| Num | Convention |
|---|
| 1 | The terms "flag" and "indicator" are used interchangeably within this document, and "flag variables" are sometimes referred to simply as "flags." |
| 2 | Population flags must be included in a dataset if the dataset is analyzed by the given population. At least one population flag is required for datasets used for analysis. A character indicator variable is required for every population that is defined in the statistical analysis plan (SAP). All applicable subject-level population flags must be present in ADSL. |
| 3 | Character and numeric subject-level population flag names end in FL and FN, respectively. Similarly, parameter-level population flag names end in PFL and PFN, and record-level population flag names end in RFL and RFN. Please also refer to Section 2.9.3.1 General Variable Conventions. |
| 4 | For subject-level character population flag variables: N = no (not included in the population), Y = yes (included). Null values are not allowed. |
| 5 | For subject-level numeric population flag variables: 0 = no (not included in the population), 1 = yes (included). Null values are not allowed. |
| 6 | For parameter-level and record-level character population flag variables: N = no (not included), Y = yes (included). Null values are allowed. |
| 7 | For parameter-level and record-level numeric population flag variables, 0 = no (not included), 1 = yes (included). Null values are allowed. |
| 8 | In addition to the population flag variables defined in 2.9.5.3 Population Indicator Variables for ADSL Datasets other population flag variables may be added to ADaM datasets as needed, and must comply with these conventions. |
| 9 | For character flags with variable names that end in FL and that are not population flags, a scheme of Y/N/null, or Y/null may be specified. As indicated in Section 2.9.6.6 Analysis Parameter Criteria Variables for BDS Datasets and Section 2.9.6.10 Indicator Variables for BDS Datasets, some common character flags use the scheme Y/null. The choice of Y/N/null vs Y/null is dependent on analysis needs. Y/N/null should be used when N and null values need to be analyzed differently. Y/null can be used when the need is to analyze just the Y values. Corresponding 1/0/null and 1/null schemes apply to numeric flags with variable names that end in FN and which are not population indicators. |
| 10 | Additional flags may be added if their names and values comply with these conventions. |