Manage the MedDRA Dictionary

Set up and manage the MedDRA dictionary for coding medical terms.

About MedDRA Administration

Vault Safety supports medical coding of symptoms, diseases, indicators, and adverse events using the Medical Dictionary for Regulatory Activities (MedDRA) dictionary. The central MedDRA dictionary is system-managed and regularly updated. When a new dictionary version is available, you can immediately download it, including all global and localized terms. When you are ready to transition your active dictionary version to the latest dictionary, you can complete this in a single step.

When you update the active MedDRA Version of a Case to the already-downloaded version, Vault automatically reflects the newest terms, including hierarchy changes, on Cases and Inbox Items.

MedDRA terms with currency changes can be updated either on a case-by-case basis or in a single action, using MedDRA Bulk Recode.

Central MedDRA

Vault Safety manages and updates the centralized MedDRA dictionary twice per year. When a new dictionary version becomes available in the centralized repository, you can download it immediately and then choose when to transition the active MedDRA dictionary to the new version.

Prerequisites

You must maintain a valid MedDRA license to use the centralized MedDRA service and upgrade your Vault’s MedDRA dictionary to the latest version. For more information about how to validate your license during MedDRA dictionary version updates, see Enable Licensing Check for MedDRA.

Set Up MedDRA Centralization

Complete the following steps to set up the central MedDRA dictionary on your Vault:

1. Navigate to Business Admin > Objects > Dictionaries.
2. On the Dictionaries page, select MedDRA Dictionary from the table.
3. On the MedDRA Dictionary page, select Edit.
4. In the Dictionary Source field, select Central. If you do not populate this field, Vault considers the source as Central.
5. In the Active MedDRA Version field, select the dictionary version you want to use.
6. In the Languages field, select one or more of the supported languages. This field determines which languages are available for localized MedDRA coding.
7. In the MedDRA ID and MedDRA API Key fields, enter your MedDRA credentials. These fields are PHI-protected and are used only to ensure you have an active MedDRA license.
   • Visit the MedDRA API Key Registration site to obtain the MedDRA API Key.
8. Select Save.

Upgrade from a Self-Managed (Local) Dictionary to Centralized MedDRA

If you previously uploaded a MedDRA dictionary manually and want to transition to the central MedDRA dictionary, perform the following steps:

1. Navigate to Business Admin > Objects > Dictionaries.
2. On the Dictionaries page, select MedDRA Dictionary from the table.
3. On the MedDRA Dictionary page, select Edit.
4. In the Dictionary Source field, select Central.
5. In the MedDRA ID and MedDRA API Key fields, enter your MedDRA credentials. These fields are PHI-protected and are used only to ensure you have an active MedDRA license.
   • Visit the MedDRA API Key Registration site to obtain the MedDRA API Key.
6. In the Active MedDRA Version field, select the dictionary version you want to use.
7. Select Save.

Result

The MedDRA Dictionary record updates to the Importing lifecycle state. A system notification appears when the import is complete.

Troubleshoot MedDRA Transition Issue

When you transition from local MedDRA to central MedDRA, an issue can occur where certain dictionary term records are missing the llit_term field value. When this occurs, Vault prevents some actions. For example, when promoting an Inbox Item to a Case, Vault displays the following error message:

“Failed to open case from case RecordFamily. Error: java.lang.IllegalStateException: Duplicate key com.veeva.vault.app.safety.common.util.SdkRecordAdapter@148e193b.”

To resolve this MedDRA issue, complete the following:

• Delete any uploaded attachments
• Ensure the Dictionary Source is Central”

Delete MedDRA Dictionary Attachments

If any attachments have been uploaded, delete them using the following steps:

1. Navigate to Business Admin > Objects > Dictionaries.
2. On the Dictionaries page, select MedDRA Dictionary from the table.
3. In the Attachments section, on each attachment select the All Actions menu, and then select Delete.
4. Confirm the deletion request.

