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St Vincent's Centre for Applied Medical Research

Post Approval

In Research Ethics:

  • New Submissions
  • Post Approval
  • Authorised Prescriber

On this page:

  • Amendments
  • Progress Reports
  • Safety Reporting

Amendments

Any proposed changes (amendments) to an approved project must be submitted via REGIS for HREC review prior to implementation.

Simple amendments are routinely reviewed by the HREC Executive Committee. More complex amendments are referred to the next full HREC Meeting.

Where possible, governance review of an amendment is provided concurrently with HREC review. The amendment will be referred for further governance review if there are variations to contracts, departmental involvement or other study changes which impact institutional resources or if site specific documents are required.  It is the responsibility of the Principal Investigator (PI)/Coordinating Principal Investigator (CPI) to declare any potential governance implications in the initial amendment submission. 

Progress Reports

Once research is approved, mandatory progress reports must be provided annually for both HREC and governance review. 

All Annual and Final Progress Reports to the St Vincent’s Hospital HREC must be submitted via REGIS. 

In REGIS, progress/final reports are processed through ‘Milestones’.

For projects migrated from the previous system (Online Forms), the appropriate progress/final report milestones may not have been created on REGIS. If this has occurred, please contact the Research Office by email to SVHS.Research@svha.org.au for assistance. 

Where St Vincent’s Hospital Sydney, St Vincent’s Private Hospital, the Victor Chang Cardiac Research Institute or the Mater Hospital are sites, these reports will undergo concurrent governance review and no further action will be required.

Safety Reporting

All safety reporting in relation to clinical trials must be done in accordance with the NSW Health Safety Monitoring and Reporting Policy.

It is the responsibility of the study sponsor to determine the appropriate safety reporting pathway. 

Significant Safety Issues

A Significant Safety Issue (SSI) is a safety issue that could adversely affect the safety of participants or materially impact on the continued ethical acceptability or conduct of the trial.

SSI Notification Form is to be completed and sent to the HREC via REGIS (in NSW) for all clinical trials (therapeutic goods and non-therapeutic goods). 

SSIs that have been implemented as an Urgent Safety Measure (USM) should be reported within 72 hours of the sponsor becoming aware of the issue. All other SSIs should be reported within 15 calendar days of the sponsor becoming aware of the issue.

The SSI Notification Form also should be submitted via REGIS for governance review following noting by the HREC. 

Please see the Research Governance Post Authorisation page for more information.

Local Safety Events

Local safety events include the following:

  • A Suspected Unexpected Serious Adverse Event (SUSAR) in a medicine or biological trial.
  • An Unanticipated Serious Adverse Device Event (USADE) in a medical device trial.
  • An Unanticipated Serious Adverse Device Event (USADE) in any other interventional trial. 

The above are submitted using the SUSAR-USADE-URSAE Notification Form to the Research Governance Officer via REGIS.

See our Research Governance Post Authorisation page for more information.

Serious Breaches

Previously known as protocol violations, a serious breach is defined as a breach of Good Clinical Practice or the protocol that is likely to have a significant impact on the:

  • Continued safety or rights of participants
  • Reliability of the data generated in the clinical trial.

Serious breaches must be reported to the HREC and Research Governance Office via REGIS within 7 calendar days of confirming a serious breach has occurred.

These events must be reported by the investigator to their institution, as they may have an impact on medico-legal risk, the responsible conduct of research, or adherence to contractual obligations.

Protocol Deviations 

Protocol deviations are minor administrative departures from HREC approved protocol which do not affect:

  • The scientific soundness of the research plan
  • The rights, safety, welfare of research participants

The reporting process for protocol deviations is completed by attaching a list of all protocol deviations to the progress/final report.

For all other types of study related correspondence and inquiries please email the Research Office at svhs.research@svha.org.au