Skip to main content

Analyze operation history of autoexecution task

The autoexecution tasks added to CTMS to trigger for a certain event—monitoring visit creation or KRI email notification—can be modified in the course of a clinical trial. It is vital to keep record of such changes for compliance and traceability reasons. The operation history provides an exhaustive, structured log of events, helping you trace what they were, who performed them, and when.

To analyze the operation history of an autoexecution task

  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. From the left pane of the study page that opens, select RBM > Auto-execution Engine.

    Accessing autoexecution engine
    Figure 3. Accessing autoexecution engine

  3. In the Auto-execution Task List table that appears, next to the needed autoexecution task, select More more_icon.png > Operation History history_icon.png.

    Accessing operation history of autoexecution task
    Figure 4. Accessing operation history of autoexecution task

  4. In the Operation History dialog that opens, analyze the details of all the actions performed with the autoexecution task from its creation and up to date.

    Analyzing operation history of autoexecution task
    Figure 5. Analyzing operation history of autoexecution task

You have analyzed the operation history for the autoexecution task. You can now select OK to close the dialog and return to Auto-execution Task List.

In this section:

An activity in which a monitor, usually a clinical research associate (CRA), visits sites to review and verify study-related activities, including data collection, patient safety, and adherence to the study protocol. The monitor also verifies that the study complies with relevant regulatory requirements and GCP guidelines.

A specific measurement used to monitor and assess potential risks associated with the conduct of the trial. They provide early warning signs of potential issues or deviations that may impact participant safety, data integrity, or the overall success of the study.

Examples of KRIs can be AE report timeliness or query resolution time. The delays in both activities may be considered a sign of the study personnel's neglect. Thus, monitoring is required to ensure the proper conduction of trial activities.