Biomedical Engineering Reference
In-Depth Information
Subsequent investigation of an SAE includes the following
two aspects:
1. Case specifi c - reviewing the demographics of the patient,
dosage levels and length of exposure, other medications,
and other medical conditions;
2. Tracking and trending similar events.
Then two other medical reviewers must independently review
the case narratives and lab reports including the diagnosis,
clinical course, therapeutic steps, and outcome of the event.
They must also independently check the medical coding and
confi rm the case assessment. If the blinded assessments differ,
they must be reconciled. Once reconciled, the case report is
submitted to the company's Regulatory Affairs offi cer.
Remediation may be called for if the tracking and trending
of similar events show a pattern and the trend reaches a
predetermined threshold, or if the individual event is serious
enough. In fact, the two factors that drive the decision to
make a response are frequency and severity. If the event is a
minor complaint (such as a rash) and also a frequent
complaint, this may warrant a labeling change.
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Remediation
will also be considered for a more serious event, such as
acute renal failure, that occurs at a low frequency. Insofar as
remediation requires the revision of an operational SOP, the
observation and reporting of an AE initiates the revision,
similar to the case of the quality audit discussed previously.
1.5.3 Customer quality complaint
A third kind of observation takes the form of a complaint
made by a customer routed to the organization's quality
complaint unit (CQU). FDA has defi ned a customer quality
complaint as “any written, electronic, or oral communication
