Manage the MedDRA Dictionary

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

About MedDRA Administration

Veeva 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 bulk recode action.

Central MedDRA

Vault manages and updates the centralized MedDRA dictionary version 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 > MedDRA Dictionary.
  2. Select Edit.
  3. For Dictionary Source, select Central. If you do not populate this field, Vault considers the source as Central.
  4. For Active MedDRA Version, select the dictionary version you want to use.
  5. For Languages, select one (1) or more of the supported languages to specify which languages are available for localized MedDRA coding.
  6. 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.
  7. 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 > MedDRA Dictionary.
  2. Select Edit.
  3. For Dictionary Source, select Central.
  4. 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.
  5. For Active MedDRA Version, select the dictionary version you want to use.
  6. 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 certain 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:

  • If the MedDRA Dictionary Source field value is Local or blank, update the value to Central.
  • Delete any uploaded attachments:
    1. Navigate to Business Admin > Objects > Dictionaries > MedDRA Dictionary.
    2. For each attachment in the Attachments section, select Delete from its Actions menu.
    3. Confirm the deletion request.

Managing MedDRA Versions

When a new central MedDRA dictionary version becomes available, you must make the following udpates to the MedDRA Dictionary record:

  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:

  1. From the record’s All Actions menu, select Upgrade to Latest Version. The Upgrade to Latest Version dialog appears and confirms which MedDRA Dictionary version Vault will download.
  2. To apply the upgrade, select Continue.

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

Validate Dictionary Licenses

To validate your organization’s MedDRA credentials and license:

  1. Ensure that the record’s MedDRA ID and MedDRA API Key field values are correct.
  2. From the All Actions menu, select Validate Dictionary License.

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 for new Cases and Inbox Items:

  1. On the MedDRA Dictionary record’s details page, select Edit.
  2. In the Active MedDRA Version field, select the dictionary version you want to activate.
  3. Select Save.

When you update the active version, 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

For details about which MedDRA versions Safety supports, see Safety Central Dictionary Updates.

Supported Languages

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 > MedDRA Dictionary.
  2. Select Edit and then select the Enable Multilingual MedDRA Control checkbox.
  3. 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

Vault copies the MedDRA Version on initial Cases 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 > MedDRA Dictionary.
  2. Select Edit.
  3. For Follow-Up Case MedDRA Version, select Active MedDRA Version.
  4. Select Save.

Bulk Recode MedDRA-Coded Terms on Cases

Vault 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 details, 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 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

To update the MedDRA hierarchy in your Vault, select Update MedDRA Hierarchy from the All Actions menu of the MedDRA Dictionary.

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 as needed or by using a bulk action.

Case MedDRA Version Update Best Practices

We reccomend the following best practices 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. If you do not see this field on the Cases table, you must edit the table columns and add it.

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.
  2. Select the All Cases view.
  3. Optional: Apply a filter to limit the list of Cases, such as by Lifecycle State or MedDRA Version.
  4. From the All Actions menu, select the option to perform a bulk action.
  5. On the Refine Selection page, select the Claim you want to update, and then select Next.
  6. On the Choose Action page, select Edit Fields, and then select Next.
  7. On the Edit Fields page, under MedDRA Version select Edit (Edit) and set the field to the MedDRA Version you want to make active, and then select Next.
  8. On the Confirmation page, review the summary of the changes that will be applied. To apply the changes, select Finish.

Vault sends you a notification with details about the update.