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Export indicator data

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 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.

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 monitors to analyze study management activities in order to initiate any required corrective actions. You can download the data pertaining to a specific indicator in XLSX format to your computer so you can work with this data offline.

To export the indicator data

  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.

    Accessing indicators
    Figure 3. Accessing indicators

  3. From the workspace toolbar of the Indicators table that appears, select the needed indicator.

    Selecting indicator
    Figure 4. Selecting indicator

    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.

  4. Then from the same workspace toolbar, select Export export_icon.png. Then choose if you want to export data from all the indicators or the specific indicator selected previously.

    Exporting indicator data
    Figure 5. Exporting indicator data

  5. The downloads widget appears showing the export progress. Select the widget to access exported files.

    Downloads widget showing indicator data being exported
    Figure 6. Downloads widget showing indicator data being exported

  6. In the My Downloads dialog that appears, in the Download is Ready tab, select download_icon.png next to the required exported file.

    Downloading indicator data
    Figure 7. Downloading indicator data

Once selected, the data pertaining to a specific indicator is downloaded in the XLSX format to your computer. You can now work with it offline.

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.