Category: ADaM

  • 3 things you should know about ADaM standards

    One of the most important standards when it comes to clinical trial submission is the Analysis Data Model (ADaM). It outlines how to create analysis datasets and associated metadata. This in turn allows a statistical programmer to generate tables, listings, and figures (TLFs) more easily and ensures traceability. That means that reviewers can review and approve […]

  • Using SDTM, ADaM, and SEND for Regulatory Submissions

    It’s a safe bet that most people’s first introduction to CDISC standards is through the Study Data Tabulation Model (SDTM). This is a content standard that ensures clinical data is submitted in a consistent manner, helping to reduce review time and facilitating cross-study analysis. Another content standard, the Analysis Data Model (ADaM), aims to perform […]