About the Feature
Smart MedDRA Coding 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 reduces 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, Smart MedDRA Coding returns suggested results in seconds. The system 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 Smart MedDRA Coding 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 Smart MedDRA Coding support.
Note This feature is currently supported in English only.
Smart 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 Smart MedDRA Coding to E2B and JSON import to Inbox Items. 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 MedDRA Coding Connection, which includes Smart MedDRA Settings. These settings control such features as the confidence threshold for auto-coding, the number of Smart MedDRA Coding suggestions that will be returned in the MedDRA browser, and the criteria for sending a Smart MedDRA Coding request to the connection.
If your Vault is pre-configured with the Smart MedDRA Settings, we recommend reviewing the default settings, which can be adjusted.
For Vaults deployed before 23R1, you must first add the MedDRA Coding Settings to the Veeva MedDRA Coding Connection page layout.
Add MedDRA Coding Settings to the Veeva MedDRA Coding Connection Page Layout
Use the following steps to add MedDRA Coding Settings to the Veeva MedDRA Coding Connection page layout.
- Go to Admin > Configuration > Objects > Connection > Page Layouts.
- Select Connection Detail Page Layout.
- Add the MedDRA Coding Settings related object. To rearrange sections, drag and drop.
Add MedDRA Coding Settings - 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
- Select Save.
Result
The MedDRA Coding Settings section is added to the Veeva MedDRA Coding Connection page 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.
- Go to Admin > Connections > Veeva MedDRA Coding Connection.
- In the MedDRA Coding Settings section, select Veeva MedDRA Coding Settings.
Veeva MedDRA Coding Settings - 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 the system makes a Smart MedDRA Coding request. |
| Maximum Number of Characters Per Request | Sets the maximum number of characters from a reported term to include in a Smart MedDRA Coding request. If the reported term exceeds the maximum, the system search is based on all characters up to the maximum. |
| Maximum Number of Requests Per Month | Sets the maximum number of Smart MedDRA Coding requests that can be performed in a month. If this limit is reached, Smart MedDRA Coding suggestions aren’t requested. |
| Number of Requests in Current Month | Displays the number of Smart MedDRA Coding requests in the current month. |
| Minimum Auto Coding Confidence Score | Sets the minimum confidence threshold for auto-coding a match between a reported term and a Smart 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 Smart MedDRA Coding suggestions at the top of the list, followed by the standard search results. |
Update the MedDRA Dictionary Page Layout
On the MedDRA dictionary, add the MedDRA Smart Coding options using the following steps:
- Go to Admin > Objects > Dictionary > Page Layouts.
- Select the MedDRA Detail Page Layout.
- In the Details section, add the following fields:
- Enable Smart Auto-Coding
- Enable Smart MedDRA Coding Predictions
- Smart MedDRA Coding Field Exclusions
Smart MedDRA Coding Options on the MedDRA Dictionary Detail Page Layout - Select Save.
Configure the MedDRA Dictionary for Smart MedDRA Coding
Complete the following setup to enable Smart MedDRA Coding on the MedDRA dictionary.
- Go to Business Admin > Objects > Dictionaries.
- On the Dictionaries page, select MedDRA Dictionary.
- 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
Configure Smart MedDRA Coding - (Optional) In the Smart MedDRA Coding Field Exclusions field, select fields to exclude from MedDRA Smart Coding support.
- 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 the Smart MedDRA Coding feature, users must be given Edit access for the following object field permissions:
| Object | Field |
|---|---|
| Case Adverse Event |
|
| Case Cause of Death |
|
| Case Diagnosis |
|
| Case Drug History |
|
| Case Medical History |
|
| Case Product Indication |
|
| Case Test Result |
|
