Adverse Reportable Events

Adverse or Reportable Events

Any adverse effects on research participants or reportable events must be reported to the Human Research Ethics Office in line with the NHMRC requirements (humanethics@unisa.edu.au) using the Adverse or Reportable Event Form.

In the case of SSIs, the following applies. For further information, please review the NHMRC Guidance of safety monitoring and reporting at

https://www.nhmrc.gov.au/sites/default/files/images/NHMRC-guidance-safety-monitoring-and-reporting.pdf

Sponsor Reporting of Significant Safety Issues

Action	What is communicated	Recipients	Timelines and further review
a. Urgent safety measure (USMs)¹	Reasons for the urgent safety measure Measures taken Further actions planned	Notify the TGA, investigators and the HREC	Without undue delay and no later than 72 hours of the measure being taken. The HREC is not required to approve USMs but may consider whether any proposed actions are appropriate, such as the submission of an amendment relating to revised trial documentation.
b. Notification of an amendment	Details of the significant safety issue Further actions planned	Notify the TGA², investigators and the HREC	Without undue delay and no later than 15 calendar days of the sponsor becoming aware of the issue. Sponsors should submit to the HREC an amendment relating to any revised trial documentation, without undue delay.
c. Temporary halt of a trial for safety reasons³	Reasons for the halt The scope of the halt (e.g. suspension of recruitment or cessation/interruption of trial treatment) Measures taken Further actions planned	Notify the TGA, investigators and the HREC	Without undue delay and no later than 15 calendar days of the sponsor’s decision to halt the trial. Where it is necessary to seek ethical review of related actions (e.g. informing participants or arranging continuing care and follow-up), a letter describing these actions should be submitted to the HREC within 15 calendar days of the temporary halt

Action

What is communicated

Recipients

Timelines and further review

a. Urgent safety measure (USMs)¹

Reasons for the urgent safety measure

Measures taken

Further actions planned

Notify the TGA, investigators and the HREC

Without undue delay and no later than 72 hours of the measure being taken.

The HREC is not required to approve USMs but may consider whether any proposed actions are appropriate, such as the submission of an amendment relating to revised trial documentation.

b. Notification of an amendment

Details of the significant safety issue

Further actions planned

Notify the TGA², investigators and the HREC

Without undue delay and no later than 15 calendar days of the sponsor becoming aware of the issue.

Sponsors should submit to the HREC an amendment relating to any revised trial documentation, without undue delay.

c. Temporary halt of a trial for safety reasons³

Reasons for the halt

The scope of the halt (e.g. suspension of recruitment or cessation/interruption of trial treatment)

Measures taken

Further actions planned

Notify the TGA, investigators and the HREC

Without undue delay and no later than 15 calendar days of the sponsor’s decision to halt the trial.

Where it is necessary to seek ethical review of related actions (e.g. informing participants or arranging continuing care and follow-up), a letter describing these actions should be submitted to the HREC within 15 calendar days of the temporary halt

¹ Temporary halts/early terminations implemented as urgent safety measures (USM) should be notified within USM timeframes.
² The TGA should receive notification that a SSI has occurred but the amendment revising trial documentation does not require submission to
the TGA.
³ Both the TGA and the HREC should be notified if the trial restarts, including evidence that it is safe to restart.