Chapter 2: Using SAS to Generate Graphs for Adverse Events
2.1 Introduction to Adverse Events
The International Conference on Harmonization (ICH) has produced a guideline on the structure and content of clinical study reports. This guideline is known as the “ICH E3 Guideline: Structure and Content of Clinical Study Reports.” Many pharmaceutical companies adopt this guideline when creating a clinical study report (CSR); therefore, knowing how to create figures that can fulfill some of the recommended outputs is valuable.
CSRs are submitted to the Food and Drug Administration (FDA) in order for the drug, biologic, or medical device to gain approval. If the FDA approves the product, then the product can be marketed within the US. There are many ...
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