Manage the MedDRA Dictionary

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

Sections in This Article

About MedDRA Administration

To enable medical coding with the Medical Dictionary for Regulatory Activities (MedDRA) for coding symptoms, disease, indicators, and adverse events, you must activate a MedDRA dictionary.

There are two ways you can activate and manage a MedDRA dictionary in Vault Safety: central MedDRA or local MedDRA. We recommend using central MedDRA, which is system managed and regularly updated. Alternatively, you can manually upload a MedDRA dictionary to your vault and maintain upgrading the dictionary manually. You must have a current MedDRA license to use either option.

View MedDRA terms within the active dictionary on the Business Admin > MedDRA page. You cannot edit MedDRA terms in Vault Safety. If you must change MedDRA terms, activate a new version of the dictionary.

Central MedDRA

Vault Safety hosts a centralized MedDRA dictionary that is managed and regularly updated twice a year by Veeva. If you decide to use this centralized MedDRA dictionary, you will not have to manually update it in your own vault.

When a new dictionary version becomes available in the centralized repository, you can choose when to transition to it.

Note With central MedDRA you must still manually upload Standardized MedDRA Queries (SMQs) and import a MedDRA .zip file. SMQs will not be managed or updated by the system.

Prerequisites

You must maintain a valid MedDRA license to use the centralized MedDRA service.

Set Up MedDRA Centralization

  1. Go to Business Admin > 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 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.

    Note If selected, a new MedDRA language will only take effect on new cases.

  7. In the MedDRA ID and MedDRA Password fields, enter your MedDRA credentials.
    Your MedDRA username and password are PHI-protected and will only be used to ensure you have an active MedDRA license. Also, these fields will only appear when you select Central as your Dictionary Source.
  8. Select Save.

Result

Your system has been updated to use the Centralized MedDRA dictionary.

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. Go to Business Admin > 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 Password fields, enter your MedDRA credentials.
  6. Select Save.
    You must save to update the MedDRA Dictionary record before selecting a new active version.
  7. To fetch the latest available dictionary versions, select the All Actions (All Actions) menu and then select Fetch Dictionary Releases from the menu.
  8. Select Edit.
  9. In the Active MedDRA Version field, select the dictionary version you want to use.
  10. Save the MedDRA Dictionary record.

Result

Your system has been updated to use the centralized MedDRA dictionary.

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, the system 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 setup:

Delete any attachments that were uploaded

Ensure the Dictionary Source is Central

Fetch Dictionary releases

Delete MedDRA Dictionary Attachments

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

  1. Go to Business Admin > Dictionaries.
  2. On the Dictionaries page, select MedDRA Dictionary from the table.
  3. In the Attachments section, on each attachment select the Actions (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. Go to Business Admin > Dictionaries.
  2. On the Dictionaries page, select MedDRA Dictionary from the table.
  3. Select the All Actions (All Actions) menu, and then select Edit from the menu.
  4. From the Dictionary Source picklist, select Central.
  5. Save the page.
Fetch Dictionary releases
  1. Go to Business Admin > Dictionaries.
  2. On the Dictionaries page, select MedDRA Dictionary from the table.
  3. Select the All Actions (All Actions) menu, and then select Fetch Dictionary Releases from the menu.
  4. When the process completes, select Edit.
  5. In the Active MedDRA Version field, select a previous MedDRA version, and then select Save.
  6. When the process completes, select Edit.
  7. In the Active MedDRA Version field, select the latest dictionary version, and then select Save.

Result

All of the MedDRA records are updated.

Download the Full Active MedDRA Version to Your Vault

When you upload .zip files for the MedDRA dictionary, this can lead to loading discrepancies. Instead, you can download the full active MedDRA version from the central dictionary to your vault.

Tip You can run this user action for vault migrations instead of manually uploading .zip files for the MedDRA dictionary.

Prerequisites

An admin must first update the Dictionary object to add and enable the Download Full MedDRA to Vault action for it to appear in the actions menu.

