Understanding SDTM Trial Summary Domain: ACTSUB and Screen Failures
Understanding SDTM Trial Summary Domain: ACTSUB and Screen Failures In SDTM, the Trial Summary (TS) domain captures study-level information about a clinical trial. It does not contain subject-level data, but instead stores key summary values such as trial characteristics and subject counts. TS is commonly included in SDTM-based submissions to provide high-level trial information. One parameter that often creates confusion is TSPARMCD = ACTSUB . It is sometimes interpreted as the number of treated subjects, but that interpretation is not always correct. What Is the TS Domain? The TS domain contains trial-level metadata. Each record represents a parameter: TSPARMCD = parameter code TSPARM = parameter description TSVAL = parameter value TS values should be consistent with the study protocol, metadata, and define.xml. What Does ACTSUB Mean? ACTSUB is the TS parameter used to represent the actual number of subjects in the study. A careful working definiti...