These metadata Analysis results metadata
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provide traceability from a result used in a statistical display to the data in the analysis datasets.
Analysis results metadata are Although not required
. However, best practice is that
they 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 effectproduct 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 (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 sponsor applicant determines which analyses should have analysis results metadata. For example, the sponsor applicant might elect to provide analysis results metadata only for the primary efficacy safety analysis and the secondary efficacy safety 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 CSR or submission. The metadata fields to be used to describe an analysis result are listed in the following table below. The word “Display” “display” is used instead of “Table” “table” as it is more generic, referring to tabular or graphical presentation of results.
| Metadataspec |
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Num | Analysis Results Metadata Field | Description | 1 | DISPLAY IDENTIFIER | A unique identifier for the specific analysis display ( |
such as e.g., a table or figure number) | 2 | DISPLAY NAME | Title of display, including additional information if needed to describe and identify the display (e.g., analysis population) | 3 | 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 1 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. | 4 | 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. | 5 | PARAMCD | Corresponds to PARAM in the BDS analysis dataset. Does not apply if the result is not based on a BDS analysis dataset. | 6 | ANALYSIS VARIABLE | The analysis variable being analyzed | 7 | 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 applicant defined. An example of a reason is |
“Primary Efficacy “Safety Analysis as Pre-specified in Protocol.” | 8 | 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. | 9 | SELECTION CRITERIA | Specific and sufficient selection criteria for analysis subset and/or |
numerator – a 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. | 10 | 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 planSAP, 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 applicant is providing a corresponding analysis generation program, and |
sponsorapplicant-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. | 11 | 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 |