WebDCU™: Site Monitoring Module
The goal of monitoring is to ensure that the subjects are safe, the trial is being conducted appropriately and that the data is accurate.
The Monitor Module in WebDCU™ represents a centralized effort to ensure that sponsors can fulfill their responsibilities related to the monitoring trial conduct and data quality overall and at the individual clinical centers.
This module is divided into 2 components, central monitoring and site monitoring.
Risk-based Centralized Site Monitoring
Central monitoring is done remotely, based upon real time information in the database, and allows for aggregate review and comparison within/across sites. When problems/patterns are identified via central monitoring, a site monitor can conduct an onsite visit to further investigate. Site monitoring is done at the enrolling centers and entails source document verification. The WebDCU™ supports both central and site monitoring efforts by defining work to be completed by monitors, identifying risky sites and CRFs based on data correction rates, allowing for the adjustment of the monitoring plan as risks are identified, automatically composing and storing monitoring reports based upon information entered into WebDCU™, tracking corrective actions required at site, and supporting remote monitoring. This module maximizes the efficiency of monitoring, reduces redundancy, and allows for the targeted use of available resources and allows the sponsor to efficiently and effectively monitor the trial conduct across all participating clinical centers using a combination of remote and on-site monitoring.
On-Site Monitoring
The WebDCU™ is designed for the site monitors to retrieve the most up-to-date information on the progress of studies they are involved in, including screeningn logs, subject enrollment, CRF collection, DCRs, adverse events, and study material inventory.
The WebDCU™ on-site supporting tools includes subject selection (100% or partial), monitoirng visit planner, final visit report creation, Corrective and Preventive Action (CAPA) communication, and project manager monitoring review. In case any critial issue identified by the site monitor, the site is expected to respond to each CAPAs, which is reviewed and closed by the site monitor.
Site Performance Monitoring
The WebDCU™ is powered by an integrated site performance evaluation metric that provides summarized and searchable information on subject recruitment, subject study progress, Case Report Form (CRF) data collection timeliness and completeness, Data Clarification Request (DCR) processing, protocol violations, Serious Adverse Event reporting, regulatory document collection and tracking, and findings from site monitoring visits conducted by monitors as well as the central coordination center.
