Configure the Integrated Data Review Plan (IDRP) in Data Central Configuration

Permissions: Users with the Data Central or Study Configuration privileges can configure an Integrated Data Review Plan within Data Central Configuration. Note that Data Central users must also have a role other than Read Only.

The IDRP (Integrated Data Review Plan) is configured for a study within Data Central Configuration.

Access Data Central Configuration

From a study card on the Data Central Studies page, either click the red triangle (visible when the study is not yet configured) or click the Configuration icon, then select Data Central Configuration.

Access Configuration Study Card

From within a Data Central study, access Data Central Configuration using the Configure icon in the master header.

Open a study in Data Central.
Click the Configure icon in the master header.
Select Configure Data Central Settings.

The Data Central Configuration window opens. Select Review Plan in the left navigation. Users without the Study Configuration privilege and with a Data Central Reviewer role see only the Review Plan tab.

Create Review Objectives

If no review objectives exist, the page displays options to create review objectives manually, import objectives from the Global Library, import objectives from Excel, or download the Review Objectives template. Populate the template and import it as needed.

Review Objectives Grid

When review objectives exist, the Review Objectives grid displays.

The blue badge shows the count of filtered review objectives.

All columns support filtering, sorting, and fixing. The grid uses standard Data Central functionality.

To filter rows by value, right-click a value in the grid and select Filter Rows By Value. The blue badge updates to show the number of rows selected, and the filter icon in the badge indicates that a filter is applied. Click the badge to open the popout to view or clear filters.

Select a record to display the review objective details in vertical format to the right of the table.

Toolbar Actions

Right-click a review objective to access key actions without using the toolbar icons. The menu adjusts based on whether one or multiple review objectives are selected.

See sections below for instructions on each action.

Go to Data Central: Click to exit Data Central Configuration and return to the study in Data Central.
Search: Enter text in the search field, then click the Search icon or press Enter to find matches across all columns in the grid. Matching text displays in blue.
Add: Click to open the Add Review Objective window.
Action: Click to update the Approval Status for selected review objectives. Available actions depend on the current status. Approved objectives are locked and require versioning before changes.
Copy: Select one review objective, then click the Copy icon to open the Copy Review Objective window.
Edit: Select one review objective, then click the Edit icon to open the Edit Review Objective window.
Delete: Select one or multiple review objectives, then click the Delete icon to open the Delete Objective window.
Activate: Select one or multiple review objectives, then click the Activate icon to activate the selected review objectives.
Deactivate: Select one or multiple review objectives, then click the Deactivate icon to inactivate the selected review objectives.
Export: Click the Export icon and select Export to Excel to download the filtered list of review objectives, or select Promote to Global Library to promote the selected review objectives to the Global Library. For more information, see the Promote Review Objectives to the Global Library section.
Import: Click the Import icon and select Import from Excel to import a list of review objectives from an Excel file, or Import from Global Library. For more information, see the Add or Edit Review Objectives Via Import or Import Review Objectives From Global Library sections.
Download Excel Template: Click to download an Excel file with all required columns for import.
Bulk Edit Grid: Click to open an editable grid for updating multiple review objectives and / or multiple fields. Enter, copy, paste, or drag values to modify supported fields. The grid validates all changes on save and displays errors or warnings in place.

Add Review Objectives Manually

Click the Create Objectives button under No Objectives Defined, or click the Add icon in the Review Objectives toolbar.
The Add Review Objective window opens. The top left displays the review objective version, and the top right displays the Comments & Activity button.
Add Review Objectives manually

Tip: Hover over info icons to see details about each field.

Enter Review Objective Details

Review objective details display on the left side of the window. Review materials display on the right. Required fields display with a red asterisk and red border.

