Understand the SAE process
When an SAE report is sent by an investigator, health worker, or
employee (clinical research associate or pharm center), it is immediately
assigned a number and reviewed to determine whether the event is a reportable
SAE. If it is reportable, the company needs to send the SAE to FDA by one of
the following methods.
• Form 3500A only (can be filed manually or electronically via the AERS system)
• A narrative report
• VAERS form (vaccines only)
• CIOMS I form (foreign reports only).
A company’s culture and experience dictate the way it meets these reporting requirements. Whatever the method it uses, a company must keep an audit trail, either manual or electronic, that shows:
• Form 3500A only (can be filed manually or electronically via the AERS system)
• A narrative report
• VAERS form (vaccines only)
• CIOMS I form (foreign reports only).
A company’s culture and experience dictate the way it meets these reporting requirements. Whatever the method it uses, a company must keep an audit trail, either manual or electronic, that shows:
• the initial receipt date of the SAE
• all changes made to the original SAE by any personnel.
• all supporting documentation requested and sent in from the site.
• any internal or external correspondence.
• any internal notes, such as medical review.
• all attempts to get additional information regarding the event.
• whether the event is open or closed.
We need to code the SAEs in such a way that they become categorical in nature, such as assigning a code for the event and a MedDRA term
Source: FDA Guidelines
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