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  • Appendix I: Inclusive Information Model

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After considering reference information models from various standards development organizations and other national or regional sources, this inclusive information model was synthesized. The purpose of the model is to provide a conceptual framework to understand and align the various models but does not replace the individual models. (The details on each of the source information models are available in the appendixes)

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illustrates the inclusive information model and shows the relationship between the three classes included in the model. The Propensity class is the centerpiece. A propensity class may be associated with zero-to-many Adverse Reaction classes and zero-to-many Adverse Sensitivity Test Result classes.

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