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View system document operation history

Data acknowledgment before the end of the study is a process of confirming the receipt and accuracy of data and findings collected during a clinical trial.

In the EDC application, you can define the system documents that have to be acknowledged before the end of the study and then create individual tasks per each system document to be acknowledged and downloaded by the dedicated personnel before the data is archived.

For traceability and transparency, System Document History comprises the complete log of operations with files under the System Document page, such as task creation, data acknowledgment, file download, and task deletion.

For instance, the data acknowledgment task has been assigned to your role and you see that it is already acknowledged and want to discuss this with the user who performed the action. Using the System Document History log you can identify the operator of such action.

To view the system document operation history
  1. In the EDC application header, select the REPORTS tab.

  2. On the page that opens, in the left pane, select End of Study > System Document History.

    Accessing system document history
    Figure 1. Accessing system document history

  3. On the System Document History page that opens, view the details of operations on the data acknowledgment tasks for the system documents.

    Analyzing system document history
    Figure 2. Analyzing system document history

You have viewed the history of operations with the data acknowledgment tasks for the system documents.