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Work on potential PDs pending audit

When managing a study in CTMS, you can access all your tasks from a single interactive dashboard called My Work. This dashboard features all your tasks conveniently categorized by tiles.

One of the tiles comprises all your tasks related to auditing the potential protocol deviations (PDs). With this functionality, users in charge can directly access all the potential PDs—submitted manually or script-generated—awaiting their review and approval.

To work on potential PDs pending audit

  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 Potential PDs task category tile.

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

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

    Tip

    To facilitate your search, select the number next to the potential PD type of your interest—Potential PDs Entered Manually or Potential PDs Generated by Script—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 potential PD auditing page.

Potential PD auditing page
Figure 5. Potential PD auditing page

Tip

Use the Potential PDs table to navigate between potential 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 records or collapse collapse_icon.png or close x_icon.png the table if not needed.

In this section:

A divergence from the IRB or sponsor-approved study design or procedures defined in the protocol, consent document, or study materials. 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 criteria, failing to perform a required lab test, and so on.