Smart MedDRA Coding enhancements

Summary

Smart MedDRA Coding now combines suggestions from historical coding data and the AI model to improve coding efficiency. Additional configuration controls and user interface enhancements support more efficient human review.

Description

Configuration Changes

Argus Console now provides additional controls for Smart Coding suggestions, automatic coding, and historical coding data. These settings are available under: Argus Safety > Console > System Management (Common Profile Switches) > Case Form Configuration > Modify Case Form Configuration > Auto-Encoding, Dictionary & Central Encoding

The changes are as follows:

• The Smart - Event Encoding common profile switch is renamed to Enable Smart Coding. This switch is independent of the selection/deselection of the Events & Indications checkbox. That is, the smart coding suggestions are available in the MedDRA browser even when the Events & Indications checkbox is unchecked.
• The following enterprise-level switches are added:
  • Threshold to display suggestions in MedDRA Browser (in Percentage) is added to control the number of suggestions being displayed in the MedDRA browser. This switch is enabled when the Enable Smart Coding switch is checked and returns the results based on the pre-configured confidence score threshold.
  • Enable Auto-coding for Smart Coding suggestions is added to configure whether to auto-code the term returned by the Smart Coding solution or not based on the score threshold to enable you to review the term before coding. This switch can be enabled only when the Enable Smart Coding switch and the Events & Indications Auto-Coding checkbox are checked. The Threshold for auto encoding switch is moved under this switch. By default, this switch is unchecked.
  • Historical Coding data time period is added to specify the start and end date for historical coding data, based on when case records were last updated. This switch is enabled when the Enable Smart Coding switch is checked.
    • When Smart Coding is enabled, the historical period defaults to four years ending at the beginning of the previous calendar quarter. For example, enabling Smart Coding on 01-Sep-2025 sets the period to 01-Apr-2021 through 01-Apr-2025.

      Note:

      This is to ensure that the most recent data is not included, as it may include cases for which coding is not yet reviewed or corrected.
    • If Smart Coding was enabled before an upgrade, the default period is calculated using the upgrade date.
    • Historical data load runs in the background, and the status is displayed in the Load Status field.

MedDRA browser and encoding enhancements

The MedDRA Browser has been enhanced to display AI and historical coding data suggestions ranked by confidence score. New icons identify AI or historical auto-coding data and signal when they require human review.

The MedDRA Browser displays Smart Coding suggestions in descending confidence-score order, whether the suggestion comes from the model or from historical data.

When auto-coding by using Smart Coding is enabled, the system displays an AI icon (). When it auto-codes a term by using historical data, it displays a Historical Coding icon (). Both icons signal that human review is required. The application removes the blue manual-review icon that was displayed when an auto-coded Smart MedDRA term had other suggestions with the same score.

You can review an auto-coded term from the MedDRA browser or from the Quality Check tab. Confirming the existing term changes the status icon to a green tick and records the result as verified.

Selecting a different term changes the icon to a green tick and records the result as manually overridden.

Selecting Cancel leaves the icon and coding status unchanged.

The system displays the Coded with Smart Encoder using AI message in the intake form when you hover over the Coding icon and if the terms are coded by Smart Encoder using AI. This text is updated when human action is taken. Similarly, when you use historical data, the Coded with Smart Encoder using historical data message is displayed.

Quality Check tab changes

Events that are auto-coded by Smart Encoder now include a Quality Check review action, allowing you to verify, override, or retain the coding status in the Intake form.

When an event is auto-coded by using Smart Coding, the Quality Check tab displays a review item with a Verify action. To solve it, you can take the following steps:

Select Verify, or select OK in the MedDRA Browser without changing the term, to change the status icon to a green tick and mark the event as Coded with Smart Encoder and Verified.

Select a different term in the MedDRA Browser to change the status icon to a green tick and mark the event as Coded with Smart Encoder but manually overridden.

If you select Cancel, the application retains the current status icon and coding status, such as Coded with Smart Encoder using AI or Coded with Smart Encoder using Historical data.