The Protocol Deviations Dashboard within Data Central provides a centralized location for documenting, standardizing, and managing Protocol Deviations (PDs) for a study. This oversight allows users to quickly identify deviation trends that may put the study at risk if not addressed.

Protocol Deviations can be entered manually, or source data can be imported into elluminate and mapped to the PD Staging area.

Permissions: Users with the Protocol Deviation View privilege can access a read-only view of the PD Dashboard.
Users must have the Protocol Deviation Edit privilege to manually add or edit PD records from the PD Dashboard.

PD Dashboard Overview

The PD Breakdown metrics provide an overview summarizing the deviation counts, the importance ratio, top standard categories, and review progress and status counts.

The interactive list of all PD records includes both manually created and imported PD records, where users can view and create new PD records, and move them through the PD management workflow by editing.

Tip: Easily understand and manage Protocol Deviation importance by viewing the PDAP Importance Classification and the Importance Override (Yes / No) columns side-by-side, both on the dashboard for quick identification and during editing for informed override decisions.

Columns can be sorted, filtered, repositioned, fixed, and hidden.

Note: Other Data Central listings cannot be docked on the PD Dashboard; however, they can be opened and float on top of the PD Dashboard.

Access the PD Dashboard

The PD Dashboard is accessed in Data Central from the left navigation. It opens as a new sheet on the workspace.

Columns in the Protocol Deviations listing include a record selection checkbox, Comments, Status, Site, Subject, Description, Start Date, End Date, External Comments, Code, Standard Category, Standard Description, PDAP Importance, Importance Override, External Source, Deviation Source, ID, Identified Date, PD Type, Category, Source Importance, External Status, Reviewed Date, Reviewed By, Last Updated Date, and Last Updated By.

Tip: For manually created PDs, the ID column displays in the format 'MAN-PD-####', making it easier to reference and collaborate during PD review.

Toolbar Icons

Customize the PD Dashboard

Users can refine the PD Dashboard view by configuring field visibility, repositioning columns, and fixing columns as needed during PD review.

These options allow users to customize the PD Dashboard layout and improve access to Protocol Deviation data.

Configure Field Visibility

Any column can be removed from view to streamline the review process. The selected configuration is retained per user and per study and is applied each time the PD Dashboard is accessed for that study.

1. Click the Protocol Deviations Settings icon in the Protocol Deviations listing to open the Settings window.
   
2. Select the fields to hide from the PD listing. 
3. Click Save. 
4. Use the Toggle Hidden Variables icon to view only the selected variables in the list.
5. Use the Restore Default Variable Settings icon to clear all selections and restore the default variable settings.

Reposition Columns

Repositioned columns remain in place until the window is closed or the workspace changes.

1. Click and hold a column header in the Protocol Deviations listing.

2. Drag the column to the desired position on the dashboard.

3. Release the column to place it. 

Fix Columns

Fixed columns remain in place across user sessions and support faster navigation during PD review.

1. Right-click a column header in the Protocol Deviations listing.

2. Select Fix > To the left or To the right.

3. Select Unfix to remove the fixed column setting.

View Record Details

The Details panel can be used to see the details and comments for a record in one panel. 

Highlight a record in the PD listing and click the Details icon, or double-click a record.

Click Comments at the bottom of the window to expand the section and view existing comments.

Toolbar Icons

Add a Protocol Deviation

Manually add a Protocol Deviation.

1. From the PD list, click the Add Protocol Deviation (plus sign) icon. The Add Protocol Deviation window opens.
   
2. Enter each field accordingly:
   1. Deviation Type (Required): The level at which the PD occurred. For example, Study, Country, Site, or Subject. If Country or Subject is selected, the user can select the relevant input.
   2. Description (Required): The description of the PD that occurred.
   3. Identified Date: The date the PD was first identified or recognized.
   4. Start Date: The date the PD started.
   5. End Date: The date the PD was resolved.
   6. Status: The current PD management workflow status of the PD. Unreviewed is selected by default.
   7. Select Applied PDAP Entry: Click to select from the Study PDAP list to apply that standard to the PD. Aids with PD metric tracking and identifying trends.

   8. Comments: (Sometimes Required): Enter relevant text.

      Note: The title of the comments field dynamically updates based on the selected status to guide users to provide relevant information. For example, Additional Protocol Deviation Context, Reviewed Context, or Reason for Follow-Up.

3. Click Save.

Edit a Single Protocol Deviation Record

The workflow for a PD is managed by editing a record. 

1. Highlight a row to edit.
2. Click the Edit Protocol Deviation (pencil) icon. The Edit Protocol Deviation window opens with Deviation Details displayed on the left, workflow review items in the center, and Deviation Comments on the right.
   
3. Status: Update the PD management workflow status.

   1. Select from: Unreviewed (default), Reviewed, Requires Follow-Up, or Canceled.

      Important: Imported PD records marked 'Reviewed' in Data Central that contain updates to priority fields in the external source automatically change to 'Re-review' upon import.

