Code MedDRA Terms | Vault Help

Search for and apply codes from the MedDRA dictionary when processing Inbox Items and Cases.

Note: Depending on your Admin’s configuration, object, field, and section labels, lifecycle states, and workflows may differ from the general information on this page. Refer to your organization’s business processes for guidance.

About MedDRA

Vault Safety supports the Medical Dictionary for Regulatory Activities (MedDRA) to code medical terms for symptoms, disease, indicators, and adverse events. MedDRA coding is available when processing Inbox Items and Cases and when setting up Datasheets, Study Indications, and Study Arm Indications.

The MedDRA dictionary defines medical conditions. MedDRA codes are organized by five organizational levels, starting with System Organ Class (SOC). The code begins with Vault of the body affected and becomes more specific. The SOC codes are divided into High-Level Group Terms (HLGT), High-Level Terms (HLT), Preferred Terms (PT), and Lowest Level Terms (LLT).

By default, coding uses either the LLT or PT code. However, your Admin may configure the MedDRA dictionary to use only PT codes.

The version of the MedDRA dictionary that you can use depends on the active version in your Vault at the time of creating the Case. The MedDRA Version field in the Case > Details section shows which version of MedDRA the Case uses.

Overview of MedDRA Coding Options

Vault Safety includes several methods for coding MedDRA terms. Each option offers advantages in ease, efficiency, and level of control.

Option	Description
Auto-coding	When a reported term is an exact match to a MedDRA dictionary term or MedDRA Synonym, the MedDRA term is automatically coded. For reported terms without an exact match, MedDRA terms can be selected from the MedDRA Browser.
MedDRA Synonyms	You can manually create and edit a MedDRA Synonym list. This supports company-specific MedDRA coding preferences for reported terms that are not an exact match to terms in the MedDRA dictionary.
MedDRA Synonym Candidate Auto-Creation	Reported terms without an exact match in the MedDRA dictionary or MedDRA Synonym list can automatically become Synonym Candidates. Synonym Candidates must be reviewed and activated before being added to the MedDRA Synonym list.
Smart MedDRA Coding	Our most advanced coding tool uses AI and automation to code reported terms that are not an exact match to the active MedDRA dictionary or your MedDRA Synonym list. For example, Vault offers MedDRA code suggestions for misspelled terms, abbreviations, ambiguous information, multiple reported terms, and more. This advanced MedDRA coding method can be configured for auto-coding and when searching for terms in the MedDRA Browser. Based on your Admin's configuration, when you search for a MedDRA code, Vault adds it to your MedDRA Synonym Candidates list. This contributes to more consistent coding over time.

How MedDRA Coding Works

By default, Vault uses the following logic to support MedDRA coding:

When your Admin has configured Smart MedDRA Coding, Vault uses the following logic to support coding:

Prerequisites

To match reported terms to MedDRA Synonyms, your Admin must have enabled MedDRA Synonyms and MedDRA Synonym Field Exclusion and Candidate Auto-Creation.
For AI and automation-based coding, your Admin must have enabled Smart MedDRA Coding.

MedDRA Auto-Code Field

The following image shows an example of the MedDRA auto-code field, which combines the Reported field and MedDRA term field:

Code a MedDRA Term

You can code MedDRA terms automatically or use the MedDRA Browser to find a term.

Note: The Non-Primary tag identifies terms that are not under their primary SOC. An asterisk (*) identifies terms that are under their primary SOC.

Auto-Code a MedDRA Term

Complete the following steps to auto-code a term based on the reported text.

In the MedDRA Auto-code field, enter the name of the medical term as it was reported by the source.
Select Auto-code.

Result

Vault searches for the reported term within the MedDRA dictionary and any preconfigured MedDRA Synonyms. If a match is found, the MedDRA term and code appear below the field. To clear the term, select Clear Selection.

If Vault cannot find a match, you can use the MedDRA Browser to find the term. Results are automatically filtered by the reported term entered in the field.

When you change the reported term with the MedDRA Browser, the coded term is also cleared. The previous coded term will be struck through to indicate that it will be cleared when you save. You can clear the coded MedDRA term and the reported term by selecting Clear Selection.

