The Sponsor-Investigator is responsible for reporting to various stakeholders throughout the conduct of the trial.
For multi-centre trials, the reporting responsibilities of the Sponsor-Investigator, Coordinating Principal Investigator (CPI), and Site Principal Investigators to the approving Human Research Ethics Committee (HREC) and Research Governance Office are provided in a Monitoring and Reporting Matrix. Sponsor-Investigator reporting responsibilities are the same as those listed for Sponsor in the matrix. This matrix outlines the reporting requirements and process for the Australian States and Territories participating in the National Mutual Acceptance (NMA) scheme.
Post approval reports to the approving HREC include:
See Safety Reporting for further information, including reporting timeframes, about safety events or updates, including SSIs, USMs, updates to IB and the annual safety report.
Download the report to HREC and RGO post approval workflow.
If the trial has a DSMB, there will be a Charter that outlines reporting responsibilities of the DSMB, Sponsor-Investigator and trial teams, including:
For further information about DSMBs, see Safety Monitoring.
If the trial is conducted under a Clinical Trial Notification (CTN) or Clinical Trial Exemption (CTX), the Sponsor-Investigator is responsible for reporting the following events to the TGA:
For further information about reporting safety events to the TGA, see Safety Reporting.
Once a participant has enrolled on a trial, the Sponsor-Investigator is responsible for keeping them informed of substantial changes to:
This may require the Site Principal Investigator or their delegate to reconsent participants. In this situation, the Sponsor-Investigator should clarify who needs to be reconsented and update the protocol and any formalised informed consent procedure, eg trial-specific informed consent SOP.