Module 12 Presentations

26/01/2024

Analysis Data Model (ADaM)

 It is possible to add derived analysis parameters if required for an analysis  ADaM provides the flexibility to add various kinds of derived rows to meet analysis needs.  It includes a central set of variables that represent the actual data being analyzed and supports parametric and nonparametric analyses*

*or as I like to call it – the stuff that statisticians do

The Organisation for Professionals in Regulatory Affairs

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Required Documentation: Data Definition Files -Define.xml

 All study datasets (SDTM/ADaM/SEND) require a data definition file which describes the structure and contents of the data collected during a clinical trial and is based on the CDISC Operational Data Model (ODM).  It is essentially metadata about your the data sets: data that describes any tabular dataset structure and informs regulators which datasets, variables, controlled terms, and other specified metadata were used.  The Data Definition Document enlists the data sets included in the submission and provides a detailed description of the contents of each data set.  Define.xml file is the Data Definition Document in a machine-readable (XML) format

The Organisation for Professionals in Regulatory Affairs

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