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ADaM Theory and Application

 

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 DocumentsADaM Metadata

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

 

Current Course Material Used: 
Analysis Data Model v2.1, ADaMIG v1.1, ADaM Exercises, ADaM Examples
Prerequisites: 

1. Be familiar with CDISC models including the goals and basic background of CDISC.

2. Have a general understanding of what the SDTM and ADaM are.

3. Have a general knowledge of FDA and/or PMDA data standards regulations.

4. Have a general understanding of the statistical analysis process.

5. Be aware of what ADaM documentation exists.

6. Understand the ADaM fundamental principles.

7. Understand what ADaM traceability is and how ADaM appears in define.xml.

8. Be aware of ADaM general rules and best practices.

9. Have a very basic understanding of ADaM ADSL, BDS, and OCCDS.

 

Individuals who do not meet the above pre-requisites are strongly advised to take the ADaM Primer course first.

Course Length: 
1 Day
Course Type: 
Public, Private, Online, Licensed
Audience: 
Biostatistician
Programmer