Cabrini Institute - Human Research Ethics - Serious Adverse Events
All deaths that occur on this trial (anywhere) and incidents which occur within the Cabrini study population must be reported.
The form for reporting serious adverse events forms attachment 9. Please complete the form and supply an original cover sheet and full report. If there are no deaths or events relating to your patient population then please supply an additional six cover sheets. Should any events include a death or a member of your patient population we require six copies of the full report of these events (one copy attached to each cover sheet copy).
The matter of overseas serious adverse event reporting for phases 3 and 4 trials was considered at the Cabrini Human Research Ethics Committee Executive meeting on 30 May 2005.
The TGA’s “Note for Guidance on Clinical Safety Data Management: Definitions and Standards for Expedited Reporting. (CPMP/ICH/377/95) Annotated with TGA comments” was reviewed. Particular note was taken of the TGA comment on page 7: TGA does not require sponsors to submit individual overseas reports of suspected adverse drug reactions. The TGA expects sponsors to continually monitor the safety of its clinical development program and advise the TGA within 72 hours of any significant issue that has arisen from its analysis of overseas reports or action which has been taken by another country’s regulatory agency and also the TGA comment on page 11: Sponsors should inform any Australian investigator(s) and, through the investigator, the HREC(s) of any information that may be new and have an impact on the continued ethical acceptability of the trial, or that may indicate the need for amendments to the trial procotol, including altered monitoring of safety.
Having considered this guidance, the CHREC Executive decided that, as long as the sponsors continually update the investigator with ongoing safety reports for the product under study, the investigator need only report to the CHREC should any information derived from the safety reports have an impact on the continued ethical acceptability of the trial, or that may indicate the need for amendments to the trial procotol, including altered monitoring of safety.
Pharmaceutical studies of phases earlier than three are typically studies where less is known about the safety and efficacy of the compound/study drug/device being trialled. This being the case, it is our current interpretation of the NHMRC National Statement and the ICH Guidelines for Good Clinical Practice that all serious adverse events (for studies in phases earlier than three) be reported to and reviewed by the Cabrini Human Research Ethics Committee or its Executive.