Enter fields on the left side of the window (Objective Details).
- Identifier: Enter a unique alphanumeric value (up to 16 characters). The same values cannot be used within a study. Once a review objective is saved, the Identifier cannot be edited.
- Review Objective: Enter the review objective (5000-character limit).
- Primary Domain: Select the primary domain associated with the objective. The drop-down list includes all domains within the study.
- Secondary Domain(s): Select any additional domains associated with the objective.
- Field(s): Select the fields associated with the objective. The list adjusts as domains are added. Expand a domain to view its fields. Fields with orange text and an exclamation icon indicate critical fields as defined in Metadata.
- Priority: Select the priority. The default options are High, Medium, and Low. To update priority options, go to Platform Administration > Configuration, select the Review Objective Priority tab, and update priorities as needed.
- Risk(s): Select the associated risk(s) from the drop-down. The list displays risks from the latest finalized Risk Assessment in RACT to ensure alignment with study risks. This field is grayed out if no risks exist for the study.
- Reviewer Role(s): Auto-populated with the logged-in user’s reviewer role. Select one or more reviewer roles as needed.
- Programmatic Review Frequency: Select the frequency (On Data Refresh, Daily, Weekly (default), Monthly, Quarterly, or Annually), then use the calendar to select the start date, hour, and minute. Default is Weekly and the current day of the week at midnight.
  - If On Data Refresh is selected, select the timeframe in which the review materials need to be reviewed from the Completion Timeframe drop-down: 24 Hours, 48 Hours, 3 Days, 5 Days (default), 1 Week, 2 Weeks, or 1 Month.
- Manual Review Frequency: Select the frequency (Daily, Weekly (default), Monthly, Quarterly, or Annually), then use the calendar to select the start date, hour, and minute. Default is Weekly and the current day of the week at midnight.
  
  Note: Review Objective Review Cycle Notifications
  
  When Review Objective Notifications are enabled for a user, either through the Review Objective Notifications column or the Receives Review Objective Notifications checkbox in Reviewer Roles configuration, the user receives reminder and missed-cycle notifications based on the Review Objective’s configured review frequency.
  Notification behavior by frequency:
  Daily: No reminder or missed-cycle notifications are sent.
  
  Weekly: Reminder notifications are sent 2 days before and 1 day before the review cycle end. On the final day, if the review is not completed, a missed-cycle notification is sent and the review cycle is reset.
  
  Monthly: Reminder notifications are sent 15 days from the start date, 2 days before, and 1 day before the review cycle end. On the final day, if the review is not completed, a missed-cycle notification is sent and the review cycle is reset.
  
  Quarterly: Reminder notifications are sent 45 days from the start date, 2 days before, and 1 day before the review cycle end. On the final day, if the review is not completed, a missed-cycle notification is sent and the review cycle is reset.
  
  Annually: Reminder notifications are sent 180 days from the start date, 2 days before, and 1 day before the review cycle end. On the final day, if the review is not completed, a missed-cycle notification is sent and the review cycle is reset.
  
  To configure Review Objective Notifications, see the Configure Data Central article, Assign Reviewer Roles section.
Enter fields on the right side of the window (Review Materials).
Programmatic – Review Materials systematically tracked and factor into Objective Status.
- Data Central Listing(s): Select one or more listings used for review. The list includes domains and listings enabled for data review.
- eIQ Review Model: If enabled, select a model.
- Orchestrator Rule: If enabled, select a rule.
Manual – Review Materials not systematically tracked but factor into Objective Status.
- Data Central Visualization(s): Select one or more visualizations. The list includes only visualizations saved as Public.
- Data Central Workspace: Select a workspace. The list includes only workspaces saved as Public.
- Analytics App: Select an Analytics app enabled for the study.
- App Sheet(s): Select one or more sheets. The list includes only Public and Community sheets for the selected app.
- RBQM Dashboard: Select an RBQM dashboard.
- Additional Instructions: Enter any additional instructions, such as those related to the review workflow (2,500-character limit).
- State: The state of the review objective remains ‘Draft’ until at least one Review Material is selected. Use the toggle to select Active or Inactive. Update the state as needed based on milestone or lock activities. For example, before a lock, set review objectives to inactive to freeze their status. Inactive review objectives still display in Data Central but are not recalculated. After the milestone or lock is complete, set the review objectives to active again.

Click Save & Submit For Approval, Save, or Cancel to cancel the action. The review objective is added to the Review Objectives list based on the Identifier.

Copy a Review Objective

Select a review objective.
Click the Copy icon, or right-click and select Copy. The Copy Review Objective window opens.
Identifier: Enter a unique alphanumeric value (up to 16 characters). The same value cannot be used more than once within a study.
Edit other fields as needed. See the Enter Review Objective Details section for details on each field.
Click Save & Submit For Approval, Save, or Cancel to cancel the action.

