Analysis Results Metadata (ARM)
Analysis Results Metadata (ARM) shows the relationships between the analysis results and the corresponding analysis datasets and its variables. It provides traceability for a given analysis result to a specific ADaM element. Although according to the ADaM version 2.1 ARM is an optional ADaM metadata component, it is a required for PMDA data submission. It is an extension of the Define-XML.
It assists the reviewer by providing traceability for :
- Key efficacy and safety analysis results
- Analysis datasets and its related elements.
ARM is mainly used for the main results of efficacy and safety of a clinical study. It is a specification that describes the major attributes of a specified analysis result found in a clinical study submission. It also provides information about the analysis method used and the reason why the analysis was performed.
The key components in ADaM Analysis Results Metadata are:
- Analysis Result metadata definitions,
- Analysis parameter(s),
- Analysis dataset(s),
- Analysis variable(s),
- Selection criteria,
- Documentation,
- Programming statements.
