SDTM Trial Summary Domain: ACTSUB vs Screen Failures Understanding SDTM Trial Summary Domain: ACTSUB vs Screen Failures In the world of clinical data management, the Study Data Tabulation Model (SDTM) plays a vital role in organizing and submitting clinical trial data to regulatory agencies. One of the most essential domains in SDTM is the Trial Summary (TS) domain, which provides key information about the clinical trial itself. In this blog post, we will explore the Actual Number of Subjects (ACTSUB) and how it differs from screen failures. We will also reference regulatory guidelines and SDTM Implementation Guides to ensure a deeper understanding. What is the TS Domain? The Trial Summary (TS) domain contains high-level information about the clinical trial. This includes essential data such as the number of subjects, the start and end dates of the trial, trial objectives, and much more. The TSPARMCD variable define...
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