Permissions: Users with the Administer or Study Configure privilege can accept, edit, and reject Review Objective suggestions.

Study Advisor uses AI to analyze uploaded Study Protocols and generate Review Objective suggestions, supporting faster and more consistent creation of study-specific review plans. Suggestions are presented in two categories:

• Global Library Suggestions: Existing Review Objectives in the Global Library that closely match the Study Protocol and can be reused.
• Study Document Suggestions: New Review Objectives generated from the Study Protocol when suitable matches do not already exist.

For uploading and managing Study Protocols, refer to the Manage Study Documents and Details in Study Advisor article in the Study Advisor section.

Both suggestion types can be reviewed, searched, filtered, exported, and managed for each uploaded Study Protocol version. The Viewing Protocol drop-down switches between Study Protocol versions, allowing comparison of suggestions across versions while preventing duplication of previously accepted or rejected Review Objectives.

Note: If the study already has a Review Plan, Study Advisor considers the existing Review Objectives to avoid generating duplicate suggestions.

Access Review Objective Suggestions

1. Open Study Advisor from the Study Management drop-down within a study, or from the Study Management section of the Platform Menu.
2. Select Review Objectives in the left navigation.
3. Select the Global Library Suggestions or Study Document Suggestions tab.

Note: Each tab includes clickable status badges displaying the number of suggestions that are Pending Review (yellow), Accepted (green), and Rejected (red). Selecting a badge filters the grid to the corresponding suggestions.

Review Study Document Suggestions

Study Document Suggestions include AI-generated recommendations for key configuration details: Primary Domain, Secondary Domain(s), Field(s), Priority, Risk(s), Reviewer Role(s), and Review Frequency, along with the supporting Protocol Reference and Rationale used to generate each suggestion. Select a suggestion to open a details panel displaying all fields for that suggestion.

Note: If study data have not been imported yet, suggestions use generic SDTM domains (for example, AE or DS) for Primary Domain, Secondary Domain(s), and Field(s), and the Accept Review Objective icon is disabled. After study data are imported, click the Connect to Study Data (link) icon in the toolbar to recalculate these fields using the study's imported data. A 'Connecting to study data' message displays, and the grid refreshes with the recalculated fields. Hovering over the icon displays the tooltip 'Connect Review Objective domain details to study data'.

Accept, Edit, or Reject Suggestions

Suggestions can be edited, accepted, rejected, or filtered from the toolbar or the right-click menu.

1. Review a suggestion and edit its details as needed by double-clicking the suggestion or clicking the pencil icon. The Edit Review Objective window opens. All fields can be edited, including the Identifier and the Review Objective description, except the Protocol Reference and Rationale, which are AI-populated and read-only.

   

2. To accept, select the suggestion and click the Accept checkmark icon in the toolbar, or click Save & Accept in the Edit Review Objective window. The Accept Review Objective window opens, displaying a validation summary of the total, new, updated, existing and unchanged, and skipped Review Objectives, along with any warnings. Click Accept. The Review Objective is added to the study's Review Plan.

   Note: Warnings display when an accepted Review Objective requires attention in the Review Plan. For example, an objective without valid review materials is added to the Review Plan in the Draft state.

   

3. To reject, select the suggestion and click the Reject X icon in the toolbar, or click Reject in the Edit Review Objective window. The Reject Review Objective window opens. Select a Rejection Reason from the drop-down, such as Not Applicable to this Study, Duplicate Suggestion, Too Broad or Generic, or Too Narrow, or select Other and enter a reason. The decision is retained so the Review Objective is not suggested again for future Study Protocol versions, and rejection reasons inform future suggestion quality.

   

Tip: Use multi-select to accept or reject multiple suggestions at once through the toolbar or the right-click menu.

Note: Review Objectives added to the Review Plan from Study Advisor display a sparkle icon in the Review Plan; hovering over the icon shows that the objective was accepted from Study Advisor and the Study Protocol version it came from. Suggestions can also be imported from Study Advisor within the Review Plan using the same tabs and workflow.

Restore a Rejected Suggestion

1. Filter the grid to Rejected suggestions using the red status badge or the grid filters.

2. Select the suggestion and click the Unreject icon in the toolbar. The Unreject Review Objective window opens.

   

3. Click Unreject. The suggestion returns to the Pending Review state.

   

Search, Filter, and Export Suggestions

Suggestions can be searched using the search field, filtered using the grid filters, and exported to Excel using the Export icon in the toolbar. Filters apply to each tab independently. Within a tab, filters persist when switching Study Protocol versions in the Viewing Protocol drop-down. For example, a filter on Primary Domain applied to one Study Protocol version remains applied after switching to another version.