Note: When Vault cannot find a match in the MedDRA dictionary or MedDRA Synonym list, if configured by your Admin, the reported term automatically becomes a Synonym Candidate. To become available for use, Synonym Candidates must be activated by Admins. For more information, see Synonym Candidate Auto-Creation.

Depending on your Admin’s configuration, if the reported term is not an exact match to a term in the MedDRA dictionary or MedDRA Synonym list, Vault may suggest a term. If a high-confidence match is found, the term is auto-coded.

If Vault doesn’t find a high-confidence match, when Auto-code is selected the MedDRA Browser window appears.

Browse for a MedDRA Term

You can browse the MedDRA dictionary to find a term.

In the MedDRA field, select the Advanced Search () icon. The MedDRA Browser window appears.
Use any of the following options alone or in combination to search for a term:
- To browse the MedDRA hierarchy, use the tree in the Terms Hierarchy pane to navigate through the five (5) levels. You can filter terms by any level in the hierarchy. Select a term in the pane and then select Apply. Filters appear at the top of the browser.
  - To change the filter, select another term and select Apply once again.
  - To clear the filter, select next to the filter.
- To filter the MedDRA Browser to show only terms that are part of a primary system organ class, select Only Primary SOC.
- To search for a specific term, enter some or all of the term and then select the Search () icon. When you search for a term, the MedDRA Browser searches for terms at the LLT level only.
  Depending on your Admin’s configuration, MedDRA coding suggestions appear first in the results. Otherwise, if an exact LLT match exists, that appears at the top of the results. Additional results are returned in order of closest match alphabetically. Use the left and right arrows at the bottom-right of the browser to page through the results.
To code a MedDRA term, select the term, and then select Confirm.

Note: There is a limit of 5,000 search results in the MedDRA Browser.

MedDRA Browser

The following image shows the MedDRA Browser:

If the reported term is not an exact match to a term in the MedDRA dictionary, Vault suggests possible matches. Double or single green chevrons to the left of terms clearly indicate the confidence level for the suggestion.

Note: If configured by your Admin, when you select and confirm a MedDRA coding suggestion, the reported term is added to the Synonym Candidate list.

The following table describes the MedDRA browser columns.

Column	Description
LLT	Lowest-level term
PT	Preferred term
HLT Code	High-level term code
HLGT	High-level group term
SOC	System organ class

Recode a MedDRA Term

Vault will warn you to recode a term if its MedDRA version is not in sync with the MedDRA version on the Case. This situation can occur in the following instances:

The Case was imported with multiple MedDRA versions.
An Inbox Item was created with one active MedDRA version, and the version changed before the Promote to Case action.
The MedDRA version on the Case was changed manually.
A Follow-Up Case was created with Active MedDRA Version enabled.

Vault Safety’s MedDRA update logic ensures that most terms will not require recoding. However, some MedDRA changes, such as a MedDRA term becoming non-current, could require recoding.

For more information, refer to your MedDRA-provided documentation.

When a term needs to be recoded, the RECODE () badge will appear next to it in the Medical Event section of your Inbox Item. To recode the term, you can browse for a new term in the MedDRA browser. The term that requires recoding will remain at the top of the MedDRA browser until it is changed.

The following image shows an example of a term that needs to be recoded because its MedDRA version is different from the current MedDRA version on the Case:

Code Multilingual MedDRA Terms

You can auto-code or browse for a term in any non-English MedDRA-supported language.

Note: Multilingual MedDRA is only supported in Vaults using the central MedDRA dictionary.

Multilingual MedDRA Prerequisite

An Admin must enable the multilingual MedDRA Dictionary in order to access these capabilities.

MedDRA-Supported Languages

The following list includes the languages that are currently supported by the multilingual MedDRA browser.

Chinese
Czech
Dutch
French
German
Hungarian
Italian
Korean
Spanish
Brazilian Portuguese
Portuguese
Russian

Supported Fields

This feature is available for the following fields:

Inbox Item
- The Event control under Medical Events
- The Indication control under Products
Case
- The Event (Reported) control on a Case Adverse Event

MedDRA Translation Mode

You can transition between English Mode and Translation Mode by changing the value of the Reported Event Language.

