ADaM Core Theory and Application

CDISC provides training on this standard via: Virtual Classroom Training (New!) | Self-Paced Online Training

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ADaM Core Theory and Application is a deep dive into the implementation and use of the ADaM standard. Materials reviewed include the current implementation guide, data structures, and related supplements for submissions.

Course Agenda

  • ADaM in the Clinical Data Process
  • ADaM Basics
  • ADaM Basics – Fundamental Principles
  • Traceability and Define-XML
  • ADaM Rules and Best Practices
  • ADaM Data Classes
  • ADaM Subject Level Analysis Dataset (ADSL)
  • Basic Data Structure (BDS)
  • ADaM Occurrence Data Structure (OCCDS)
  • ADaM Implementation Guide
  • ADaM Supplemental Documents

At the end of this course, you will be able to:

  • Undestand ADaM basics and general rules and distinguish among ADaM data classes to build a foundation for ADaM implementation.
  • Establish a basis for constructing different classes of ADaM datasets, including ADaM Subject Level Analysis Dataset (ADSL), ADaM Basic Data Structure (BDS) and ADaM Occurrence Data Structure (OCCDS).
  • Implement Time to Event (using BDS), describe conformance rules, list the components of ADaM metadata and define.xml, as well as demonstrate working knowledge of the ADRG.
Continuing Education Units (CEUs)

Learners will receive 0.7 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 must attend course for 80% of total course time. Specific attendance requirements are posted in course information pages.
    3. A learner will complete final course assessment with a score of at least 80% correct.
    4. 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.

Course Length

1 Day

Course Type

Private
Public
Virtual Classroom

Audience

Biostatistician
Programmer

Industry

Academic Institution
BioTech
Clinical Laboratory
Consulting
CRO
Government
Healthcare Provider
Medical Device
NPO
Pharmaceutical
Technology Service Provider