Enable Smart MedDRA Coding

Configure your Vault for faster and more accurate MedDRA-term coding that goes beyond the MedDRA dictionary and MedDRA Synonym list.

About the Feature

Vault Safety now offers advanced coding of reported terms that aren’t an exact match to the active central MedDRA dictionary or your MedDRA Synonyms list. Using artificial intelligence (AI) and automation, Vault offers MedDRA code suggestions, reducing the manual effort of MedDRA coding. This feature is available when coding MedDRA terms on Inbox Items, Cases, Study and Study Arm Indications, and Datasheets.

Overcoming common problems such as alternate and incorrect spelling, abbreviations, and multiple reported terms, Vault returns suggested results in seconds. Vault calculates the confidence for each possible match, and suggests only those terms that pass a high threshold for mapping. You have control over setting the confidence threshold.

When setting up this feature in your Vault, you have the following options:

  • Enable Smart Auto-Coding: For high-confidence system matches, MedDRA terms are auto-coded.
  • Enable Smart MedDRA Coding Predictions: Suggested terms appear at the top of the MedDRA Browser for manual selection.
  • Smart MedDRA Coding Field Exclusions: Specify fields to exclude from suggested MedDRA codes.

Using this advanced method of MedDRA coding also reduces the administrative burden of manually maintaining the MedDRA Synonym list. When system-suggested MedDRA terms are applied to reported terms, those are automatically added to the Synonym Candidate list. As your Synonym list becomes more comprehensive, the result is more consistent coding over time.

After completing the required configuration, see Code MedDRA Terms for details on using this feature.

23R2 Update: Smart MedDRA Coding on Import

With the 23R2 release, Vault Safety extends its most advanced MedDRA coding method to E2B and JSON import to Inbox Items and auto-codes MedDRA codes based on the reported medical term. Completing the enablement instructions on this page also configures your Vault with this capability.

After completing the required configuration, see Import an Inbox Item: Imported MedDRA and Automated Case Promotion: Automated MedDRA Coding for details on using this feature.

MedDRA Coding Connection

Vaults deployed in 23R1 or later come configured with the Veeva MedDRA Coding Connection. These Connection settings control such features as the confidence threshold for auto-coding, the number of MedDRA coding suggestions that will be returned in the MedDRA browser, and the criteria for sending a MedDRA coding suggestion request to the connection.

If your Vault is pre-configured with the Veeva MedDRA Coding Connection, we recommend reviewing the default settings, which can be adjusted.

For Vaults deployed before 23R1, you must first insert the MedDRA Coding Settings on the Veeva MedDRA Coding Connection layout.

Insert MedDRA Coding Settings on the Veeva MedDRA Coding Connection Layout

Use the following steps to insert the MedDRA Coding Settings section on the Veeva MedDRA Coding Connection layout.

  1. Go to Admin > Configuration > Objects > Connection > Layouts.
  2. Select Connection Detail Page Layout.
  3. Insert the MedDRA Coding Settings related object. To rearrange sections, drag and drop.
  4. In the MedDRA Coding Settings section, select Edit Columns to add the following columns:
    • Minimum Auto Coding Confidence Score
    • Number of Requests in Current Month
    • Maximum Number of Predictions
    • Maximum Number of Characters Per Request
    • Minimum Number of Characters Per Request
  5. Select Save.

Result

The MedDRA Coding Settings section is inserted on the Veeva MedDRA Coding Connection layout. The default settings are applied. We recommend reviewing the default settings, which can be adjusted.

Review the MedDRA Coding Settings

Complete the following steps to review the default MedDRA Coding Settings.

  1. Go to Admin > Connections > Veeva MedDRA Coding Connection.
  2. In the MedDRA Coding Settings section, select Veeva MedDRA Coding Settings.
  3. On the MedDRA Coding Settings page, review the settings in each field.

Veeva MedDRA Coding Settings Fields

The following table describes the MedDRA Coding Settings fields.

Field Description
Name The label for the MedDRA Coding Settings record.
Status Determines whether the MedDRA Coding Settings record is active or inactive. Inactive records are not available for use.
Minimum Number of Characters Per Request Sets the minimum number of characters required on a reported term before Vault makes a MedDRA coding suggestion request.
Maximum Number of Characters Per Request Sets the maximum number of characters from a reported term to include in a MedDRA coding suggestion request. If the reported term exceeds the maximum, Vault search is based on all characters up to the maximum.
Maximum Number of Requests Per Month Sets the maximum number of MedDRA coding suggestion requests that can be performed in a month. If this limit is reached, MedDRA coding suggestions aren't requested.
Number of Requests in Current Month

Displays the number of MedDRA coding suggestion requests in the current month.

The Number of Requests in Current Month counter has been turned off temporarily. This known limitation will be addressed in a future release.
Minimum Auto Coding Confidence Score Sets the minimum confidence threshold for auto-coding a match between a reported term and a MedDRA coding suggestion. The score can have a value between 0 and 1.
Maximum Number of Predictions

Sets the maximum number of suggested MedDRA terms that will appear at the top of the MedDRA Browser.

The MedDRA Browser displays MedDRA coding suggestions at the top of the list, followed by the standard search results.

Update the MedDRA Dictionary Layout

On the MedDRA dictionary, add the MedDRA Smart Coding options using the following steps:

  1. Go to Admin > Objects > Dictionary > Layouts.
  2. Select the MedDRA Detail Page Layout.
  3. In the Details section, add the following fields:
    • Enable Smart Auto-Coding
    • Enable Smart MedDRA Coding Predictions
    • Smart MedDRA Coding Field Exclusions
  4. Select Save.

Configure the MedDRA Dictionary to Offer Suggestions

Complete the following setup to configure MedDRA coding suggestions on the MedDRA dictionary.

  1. Go to Business Admin > Objects > Dictionaries.
  2. On the Dictionaries page, select MedDRA Dictionary.
  3. On the MedDRA Dictionary page, select Edit, and then select one or both of the following checkboxes, depending on your business process:
    • Enable Smart Auto-Coding
    • Enable Smart MedDRA Coding Predictions
  4. (Optional) In the Smart MedDRA Coding Field Exclusions field, select fields to exclude from MedDRA coding support.
  5. Select Save.

Grant Permissions

Ensure your Case Entry Actions permission sets are granted the appropriate level of access to objects and fields according to your organization’s process. Manage these permissions from Admin > Users & Groups > Permission Sets > Case Entry Actions > Objects.

For access to this MedDRA coding feature, users must be given Edit access for the following object field permissions:

Object Field
Case Adverse Event
  • Event (LLT) - MedDRA Coding Method
  • MedDRA Synonym Session Store ID
Case Cause of Death
  • Cause of Death - MedDRA Coding Method
  • MedDRA Synonym Session Store ID
Case Diagnosis
  • Name (MedDRA) - MedDRA Coding Method
  • MedDRA Synonym Session Store ID
Case Drug History
  • Indication (LLT) - MedDRA Coding Method
  • Reaction (LLT) - MedDRA Coding Method
  • MedDRA Synonym Session Store ID
Case Medical History
  • Name (LLT) - MedDRA Coding Method
  • MedDRA Synonym Session Store ID
Case Product Indication
  • Name (MedDRA) - MedDRA Coding Method
Case Test Result
  • Test Name (LLT) - MedDRA Coding Method
  • MedDRA Synonym Session Store ID