Run the Download Full MedDRA to Vault Action

Follow these steps to download the full MedDRA dictionary to your vault:

  1. Go to Business Admin > Dictionaries.
  2. Select alt-text beside MedDRA Dictionary.
  3. Select Download Full MedDRA to Vault.

    Note The Active MedDRA Version must be 19.0 or later to successfully run this action.

Result

The system sends a notification to alert you of whether the action was successfully completed. If successful, the full active MedDRA version is snapshotted from the centralized MedDRA dictionary to your vault.

Update the MedDRA Version

When a new central MedDRA dictionary version becomes available, an administrator must activate the new version.

  1. Go to Business Admin > Dictionaries.
  2. On the Dictionaries page, select MedDRA Dictionary from the table.
    The MedDRA Dictionary page appears.
    When the list of available MedDRA versions is out of sync with the server, you will see the following notification in the Active MedDRA Version field:
    The list of available MedDRA versions is out of sync with the server. Please sync the MedDRA versions to update the list.
  3. To sync the list of available MedDRA versions, perform the following steps:
    1. Open the All Actions (All Actions) menu.
    2. Select Fetch Dictionary Releases.
      This action retrieves any new central MedDRA dictionary versions.
  4. To activate a new MedDRA version:
    1. Select Edit on the MedDRA Dictionary.
    2. In the Active MedDRA Version field, select the dictionary version from the picklist.
    3. Save the MedDRA Dictionary.

    Note Ensure that your MedDRA license is up to date before activating a new MedDRA version.

Result

Your system has been updated with the current active MedDRA version. New Cases default to the latest active MedDRA Version by default. If configured, Follow-Up Cases also default to the latest active MedDRA.

Note Existing Cases already being processed will not be impacted by the new MedDRA version.

Central MedDRA Versions

Vault Safety currently supports the following dictionary versions in central MedDRA:

  • 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
  • Korean
  • Portuguese
  • Brazilian Portuguese
  • Russian
  • Spanish

Enable Multilingual MedDRA

An administrator must enable Multilingual MedDRA in order to auto-code and browse for multilingual terms on a Case.

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

Result

Your vault has been updated with the multilingual MedDRA capabilities.

Configure the Default MedDRA Version on Follow-Up Cases

Perform the following steps to configure Follow-Up Cases to default to the currently active system MedDRA Version instead of copying the MedDRA Version from the initial Case.

Tip This configuration is highly recommended as health authorities require the latest MedDRA version for submissions. Please consult your standard operating procedures for your regulatory agency MedDRA guidelines regarding grace periods and standard practices.

  1. Go to Business Admin > Dictionaries.
  2. On the Dictionaries page, select MedDRA Dictionary from the table.
  3. On the MedDRA Dictionary page, select Edit.
  4. In the Follow-Up Case MedDRA Version field, select Active MedDRA Version.
  5. Select Save.

Result

All future Follow-Up Cases default to the active system MedDRA Version.

Note If you leave the Follow-Up Case MedDRA Version field blank, Same as Previous Case will automatically be used and the MedDRA Version on each Follow-Up Case will not change from the initial Case.

Update the MedDRA Hierarchy

Whether you are using the Central or Local Dictionary Source, you can update the MedDRA hierarchy for all existing LLT terms in your vault.

The system also 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.

Prerequisites

An admin must first update the Dictionary object to add and enable the Update MedDRA Hierarchy action for it to appear in the actions menu.

Run the Update MedDRA Hierarchy Action

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

  1. Go to Business Admin > Dictionaries.
  2. Select alt-text beside MedDRA Dictionary.
  3. Select Update MedDRA Hierarchy.

Result

The system sends a notification to alert you of whether the action was successfully completed. If successful, the different level terms under the same MedDRA hierarchy are updated for all existing LLT terms in your vault.

MedDRA Synonyms

Administrators can configure MedDRA Synonyms with the centralized MedDRA dictionary to allow for more comprehensive auto-coding, allowing for synonyms, coding preferences, common typos, and deprecated terms to take on different codes without human intervention.

