Simplifying the process of documenting Analysis Results Metadata (ARM)

Analysis Results Metadata (ARM) has been part of the CDISC Analysis Data Model (ADaM) for a number of years, however there was no standard to follow for its inclusion in submissions until the release by CDISC of the ARM v1.0 specification for Define-XML standard V2.0 in 2015.

ARM provides traceability for selected analysis results to the data used as input. It also delivers a standard format for identification of key analyses, information about analysis methods used, ADaM datasets and variables used and the reasons why analyses were performed.  ARM supports regulatory review by linking results, documentation, and data together and enables reviewers to easily identify and understand how and why selected study results were generated.

End-to-end traceability using ARM

Define-XML facilitates the health agency review process by providing information about the structure and content of standard clinical data (SDTM and ADaM) in a machine readable format. It is an integral part of electronic submissions and supports the transmission of datasets along with their supporting metadata. Since the release of the ARM v1.0 specification, sponsors have begun to realise the benefit of including ARM in Define-XML and it is becoming more common practice.  With the addition of ARM, Define-XML provides end-to-end traceability from collected data to analysis results.

Automating the process for Define-XML with ARM

The process of generating Define-XML with ARM can be very time-consuming if it is handled manually and without proper planning. It can also be challenging because of compliance standards and data complexity.

ICON has developed a tool which automates the creation process for Define-XML. The contents of ADaM dataset specifications are used by the tool as well as annotations for selected analysis results. The metadata is pulled from Excel spreadsheets that are maintained in standard formats. The spreadsheets serve two purposes: teams can make use of the metadata in developing dataset and TFL programming and then again to generate Define-XML with ARM.