Prerequisites for ADaM Theory and Application full day class:
Students who wish to take the ADaM Theory and Application class without first taking the ADaM Primer course should:
· Be familiar with CDISC models including the goals and basic background of CDISC. · Have a general understanding of what the SDTM and ADaM are. · Have a general knowledge of FDA and/or PMDA data standards regulations. · Have a general understanding of the statistical analysis process. · Be aware of what ADaM documentation exists. · Understand the ADaM fundamental principles. · Understand what ADaM traceability is and how ADaM appears in define.xml. · Be aware of ADaM general rules and best practices. · Have a very basic understanding of ADaM ADSL, BDS, and OCCDS.
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