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Adverse Event Reporting

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Uploaded by on Feb 22, 2010

The reporting of adverse event data to regulatory agencies is undergoing a transition from paper-based reporting like the FDA's MedWatch forms (or CIOMS* forms in many other countries) to electronic reporting. This reporting method uses a standardized format that specifies the structure of the data elements and technical aspects of the data transmission and enables near-simultaneous transmission to multiple agencies.

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