HBRA e-Training Materials
DURING YOUR STUDY

Incident Reporting - Serious Adverse Event (SAE)

SAEs are untoward occurrences associated with the conduct of HBR or removal of tissues primarily for research which result in serious outcomes. SAEs have to be promptly reported to your Research Institution (RI) or Tissue Bank (TB).

HBRA defines a Serious Adverse Event (SAE) as an untoward occurrence which:

Results in or contributes to death
Is life-threatening
Requires in-patient hospitalisation or prolongation of existing hospitalisation
Results in or contributes to persistent or significant disability or incapacity
Results in or contributes to a congenital anomaly or birth defect
Results in the transmission of a communicable disease [for human tissue removal]
Results in any misidentification or mix-up of any type of tissue, gametes or embryo [for human tissue removal]

SAE Reporting Process*

Who to Report to

Your reviewing IRB
For HBR SAEs: Your RI's Principal Person in Charge (or his/her designated officers), who will assess the incident and report to MOH if the incident is related (i.e. possible causal relationship with HBR procedures) and unexpected. Reporting by the RI to MOH is required within 7 days if such SAE caused death/is life-threatening and within 15 days if otherwise.
For SAE or Untoward Occurrence (UO) associated with the removal of human tissue primarily for research: Your TB's Principal Person in Charge (or his/her designated officers), who will assess the incident and report to MOH. Reporting by the TB to MOH is required within 7 days if such SAE caused death/is life-threatening and within 15 days if otherwise.

When to Report

As soon as possible.
NUS Researchers are required to report SAEs within 1 working day

What to Report

For HBR SAEs, please refer to MOH SAE Reporting Form A2.
For SAE/UO associated with tissue-banking activities, please refer to MOH SAE Reporting Form B2.
For SAEs associated with medical devices, please refer to HSA webpage.

* Please check if your RI/TB has stipulated any specific SAE reporting procedures. For NUS Researchers, please see NUS Policy on Reporting of Serious Adverse Events, Contraventions and Other Reportable Events in Additional Resources (last page).

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