Informatics tools to improve clinical research study implementation

Background: There are numerous potential sources of problems when performing complex clinical research trials. These issues are compounded when studies are multi-site and multiple personnel from different sites are responsible for varying actions from case report form design to primary data collection and data entry. Methods: We describe an approach that emphasizes the use of a variety of informatics tools that can facilitate study coordination, training, data checks and early identification and correction of faulty procedures and data problems. The paper focuses on informatics tools that can help in case report form design, procedures and training and data management. Conclusion: Informatics tools can be used to facilitate study coordination and implementation of clinical research trials. (c) 2005 Elsevier Inc. All rights reserved.