Serious Adverse Event (SAE)

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An Adverse Event includes any untoward or unfavourable medical occurrence in a human subject, including abnormal signs, symptoms, or disease, temporarily associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research. Adverse events can be both physical and psychological. A serious adverse event is any event that:

  • Is life-threatening condition or results in death
  • Requires patient hospitalization or extension of existing patient hospitalization
  • Results in persistent or significant disability or incapability
  • Results in a congenital anomaly or birth defect
  • Requires intervention to prevent permanent impairment or damage to the human subject.

SAE reporting is a critical part of any Clinical Trial. The Investigator is responsible for the medical care of the trial subject and also ethically bound to report any SAE to the stakeholders involved in the clinical trial. The trial Investigator should report all SAEs to the drug regulatory body, sponsor of the trial, and the concerned ethics committee that approved the trial protocol within 24 hours of occurrence of the SAE. The drug trial sponsor is responsible for the ongoing safety evaluation of the investigational product or drug trial, reporting, and compensating the participant in case of any SAE.  SAE’s can be further categorized as expected or unexpected.

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About the Author
Proxima CRO Team
Isabella Schmitt
Regulatory Affairs Consultant

Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.

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