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Health Research Ethics

Forms & instructions: SAE Report

? Serious Adverse Event Form (Afr)

? Serious Adverse Event Form (Eng)
 
SAE Report: The term Serious Adverse Event (SAE) is usually used within the context of clinical or drug trials. However an Adverse Event (AE) or SAE can occur in non-pharmaceutical research as well. Any event that can affect research participants or data integrity negatively, or that has the potential to impact negatively on members of the research team, or on the project as a whole, and that is deemed significant by the investigator, should be reported to the HREC that approved the original study.Adverse events can include a wide range of events such as breach of confidentiality, injury sustained during a procedure e.g. exercise program, assault or robbery of staff members, needle stick injuries etc. Adverse events may obviously, in certain studies also include adverse drug events.

How to report SAEs and AEs:
Investigator's site:

• Report all significant adverse events to the HREC within a maximum of 21 days. 
  
• Report any event which, in the opinion of a reasonable and competent investigator, could have serious negative consequences for research participants, research team members, the project as a whole, or the university, within 48 hours of the investigator becoming aware of the event. 
  
• Report any other serious study related event, which in the opinion of the investigator is significant with respect to study participants, staff or data integrity.?
  
• Complete and submit a standard reporting form for drug related SAEs 
  
• Attach a more detailed narrative
  

Other sites:

• Report all SAEs to the HREC, if deemed necessary by the investigator, i.e. significant or unexpected. 
  
• Complete and submit a standard reporting form for drug related SAEs 
  
• Attach a summary of adverse events in a letter
  

DEFINITION OF A SERIOUS ADVERSE DRUG EVENT (FDA TITLE 21 PART 312, 32): Any adverse drug experience, occurring at any dose that results in any of the following outcomes:

• ?Death 
  
• A life threatening incident 
  
• Inpatient hospitalisation or prolongation of existing? hospitalisation, 
  
• Significant or persistent disability/incapacity, 
  
• Congenital abnormality/birth defect. 
  
• Important medical events that may not result in death, be life threatening, or require hospitalization, may be considered a SAE when based on appropriate medical judgment; they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition e.g. allergic bronchospasm, blood dyscrasias.