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KRI-central monitoring report

Key Risk Indicator (KRI) refers to the specific EDC parameters that are used to monitor the overall risk associated with the clinical trial. The KRIs are carefully selected by the study team as they are designed to track critical aspects of the study that can potentially lead to issues with patient safety, data quality, or the overall success of the trial.

Each KRI is usually based on a set of predefined thresholds that indicate whether the trial is on track or if there are potential issues that need to be addressed. For example, a KRI may be the number of adverse events reported, with a predefined threshold indicating when the number of adverse events has reached a high level that potentially can pose a risk to patient safety.

Other KRIs may include data quality metrics, such as the completeness and accuracy of data collected, patient recruitment rates, and protocol compliance. By monitoring these KRIs, the study team can quickly identify potential issues and take corrective actions to mitigate risks and keep the trial on track.

The KRI creation and management are done in the CTMS application, and the EDC system reflects the overall statistics pertaining to each KRI. In EDC, the KRI-related reports reside under the REPORTS tab > KRI-Central Monitoring subtab. This subtab comprises the following reports:

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.

An eClinical application that is mainly used to manage and control the personnel, communication, budget, progress, expenses, documents, and declaration involved in the entire clinical trial. It provides study and site management, study quality control, study progress tracking, project management, risk management, reports, and a visualized dashboard.

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