Capture and Analysis of Spontaneous Adverse Event Data at A. H. Robins

Abstract

This article discusses the responsibilities of the Drug Surveillance Department at A. H. Robins, the methods by which the Department receives spontaneous adverse reaction data, and the protocol used to obtain follow-up data. It further reviews the items of data requested from reporters of adverse reactions and the methods by which this data can be graphically represented.

Keywords

Adverse reaction Computer Follow-up Suspected Adverse Reaction Form Graphic analysis

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