Add or Edit Review Objectives Via Import

The approval workflow applies to Review Objectives created or updated through Excel import. The Import Summary displays warnings or errors when approval-related validations fail.

There are multiple options for adding and editing review objectives:
- Use the template: Click the Download Excel Template icon in the Review Objectives toolbar. The Excel file downloads. It contains all column headers needed for a successful import.
- Export the existing grid: Click the Export icon in the Review Objectives toolbar and select Export to Excel. The Excel file downloads. It includes all the data in the grid.
Populate or edit the Excel file, then save the file locally.
Click the Import icon and select Import from Excel.
Drop or add the updated Excel file to the import window.
Review the preliminary Import Summary. The summary indicates:
- Total Review Objectives in File
- New Review Objectives
- Updated Review Objectives
- Exists & Unchanged Review Objectives
- Skipped Review Objectives
- Errors (reasons for skipping) and warnings
If the result is as expected, click Import. If not, click Cancel.

Import Review Objectives From Global Library

Users can import Review Objectives from the Global Library to support reuse and standardization across studies.

Click the Import icon in the Review Objectives toolbar.
Select Import From Global Library. The Import Review Objective(s) from Global Library window opens.
Browse and select one or more Review Objectives stored in the Global Library. The list is pre-filtered to match the study’s Therapeutic Area, Compound, or Program. Adjust or clear filters as needed.
Click Validate. The window updates to display errors and warnings.
The system validates all selected Review Objectives. The Import Summary indicates whether each Review Objective is new, updated (up-versioned), or unchanged, and displays any warnings or errors.
Click Back to return to the selection window and make updates as needed, then click Validate again.
Review each selected objective and update Identifier values if required.
- To update the Identifier, click in the Identifier field and enter over the existing value.
Click Import to proceed.

Imported Review Objectives appear in the Review Objectives table in Configuring status and display a globe icon in the Identifier column. Hover over the icon to view the Library Display Name.

All import actions are recorded in the Audit Log.

Bulk Edit Review Objectives

Use the Bulk Edit grid to update multiple fields across multiple Review Objectives at once. The Bulk Edit grid is accessible from the Bulk Edit Grid icon in the Review Objectives toolbar. The Bulk Edit grid streamlines bulk updates, reduces manual effort, and promotes consistency across review objectives.

Click the Bulk Edit Grid icon in the Review Objectives toolbar.
Review the editable spreadsheet-style grid.
Click in any editable cell to type directly, or use copy, paste, or drag to update multiple values. The Bulk Edit grid supports updates to most fields. The following fields cannot be edited: Identifier, Version, State, and Approval Status.
Review validation messages. Errors and warnings display in the grid and must be resolved before saving.
Click Save. All changes are recorded in the Audit Log.

Comments & Activity

Use Comments & Activity to record notes, communicate with collaborators, and track status transitions performed on a review objective. Comments support @ mentions. Type '@' to view a list of study-accessible users and select a collaborator. Tagged users receive an email notification with a direct link to the review objective. Comments are available during submission, approval, rejection, versioning, and standard commenting workflows.

Add and View Comments and Activity

Workflow activities display in chronological order, recording status changes as they occur. Comments and activities are version specific. Adding a comment to an approved version requires the user to version and save the review objective.

Click the Comments & Activity button in the Add / Edit Review Objective window.
Enter a comment in the text box. Type @ to display a list of study-accessible users, then select a user to tag.
Review the Activity section to view a detailed log of status changes, comments, and versioning events associated with the review objective.
Save the comment based on the current status of the review objective:
- Approved: Click Version & Save to save the comment. This creates a new version of the review objective.
- Pending Approval: Options are Revert to Configuring or Cancel.
  - In the confirmation window, click Yes to revert to Configuring, or No to close the confirmation window.
  - Click Cancel to close the review objective window without saving the comment.
- Configuring: Options are Save & Submit for Approval, Save, or Cancel.
  - Save & Submit for Approval saves the comment and submits the review objective for approval.
  - Save saves the comment to the current Configuring version.
  - Cancel discards the comment and closes the window.
Tagged users receive an email notification.

Activate or Deactivate Review Objectives

View the State column to identify the current state for each review objective. Hover over the icon in the State column to view the tooltip.

State definitions:

Active: The review objective is available for use in Data Central review activities.
Inactive: The review objective is not available for use. Inactive objectives remain visible for reference and can be reactivated if needed.

