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Upcoming Public Training Opportunities:

 

 

 

 

 

 

 

Course Description

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.

Learning Outcomes

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

  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