The CRIT sponsors and supports a variety of electronic data capture and clinical data management systems. Currently, the CRIT support the following three major systems.
Phase Forward InForm ITM™
The CRP applications development team employs the InForm Integrated Trial Management (ITM) system for all moderate and large-scale research projects. The system supports a variety of features including Web-based data capture, protocol tracking, clinical trials monitoring, and ad hoc reporting. The system provides a hierarchical view of each study participant, which allows study staff to manage study visits and case report forms as defined by the clinical protocol.
The InForm system employs a combination of Microsoft and Oracle technologies including ASP.NET, Web Services, Serviced Components (COM+) and Oracle 10g. The application provides adapters to accommodate the CDISC (Clinical Data Interchange Standards Consortium) object data model (ODM) and employs XML technologies to facilitate exchanging and transforming data between the client, server and data repository.
The data capture component validates user responses based on specified range checks, executes conditional logic and resolves outlier responses through an integrated query dialog. The system maintains a complete audit trail of transactions to ensure data integrity and regulatory compliance. The system provides staff with a variety of canned reports to assist project management. A comprehensive ad hoc reporting feature is also available. The study data may be readily exported for use with Microsoft Excel and SAS.
Please consult the Phase Forward Web site for more information regarding product functionality.
Boston Children's Hospital is a participating member of the REDCap Consortium. REDCap is an excellent product for use on studies requiring a simple Web-based data capture and reporting solution. Please review the REDCap Web site for more information regarding this product and product plans.
CHB Scientific Research Information Software (SciRIS)
The SciRIS framework is a comprehensive electronic data management and clinical data management system developed by the CRIT. It supports many of the features found in its successor, Phase Forward InForm. SciRIS and InForm are based on similar technologies and functionality. Please contact the CRIT for more information regarding the status of this product and future use.