The ADaM establishes a standard way to build datasets that support analysis needs. Guidance in this section implements the ADaM for TIG Product Description, Product Impact on Individual Health, and Product Impact on Population Health use cases. The underlying assumptions, statistical methods, transformations, derivations and imputations performed in the analysis of a clinical trial should be communicated clearly and in such a manner that the values and results can be easily replicated. ADaM metadata facilitates this communication by providing specification of details and links between the general description of the analysis (as found in the protocol’s data analysis section, SAP, or the reported analysis methods), the analysis results, the data used in the analysis, and the SDTM domains.
Update text here to include reference datasets and Product Description.
Overview
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