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When the treatment portion of a clinical study requires further analysis at sublevel time periods, it complicates creating CDISC Analysis Data Model (ADaM) datasets. In a new article, CDISC ADaM Phases, Periods, and Subperiods: A Case Study that appears in Journal of the Society for Clinical Data Management, Jennifer Fulton, MS, a Westat biostatistician, explores the challenges of correctly implementing the ADaM guidelines in a non-standard study.
By using example data from the case study, the correct method to utilize the full set of phase, period, and subperiod variables is shown. Fulton concludes that despite multiple challenges in adhering to CDISC requirements, a well-thought-out plan and use of the ADaM Implementation Guide will result in submission-ready data for a complicated study design.