Large trials generate many analysis results in the form of tables, figures, and written reports, yet these results are rarely output in a form that is machine-readable. Additionally, there is no standard way of describing and organizing these results, making it difficult to automate their generation, make them reproducible, trace their origin or enable them to be reused in other outputs.
To address these inefficiencies, CDISC is developing the Analysis Results Standards (ARS), which aim to facilitate automation, reproducibility, reusability, and traceability of analysis results data.
Use analysis results metadata to drive the automation of results.
Store, access, process and reproduce results.
Improve navigation and reusability of analyses and results.
Provide traceability to Protocol/SAP and to input ADaM data.
A Logical Model.
Analysis Results Metadata Technical Specification (ARM-TS) to prospectively define metadata to produce statistical analysis results and associated data displays.
Analysis Results Dataset (ARD): A standard supporting the exchange of statistical analysis results with a predictable, consistent, and interoperable structure and meaning.
For more information, please visit project progress on GitHUB.
The draft version of the ARS Logical Model is currently in its final stages of development and anticipated to enter Public Review in summer 2023.
TFL Designer Open-Source Tool
TFL Designer is a COSA-approved tool that aligns with the ARS and designs tables, figures, and listings as well as generates associated metadata to support clinical trial data analysis and reporting. A community-version release (access limited to beta users) is planned for later this year.