Upcoming Public Training Opportunities:
The ADaM Theory and Application training is a deep dive into the ADaM standard and should orient the student so that they can begin to implement CDISC ADaM. The training is intended for Individuals who need to implement the CDISC ADaM model, which typically include statistical programmers, statisticians, standards managers, and informaticists, and others. The objective of this training is to support consistent implementation and use of ADaM standard which is required by select regulatory authorities for submission of certain data.
1. At the end of this course, the learner will be able to establish a basis for constructing ADaM data class datasets, including ADaM Subject Level Analysis Dataset (ADSL), ADaM Basic Data Structure (BDS) and ADaM Occurrence Data Structure (OCCDS).
2. In a clinical scenario, the learner will be able to create and recognize the difference between columns and rows in BDS, recognize the need for supportive data, identify rows used for analysis and population specific records, and identify records which satisfy a pre-defined criterion for analysis purposes.
3. In a clinical scenario, the learner will be able to implement Time to Event (using BDS), describe validation checks, 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
Have attended ADaM Primer course previously,
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.