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How to Report a Serious Adverse Event
Adverse Event Reporting
This guide is written for CRCs or other people who want to learn how determine if the event is considered a serious adverse event (SAE) or an adverse event (AE).
In clinical studies, the investigator is required to report any events that are considered serious while a patient is participating in a clinical research study. The study therapy may include study medication or treatment that is investigational and considered experimental, so reporting events that are serious allows for more complete analysis of what is considered harmful in study therapy ultimately done to ensure the safety of patients enrolled in the studies.
The Clinical Trial Coordinator (CRC) will notify the Sponsor, Institutional Review Board (IRB), and Food and Drug Administration (FDA).
Serious Adverse Event
An SAE is the occurrence of an incident results in death, life-treating injury or illness, inpatient hospitalization, or is significant impairment or disability while a person is participating in a clinical trial or within a pre-specified period of time after the participant comes off study. Usually SAEs will need to be reported to the FDA within 48 hours, as indicated in the protocol.
An adverse event is a change that occurs in a person's health while they are on study therapy. In most situations, AEs need to be recorded but not reported.
- Grade the Event - Determine how severe the event is based on the grade. In oncology, the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) is often used to determine what an event should be graded. The protocol will specify what you should use to grade an event.
Attribution - Not Related, Unlikely, Possibly, Probably, Definite - Have the physician determine the attribution or how likely the event is due to the study therapy. Ask the physician to dictate the specific attribution so you have a record.
Expected or Unexpected Event - Review the protocol, investigator brochure (IB) and the consent form to determine if the event is anticipated or not. The protocol will list the most common adverse events that are likely to occur for the therapy. The consent form will list out all of the risks and side effects that are likely to occur while the patient is on study. Use these as guides to determine whether or not the event was expected. If you have questions call the sponsor who manufactures the drug and ask them to indicate this to you.
Put it All Together
If, for example, the event is unexpected, grade 3, related to therapy, then in most cases you would have to report this event as a serious adverse event. The protocol will indicate what the expedited reporting requirements are based on the attribution and grade.
NCI's Adverse Expedited Reporting System (AdEERS).
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