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 has developed the Analysis Results Standard (ARS), which aim to facilitate automation, reproducibility, reusability, and traceability of analysis results data.
Key Objectives
- 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/Statistical Analysis Plan and to input ADaM data.
Key Results
- A Logical Data Model that describes analysis results and associated metadata.
- A User Guide to illustrate and exercise the model with common safety displays.