Manage AI-Powered Review Objective Suggestions in Study Advisor

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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 independently for each uploaded Study Protocol version using the Viewing Protocol drop-down, allowing comparison of suggestions across Study Protocol versions while preventing duplication of previously accepted Review Objectives.

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 Objectives section with the Global Library Suggestions and Study Document Suggestions tabs, status badges, and the suggestions grid

Review Study Document Suggestions

Study Document Suggestions include AI-generated recommendations for key details: Primary Domain, Secondary Domain(s), Field(s), Priority, Risk(s), Reviewer Role(s), and Programmatic 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, including the Protocol Reference and Rationale used to generate it.

Note: If study data have not been imported yet, suggestions use SDTM domains for Primary Domain, Secondary Domain(s), and Field(s), and the Accept button is disabled until Connect to Study Data is selected to recalculate these fields using the study's imported data.

Review Objective suggestion in the transposed record view with the suggestion details, Protocol Reference, and Rationale

Accept, Edit, or Reject Suggestions

  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.

    Edit Review Objective window with the suggestion details, read-only Protocol Reference and Rationale, and the Cancel, Save, Reject, and Save & Accept buttons

  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.

    Accept Review Objective window with the validation summary, a warning message, and the Cancel and Accept buttons

  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.

    Reject Review Objective window with the Rejection Reason drop-down open

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 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.

    Rejected Review Objective suggestion selected in the grid with the Unreject icon in the toolbar

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

    Unreject Review Objective window with the Cancel and Unreject buttons

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. Search, filtering, and export apply independently to each tab and to each uploaded Study Protocol version selected in the Viewing Protocol drop-down.

Export icon with its tooltip in the Review Objective suggestions toolbar

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