CDASH and SDTM for Clinical Trials and Reporting

Authors

• J Singh
• H Kandaswamy
• JD Otoo
• P Gumne
• M Duvenhage
• CJ Whalen
• M Tartakovsky

Abstract

The NIH/NIAID/OCICB provides clinical research data management tools for protocols that require prospective management and oversight by scientific investigators and study teams to ensure capture of accurate and consistent data. To take advantage of new oversight and management tools the data must be transportable to data warehouses and other tools. By capturing the data in a consistent model like CDASH/SDTM ensures that it is possible to move data in a timely way for trial planning and decision-making. We describe a process of creating an integrated solution that uses recognized CDISC CDASH standards. We will demonstrate a Clinical Data life cycle from building case report forms (CRF) using CDASH then mapping those clinical database source systems into the standard SDTM data model using extraction, transformation, and loading, and creating visualizations. The process and data model support integrating historic with active studies and provide longitudinal data analysis. Using CDASH to build CRFs provides an effective approach for cross-protocol analysis and a centralized reporting framework for common data indicators and trial meta-data. These are important tools for managing clinical trials and observational research. This implementation also help us understand pros and cons of using the CDISC standardized model for protocols. Implementing CDASH and our Study Visuals system provides a model for other institutions with clinical research data that have similar needs.

Scientific Focus Area: Research Support Services

This page was last updated on Friday, March 26, 2021