| ADSL | Subject-Level Analysis Dataset | SUBJECT LEVEL ANALYSIS DATASET | The label of the ADSL dataset is "Subject-Level Analysis Dataset." In a study, there is only 1 dataset in the class "SUBJECT LEVEL ANALYSIS DATASET", and its name is ADSL. Any other datasets with 1 record per subject would be members of other classes (e.g., the "BASIC DATA STRUCTURE" and "ADAM OTHER" classes). ADSL contains variables such as subject-level population flags, planned and actual treatment or product variables, demographic information, randomization factors, subgrouping variables, stratification factors, and important dates. ADSL is used to provide key facts about the subject that are analysis-enabling or which facilitate interpretation of analysis. ADSL is a source for subject-level variables used in other ADaM datasets, such as population flags and treatment or product variables. The process for adding ADSL variables into BDS datasets is set by the producer of the datasets. It should be noted that although the ADSL contains subject-level variables that are also important in other datasets, there is no requirement that every ADSL variable be present in other analysis datasets. However, at a minimum, any ADSL variable needed to enable analysis (e.g., statistical model covariates, population flags, subgrouping variables) should appear in the analysis dataset. Other ADSL variables may also be included for traceability or other reasons. A variable that is present in both ADSL and any other ADaM dataset must have the same values, type, and label. |