4. Select Applied PDAP Entry: Click to change the Study PDAP applied to the PD, or select a PDAP if one was not selected when the PD was created.
5. PD Code: This displays based on the selected Study PDAP, if a Study PDAP was applied.
6. PDAP Importance: Displays if the PDAP was marked as 'Yes' for Importance. This field is read-only.
7. Importance Override: Select Yes or No to override the PDAP Importance setting.
8. Standard Category: Displays the standard category.
9. Standard Description: Displays the standard description.

10. Comments (Sometimes Required): Enter relevant text.

    Note: The title of the comments field dynamically updates based on the selected status or changes to the PDAP standard. This prompts users to enter context-appropriate information, such as Reason for Canceling, Reviewed Context, or Reason for PDAP Standard Change. If both the status and PDAP standard are changed, the title of the comments field displays Reason for PDAP Standard Change and becomes required.
    All deviation comments display in the Deviation Comments section on the right.

11. Click Save.

Edit Multiple Protocol Deviation Records

Multiple PD records can be edited regarding review status and PDAP standards.

1. Select multiple records by checking the checkboxes in the left column, or select the header checkbox to select all records.
2. Click the Edit Protocol Deviation (pencil) icon. The Bulk Edit Protocol Deviation window opens with selected deviations on the left and workflow review items on the right. 
   
3. Status: Update the PD management workflow status.

   1. Select from: Unreviewed (default), Reviewed, Requires Follow-Up, or Canceled.

      Important: Imported PD records marked 'Reviewed' in Data Central that have updates to priority fields in the external source automatically change to 'Re-review' upon import.

4. Select Applied PDAP Entry: Click to change the Study PDAP applied to the PDs, or select a PDAP if none was selected when the PDs were created. When a PDAP Standard changes, additional details display.
   1. Select a PDAP, and click Select.
      

5. Comments (Sometimes Required): Enter relevant text.

   Note: The title of the comments field dynamically updates based on the selected status or changes to the PDAP standard. This prompts users to enter context-appropriate information, such as Reason for Canceling, Reviewed Context, or Reason for PDAP Standard Change. If both the status and PDAP standard are changed, the title of the comments field displays Reason for PDAP Standard Change and completion becomes required.

6. Click Save.

View or Add PD Comments

Comments are added when a record is added or edited, and can be accessed from the PD list.

1. Click the number in the Comments column for a record. The Comments window opens.
   
2. Any existing comments are displayed in the lower section of the window.
3. To add a comment, enter text in the Your comment here field.
4. Click Add. The window automatically closes.

Export Protocol Deviation Records

Users can export Protocol Deviation (PD) records directly from the Protocol Deviations listing, providing flexibility for sharing and analyzing PD data at the desired level of detail. The export includes two options: exporting PDs with comments or exporting PDs without comments.

1. Click the Export icon in the Protocol Deviations listing.

2. Select Export Protocol Deviations or Export Protocol Deviations with Comments.

3. The Excel file downloads.

When the Export Protocol Deviations with Comments option is selected, the exported file includes a Comments column that displays each record’s comments in descending chronological order. The column includes the username, comment type, and timestamp, with each comment separated by dashed lines for clarity.

Best Practices for Protocol Deviations

• Apply a PDAP as early as possible. When adding a protocol deviation, it is best to include the PDAP (Protocol Deviation Assessment Plan) during creation or initial review to speed up the workflow and minimize rework. Note that a PD record cannot be saved in Reviewed status without a PDAP. It is recommended to use mappings for imports to automatically apply PDAP entries, ensuring that records are pre-classified where applicable.
• Customize the PD Dashboard to streamline review. Use the dashboard configuration options to tailor the Protocol Deviations listing to the needs of each user. Hide unused fields to reduce visual noise and focus on relevant data. Reposition frequently referenced columns and fix key identifiers such as Site, Subject, or Status to the left or right to maintain visibility when scrolling. These adjustments support faster navigation, improve data interpretation, and enhance efficiency during PD review activities.
• Record review actions and reasons in the Edit window. Use the Edit Protocol Deviation window for any needed PDAP assignment or adjustments, and importance overrides, and to add comments explaining reasons for any status changes. The required comment field changes based on the selected status (for example, choosing Canceled prompts for a Reason for Canceling). These embedded notes create a clear history of activity on the record and speed up follow-up, by keeping that activity attached to the PD.
• Specify the records to be selected before performing bulk edits. Filter and choose only the PD records that have the same Status and the same Applied PDAP Entry, and provide a shared context comment. Run separate bulk edits for different outcomes to prevent unintended status changes or PDAP reclassification.
• Clearly define re-review triggers. A re-review trigger is an imported field that, when changed from the previous import, automatically updates the Status to Re-Review. The list of tracked fields is set by eCS at the environment level; submit a request to eCS to add or remove fields. Eligible fields include Category, Description, Importance, Identified Date, Start Date, and End Date. Limiting the tracked fields helps reduce unnecessary re-reviews.