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Safety reporting

  • Safety reporting for clinical trials must follow the 2016 NHMRC Guidance: Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods

    Additional requirements for post approval monitoring at Victorian public health sites are also available from the Victorian Department of Health and Human Services website.  

    For research that is either ethically approved by the RCH HREC, or where RCH has issued governance authorisation only, the following reporting structure applies:

    Type of Report  

    Terminology defined in the below Frequently asked questions

    Reporting Requirement   
    When RCH is the reviewing HREC When RCH is an accepting site (governance only)
    All Significant Safety Issues (SSIs) that meet the definition of an urgent safety measure and occur at participating sites listed on the RCH ethics approval letter.                                                                         

    Report within 72 hours of study staff becoming aware of the SSI using the Safety Report Form via   ERM.                      

    For SSIs that occur in research participants  report within 72 hours of study staff becoming aware of the SSI using the Site Notification Form via   ERM .
    All Significant Safety Issues (SSIs) that do not meet the definition of an urgent safety measure and occur at participating sites listed on the RCH ethics approval letter. 

    Report within 15 days of study staff becoming aware of the SSI using the  Safety Report Form via   ERM .

    For SSIs that occur in research participants  report within 72 hours of study staff becoming aware of the SSI using the Site Notification Form via   ERM .                                                     
    Notification of SUSARs - suspected unexpected serious adverse reaction

     All SUSARs should be included in the Annual Safety Report  via ERM

    **Please note: SUSARs must be reported to the Victorian Managed Insurance Authority (VMIA) and Therapeutic Goods Administration (TGA).

    Report within 72 hours of study staff becoming aware of the SUSAR using the Site Notification Form via ERM .                                                     
    Notification of an amendment due to safety information Submit the notification and/or amendment via ERM as soon as possible without undue delay.                                Submit the SSA amendment via ERM once ethical approval has been received. 
    Annual Safety Report Submit the annual safety report without undue delay using the Annual Safety Report Form via ERM.                                                                     The Annual Safety report (received from the lead site & acknowledged by the reviewing HREC) can be submitted to RCH Governance on the Site Notification Form via ERM for acknowledgement or can be included within the ERM Site Progress Report.  
    Notification of a temporary halt or termination of a trial for safety reasons.  Submit the notification to RCH ethics within 15 calendar days.                            Submit the Site Notification Form via ERM within 15 calendar days. 

    Please refer to the Safety Reporting Timelines table for Investigational Medicinal Products (IMPs) and Investigational Medical Devices (IMDs). 

    Annual Safety Reports are only required for any study which involves the use of an investigational product i.e. when an investigational product is being provided to the participants as part of the study. 

    All reports for RCH ethics and governance must be  submitted via ERM and signed by the CPI or PI.  

    Guidance for MCRI Sponsored Investigator Initiated Trials

    The Clinical Research Development Office (CRDO) have guidance available for MCRI-sponsored-investigator-initiated trials with the following documents: Standard Operating Procedures for safety monitoring and reporting, Safety Report Form and Safety Assessment, Documentation and Reporting Process Maps. Information can be found here

    Frequently asked questions

    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 initial 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 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.