The NHMRC publication Reporting of serious breaches of Good Clinical Practice (GCP) or the protocol for trials involving therapeutic goods (2018) sets out the requirements for reporting serious breaches that occur in clinical trials.
A serious breach is likely to significantly affect:
- the safety of a participant
- the rights of a participant
- the reliability and robustness of the data
Serious breaches are reportable to the Alfred Hospital Ethics Committee within 7 calendar days if the Committee has ethical oversight of the research.
The Ethics Committee
- will review the impact on ongoing ethical acceptability of the research
- will review the management of the breach
- may provide ethical advice
- will assess the corrective and preventative action outlined in the report
Serious breaches that occur at an Alfred Health site are reportable to Alfred Health within 72 hours.
To report to the Alfred Hospital Ethics Committee or to Alfred Health, the serious breach report form should be completed and emailed to email@example.com.
If any changes to the project/protocol are required, an amendment should be submitted to the reviewing Ethics Committee.
In the event that a serious breach has occurred and the sponsor of the research does not agree or is unwilling to report the breach to the Ethics Committee, a suspected breach report form can be completed.
If the Alfred Hospital Ethics Committee has ethical oversight of the research, the form should be emailed to firstname.lastname@example.org.
In the event a non-serious breach at an Alfred Health site needs to be reported to Alfred Health, the non-serious breach report can be completed.
This should be emailed to email@example.com.