Trial Progress Reporting

The Sponsor-Investigator is responsible for reporting to various stakeholders throughout the conduct of the trial. 

Reporting to the approving HREC and site RGO

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: 

• Amendments, protocol, Participant Information and Consent Form, Investigator’s Brochure (IB) 
• Annual safety report
• Complaints -Research conduct 
• Complaints – HREC or RGO decision
• HREC annual report
• HREC final report
• Serious breach
• Suspected breach
• Significant Safety Issue (SSI)
• Urgent Safety Measure (USM)
• Site closure
• Site progress report (ACT, NSW, QLD)

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.

Reporting to the Data Safety Monitoring Board (DSMB)

If the trial has a DSMB, there will be a Charter that outlines reporting responsibilities of the DSMB, Sponsor-Investigator and trial teams, including:

• Frequency of DSMB meetings (usually annually or biannually)
• DSMB membership
• DSMB reports to the Sponsor-Investigator, Trial Steering Committee, or site Principal Investigators
• Trial statistician interim report(s) to the DSMB

For further information about DSMBs, see Safety Monitoring. 

Reporting to the Therapeutic Goods Administration

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:

• Suspected unexpected serious adverse reactions (SUSARs)
• Unanticipated serious adverse device effects (USADEs) 
• Significant safety issues (SSIs) 
• Urgent safety measures (USMs) 
• Temporary halt or early termination of the trial for safety reasons

For further information about reporting safety events to the TGA, see Safety Reporting.

Reporting to participants

Once a participant has enrolled on a trial, the Sponsor-Investigator is responsible for keeping them informed of substantial changes to:

• Trial design
• Investigational product
• Risks associated with participation

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.