You can manually create and edit synonyms in Vault Safety, or bulk import synonyms from an external source using Vault Loader or the REST API.

Synonym Auto-Coding

When auto-coding a MedDRA field from a reported term, Vault Safety first searches for an exact match to an active MedDRA Synonym. If there are multiple matching synonyms, they will be shown in the MedDRA browser.

If no exact match to a MedDRA synonym is found, the system then attempts to auto-code a match from the MedDRA dictionary.

Considerations for MedDRA Synonyms

  • Synonyms are supported for the central MedDRA dictionary only.
  • Synonyms must be in the "Active" or "Updates" lifecycle states to be used in auto-coding.
  • Synonyms apply to all MedDRA fields. You cannot exclude fields.

Add a MedDRA Synonym Manually

  1. Go to Business Admin > MedDRA Synonyms.
  2. Select Create.
  3. On the Create MedDRA Synonym page, complete the following fields:
    Field Description
    Verbatim (Required) Enter the verbatim (reported) term to match to this synonym for auto-coding. Verbatim terms must match this text exactly to be auto-coded using this Synonym (case-insensitive).
    MedDRA Reference (Required) Code the MedDRA term PT/LLT that will be auto-coded to the verbatim term.
  4. Select Save.
  5. Ensure the Synonym lifecycle state is Active.

Bulk Import MedDRA Synonyms

You can bulk import synonyms from an external source using Vault Loader or the REST API. The following resources provide information on these tools:

The following example shows the syntax for a sample Vault Loader .csv that can be loaded to bulk import MedDRA synonyms:

verbatim__v,meddra_code__v
Rash with itching,10023092
Rash on nose,10037873
Rash on nose,10037856
haemorrhage,10019524
headache recurrent,10019211
recurrent headache,10019211
headache occuring,10019211
occurin headache,10019211

Local MedDRA Dictionary

The instructions in this section apply if you choose to manually upload a MedDRA dictionary rather than use the Vault Safety centralized MedDRA dictionary.

Prerequisites

  • To upload a MedDRA dictionary, you must have a .zip file containing the dictionary and the license key to access the file.

    Note Non-English .zip files are not supported for local MedDRA.

  • You cannot upload a version of MedDRA that is older than the currently active version. If you are migrating older versions of MedDRA, start with the oldest version and proceed in order to the newest version.

Upload a Self-Managed (Local) MedDRA Dictionary

  1. Go to Business Admin > Dictionaries.
  2. On the Dictionaries page, select MedDRA Dictionary from the table.
    meddra dictionary record
  3. On the MedDRA Dictionary page, select Edit.
  4. In the License Key field, enter the password for the MedDRA dictionary .zip file.
    Vault Safety encrypts the MedDRA license key.
  5. Select Save.

    Note For self-managed MedDRA dictionaries, the Languages field is informational only. The list of supported languages only applies to the Centralized MedDRA dictionary.

  6. Expand Attachments, and then select Upload.
    Note that if you upload more than one .zip file, only the most recently uploaded one will be used.
  7. Browse to the MedDRA .zip file, select the file, and then select Open.
  8. Open the All Actions (All Actions) menu, and then select Import MedDRA Dictionary.

Result

The system imports the MedDRA dictionary into the environment, including SMQs. A notification appears on the Home tab when the import operation completes.

Activate a MedDRA Dictionary Version

If you upload a new version of the MedDRA dictionary and want to use the new version for medical coding, you must make the new version active.

  1. On the MedDRA dictionary page, open the All Actions (All Actions) menu , and then select Change Active MedDRA.
    A dialog box appears with the following message:
    Changing the active MedDRA version will impact all new Cases. Do you wish to proceed?
  2. To accept the message and continue, select Start.
    An action banner appears at the top of the page for the Change Active MedDRA action.
  3. In the action banner, select Complete.
  4. In the Change Active MedDRA Version window, under Verdict, select Change.
  5. From the Current MedDRA Version list, select the MedDRA version that you want to make active.
  6. Select Complete.

