.  If this information is not included within the main body of the protocol and instead within separate documents, ensure it is referenced appropriately within the protocol and added as an appendix for reference. 

  • HREC approval will be established before recruitment and data collection commences.  

  • The trial will be registered on a Clinical Trial on Publicly Accessible Registry before the recruitment of the first trial participant.  

  • UNSW administers funding for the trial via the UNSW research grants and contracts team. 

  • UNSW insurance has confirmed that clinical trial insurance covers the trial. 

  • UNSW will retain the research or trial's financial, academic, and reputational benefits (either wholly or partially). 

  • All data will be stored following the Research Data Governance & Materials Handling Policy

  • Original research data and primary materials generated in the research conducted at the University will be owned and retained by the University subject to any contractual, statutory, ethical, or funding body requirements.  

Submission Instructions
Submission closing dates
  • Closing dates do not apply to this process. Submissions to request confirmation of sponsor responsibilities can be sent as required.
Timeframe for review
  • Researchers should allow up to 5 working days to receive outcomes. 
Kirby Institute Sponsor Related Responsibilities

Researchers from the Kirby Institute are not required to confirm sponsor responsibilities following the RECS process. However, it is a requirement that the certain steps are completed which is outlined on the following Kirby Institute Sponsor Responsibilities Submission Requirements webpage.