These metadata provide traceability from a result used in a statistical display to the data in the analysis datasets.
Analysis results metadata are not required. However, best practice is that they 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 such as 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 sponsor determines which analyses should have analysis results metadata. For example, the sponsor might elect to provide analysis results metadata only for the primary efficacy analysis and the secondary efficacy analyses being considered for a marketing claim.
Analysis results metadata describe the major attributes of a specified analysis result found in a clinical study report or submission. The metadata fields to be used to describe an analysis result are listed in the table below.ADD TABLEThe word “Display” is used instead of “Table” as it is more generic, referring to tabular or graphical presentation of results.