Our last post in this series on the 62 Good Clinical Practice (GCP) glossary terms described three of the four categories of side effects in a clinical investigation: adverse events (AEs), unanticipated AEs, and adverse device/drug effects. The last category of side effects in the glossary for us to explain here is the term, serious adverse events, or SAEs.
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FDA defines an SAE as an adverse event, which is any undesirable experience associated with a medical product in a patient, and which is serious enough that it may jeopardize the patient. On the list of events considered serious enough to be an SAE are any untoward medical occurrences that:
- Result in death,
- Are life-threatening,
- Require inpatient hospitalization or prolongation of existing hospitalization,
- Result in persistent or significant disability or incapacity,
- Cause a congenital anomaly or birth defect, or
- Result in any medical or surgical intervention to prevent permanent impairment or damage.
If an event doesn’t fit into any of these categories, but is significant enough to jeopardize the patient, requires medical or surgical treatment, or is another important medical event, it should be considered an SAE and reported as such to the appropriate agencies. SAEs should be reported at the hospital level to the Institutional Review Board (IRB) if the medical product is being used in an IRB-approved research protocol, any study sponsors, hospital-specific patient safety boards, and as appropriate, FDA or other country-specific regulatory agencies.
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Any SAEs that occur in medical products approved for sale by the FDA also should be reported using MedWatch, which is the FDA’s program for voluntary reporting of adverse events. Adverse event categories to report to MedWatch include prescription and over-the counter medicines, blood components or derivatives, human tissues and tissue-based products, medical devices, combination products, dietary supplements, infant formulas, medical foods, cosmetics, and foods and beverages. Since 1993, the FDA has used this program to disseminate information about product safety to the medical community and to the public, including recalls and other safety alerts. You can learn more about medical product safety resources from MedWatch and FDA, here.
Thanks for tuning in to Hart Clinical Consultants’ glossary series!
Next time, we will look at the GCP glossary terms related to auditing.
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