Post-approval management

Maintaining and reporting of adverse events and safety information in research will ensure that Royal Women’s Hospital (RWH or the Women’s) complies with the NHMRC's National Statement.

Monitoring and reporting

The Women's complies with the NHMRC Guidance: Safety monitoring and reporting in clinical trials involving therapeutic goods November 2016 (NHMRC Guidance), National Statement on Ethical Conduct in Human Research 2023  (The National Statement 2023), the Australian Therapeutic Goods Administration, and the Victorian Managed Insurance Authority, maintaining and reporting of adverse events and safety information in clinical research.

It is essential that all Principal Investigators are familiar and comply with the requirements of the Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods.

Reporting time frames

Reporting time frames are defined in the Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods (NHMRC, 2016). As some reporting timeframes are time sensitive (ie within 24 hours-72 hours) it is imperative to be familiar with the NHMRC Guidance.

Researchers should also comply with the Women's policies and procedures, as well as its guidance document for reporting adverse events including:

• The Women’s Research Policy
• The Women’s Risk Management Policy
• The Women’s Incident Management – guideline
• Guidance Document – Research Incident Reporting in VHIMS (in development)*
• The Women’s Adverse Drug Reaction Reporting – Procedure

Documents are available via PROMPT

*currently under review

Common acronyms used in safety reporting:

AE: Adverse Event

SAE: Serious Adverse Event

SSI: Significant Safety Issues

SUSAR: Suspected Unexpected Serious Adverse Reaction

USADE: Unexpected Serious Adverse Device Effect

USM: Urgent Safety Measures

Instructions for Safety reporting

Responsibilities of the Women’s Principal Investigator

Investigators should assess all site-specific safety events and act on any events as clinical care dictates. In addition, certain safety events require further reporting as outlined below.

What do I report?

Investigator reporting to the sponsor

Within 24 hours of becoming aware of any event that meets the criteria below in clinical trial participants from the Women’s site, the PI should report to the Sponsor*

*This includes where the project is Investigator-Initiated and/or the Women’s is acting as the Sponsor

• SAEs, except those that are identified in the protocol as not needing immediate reporting
• Any occurrences of congenital abnormality/birth defect arising from any pregnancy of a participant (or partner)

• USMs instigated by the site
• SSIs
• Safety critical events
• SUSARs/USADEs

Any additional information requested relating to reported deaths, must be reported in a timely manner.

Investigator reporting to the Women’s Research Office

Within 72 hours of becoming aware of the event, Principal Investigators should report the following safety information to the Research Office:

• All SSIs-including those notified by the Sponsor that have occurred at other sites
• All USMs (strongly recommend reporting within 24 hours) - including those notified by the Sponsor that have occurred at other sites
• SUSARs/USADEs arising from the Women’s clinical research participants.

Responsibilities of the Sponsor

The Sponsor* is responsible for notifying:

• All USMs within 24-72 hours to the TGA, HREC and site PIs
• fatal or life-threatening Australian SUSARs/USADEs immediately, but no later than 7 calendar days after being made aware to the TGA
• all other Australian SUSARs/USADEs within 15 days of being made aware to the TGA
• All SSIs within 15 days to the TGA, HREC and site PIs
• Annual Safety Report to HREC and site PIs
• Investigator Brochures Updates as required to HREC and PIs as required.

1. For guidance on your reporting requirement, review the "Reporting Structure" section below.
2. Download and complete the safety reports relevant to your circumstance
   • Annual Safety Report (subform in ERM)
   • Safety Report (subform in ERM)
   • Please submit the report via ERM, using the ‘Site Notification Form’ ensure to download a copy, and then follow step 3 below.
3. Email the completed report to research.governance@thewomens.org.au
   • Name the file and the subject of the email so that it includes the ERM project number, the type of document and the date it was sent
   • Acknowledgement/queries by the Office in due course

Safety reporting flowchart responsibilities* – PDF download 

*Adapted from ACTEC resources.

Reporting Structure:

For research where the Women’s has issued governance authorisation, the following reporting structure applies:

Frequently asked questions (FAQ)

What is a significant safety issue (SSI)?

A significant safety issue, also known as an SSI, is a safety issue that could adversely affect the safety of participants or materially affect the continued ethical acceptability or conduct of the trial related to the trial intervention.

What is an urgent safety measure?

An urgent safety measure is a measure that needs to be taken to eliminate an immediate hazard to a participant’s health or safety related to the trial intervention. Note: this type of significant safety issue can be instigated by either the investigator or sponsor and can be implemented before seeking approval from HREC’s or institutions.

What does an annual safety report need to include?

An annual safety report should include a:

• brief description and analysis of new and relevant findings
• brief discussion of the implications of the safety data to the trials risk-benefit ratio
• description of any measures taken or proposed to minimise risks
• brief analysis of the safety profile of the IMP and its implications for participants taking into account all available safety data and the results of relevant clinical or non-clinical studies - this applies only to IMPs that are not on the Australian Register of Therapeutic Goods.

For investigator initiated trials, the annual safety report should be completed and submitted at the same time as the annual progress report. 

For commercially sponsored trials, the executive summary of safety information produced for international regulators, such as a Development Safety Update Report (DSUR), may serve as the annual safety report sent to HRECs via ERM. A full DSUR is not required. The timing of the annual safety report may be aligned with the reporting cycles of global companies or aligned with the annual progress report sent to the HREC.

What is an adverse event (AE)?

An adverse event (AE) is any untoward medical occurrence to a participant which does not necessarily have a causal relationship with the treatment. It is expected that sponsors, or PIs when the study is investigator initiated, collect and periodically analyse AE data.

What is a suspected unexpected serious adverse reaction (SUSAR)?

A SUSAR is a SSI for which there is some degree of probability that the event is related to the study drug and the adverse reaction is unexpected. That is, the nature or severity of which is not consistent with the applicable product information. SUSARs can be defined and reported as SSIs, with the timeliness of reporting dependent on whether the event meets the definition of an urgent safety event.  

SUSARs must be reported to the Victorian Managed Insurance Authority (VMIA),  Therapeutic Goods Administration (TGA) and to the local research governance office. For commercially sponsored studies the commercial sponsor may take on this responsibility; however, for Investigator Initiated trials, SUSAR reporting is the Sponsor-Investigator/delegate's responsibility. 

When and how should I report a safety event to the TGA?

The sponsor is responsible for reporting all fatal or life-threatening unexpected adverse drug reactions to the TGA as soon as possible, but no later than 7 days. All other serious, or unexpected adverse drug reactions should be reported no later than 15 days. 

Additional information on safety reporting can be found via the  TGA Clinical Trials webpage.