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Analyze lab management operation history

Under the Lab functionality of EDC, you can define the categories and normal ranges for laboratory tests performed for study participants.

The configurations made in the Lab module can significantly influence data collection and analysis, impacting the results and conclusions of the clinical trial. Thus, keeping track of all changes and user interactions for this functionality provides the vital traceability of all activities.

To analyze the lab management operation history
  1. In the EDC application header, select the STUDY INFO tab.

  2. In the left pane, select the Lab > Operation History subtab.

    Accessing lab operation history
    Figure 1. Accessing lab operation history

  3. On the Operation History page that opens, track the history of all activities as explained in the following table.

    Tracking operation history of lab module
    Figure 2. Tracking operation history of lab module

    Tip

    Select Refresh refresh_icon.png from the workspace toolbar to see the most recent history of operations.

    Column

    Details

    Path

    Represents the path to the subtab of the Lab module under which the activity was performed.

    Event Type

    Represents the type of action that was performed, such as Edit Lab Version, Edit Site Code for Lab Version, and so on.

    Description

    Represents the details of the performed operation. For instance, for lab version change, you can see the previous and new versions and their details, and for the change of site for the lab version, you can see for which site this version was made available.

    User

    Represents the name of the system user who performed the operation.

    Operation Time

    Represents the exact date, time, and time zone indicator of when the operation was performed.

By studying the operation history, you have analyzed the complete and most recent log of actions in the Lab functionality of EDC.