Architecture Design of Integrated Information System for Clinical Trial Management
Web-based information technology has changed the way clinical trials are managed. Commercially available clinical trial management system (CTMS) software could be prohibitively expensive for academic research institutions and hard to meet the needs of NIH funded large multicenter clinical research studies. Silo-type single task systems are difficult to reconcile information with each other, often causing data redundancies and discrepancies. To address these challenge, a web-based integrated information management system is developed by the Data Coordination Unit at the Medical University of South Carolina, which has been implemented for dozens research projects, including 10 ongoing NIH funded large multicenter phase III trials. With generic data processing modules, the system provides functions cover from electronic data capture, subject visits tracking, subject randomization with options for baseline covariate balancing and response adaptive treatment allocation, study drug/device distribution tracking range from packing, shipping, receiving, reporting of usage and damage and expiration, real time within panel and across panel case report form data validation, central data manager and site data monitoring data clarification request management, medical safety monitoring review and MedWatch report generation, central image review and scoring, central outcome adjudication, across-project regulatory document collection management, automatic and interactive coding for serious adverse events, study payment management, response adaptive treatment instruction, real time data retrieving and user configurable data reporting. This presentation will focus on the integration strategy and architecture design of the system.