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Resolve assigned action items

An action item in CTMS is created to address the issue encountered during a certain monitoring visit. Thus, if you are responsible for completing an action to address an issue, you have a respective task in the CTMS system to complete.

In CTMS, all your tasks, including the action item ones, are conveniently comprised under a single interactive dashboard called My Work.

To resolve the assigned action items

  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 My Work page that opens, select the Action Items task category tile.

    Selecting action items tile
    Figure 3. Selecting action items tile

    Important

    Note that the task categories you see may differ depending on your user role and the set of tasks assigned to you in the system according to your field of responsibilities and company arrangements.

  3. In the table that appears, the action items of all statuses are displayed—Not Started and Ongoing. Optionally, select the number next to the status of your interest to filter the table appropriately and facilitate your search.

    Selecting action item status
    Figure 4. Selecting action item status

    Tip

    Select filter_icon_red.png to collapse the filter panel and return to the unfiltered task list.

  4. Locate the action item on which you want to work and select its ID value. Above the table displaying tasks, you can select the link provided next to Not Started or Ongoing to instantly filter the table and view and access the corresponding task in the table. Select filter_icon_red.png to reset the table to its original view.

    Selecting action item to work on
    Figure 5. Selecting action item to work on

    Tip

    You can view information on the issue related to this action item by selecting the issue ID value from the Related Issue column.

    Viewing related issue
    Figure 6. Viewing related issue

You have accessed the action item completion form.

Working on action item completion
Figure 7. Working on action item completion

Tip

Use the Action Items table to navigate between action items without returning to the My Work dashboard. Otherwise, select Back to My Work to return to your other task categories.

You can also use refresh refresh_icon.png to see the latest tasks or collapse collapse_icon.png or close x_icon.png the table if not needed.

In this section:

In CTMS, a finding that is discovered during a monitoring visit at a site and requires resolution. Issues can take many forms, depending on the nature and severity of the finding. An issue may also involve correcting data errors in subject records.

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.