CDISC is pleased to announce the draft Analysis Results Standard User Guide v1.0 is entering the Public Review period to solicit your feedback.
Analysis results play a crucial role in the drug development process, providing essential information for regulatory submission and decision-making. However, the current state of analysis results reporting is suboptimal with limited standardization and poor traceability. Currently, analysis results (e.g., tables, figures, and listings) are often presented in static, PDF-based reports that are difficult to navigate and vary between sponsors. Moreover, these reports are expensive to generate and offer limited reusability. The CDISC Analysis Results Standard (ARS) Model and accompanying User Guide have been developed to support automation, consistency, traceability, and reuse of results data.
Items for review:
Instructions for providing comments: Instructions for Reviewers
Public Review closes 11 December 2023.
You will need to log in or register for the CDISC Wiki to provide comments.
- Register for the Wiki. If you already have an account on Wiki or JIRA, our issue-tracking system, simply log in to your account; Wiki and JIRA use the same login credentials. CDISC Wiki is a different login from www.cdisc.org.
Public review is a key quality step in our Standards Development Process. CDISC relies on your input to ensure neutral, consensus-based data standards are developed and adopted by a diverse global community interested in improving research processes and quality for the benefit of all.
Thank you for contributing your time and expertise.