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Initiate data-driven monitoring

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 seamless data flow between CTMS and EDC, allowing CTMS to access EDC data, which includes subject enrollment, adverse events, laboratory results, and other relevant trial data.

To start monitoring the data in the CTMS system, you need to initiate the process.

To initiate data-driven monitoring

  1. Access the study management page in one of the following ways:

    • In the CTMS application header, select the DASHBOARD tab and then select the study dashboard of your interest.

      Accessing study management from dashboard
      Figure 1. Accessing study management from dashboard

    • In the CTMS application header, select the STUDY MANAGEMENT tab. Then from the Study Data List table, select the study name of your interest.

      Accessing study management from study data list
      Figure 2. Accessing study management from study data list

  2. On the study page that opens, in the left pane, expand Data-driven Monitoring and select Indicators.

  3. Next to the name of the Indicator table that appears, select Setting gear_blue_icon.png.

    Accessing indicator settings
    Figure 3. Accessing indicator settings

  4. In the Setting tab of the dialog that appears, select checkboxes next to the indicators whose pertaining data you want to retrieve from EDC. Then select save_button.png.

    Applying indicator settings
    Figure 4. Applying indicator settings

  5. Then from the workspace toolbar, in the Indicator dropdown menu, select the needed indicator.

    Selecting indicator
    Figure 5. Selecting indicator

    Important

    Every selected indicator generates its variety of columns in the Details table that appears next. These columns represent risk assessment data describing in detail each selected indicator, allowing for precise analysis and monitoring.

  6. In the Details table, view the risk assessment data extracted from EDC. Note that the data may not be available right away due to synchronization activities between CTMS and EDC. It can take some time before the data appears in the table.

    Viewing indicator data
    Figure 6. Viewing indicator data

    Tip

    In the toolbar of the CTMS application, you can select the country and site to filter the indicator assessment data in the Details table. The columns vary depending on the indicator as the data extracted from EDC can have different meanings.

Once viewed, you can now export the specific indicator data to your computer.

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.