# Manage the MedDRA Dictionary Veeva Safety supports medical coding of symptoms, diseases, indicators, and adverse events using the Medical Dictionary for Regulatory Activities (MedDRA) dictionary. Vault manages and regularly updates the [central MedDRA dictionary][0]. When a new dictionary version is available, you can immediately download it, including all global terms, localized terms, and Standardised MedDRA Queries (SMQs). 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 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 {#central-meddra} Vault manages and updates the centralized MedDRA dictionary [version][12] 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 {#setup-centralization} 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. * Visit the MedDRA API Key Registration site to obtain the MedDRA API Key. 7. Select **Save**.
### Upgrade from a Self-Managed (Local) Dictionary to Centralized MedDRA {#upgrade} 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. * Visit the MedDRA API Key Registration site to obtain the MedDRA API Key. 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 {#update-central-meddra} When a new central MedDRA dictionary version becomes available, you must make the following updates to the _MedDRA Dictionary_ record: 1. [Download][9] the latest version. Vault downloads the full MedDRA dictionary, including localized terms and SMQs, to your Vault. 2. [Validate][10] your dictionary license. You must have current MedDRA credentials or you will be prevented from upgrading to the latest MedDRA dictionary. 3. [Update][11] 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 {#download} To download the latest central MedDRA dictionary version: 1. Navigate to **Business Admin > Objects > Dictionaries > MedDRA Dictionary**. 1. From the **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 terms, localized terms, and SMQs, is available when you choose to make it active. The _Latest Loaded MedDRA Version_ field value displays the downloaded dictionary version.
#### Validate Dictionary Licenses {#validate} 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. 3. 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 {#update-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**. 3. In the **Active MedDRA Version** field, select the dictionary version you want to activate. 4. Select **Save**. When you update the active version, new _Cases_ and _Inbox Items_ default to the latest active MedDRA version. If [configured][3], follow-up _Cases_ also default to the latest active MedDRA version.
### Central MedDRA Versions {#versions} For details about which MedDRA versions Safety supports, see Safety Central Dictionary Updates. ### Supported Languages {#languages} Safety supports the following languages for the central MedDRA dictionary: * Chinese * Croatian1 * Czech * Dutch * English * Estonian1 * Finnish1 * French * German * Greek1 * Hungarian * Icelandic1 * Italian * Japanese * Korean * Latvian1 * Lithuanian1 * Polish1 * Portuguese * Brazilian Portuguese * Russian * Spanish * Swedish1 1. Supported from version 28.0 onward and not supported on any previous version.↩ ### Enable Multilingual MedDRA {#enable-multilingual} 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 {#follow-up-meddra-version} 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**. 3. Select **Edit**. 4. For **Follow-Up Case MedDRA Version**, select **Active MedDRA Version**. 5. 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. ## (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][3]. 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][6].
### 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][3], 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. When your Vault's MedDRA version is out of sync with the _MedDRA Version_ of the _Case_, Vault displays a **RECODE** (Recode Tag) tag next to the non-current coded term, indicating that you must recode the term. ### 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 {#bulk-update} 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. [0]: #central-meddra [1]: #upgrade [2]: #update-central-meddra [3]: #follow-up-meddra-version [4]: #best-practices [5]: #bulk-update-case-meddra-version [6]: #bulk-update [7]: #delete [8]: #source [9]: #download [10]: #validate [11]: #update-active-meddra-version [12]: #versions