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The analysis variable metadata describe each variable in the analysis dataset, including the variable attributes and definition. The metadata fields used to provide these descriptions are listed below. Best practices strongly recommend that every analysis variable be described using these metadata fields. ADaM-compliant analysis datasets must be described by these analysis variable metadata fields.


Num

Analysis Variable Metadata Field

Description

1

DATASET NAME

The file name of the analysis dataset

2

VARIABLE NAME

The name of the variable

3

VARIABLE LABEL

A brief description of the variable

4

VARIABLE TYPE

The variable type. Valid values are as defined in the Case Report Tabulation Data Definition Specification Standard (e.g., in version 1.0.0 they include “text,” “integer,” and “float”)  TOBA-70 - Getting issue details... STATUS

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DISPLAY FORMAT

The variable display information (i.e., the format used for the variable in a tabular or graphical presentation of results). It is suggested that the syntax be consistent with the format terminology incorporated in the software package used for analysis (e.g., $16 or 3.1 if using SAS).

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CODELIST / CONTROLLED TERMS

A list of valid values or allowable codes and their corresponding decodes for the variable. The field can include a reference to an external codelist (identified by name and version) or a hyperlink to a list of the values in the codelist/controlled terms section of the define file.

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SOURCE / DERIVATION

  • Provides details about the variable’s lineage – what was the predecessor, where the variable came from in the source data (SDTM or other analysis dataset) or how the variable was derived. This field is used to identify the immediate predecessor source and/or a brief description of the algorithm or process applied to that source and can contain hyperlinked text that refers readers to additional information.
  • The source / derivation can be as simple as a two level name (e.g., ADSL.AGEGR) identifying the data file and variable that is the source of the variable (i.e., a variable copied with no change). It can be a simple description of a derivation and the variable used in the derivation (e.g., “categorization of ADSL.BMI”). It can also be a complex algorithm, where the element contains a complete description of the derivation algorithm and/or a link to a document containing it and/or a link to the analysis dataset creation program.

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