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Metadataspec
NumConvention
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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 must be included in a dataset if the dataset is analyzed by the given population. At least

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1 population flag is required for datasets used for analysis. A character indicator variable is required for every population that is defined in the

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SAP

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. All applicable subject-level population flags must be present in ADSL.
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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

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Section 2.9.3.1

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General Variable Conventions.
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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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For subject-level numeric population flag variables: 0 = no (not included in the population), 1 = yes (included). Null values are not allowed.
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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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For parameter-level and record-level numeric population flag variables, 0 = no (not included), 1 = yes (included). Null values are allowed.
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In addition to the population flag variables defined in

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2.9.5.3,

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Population Indicator Variables for ADSL Datasets, other population flag variables may be added to ADaM datasets as needed, and must comply with these conventions.
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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

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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.
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Additional flags may be added if their names and values comply with these conventions.

Pagenav