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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

    • Time to Events (using BDS)
    • Statistical Examples
    • Validation Checks
  • ADaM Metadata

  • Additional Materials for Submission

Learning Outcomes

  1. After completing this course, a learner will be able to identify and explain the role of the essential XML elements required to generate a Define-XML document.
  2. After completing this course,  a learner will be able to identify the metadata elements that are necessary for representing SDTM and ADaM datasets, variables and codelists.
  3. After completing this course, a learner will be able to correctly and accurately represent the traceability metadata required for SDTM and ADaM study dataset submissions.
  4. After completing this course, a learner will be able to identify use cases when Value Level or Parameter level metadata is required and be able to accurately represent that metadata using Define-XML.
  5. After completing this course, a learner will be able to effectively manage challenges that arise when implemented Define-XML for a given study.
  6. After completing this course, a learning will be able to explain the relationship between the Define-XML, the ODM and the other CDISC Data Exchange standards.

Continuing Education Units (CEUs)

Learners will receive 1.4 CEUs for successfully completing this course.

Successful Course Completion

  1. In order for a learner to successfully complete a course:
    1. An education representative or learner will complete training registration.
    2. A learner will complete formative assessment survey
    3. A learner must attend course for 80% of total course time. Specific attendance requirements are posted in course information pages.
    4. A learner will complete final course assessment with a score of at least 80% correct.
    5. A learner will complete summative assessment surveys
  2. Remediation: The following requirements will be in effect if learner does not successfully complete all parts of training:
    1. If learner registers for course but fails to complete formative assessment in required time, learner will be notified that they must transfer registration to later date.
    2. If learner completes formative assessment but does not meet attendance requirement, learner will be notified that they must re-attend course in full.
    3. If learner meets attendance requirement in full but fails content assessment, learner is given a maximum of two additional re-attempts before being required to re-attend the course in full. Learner will be notified and will receive a certificate of attendance after the third failed assessment attempt.
    4. If learner successfully completes content assessment but fails to complete summative assessment, learner will be notified and CEUs will be on hold until summative assessment is completed.

CDISC also offers this course through Private Training and Licensed Training.

 

 

Course Applies To: Analysis Data Model v2.1, ADaMIG v1.1
Prerequisites: 

Have attended ADaM Primer course previously,

OR

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, Licensed
Audience: 
Biostatistician, Programmer
Industry: 
Academic Institution, BioTech, Clinical Laboratory, Consulting, CRO, Government, Healthcare Provider, Medical Device, NPO, Pharmaceutical, Technology Service Provider