Update MedDRA Dictionary Source

If the MedDRA Dictionary Source is Local or blank, update it to Central using the following steps:

1. Navigate to Business Admin > Objects > Dictionaries.
2. On the Dictionaries page, select MedDRA Dictionary from the table.
3. Select the All Actions menu, and then select Edit.
4. For Dictionary Source, select Central.
5. Select Save.

Managing MedDRA Versions

When a new central MedDRA dictionary version becomes available, you must complete the following steps:

1. Download the latest version. Vault downloads the full MedDRA dictionary, including localized terms, to your Vault.
2. Validate your dictionary license. You must have current MedDRA credentials or you will be prevented from upgrading to the latest MedDRA dictionary.
3. Update the active MedDRA version. This controls the MedDRA dictionary version that is set at the Case level. When you activate the downloaded dictionary, all terms and hierarchy changes are immediately reflected on Cases and Inbox Items.

Download the Latest MedDRA Version

To download the latest central MedDRA dictionary version, complete the following steps:

1. Navigate to Business Admin > Objects > Dictionaries > MedDRA Dictionary.
2. From the All Actions menu, select Upgrade to Latest Version. The Upgrade to Latest Version dialog appears and confirms which MedDRA Dictionary version will be downloaded.
3. To apply the upgrade, select Continue.

Result

The full MedDRA dictionary, including global and localized terms, is downloaded and available when you choose to make it active. If the Latest Loaded MedDRA Version field is included in your MedDRA Dictionary layout, the downloaded dictionary version is displayed.

Validate Dictionary Licenses

You must validate your organization’s MedDRA credentials and license. To do this:

1. Navigate to Business Admin > Objects > Dictionaries > MedDRA Dictionary.
2. Ensure that the MedDRA ID and MedDRA API Key field values are correct.
3. From the All Actions menu, select Validate Dictionary License.

Result

Vault displays a message to indicate the validation results and updates the Last Valid License Check Status and Last Valid License Check Date fields. If validation is successful, you can proceed with updating the active MedDRA version.

Update the Active MedDRA Version

To update the active MedDRA version, which is applied to new Cases and Inbox Items, complete the following steps:

1. Navigate to Business Admin > Objects > Dictionaries > MedDRA Dictionary.
2. Select Edit.
3. In the Active MedDRA Version field, select the dictionary version you want to activate.
4. Select Save.

Result

New Cases and Inbox Items default to the latest active MedDRA version. If configured, follow-up Cases also default to the latest active MedDRA version.

Central MedDRA Versions

Vault Safety supports the following dictionary versions in central MedDRA:

• 27.1
• 27.0
• 26.1
• 26.0
• 25.1
• 25.0
• 24.1
• 24.0
• 23.1
• 23.0
• 22.1
• 22.0
• 21.1
• 21.0
• 20.1
• 20.0
• 19.1

Supported Languages

Vault Safety supports the following languages for the central MedDRA dictionary:

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

Enable Multilingual MedDRA

To auto-code and browse for multilingual terms on a Case, you must enable Multilingual MedDRA.

1. Navigate to Business Admin > Objects > Dictionaries.
2. On the Dictionaries page, select MedDRA Dictionary from the table. The MedDRA Dictionary page appears.
3. Select Edit and then select the Enable Multilingual MedDRA Control checkbox.
4. Select Save.

View MedDRA Terms

You can view the active and superseded MedDRA terms for every MedDRA dictionary version that has been downloaded to your Vault. While you can view MedDRA terms, you cannot edit them. MedDRA terms are added only when a new dictionary version is downloaded. When MedDRA terms have a hierarchy change, the record includes a link to the later version in the Superseded By field.

To view the list of MedDRA terms, go to Business Admin > Objects > MedDRA. Select any term to view its details.

Configure the Default MedDRA Version on Follow-Up Cases

The MedDRA Version on initial Cases is copied to follow-up Cases. You can configure your Vault so follow-up Cases default to the currently active Vault MedDRA version instead.

1. Navigate to Business Admin > Objects > Dictionaries.
2. On the Dictionaries page, select MedDRA Dictionary.
3. On the MedDRA Dictionary page, select Edit.
4. For Follow-Up Case MedDRA Version, select Active MedDRA Version.
5. Select Save.

