Abstract:

The CDISC Analysis Results Standard (ARS) Team is developing standards to improve and facilitate the automation, reproducibility, reusability, and traceability of analysis results (Tables, Figures and Listings, aka TFL). The team is working towards this objective by creating a logical model to incorporate the elements for both analysis results and associated metadata.

In this paper, we will provide a comprehensive overview of the CDISC Analysis Results logical model, including its background and development. We will discuss the current state workflow and challenges faced by analysts, as well as the future state envisioned with the introduction of the machine-readable analysis results metadata and analysis results data structure to automate the generation of statistical outputs and displays. We will describe the model's elements using examples to give a better understanding of the model itself and how it can improve traceability, reproducibility, and quality in clinical trial analysis and reporting.

is recognize…