To understand when an adverse event is a serious
adverse event
To understand the FDA reporting system for AEs
and SAEs
To understand the following documents: MedWatch Forms, Narratives,
IND Annual Update, Periodic Safety Update Report:
Workshop 5:
Adverse Events (AEs) and AE reporting are a
central part of all clinical regulatory documentation. Do the activities below,
read the AE definition slide show and the documents in the Course Documents
section.Describe the difference between
a serious adverse event and a severe adverse event.
The FDA takes very seriously the reporting adverse events,
because when anything happens when a patient or a clinical trial subject is
taking a drug, the FDA needs to determine whether the adverse event resulted directly
because of taking the drug (eat pill, arm falls off) or indirectly (eat pill,
fall off a roof) or had nothing to do with taking the pill (eat pill, husband scares
cat, she trips over cat and cat scratches her face): http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/default.htm
Watch the Frontline documentary Dangerous Prescription (available from PBS on DVD, I cant find it on Neflix, but they have other Frontline episodes)
What happens to adverse events reported during clinical trials? They are written into narratives, depending on the agreement the drug company has with the FDA. In general, a narrative is written for a SAE or a death.
Adverse events
result from life happening when the trial participant is taking a does
or 2 of a drug a day, and is either spending the day going about normal
business, or is in hospital (usually only cancer therapies). The drug
company consults with the FDA to decide when narratives need to be
written. A general rule is if a trial participant is hospitalized or
the event is considered serious, and the adverse event is known as a
serious adverse event, or an SAE. The FDA wants to know if a serious
adverse event occurs during a clinical trial, and the study
co-ordinator is required to fax in or email notification. You can see
where this is submitted on the FDA website. This document is taken with
the final data outputs from the case report forms and a narrative is
compiled by the medical writer. These compiled narratives are included
in the appendix of the clinical study report.
Download a sample form 3500A from the FDA site and use it as a
guide (this is a passworded document so it cannot be used independently). Use
the numbering scheme in the form and make a numbered list with headings that
corresponds to the form; fill the numbered list subsections in from the patient
information given in the full assignment section. Also, watch the Frontline
documentary Dangerous Prescription and be prepared to discuss it.
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