From a Statistical Analysis Plan (SAP) written or not within the company and after receiving an SDTM database (or not), the Biostatistics team can produce a derived database following the ADaM (Analysis Dataset Model) structure.
Two standard ADaM data structures exist and will be created as required: the subject-level analysis dataset (ADSL) and the Basic Data Structure (BDS).
From the ADaM base, statistical programmers and biostatisticians will be able to program in SAS and validate the TFLs as well as the programming of the statistical tests described in the SAP.
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