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| Num | Convention | Implementation |
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| 1 | Terms Flag and Indicator |
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| The terms "flag" and "indicator" are used interchangeably within this document, and "flag variables" are sometimes referred to simply as "flags." |
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| Population Flags | - 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.
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- For character and numeric subject-level population
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- flags:
- Names end in FL and FN, respectively
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- .
- Values N = no (not included in the population) and Y = yes (included). Null values are not allowed.
- Values 0 = no (not included) and 1 = yes (included). Null values are not allowed.
- 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 ADD LINK Item 8 in Section 3.1.1, General Variable Conventions.
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4. For subject-level character population flag variables: N = no (not included in the population), Y = yes (included). Null values are not allowed.
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5. 5. For subject-level numeric population flag variables: 0 = no (not included), 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.
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