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Data-driven monitoring

Traditionally, monitoring in clinical trials involves on-site visits by monitors to ensure protocol compliance, data accuracy, and participant safety. The data-driven monitoring utilizes the real-time data collected through the EDC system to provide insights and enable remote monitoring, reducing the need for frequent on-site visits. This integration enables data flow between CTMS and EDC, allowing CTMS to access EDC data, which includes subject enrollment, adverse events, laboratory results, and other information.

Since data is accessible remotely through the CTMS application, monitors can perform their monitoring activities without being physically present at study sites. They can review and verify data electronically, collaborate with site personnel, and provide guidance remotely. Remote monitoring reduces travel costs and minimizes disruption to sites, making monitoring more efficient.

All data-driven monitoring activities are done under the Data-driven Monitoring tab of CTMS. Within this tab, you can switch between different risk assessment indicators that provide the overall statistics on various aspects of the clinical trial. This statistical data can help the monitor to analyze study management activities so they can initiate any required corrective actions.

In this section, you can learn how to do the following:

In this section:

An eClinical application that is mainly used to collect and manage subject data during clinical trials. It integrates with the Study Designer (SD) application and uses preconfigured there case report forms (CRFs) to complete data collection and management. It also provides an audit trail, data alert, source data verification (SDV), payment management, adjudication, and other functions as well as supports data export according to the CDISC ODM standard.

Get to know all the possibilities of the app with the comprehensive EDC User Guide.

Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.