Analysis results metadata TOBA-120 - Getting issue details... STATUS provide traceability from a result used in a statistical display to the data in the analysis datasets. Although not required, best practice is that this metadata be provided to assist the reviewer by identifying the critical analyses; providing links between results, documentation, and datasets; and documenting the analyses performed.
Analysis results include statistical displays (e.g., text, tabular, or graphical presentation of results) or inferential statements such as p values or estimates of treatment effect. Analysis results metadata provide a link between analysis results and the data used to generate it in a standard format and a predictable location. This allows reviewers to link from an analysis result to important information describing the analysis (e.g., the reason for performing the analysis) and the dataset and selection criteria used to generate the analysis.
Analysis results metadata are not needed or even advisable for every analysis included in a clinical study report or submission. The applicant determines which analyses should have analysis results metadata. For example, the applicant might elect to provide analysis results metadata only for the primary safety analysis and the secondary safety analyses being considered for a marketing claim.
Analysis results metadata describe the major attributes of a specified analysis result found in a CSR or submission. The metadata fields to be used to describe an analysis result are listed in the following table. The word “display” is used instead of “table” as it is more generic, referring to tabular or graphical presentation of results.
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