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Reporting safety issues and study breaches

Learn about your responsibilities in monitoring health and safety issues and reporting study breaches during clinical trials.
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Overview

At the Office for Research, the safety and wellbeing of all our clinical trial and clinical research participants is our highest priority. Rigorous safety monitoring and reporting is essential to ensure that all research conducted at a Western Health site meets the highest ethical and clinical standards and complies with clinical research guidelines.

 

Safety reporting 

It is essential that all Principal Investigators are familiar with and comply with the requirements of the Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods (NHMRC, 2016).  

Responsibilities of the Principal Investigator  

Principal Investigators (PIs) are responsible for reviewing all safety events that occur at their trial site and responding to them as needed. Their role in safety reporting is to ensure that the sponsor receives all relevant details so that a thorough and accurate safety assessment can be carried out.  

The Principal Investigator must:    
  1. Track and report all adverse events.
  • Keep a record of any side effects (adverse events) that happen to participants. 
  • Share this information with the sponsor as the trial protocol (plan) requires. 
  1. Report any pregnancies.
  • If a participant becomes pregnant during the trial, tell the sponsor. 
  • Follow up on the pregnancy until there is an outcome (e.g. birth or miscarriage). 
  1. Report any serious issues within 24 hours.

You must inform the sponsor if you become aware of:  

  • any Serious Adverse Events (SAEs) or Serious Adverse Device Effects (SADEs), unless the trial plan says they don’t need urgent reporting 
  • any birth defects or congenital issues from a participant’s pregnancy (or their partner’s) 
  • any Urgent Safety Measures (USM) you had to take at your site to protect participants. 
  1. Report other safety information as required.

Let the sponsor know about:  

  • all serious safety-related events listed in the protocol 
  • any extra details the sponsor asks for about participant deaths. 
  1. Notify Western Health within 72 hours.  

You must inform your institution (e.g. hospital or research centre) if:  

  • there’s a Significant Safety Issue (SSI) 
  • a Suspected Unexpected Serious Adverse Reaction (SUSAR) or Unanticipated Serious Adverse Device Effect (USADE) happens at your site.  
Important: For participants at any Western Health site  

These issues and events must be reported within 72 hours to the Office for Research at [email protected] and the reviewing HREC.  

 

What to report  

Investigators should report the following safety information only for participants at Western Health sites to the Western Health Office for Research:  

  • All SSIs and SUSARs/USADEs details to be reported within 72 hours to [email protected] & the Reviewing HREC.  

  

How to submit safety reports  

  1. Complete and submit the Safety Report Sub-Form to the reviewing HREC on the Ethics Review Manager (ERM) system. 
  • The Safety Report is found under Sub-Forms in the HREA section.  
  • If you don’t have access to the HREA form for your project, contact the applicant listed under the HREA and ask for access. 
  1. Submit a copy of the Safety Report to Western Health’s Research Governance Officer ([email protected]) and to the reviewing HREC.  

  • Make sure you name your files and email subject lines using the following format:  

    [Project Number] [Document Type] [Date Sent] 

    Example: 41234 Safety Report Form 14Nov20.  

  • Refer to our electronic naming convention guidelines.  
  1. The Office for Research will send you an email with acknowledgement or any queries once they’ve reviewed your submission.  

 

Study breaches 

In Victoria, all reporting to the reviewing Human Research Ethics Committee (HREC) must follow the NHMRC Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods (2018).  

Under this guidance, it is the sponsor’s responsibility to report serious breaches to the HREC. The sponsor may be an institution, investigator, collaborative group or commercial company.  

 

  1. Serious Breach Report Form (Sponsor)  

A serious breach is any breach of GCP or the trial protocol that: 

  • significantly affects participant safety or rights
  • compromises the reliability of the trial data. 

Important: 

  • All serious breaches must be reported to the reviewing HREC.
  • The sponsor must complete this form when:
    • notifying the HREC of a serious breach
    • providing follow-up information about a confirmed breach.
  • PIs must also report any serious breaches at their site to their Research Governance Officer (RGO) using this same form. 

 

  1. Suspected Breach Report Form (Third Party)  

A suspected breach is a potential serious breach that has not yet been confirmed by the sponsor.  

Important: 

  • This form is used by a third party (e.g. an individual or institution) to report a suspected breach directly to the HREC.
  • The report does not need to go through the sponsor.
  • It should be submitted as soon as there is reasonable concern that a serious breach may have occurred. 

 

  1. Non-Serious Breach / Protocol Deviation Report 

A protocol deviation is a minor departure from GCP or the trial protocol that does not significantly impact participant safety or data reliability. 

Important: 

  • All deviations must be reported to the sponsor to meet GCP requirements.
  • Only some deviations require reporting to the HREC – this depends on local site policy.
  • A copy of the completed deviation report should also be sent to the site’s RGO.
  • The sponsor should complete this form in collaboration with the PI. 


How to submit a Serious or Suspected Breach Report 

  1. Complete and submit the Breach Report Sub-Form (Serious Breach or Suspected Breach Report) in ERM.
  • Note: These sub-forms are found under the HREA Form. If you don’t have access to the HREA Form, contact the applicant listed in ERM and request access. 

2. Download and submit a PDF copy to Western Health’s RGO via email: [email protected].  

  • Provide a copy of the HREC acknowledgment if available.
  1. Name the file and the email subject line so that it includes the project number, the type of document and the date it was sent, e.g. 41234 Serious Breach Report Form (Sponsor) 14Nov20.
  1. The Office for Research will acknowledge receipt or contact you with any queries via email.  

 

How to submit a Non-Serious Breach/Deviation Report 

  1. Create the Deviation Report in ERM.
  • Go to your project and select the “Site Specific Assessment (SSA) Vic – Western Health" form.
  • Click “Create Sub-Form” on the left-hand Actions menu.
  • Select “Non-Serious Breach/Deviation Report VIC” and complete the form.
  • Submit it via ERM.
  1. Notify the RGO.
  • After submission, email [email protected] to let the RGO know.
  • Include the HREC/ERM Reference Number in your email.
  1. Use the correct naming format.
  1. You’ll receive an acknowledgement or follow-up email from the Office for Research.  

 

Related resources   

Related

ERM Post Authorisation Submission Process Map
NHMRC Guidance: Safety monitoring and reporting in clinical trials involving therapeautic goods November 2016
DHHS Monitoring & Reporting Website
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