Safety monitoring & reporting
The NHMRC publication Safety monitoring and reporting in clinical trials involving therapeutic goods (2016) sets out the requirements for the monitoring, collection and reporting of adverse events and adverse reactions that occur in clinical trials.
The NHMRC publication sets out definitions of:
- serious adverse events (SAEs)
- serious adverse reactions (SARs)
- suspected unexpected serious adverse reactions (SUSARs)
- unanticipated serious adverse device effects (USADEs)
- significant safety issues (SSIs)
- urgent safety measures (USMs)
Reporting SAEs, SARs, SUSARs and USADEs
The Alfred Hospital Ethics Committee does not require SAEs, SARs, SUSARs or USADEs to be reported to it.
Alfred Health (as an institution) requires its site principal investigators (or their delegatre) to report all RELATED SAEs/ SARs/ SUSARs/ USADEs occuring to Alfred Health participants.
SAEs/ SARs related to the drug, device, intervention or research procedure are required for medico-legal risk, contractual obligations, ongoing assessment of innovations and clinical governance matters.
The Alfred Health SAE form must be completed and emailed to firstname.lastname@example.org within 72 hours of becoming aware of the event.
The Office of Ethics and Research Governance will forward reports to Alfred Health's Legal Counsel, Innovations Committee, Clinical Governance and VMIA, as applicable.
For investigator-initiated projects, safety reports related to drugs or devices are to be reported to the Therapeutic Goods Administration (TGA).
Reporting Significant Safety Issues (SSIs) and Urgent Safety Measures (USMs)
All SSIs are to be notified to email@example.com using the safety report form.
SSIs may require USMs and these can be implemented by the Site Principal Investigator prior to reporting to the Office of Ethics and Research Governance and prior to ethics review.
SSIs should be notified to Alfred Health within 72 hours of becoming aware of the issue.
USMs should be notified within 72 hours to the reviewing ethics committee.
Amendments and temporary halts to the research should be notified within 15 calendar days to the reviewing ethics committee.
Follow the submit an amendment instructions if the safety measures trigger an amendment that requires review.
The annual safety report
For clinical trials involving an investigational drug or device an annual safety report must be submitted for ethics review to the reviewing Ethics Committee.
Reporting unanticipated events
For events that are not SAEs, but are unexpected, related or possibly related to the research, and suggest that the research placed/places participants or others (e.g. researchers) at a greater risk of harm (including physical, psychological, economic or social harm) than was previously recognized, email firstname.lastname@example.org. The email should be sent in a timely manner and outline the event, impact (if any) and actions taken or required.