The Food and Drug Administration’s (FDA) Mini-Sentinel is a pilot program that aims to conduct active surveillance to detect and refine safety signals that emerge for marketed medical products.

The purpose of this Mini-Sentinel AMI Validation project was to:

(a) develop and design an abstraction and adjudication process to use when full text medical record review is required to confirm a coded diagnosis; and

(b) to test this approach by validating a code algorithm for acute myocardial infarction (AMI).