The UNSW Sponsor’s Delegate, as specified in the UNSW delegations register, which designates the Director RECS, is responsible for the sponsor’s responsibilities as set out in the Good Clinical Practice Guideline where UNSW is nominated as the Clinical Trial Sponsor. The Director of RECS delegates the following trial responsibilities to the Coordinating Principal Investigator.
In proceeding with the research conduct of any UNSW sponsored trials, CPIs are acknowledging they bear the following responsibilities as delegated by the UNSW Sponsor’s Delegate, as specified in the UNSW delegations register, which designates the Director RECS:
· Responsibilities for the conduct and oversight of the trial are delegated to you as the Coordinating Principal Investigator. You may delegate trial-related responsibilities to the listed Principal Investigator(s) and any trial-related personnel. All trial-related duties delegated by the Coordinating Principal Investigator or Principal Investigator(s) and trial-related personnel must only be delegated to those who are qualified by experience and training. Delegated responsibilities must be retained in the UNSW Clinical Trial Delegation Log. The UNSW Sponsor’s Delegate is to be notified of the following:
· Protocol deviation reports outlined in the UNSW Research Misconduct Procedure.
· Any serious breach of Good Clinical Practice, the clinical trial protocol, the clinical trial standard operating procedures, or the human ethics approval that is likely to affect to a significant degree the safety or rights of participants or the reliability and robustness of the data generated in the clinical trial.
· Significant safety issues that are likely to (or have the potential to) affect to a significant degree the safety or rights of participants or the reliability and robustness of the data generated in the clinical trial.
· Urgent safety measures implemented to remove or prevent a significant safety issue.
· Safety reports relating to the continuation, suspension, or discontinuation of the clinical trial for safety reasons.
· Non-compliance with the protocol, SOPs, GCP, and applicable regulatory requirement(s) significantly affects or has the potential to affect human subject protection or reliability of trial results significantly.
· Participant complaints or concerns received concerning the conduct of the research.
· Significant modifications to the clinical trial that is likely to affect to a significant degree the safety or rights of participants or the reliability and robustness of the data generated in the clinical trial.
· Addition of participating trial sites, contractual arrangements at participating sites, or modifications to legal agreements.
· The intention to conduct the trial in other countries.
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.