CDISC Analysis Results Metadata 1.0 for Define-XML 2.0

The CDISC Define-XML 2.0 standard defines the metadata structures in a machine-readable XML format. These metadata structures are used to describe tabulation and analysis data sets and variables for regulatory submissions, as well as any proprietary (non-CDISC) data set structure.

The Analysis Results Metadata extension to the Define-XML 2.0.0 describes a model for the purpose of submissions to regulatory agencies such as the United States Food and Drug Administration (FDA) as well as for the exchange of analysis datasets and key results between other parties. This Analysis Results Metadata extension is based on the metadata model as described in the CDISC ADaM Analysis Data Model Version 2.1 document.

The XML schema that is used to define the metadata structures in an XML format is based on an extension to the CDISC Operational Data Model (ODM).

CDISC Analysis Results Metadata Specification for Define-XML Version 2, Production Version 1.0, January 27, 2015.

(Source: Technical Conformance Guide on Electronic Study Data Submissions, Pharmaceuticals and Medical Devices Agency, Provisional Translation [as of July 2015]).

In order for the review of clinical study data to progress smoothly, it is important that the relationship between the analysis results shown in the application documents and the analysis datasets is easily understandable. Therefore, the definition documents of the ADaM datasets should preferably include Analysis Results Metadata, which shows the relationship between the analysis results and the corresponding analysis dataset and the variables used, for the analyses performed to obtain the main results of efficacy and safety and clinical study results that provide the rationales for setting of the dosage and administration, shown in 4.1.1.3. The Analysis Results Metadata of each analysis should preferably include the following items.

For the format of the Analysis Results Metadata, the applicant should refer to the Analysis Results Metadata Specification for Define-XML by CDISC to the extent possible, but if it is difficult to include it into the definition document, it is possible to submit it as a separated file in PDF format, as specified in “Electronic Specifications of Common Technical Documents”, and “Handling of Electronic Specifications of Common Technical Documents”. The explanations in the definition document may be written in Japanese.

The domain and column metadata that constitute the SAS representation of the CDISC Define-XML 2.0 standard (including Analysis Results Metadata) are derived from the global standards library in these formats:

The tablecore column in the reference_tables data set indicates whether the table is a required (Req) or optional (Opt) part of the Define-XML 2.0 metadata, according to the XML schema. Tables with tablecore equal to Ext are part of the underlying ODM metadata model, but they should be considered extensions to the Define-XML 2.0 metadata model. The core column in the reference_columns data set indicates whether a column is required (Req) or optional (Opt) in a table when the table is part of the metadata.