Training Description:
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, lack of automation, and poor traceability. Currently, analysis results (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.
To address these issues, the CDISC Analysis Results Standard (ARS) team has developed a logical model to support consistency, traceability, and reuse of results data. This hands-on implementation training will provide an in-depth overview of the ARS model and practical examples illustrating the implementation of the model using common safety displays.
Join this four-hour hands-on implementation training consisting of:
- ARS v1.0 project overview including business cases.
- A description of artifacts included in ARS v1.0.
- A detailed review of the main components of the ARS v1.0 model and how they are used to define analyses and outputs.
- Exercises to help reinforce attendees’ understanding of the main components of the model.
- Discussion of the components of the ARS v1.0 model that support production of ARM for Define-XML.
- Discussion and example of how ARS v1.0 can support the implementation of the FDA Standard Safety Tables and Figures Integrated Guide
- A review of ARS v1.0 implementations including a demonstration of the automation of analysis through use of ARS metadata.
- Exercises that allow attendees to create ARS metadata using the TFL Designer.
- Overview of the upcoming eTFL portal and associated assets.
Learning Outcomes
At the end of this training, learners will be able to:
- Explain how ARS facilitates automation and regulatory compliance in analysis reporting
- Describe the CDISC Analysis Results Standard (ARS) model and its key components
- Apply the ARS model to define and structure analysis results
- Utilize the TFL Designer tool to create ARS metadata
Vendor Neutrality Disclaimer
- CDISC is vendor-inclusive and does not endorse any specific vendor or technology in the use of its standards.
