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Work on assigned PD records

The protocol deviation (PD) occurs when there is an unintended and unexpected divergence from the expected or Institutional Review Board (IRB)-approved protocol. The deviation can occur due to multiple reasons, such as a subject missing their visit, enrolling a participant who did not meet all the inclusion/exclusion criteria, failing to perform a required lab test, and so on.

If you have any PD records that require your attention in CTMS, the respective task is assigned to you in the system. For your convenience, all the tasks pertinent to a certain study, including PD ones, are comprised under a single interactive dashboard called My Work.

To work on the assigned PD records

  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 Protocol Deviation task category tile.

    Selecting protocol deviations tile
    Figure 3. Selecting protocol deviations 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, all the PD records assigned to you are displayed. Locate the PD on which you want to work and select its Record ID value.

    Selecting PD record to work on
    Figure 4. Selecting PD record to work on

    Tip

    To facilitate your search, select the number next to the PD record status of your interest—Initial or Completed—to filter the table appropriately. Select filter_icon_red.png to collapse the filter panel and return to the unfiltered task list.

You have accessed the protocol deviation completion page.

Working on PD record
Figure 5. Working on PD record

Tip

Use the Protocol Deviation table to navigate between PD records 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 PD records or collapse collapse_icon.png or close x_icon.png the table if not needed.

In this section:

Also known as an Independent Ethics Committee (IEC) in the European Union, the Institutional Review Board is a group that is formulated and formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research.