If a non-English language is selected for the Reported Event Language, the MedDRA control will switch to Translation Mode:

If the Reported Event Language value is English or blank, the MedDRA control will appear in English Mode:

Auto-Code a Term in a MedDRA-Supported Language

You can auto-code terms in any non-English MedDRA-supported language.

Go to the multilingual MedDRA-supported field.
From the language drop-down menu (), select a supported language.
In the (Reported) field, enter the adverse event in the language it was reported in.
Select Auto-code.

Result

Vault searches for the reported term within the MedDRA dictionary in the selected language. If a match is found, the MedDRA term and code appear below the field. On an Inbox Item, the MedDRA term and code appear in the local language specified in the Localization field. If you left the English field blank, Vault automatically populates the English MedDRA translation of the adverse event.

If Vault cannot find a match, you can use the multilingual MedDRA browser to find the term.

Auto-Code a Term in a Non-Supported Language

Go to the multilingual MedDRA-supported field.
Enter the term in the native language in the field.
From the language drop-down menu (), select a non-supported language.
Enter the English translation of the term in the Event as reported in English field and select Auto-code.

Note: Auto-code is disabled since this is a non-supported language. You must manually fill in the English translation to enable auto-code.

Result

Vault searches for the reported term within the MedDRA dictionary. If a match is found, the MedDRA term and code appear below the field.

Use the Multilingual MedDRA Browser

When you select a MedDRA-supported language, you can search for terms in English and in the selected language in the multilingual MedDRA browser.

The capabilities in the MedDRA browser for Japanese are different from other non-English MedDRA-supported languages. See Use the MedDRA browser for Japanese Terms for more detail.

Go to the multilingual MedDRA-supported field.
Select a MedDRA-supported language from the language drop-down menu ().
Select the binoculars () icon. The MedDRA Browser appears and displays English terms by default.
To change the MedDRA Browser language, select the MedDRA Browser Menu button (), and then select the preferred language. The MedDRA Browser now displays terms in the supported language.
To code a MedDRA term, select the term, and then select Confirm. If you select a term and then toggle between languages, the equivalent term will be auto-selected in the other language.

Use the MedDRA Browser for Japanese terms

The MedDRA Browser works similarly for Japanese terms. The difference is that the MedDRA Japanese dictionary has its own version for Japanese terms.

If the MedDRA control language is set to Japanese, the Only Current Terms checkbox is automatically selected on the MedDRA browser. This means only current Japanese MedDRA terms are displayed in the browser by default. If the MedDRA control language is not set to Japanese, this checkbox does not appear.

You can unselect the Only Current Terms checkbox to display both current and non-current Japanese MedDRA terms. The NON-CURRENT ( Non-Current Tag ) tag appears next to non-current LLT terms. However, if you select a non-current Japanese term, the MedDRA browser prevents you from coding the term by disabling the Confirm button.

Note: The browser only displays current terms in the MedDRA dictionary regardless of the term’s Japanese MedDRA version. Terms that are tagged with the non-current tag indicate that the term is non-current in the Japanese currency (i.e. the term is current in English but non-current in Japanese).

Records that Support MedDRA Coding

The following list describes which Vault Safety records support MedDRA coding:

Inbox Item (Medical Events section)
Case Diagnoses
Case Adverse Event
Case Drug History
Case Product Indication
Case Medical History
Case Cause of Death > Reported Cause of Death
Case Cause of Death > Autopsy-Determined Cause of Death
Case Test Result
Study Indication

Bulk Recode MedDRA-Coded Terms on Cases

When a new central MedDRA dictionary is activated in your Vault, hierarchy changes to MedDRA-coded terms are immediately reflected on active Cases and Inbox Items. In addition, Vault supports fast and accurate bulk recoding of non-current MedDRA-coded terms on Cases. For more information on this feature, see Bulk Recode MedDRA-Coded Terms on Cases.