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View protocol deviation record operation history

In CTMS, when you perform any action with a protocol deviation record, such as activate/inactivate, lock/unlock, or otherwise manage the record, the action is recorded in the history of operations for traceability and compliance.

The history of operations can be viewed for each record individually.

To view operation history for a protocol deviation record
  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, in the left pane, expand Protocol Deviation and select Protocol Deviation Record.

  3. On the page that opens, from the content panel, select the needed tab.

    Accessing protocol deviation records
    Figure 3. Accessing protocol deviation records

    Tip

    If the same protocol deviation template is associated with two or more entities—study, site, or subject—they are displayed in a single tab named through a slash, such as Study/Site, Study/Site/Subject, or else. Whereas, the entities associated with unique template forms are displayed in separate tabs, such as Study, Site, or Subject.

  4. In the table, locate the record for which you want to view the operation history.

  5. From the Actions column next to the needed record, select More more_actions_icon.png > Operation History history_icon.png.

    Selecting to view operation history
    Figure 4. Selecting to view operation history

  6. In the Operation History dialog that appears, view the log of all actions performed with the protocol deviation record.

    Viewing operation history
    Figure 5. Viewing operation history

  7. Select close_icon_red.png.

Once selected, the Operation History dialog is closed.