Description
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 Core Theory and Application course provides an overview of the current implementation guide, data structures, and related materials for submissions.
Learning Outcomes
At the end of this course, learners will be able to:
- Recognize the ADaM basics and general rules in order to build a foundation for ADaM implementation.
- Distinguish among ADaM data classes in order 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).
- Determine when to create columns and rows in BDS, recognize the need for supportive data, and identify rows used for analysis and population specific records.
- Describe conformance rules, list the components of ADaM metadata and define.xml, as well as demonstrate working knowledge of the ADRG.
Agenda
- Module 1: ADaM in the Clinical Data Process
- Module 2: ADaM Basics
- Module 3: ADaM Basics – Fundamental Principles
- Module 4: Traceability and Define-XML
- Module 5: ADaM Rules and Best Practices
- Module 6: ADaM Subject Level Analysis Dataset (ADSL)
- Module 7: Basic Data Structure (BDS)
- Module 8: ADaM Occurrence Data Structure (OCCDS)
- Module 9: Summary of ADaM Data Structures
- Module 10: ADaM Implementation Guide
- Module 11: ADaM Supplemental Documents
Continuing Education Units (CEUs)
The learner must receive a score of 80% or higher on the Final Assessment to earn 0.8 IACET CEUs.
Course Type
Private
Public
Virtual Classroom
Course Length
1 Day
Audience
Biostatistician
Programmer
Industry
Academic Institution
BioTech
Clinical Laboratory
Consulting
CRO
Government
Healthcare Provider
Medical Device
NPO
Pharmaceutical
Technology Service Provider