Sarcouncil Journal of Multidisciplinary

Abstract: The growing complexity of clinical trials necessitates innovative solutions for efficient and accurate data management across diverse therapeutic areas and multi-site international environments. Case Report Forms are the main instrument for collecting trial-specific information, but conventional CRF design and data gathering processes remain time-consuming, error-prone, and slow to respond to protocol changes that are quite common during trial execution. Artificial Intelligence provides a revolutionary solution by providing adaptive CRF design and data standardization through automated means, so they always conform to changing requirements of protocols while remaining safe and compliant with data integrity and regulations. AI-based protocol-adaptive CRFs can respond dynamically during trial execution by automatically detecting affected data fields upon protocol changes, proposing the changes, and updating validation rules without the need for extensive manual intervention or system downtime. In addition to that, AI also makes automated data mapping and standardization possible between sites and various data sources, transforming raw clinical data into standardized formats like CDISC SDTM or MedDRA with outstanding accuracy rates. This technology guarantees hassle-free aggregation and integration, and allows for timely interim analysis and regulatory submissions globally among regulatory agencies. The incorporation of AI technologies into clinical data management systems creates enormous gains that go beyond single process gains to change overall collaborative processes within clinical trial teams, providing real-time visibility into data quality metrics, protocol compliance indicators, and standardization progress. By incorporating AI into CRF design and data management, clinical trial operations gain enhanced efficiency, decreased errors, better collaboration between cross-functional teams, and faster regulatory readiness, all leading ultimately to faster delivery of effective and safe treatments to patients globally.