Research Tools Overview

DCU has established a steadfast infrastructure for web-based data capture and data sharing, including designated web servers and supporting database servers. User-friendly web-based database systems have been developed, validated and used by DCU for on-line subject registration, randomization, data entry, data validation, project progress monitoring, data processing monitoring, user customizable report generation, lab specimen tracking, secure data transfer and coordination of study medication packing, delivering, and acceptance. Data is directly entered into the database via a secure internet connection.

The web system combines all study tools into one system which includes study database, online training and help desk, CRF printing, subject calendar, electronic DCR process, case report form and participate tracking system, audit trail, and report generation mechanisms. These reporting mechanisms are useful for study specific safety reports and data timeliness reports. The reporting mechanism allows the PI to access real-time data that has been entered into the system and validated. In addition the user can retrieve enrollment status (by graph and table format), basic demographics and data summaries such as number of visits completed, number of resolved queries and outstanding queries. Summaries can be broken down by site, subject and date.

In addition, authorized users can access safety reports containing summary information on adverse events. Blinded studies are not compromised with this reporting mechanism.