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  • Appendix I: Inclusive Information Model

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Add an introduction to explain the objective of this model and how it is based on the analysis performed (details documented in the appendix). Add a short summary of the results of this analysis.


After considering reference information models from from various standards development organizations and other national or regional sources, an this inclusive information model is was synthesized. This 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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