Permissions: Users with the Data Central or Study Configuration privilege 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.

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 (displayed if the study is not yet configured), or the Configuration icon, then select Data Central Configuration.

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

1. Click the Configure icon.
2. Select Configure Data Central Settings.
   

The Data Central Configuration window for the selected study opens. Click Review Plan in the left navigation. Users without the Study Configuration privilege but with a Data Central Reviewer role will see only the Review Plan tab.

If no review objectives have been added yet, there will be options to either create review objectives manually, or download the Review Objectives template, populate the template and import them.

If review objectives exist for the study, the Review Objectives grid displays.

The number in the blue badge indicates the number of filtered review objectives listed.

All columns can be filtered, sorted, and fixed, as the grid offers standard Data Central functionality.

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

Toolbar Actions 

See sections below for instructions on each action.

• 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 will be highlighted in blue.
• Add: Click to open the Add Review Objective window.
• 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 objective(s).
• Inactivate: Select one or multiple review objectives, then click the Deactivate icon to inactivate the selected review objective(s).
• Export: Click to download the filtered list of review objectives as an Excel file.
• Import: Click to import a list of review objectives from an Excel file.
• Get Template: Click to download an Excel file with all required columns for import.

Add Review Objectives Manually

Click the Create Objectives button under No Objectives Defined, or click the Add (plus sign) icon in the toolbar of the Review Objectives grid.
The Add Review Objective window opens.

Tip: Hover over the info icon to see details about the field.

Enter Review Objective Details

Review objective details are on the left side of the window, and review materials are on the right. Fields with a red asterisk and red border indicate they are required fields.

Review Objective Details

1. Enter fields on the left side of the window.
   • Identifier: Enter a unique alphanumeric value (up to 16 characters). The same values cannot be used within a study.
   • Review Objective: Enter the review objective (5000 character limit).
   • Primary Domain: Select the primary domain associated with the objective. The drop-down list contains 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 drop-down list adjusts as domains are added. Expand the domain to see each field. Fields with orange highlighted text and an exclamation in an octagon icon indicate they have been marked as critical within Metadata.
   • Priority: Select the priority. By default, the choices are High, Medium, and Low. To update the priority options, go to Platform Administration > Configuration, click the Review Objective Priority tab in the left navigation, then update the Review Objective Priorities as needed.
   • Reviewer Role(s): This is auto-populated with the logged-in user’s reviewer role. Click the drop-down and select one or more reviewer roles.
   • Programmatic Review Frequency: Click the drop-down and select the frequency from the left (On Data Refresh, Daily, Weekly (default), Monthly, Quarterly, or Annually), then use the calendar to select the start date, hour, and  minute. This auto-populates to Weekly and the current day of the week at midnight.
   • Manual Review Frequency: Click the drop-down and select the frequency from the left (Daily, Weekly (default), Monthly, Quarterly, or Annually), then use the calendar to select the start date, hour, and minute. This auto-populates to Weekly and the current day of the week at midnight.

Review Materials

2. Enter fields on the right side of the window.
   Programmatic – Review Materials systematically tracked and factor into the Objective Status.
• Data Central Listing(s): Click the drop-down and select one or more listings to be used for review. The list contains domains and listings enabled for data review.
• eIQ Review Model: If enabled, click the drop-down and select a model.
• Orchestrator Rule: If enabled, click the drop-down and select a rule.
3. Manual – Review Materials not systematically tracked but factor into the Objective Status.
• Data Central Visualization(s): Click the drop-down and select one or more Data Central Visualizations. The list will only include visualizations saved as Public.
• Data Central Workspace: Click the drop-down and select a workspace. The list will only include all workspaces saved as Public.
• Analytics App: Click the drop-down and select an Analytics app. The list will only include apps enabled for the study.
• App Sheet(s): Click the drop-down and select one or more sheets. The list will only include Public and Community sheets for the selected app.
• RBQM Dashboard: Click the drop-down and 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 will be ‘Draft’ until at least one Review Material is selected. Use the toggle to select Active or Inactive. The state can be edited as needed based on milestone or lock activities. For example, if a lock is approaching, you may want to freeze all review objectives in their current status by making them inactive. When they are inactive, they will still show in Data Central, however, they are not being recalculated. Once the milestone or lock work is completed, the review objectives can be made active again.

3. Click Save to save the review objective. The review objective will be added to the list of Review Objectives based on the Identifier.

Add or Edit Review Objectives Via Import

1. There are multiple options for adding and editing review objectives:
   • Use the template: Click the Get Template button in the toolbar. The Excel file will download to your computer. It will contain all column headers needed for a successful import.
   • Export the existing grid: Click the Export icon in the toolbar. The Excel file will download to your computer. It will include all the data in the grid.
2. Populate or edit the Excel file, then Save the file.
3. Click the Import icon.
4. Drop or add the updated Excel file to the import window.
5. The preliminary import process runs all validations and provides a summary showing how each review objective was processed. The summary includes: Total Review Objectives in File, New Review Objectives, Updated Review Objectives, Exists & Unchanged Review Objectives, and Skipped Review Objectives, along with any errors AKA reasons for skipping and warnings. 
6. If the result is as expected, click Import. If not, click Cancel.

Copy a Review Objective

1. Select a review objective.
2. Click the Copy icon. The Copy Review Objective window opens.
   
3. Identifier: Enter a unique alphanumeric value (up to 16 characters). The same identifier cannot be used more than once within a study.
4. Edit any other fields as needed. See the Enter Review Objective Details section for details on each field.
5. Click Save.

Delete Review Objectives

1. Select one or more review objectives to delete.
2. Click the Delete icon. A confirmation question displays.
   
3. Click Delete to continue, or Cancel to cancel the action.

Activate or Deactivate Review Objectives

Easily identify the State for each review objective by viewing the State column.

1. Select one or more review objectives to update the State (active or inactive).
2. Click the Activate or Deactivate icon.