4.3 Measurements Collected at the Clinical Site

4.3.1 Tests with No Variability

Our previous discussion focused on the unusual results that may arise as part of study scheduling. Here, we will focus on the data that is collected at the study site through the various tests, procedures, and examinations performed, or questionnaires completed by the patients. In other words, these data are from the planned evaluations that assess the well-being of the participant, as well as those results that indicate whether the patient is receiving some benefit from the treatment they are receiving. In CDISC, these data come from Findings domains. Some examples of Findings domains include ECG test results (EG), vital signs (VS), laboratory measurements (LB), ...

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