Vault Safety supports the Medical Dictionary for Regulatory Activities (MedDRA) to code medical terms for symptoms, disease, indicators, and adverse events.
The MedDRA dictionary defines medical conditions. MedDRA codes are organized by five organizational levels, starting with System Organ Class (SOC). The code begins with the system 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, you can code an event using either the LLT or PT code. However, an 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.
The following image shows the combined MedDRA auto-code field, which combines the reported field and MedDRA term field:
MedDRA Auto-Code Field
Note MedDRA fields may be named differently, according to your vault's configuration.
Code a MedDRA Term
You can code MedDRA terms automatically or use the MedDRA browser to find a term.
Tip 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
In the combined reported and MedDRA term field, enter the name of the medical term as it was reported by the source. This field may be named Event (Reported) or Name (Reported).
To auto-code the term using the reported text, select .
Result
The system will search for the reported event 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 the system 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.
Successful MedDRA Auto-Code
When you change the reported term with the MedDRA browser, the coded term will also be 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 code and the reported term by selecting Clear Selection.
Modified MedDRA Reported Term
If MedDRA Synonym Candidate Auto-Creation is enabled, when the system cannot find a match in the MedDRA Browser or MedDRA Synonym library, the reported term automatically becomes a synonym candidate. To become available for use, synonym candidates must be activated by administrators. For more information, see Synonym Candidate Auto-Creation.
Browse for a MedDRA Term
You can browse the MedDRA dictionary to find a term.
In the MedDRA field, select . The MedDRA Browser window appears.
To browse the MedDRA hierarchy, use the tree in the Terms Hierarchy pane to navigate through the five levels.
To filter terms by a level in the hierarchy, select Apply.
You can apply only one filter at a time. Select a different level to change the filter.
To clear the filter, select next to the filter.
To filter the MedDRA Browser to only show terms that are part of a primary system organ class, select Only Primary SOC.
To code a MedDRA term, select the term, and then select Confirm.
Note There is a 1000 SOC search query limit in the MedDRA browser.
Note When you search for a term in the MedDRA browser, the MedDRA browser will only parse through the terms at the LLT and PT levels. You can navigate the Terms Hierarchy pane for terms at the HLT, HLGT, and SOC levels.
MedDRA Browser
The following image shows the MedDRA Browser:
MedDRA Browser
The following table describes the MedDRA browser columns.
Column
Description
LLT
Low-level term.
PT
Preferred term.
HLT Code
High-level term code.
HLGT
High-level group term.
SOC
System organ class.
Recode a MedDRA Term
The system 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, the following list describes the main types of MedDRA version changes that could lead to the required recoding of terms:
Promotions or demotions in the MedDRA hierarchy.
An LLT categorized under a different PT.
An LLT categorized under a different SOC.
A PT categorized under a different SOC.
A switched MedDRA code.
For more information, refer to your MedDRA-provided documentation.
When a term needs to be recoded, the badge will appear next to it in the Adverse Event section of your AER. 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:
Example of a term that needs to be recoded in the MedDRA browser
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.
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:
Translation Mode
If the Reported Event Language value is English or blank, the MedDRA control will appear in English Mode:
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 dropdown menu (), select a supported language.
In the (Reported) field, enter the adverse event in the language it was reported in.
Select Auto-code.
Result
The system 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, the system automatically populates the English MedDRA translation of the adverse event.
Enter the term in the native language in the field.
From the language dropdown menu (), select a non-supported language.
Note Auto-code is disabled since this is a non-supported language. You must manually fill in the English translation to enable auto-code.
Enter the English translation of the term in the Event as reported in English field and select Auto-code.
Result
The system searches for the reported term within the MedDRA dictionary. If a match is found, the MedDRA term and code appear below the field.
Successful Non-Supported Language Auto-Code
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 dropdown menu ().
Select . The MedDRA Browser appears and displays English terms by default.
To change the MedDRA Browser language, select , and then select the preferred language.
Multilingual MedDRA Browser Menu
The MedDRA Browser now displays terms in the supported language.
Multilingual MedDRA Browser
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.
Only Current Terms Checkbox Selected in Japanese MedDRA Browser
You can unselect the Only Current Terms checkbox to display both current and non-current Japanese MedDRA terms. The 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 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)
AER (Adverse Event section)
Case Assessment
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
Vault Safety supports fast and accurate recoding of non-current MedDRA codes and terms on Cases. This is useful when recoding is required following MedDRA Dictionary updates. For more information on this feature, see Bulk Recode MedDRA-Coded Terms on Cases.
.
.
next to the filter.
badge will appear next to it in the Adverse Event section of your AER. 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.
), select a supported language.
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, and then select the preferred language.
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 
button.