Researchers from the Kirby Institute are not required to confirm sponsor responsibilities following the RECS process. However, it is a requirement that the following steps are completed:
The protocol must comply with Good Clinical Practice, and the information from the following sections must be included in any clinical trial protocol UNSW is responsible for as trial sponsor. 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.
- Delegation of Trial Duties
- Safety Monitoring
- Non-compliance, Protocol Deviation and Serious Breaches of Good Clinical Practice
- Data Ownership
- Clinical Trial Delegation and Responsibilities Log
- Corrective and Preventive Action Form
Clinical Trial Research Agreements must be established for all participating trial sites that UNSW will be responsible for as a sponsor. In addition, the Clinical Trial Research Agreements Request for the Signature process must be followed.
Both as an international ‘site’ and international ‘SCC’ UNSW template have been approved for use by UNSW legal where Kirby is the designated sponsor of a clinical trial. A template will require a further UNSW legal review should the international site or SCC legal team request adjustment to the approved template wording.
There may be other acceptable contracts/agreements utilised across study designs which will require UNSW legal review prior to being submit to site or SCC for their review.
Clinical Trial Insurance cover must be confirmed with UNSW Insurance. It is requested that the research team complete the Clinical Trials Insurance Spreadsheet and submit it along with the clinical trial protocol to financehelp@unsw.edu.au.
Human Research Ethics Approval must be established for all clinical trials. If a non-UNSW HREC is used to establish HREC approval, the external ethics approval process must be completed.
Trials conducted in Australia utilising an unapproved therapeutic good or an approved therapeutic good outside of the approved indications or unapproved purpose that UNSW is responsible for as sponsor must be notified through the UNSW Therapeutic Goods Administration (TGA) Clinical Trial Notification (CTN) submission portal. Instructions for submission can be found on the UNSW TGA submission portal webpage.
The Coordinating Principal Investigator must register the clinical trial on a publicly accessible register complying with international standards before the recruitment of the first participant. Below are the recommended platforms to register clinical trials.
The therapeutic goods legislation requires that the use of investigational therapeutic medical products or devices be conducted following the requirements of Good Clinical Practice. Therefore, all research personnel participating in clinical trials that UNSW is responsible for as sponsors must have current Good Clinical Practice Training. In addition, personnel are required to update their Good Clinical Practice Training once every three years. RECS delivers good Clinical Practice Training. Requests for training can be sent to clinicaltrials@unsw.edu.au.