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Analysis Results Metadata Field

Description

DISPLAY IDENTIFIER

A unique identifier for the specific analysis display (such as a table or figure number)

DISPLAY NAME

Title of display, including additional information if needed to describe and identify the display (e.g., analysis population)

RESULT IDENTIFIER

Identifies the specific analysis result within a display. For example, if there are multiple p-values on a display and the analysis results metadata specifically refers to one of them, this field identifies the p-value of interest. When combined with the display identifier provides a unique identification of a specific analysis result.

PARAM

The analysis parameter in the BDS analysis dataset that is the focus of the analysis result. Does not apply if the result is not based on a BDS analysis dataset.

PARAMCD

Corresponds to PARAM in the BDS analysis dataset. Does not apply if the result is not based on a BDS analysis dataset.

ANALYSIS VARIABLE

The analysis variable being analyzed

REASON

The rationale for performing this analysis. It indicates when the analysis was planned (e.g., “Pre-specified in Protocol,” “Pre-specified in SAP,” “Data Driven,” “Requested by Regulatory Agency”) and the purpose of the analysis within the body of evidence (e.g., “Primary Efficacy,” “Key Secondary Efficacy,” “Safety”). The terminology used is sponsor defined. An example of a reason is “Primary Efficacy Analysis as Pre-specified in Protocol.”

DATASET

The name of the dataset used to generate the analysis result. In most cases, this is a single dataset. However, if multiple datasets are used, they are all listed here.

SELECTION CRITERIA

Specific and sufficient selection criteria for analysis subset and / or numerator – a complete list of the variables and their values used to identify the records selected for the analysis. Though the syntax is not ADaM-specified, the expectation is that the information could easily be included in a WHERE clause or something equivalent to ensure selecting the exact set of records appropriate for an analysis. This information is required if the analysis does not include every record in the analysis dataset.

DOCUMENTATION

Textual description of the analysis performed. This information could be a text description, pseudo code, or a link to another document such as the protocol or statistical analysis plan, or a link to an analysis generation program (i.e., a statistical software program used to generate the analysis result). The contents of the documentation metadata element contains depends on the level of detail required to describe the analysis itself, whether or not the sponsor is providing a corresponding analysis generation program, and sponsor-specific requirements and standards. This documentation metadata element will remain free form, meaning it will not become subject to a rigid structure or controlled terminology.

PROGRAMMING STATEMENTS

The software programming code used to perform the specific analysis. This includes, for example, the model statement (using the specific variable names) and all technical specifications needed for reproducing the analysis (e.g., covariance structure). The name and version of the applicable software package should be specified either as part of this metadata element or in another document, such as a Reviewer’s Guide.