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ADaM Theory and Application

Length: 1-day

Language: See authorized instructor list

 

The Analysis Data Model (ADaM) specifies principles for analysis datasets and standards for a subject-level analysis file and for a basic data structure, which can be used for a wide variety of analysis methods.The ADaM Theory and Application course provides an overview of the current implementation guide, data structures, and related materials for submissions.

 

Course Agenda

  • ADaM Subject Level Analysis Dataset (ADSL)

  • ADaM Basic Data Structure (BDS)

  • ADaM Occurrence Data Structure (OCCDS)

  • ADaM Implementation Guide

  • ADaM Supplemental Documents

  • ADaM Metadata

    • Time to Events (using BDS)
    • Statistical Examples
    • Validation Checks
  • Additional Materials for Submission

 

Prerequisites for ADaM Theory and Application full day class:

 

Students who wish to take the ADaM Theory and Application class without first taking the ADaM Primer course should:

  • Be familiar with CDISC models including the goals and basic background of CDISC.
  • Have a general understanding of what the SDTM and ADaM are.
  • Have a general knowledge of FDA and/or PMDA data standards regulations.
  • Have a general understanding of the statistical analysis process.
  • Be aware of what ADaM documentation exists.
  • Understand the ADaM fundamental principles.
  • Understand what ADaM traceability is and how ADaM appears in define.xml.
  • Be aware of ADaM general rules and best practices.
  • Have a very basic understanding of ADaM ADSL, BDS, and OCCDS.

 

 

Types of training available: Public | Private | Online | Licensed