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.
Overview
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