Result

The active MedDRA dictionary is the default dictionary that all future adverse event reports and cases use for coding.

Update the Local MedDRA Dictionary

To update the MedDRA dictionary, upload the new version of the dictionary, and then make the version active.

Note that you can only upload a version of the dictionary that is more recent than the currently active dictionary.

(Optional) Update the MedDRA Version on Existing Cases

When you update the MedDRA Dictionary, new Cases default to the latest active MedDRA Version by default. If configured, Follow-Up Cases also default to the latest active MedDRA.

Existing Cases and AERs in any lifecycle state continue to use the MedDRA version they were created with. If required, you can update the MedDRA version on one or more existing Cases in Vault Safety.

The Case MedDRA Version (meddra_version__v) field controls the active MedDRA version on a Case. You can update this field on a Case-by-Case basis or using the Vault Bulk Action feature.

Note FDA, EMA, and other agencies generally allow a grace period after a MedDRA update. During this grace period, you can submit ICSRs using 1 version below the latest MedDRA version. Unless you have follow-up cases that are not configured to use the latest MedDRA Version, you do not need to update the MedDRA version on all existing Cases, only ones that will be submitted after the grace period ends.

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:

  • Before you update the MedDRA Version on existing Cases, consult your company's standard operating procedures and consider the impact on your business operations. If you have updated the system MedDRA dictionary version within the grace period and you have configured follow up to the latest active version, there may be no action required.
  • We highly recommend running a MedDRA Impact Assessment report before bulk updating the MedDRA Version on existing Cases. A custom MedDRA Impact Assessment Report can be configured to find Cases with coded terms that may be impacted by the new MedDRA version. Contact Veeva Managed Services for assistance in configuring a MedDRA Impact Assessment Report for your vault.
  • Carefully consider the state Cases are in. In accordance with GxP, Cases should not be in a locked Lifecycle State (Approved, Closed, Superseded, Nullified, 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 a Case MedDRA Version, consult the MedDRA Release Documentation for guidance on the changes being introduced in that version.
  • Updating the Case MedDRA Version does not modify MedDRA terms that were previously coded on the Case. If terms must be recoded, each term must be recoded manually. The system marks terms that require recoding with a Recode Badge.

Update a Single Case MedDRA Version

To update the MedDRA Version on a Case, simply edit the value in the MedDRA Version field. You can edit this field on the individual Case, or directly from the tabular view of the Cases tab, as shown in the following image:

Update the MedDRA Version on a Single Case
Update the MedDRA Version on a Single Case

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

Bulk Update Multiple Cases to a New MedDRA Version

To quickly update multiple Cases, you can use the Vault Bulk Action feature to edit the MedDRA Version field on multiple records simultaneously.

Warning Before you bulk update the Case MedDRA Version, review the Case MedDRA Version Update Best Practices and Considerations.

  1. Open the Cases tab to 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:
    Example: Filter Cases by MedDRA Version
    Example: Filter Cases by MedDRA Version
  3. Expand the All Actions (All Actions) menu, and then under Perform Bulk Action, select All x Records.
    Start Bulk Action
    Start Bulk Action
  4. On the Refine Selection page, select which Cases you want to update, and then select Next.
    Refine Case Selection
    Refine Case Selection
  5. On the Choose Action page, select Edit Fields, and then select Next.
    Choose Edit Fields Bulk Action
    Choose Edit Fields Bulk Action
  6. On the Edit Fields page, under MedDRA Version select the pencil icon and set the field to the new MedDRA version for which you want to make active, and then select Next.
    Edit MedDRA Version Field Settings
    Edit MedDRA Version Field Settings
  7. On the Confirmation page, review the summary of the changes that will be applied. To confirm and apply the changes, select Finish.
    Confirm Bulk Action
    Confirm Bulk Action

Result

The active MedDRA Version on each of the selected Cases is updated. Vault Safety sends you a notification with the results of the operation, as shown in the following image:

Bulk MedDRA Update Notification
Bulk MedDRA Update Notification

Configure User Access to Inbox Items
Use MedDRA Queries
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