Select one or more review objectives to update the State.
Click the Activate or Deactivate icon, or right-click and select Activate or Deactivate.

Update Review Objectives Approval Status

Approval Workflow

The approval workflow strengthens governance and traceability for Review Objectives in Data Central Configuration. Each Review Objective includes an Approval Status that determines its position in the configuration lifecycle and which actions are available. Only Approved Review Objectives are visible in Data Central and available for review.

Users can transition Review Objectives individually or in bulk using the toolbar's Action icon or the right-click context menu. Bulk transitions require that all selected objectives share the same Approval Status. Examples include:

Configuring → Pending Approval
Pending Approval → Approved
Pending Approval → Rejected
Rejected → Configuring (after updates)

Note: Approvers receive an email notification when new Review Objectives are added to the Review Plan and are ready to be reviewed for approval or rejection.

Once a Review Objective reaches Approved status, it becomes locked for editing. Users must create a new version to make additional changes. Versioning ensures consistency and preserves the approved configuration for ongoing data review.

During the system upgrade to elluminate version 25.2, existing Review Objectives are assigned an initial status:

Draft → Configuring
Active or Inactive → Approved

These assignments ensure that Review Objectives align with the approval workflow and remain validated for use.

Select one or more review objectives (in the same status) to update their approval statuses.
Click the Action icon in the toolbar, or right-click to use the context menu. The available options depend on the current Approval Status of the selected review objectives. Available options include:
- Submit for Approval: Indicates that configuration is complete and requires approval. Approvers review the objective and approve or reject it.
- Revert to Configuring: Allows selected review objectives to revert to configuring so they can continue to be edited.
- Approve: Indicates that the Review Objective is validated for use and displayed in Data Central. Approved objectives are locked and require versioning to make further edits.
- Reject: Indicates that the Review Objective did not pass approval. Rejected objectives must be updated and resubmitted.
- Create New Version: Select when edits are needed for an Approved review objective.
In the popout window, confirm the details and add an optional comment.
Click Yes to proceed, or No to cancel the action.

Versioning Workflow

A versioning workflow enhances traceability and control over updates to review objectives. Once a review objective is approved, it becomes locked for editing and must be versioned before additional changes can be made. Each version is automatically numbered and displayed in the Review Objectives table, details view, and Edit window. Users can view the complete Version History to compare versions, review approval statuses, and see comments and status transitions.

Version a Review Objective

Select an approved review objective in the Review Objectives grid.
Click the Edit icon, right-click and select Edit, or double-click the row. A message appears indicating that the review objective is approved and must be versioned to continue.
Click Version & Edit to create a new version.
Update fields as needed.
Click Save & Submit For Approval, Save, or Cancel to cancel the action.

View Version History

In the Review Objectives grid, details view, or Edit window, click the version number for the review objective.
Review the Review Objective Version History window.
Select two versions to compare side by side.
Review highlighted changes, approval statuses, comments, and status transitions. The Changed button is selected by default.
Click the Differences button to view only the differences.
Click X to close the window.

Delete Review Objectives

When deleting an unapproved review objective, there is the option to delete only the unapproved version or the entire review objective.

Select one or more review objectives to delete.
Click the Delete icon, or right-click and select Delete. Depending on the status and version history of the selected review objectives, a Delete window opens. Review the question and details.
Click Delete Unapproved Versions to remove only the unapproved versions, Delete to remove the entire review objective, or Cancel to cancel the action.

Promote Review Objectives to the Global Library

Users with Study Configure, Global Library Configure, or Administer privileges can promote approved Review Objectives to the Global Library to support reuse and standardization across studies.

Select one or more approved review objectives in the Review Objectives grid.
Click the Export icon and select Promote To Global Library, or right-click and select Promote To Global Library.
In the Promote Review Objective(s) to Global Library window, confirm the selected review objectives and click Next.
Select the folder and define the scope for the promoted review objectives.
If a review objective with the same identifier exists in the Global Library, select whether to overwrite it, go back and rename the Identifier, or skip it and promote the remaining review objectives.
Confirm the promotion.

Promoted Review Objectives appear in the Global Library under the Review Objective object type. Each object displays its description, status, source study, and last updated date. Selecting a Review Objective opens a side panel that displays all configured fields. All promotion actions are recorded in the Audit Log.