Result

All future follow-up Cases default to the active system MedDRA Version.

Bulk Recode MedDRA-Coded Terms on Cases

Vault Safety supports fast and accurate recoding of non-current MedDRA coded 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.

Update the MedDRA Hierarchy

As of 23R1, when a new MedDRA dictionary is downloaded and activated in your Vault, Vault automatically reflects hierarchical changes. In addition, Vault updates the MedDRA hierarchy and creates the MedDRA Join records when any of the following events occur:

• An LLT term is coded using Auto-code or the MedDRA Browser.
• An E2B file containing an LLT term is imported to your Vault.
• An Inbox Item with a coded Adverse Event (LLT Term) is promoted to a Case.

You can also manually update the MedDRA hierarchy for all existing LLT terms in your Vault if needed.

Prerequisites

For the Update MedDRA Hierarchy action to appear in the All Actions menu, your Admin must first update the Dictionary object.

Run the Update MedDRA Hierarchy Action

Follow these steps to update the MedDRA hierarchy in your Vault:

1. Navigate to Business Admin > Objects > Dictionaries.
2. Beside MedDRA Dictionary, select the All Actions menu.
3. Select Update MedDRA Hierarchy.

Result

Vault notifies you when the update is complete. The different level terms under the same MedDRA hierarchy are updated for all existing LLT terms in your Vault.

(Optional) Update the MedDRA Version on Existing Cases

New Cases default to the active MedDRA version in your Vault. If configured, follow-up Cases also default to the latest active MedDRA.

Existing Cases and Inbox Items in any lifecycle state continue to use the MedDRA version they were created with. If required, you can update the MedDRA Version on existing Cases. You can update this field on a case-by-case basis or by using a bulk action.

Case MedDRA Version Update Best Practices and Considerations

Consider the following best practices and considerations if you must update the MedDRA Version on existing Cases:

• Consult your organization’s standard operating procedures and consider the impact on your business operations. If you have updated Vault MedDRA dictionary version within the grace period and you have configured follow-up to the latest active version, there may be no action required.
• Carefully consider the state Cases are in. In accordance with GxP, Cases should not be in a locked lifecycle state (Approved, Closed, Superseded, Nullified, and Invalid) or manually locked by a user.
• Once the coding process is complete on a Case, the MedDRA Version should not be updated.
• When switching the MedDRA Version of a Case, consult the MedDRA Release Documentation for guidance on the changes being introduced in that version.
• Updating the MedDRA Version of a Case does not modify MedDRA terms that were previously coded on the Case. If terms must be recoded, each term must be recoded manually. Vault marks terms that require recoding with a Recode Badge. For more information on recoding MedDRA terms, see Bulk Recode MedDRA-Coded Terms on Cases.

Update a Single Case MedDRA Version

To update the MedDRA Version of a Case, edit the value in the MedDRA Version field. This field is found on the Case and in the tabular view of the Cases tab, as shown in the following image:

If the MedDRA Version field is not displayed in the Cases table, you must edit the table columns to add the field.

Bulk Update Multiple Cases to a New MedDRA Version

To edit the MedDRA Version field on multiple Cases simultaneously, run a bulk action.

1. Navigate to the Cases tab and select the All Cases view
2. (Optional) Apply a filter to limit the list of Cases, such as by Lifecycle State or MedDRA Version. For example, the following image shows Cases filtered by an outdated MedDRA Version:
   
3. Expand the All Actions menu, and then under Perform Bulk Action, select All x Records.
   
4. On the Refine Selection page, select the Claim you want to update, and then select Next.
   
5. On the Choose Action page, select Edit Fields, and then select Next.
   
6. On the Edit Fields page, under MedDRA Version select Edit () and set the field to the MedDRA Version you want to make active, and then select Next.
   
7. On the Confirmation page, review the summary of the changes that will be applied. To apply the changes, select Finish.
   

Result

Vault updates the active MedDRA Version of each selected Case and sends you a notification with details about the update.