# Importing MedDRA Terminology (Registrations)

To support XEVMPD (and IDMP) product data reporting, you can import terminology from the Medical Dictionary for Regulatory Activities (MedDRA) directly into Vault using the MedDRA Dictionary Loader, found in the **RIM Maintenance** tab.

The MedDRA dictionary is structured using five (5) organizational levels. In RIM Registrations Vaults, you can import the Lowest Level Term (LLT), the associated Preferred Term (PT), and their respective codes into the _Coded Indication_ object (`coded_indication__rim`).

<div class="note-border alert-info">
  <div class="alert alert-info" role="alert">
    <div><i class="far fa-info-circle"></i></div>
    <div class="alert-text">
      <p><strong>Note</strong>: This feature is only available on Vaults that include the RIM Registrations application.</p>
    </div>
  </div>
</div>



## MedDRA Dictionary Access

  * To use this feature, you must have a license to access the MedDRA dictionary and valid credentials to download and extract the ZIP file containing the version-specific Ascii files (MedAscii/llt.asc and SeqAscii/llt.seq).
  * Vault supports only the English version of the dictionary at this time.
  * You can only load dictionary releases numbered 15.0 and greater into the _Coded Indication_ object.
  * MedAscii and SeqAscii files must be stored at the first level of the folder hierarchy in the ZIP file. If this is not the case, you must extract the files with the original password, create a new ZIP with the files stored at the correct level, and encrypt with a new password prior to loading.

## Initial Load of MedDRA Dictionary

To perform the Initial Load of the MedDRA dictionary into your Vault:

  1. Download the MedDRA dictionary ZIP file of your choice and obtain the version-specific password for the ZIP file.
  2. Navigate to the **RIM Maintenance** tab.
  3. From the **Action** drop-down menu, choose **Load MedDRA Dictionary**.
  4. From the **Action Type** drop-down menu, choose **Initial Load**.
  5. Click **Choose** to browse and select your ZIP file.
  6. Enter the version-specific **Password** for the ZIP file.
  7. Click **Start Load**.

Vault begins processing the request. When finished, you'll receive a Vault notification and email with request details and the output log file.

## Sequential Loads of MedDRA Terminology

When the MedDRA dictionary is updated, you can perform a sequential load of the dictionary into your Vault. The sequential load creates _Coded Indication_ records for any new terms, as well as applies the updates to existing terms in the _Coded Indication_ records.

To perform a sequential load of the MedDRA dictionary into your Vault:

  1. Download the MedDRA dictionary ZIP file containing SeqAscii/llt.asc.
  2. Navigate to the **RIM Maintenance** tab.
  3. From the **Action** drop-down menu, choose **Load MedDRA Dictionary**.
  4. From the **Action Type** drop-down menu, choose **Sequential Load**.
  5. Click **Choose** to browse and select your ZIP file.
  6. Enter the version-specific **Password** for the ZIP file.
  7. Click **Start Load**.

Vault begins processing the request. When finished, you'll receive a Vault notification and email with request details and the output log file.

## MedDRA Terminology Specific Field Explanations

The following fields on the _Coded Indication_ object are specific to MedDRA terminology:

|        Field                                                  |        Explanation                                                                                                                                                                                                                                                                                                                    |        Field Type                                                                                   |
|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
|        _Current In_  `current_versions__rim`                      |        MedDRA versions in which the term is current                                                                                                                                                                                                                                                                                   |        Multi-select picklist                                                                        |
|        _Non-Current In_  `noncurrent_versions__rim`               |        MedDRA versions in which the term is not current                                                                                                                                                                                                                                                                               |        Multi-select picklist                                                                        |
|        _First Added In_   `version_added__rim`                    |        MedDRA version in which a user imported the term (and its _Coded Indication_ record)                                                                                                                                                                                                                                             |        Single-select picklist                                                                       |
|        _Last Modified In_  `version_modified__rim`                |        MedDRA version in which the term was last modified                                                                                                                                                                                                                                                                             |        Single-select picklist                                                                       |
|        _Latest Modification Type_   `modification_type__rim`      |        Type of change in the most recent modification to the term, for example, a name or currency change                                                                                                                                                                                                                             |        Multi-select picklist                                                                        |
|        _Previous Term Names_   `previous_term_name__rim`          |        Names for the term in previous MedDRA versions                                                                                                                                                                                                                                                                                 |        Text                                                                                         |
|        _Preferred Term Code_  `preferred_term_code__rim`          |        Imported Preferred Term Code value from the MedDRA dictionary                                                                                                                                                                                                                                                                  |        Text                                                                                         |
|        _Preferred Term Name_  `preferred_term_name__rim`          |                  Imported _Preferred Term Name_ value associated with the _Lower Level Term_ from the MedDRA dictionary                         This field will not auto-populate when the _Preferred Term Name_ is the same as the _Lower Level Term Name_. Object referencing fields cannot reference the same value.             |                  Self-Referencing Object Field                       (_Coded Indication_)             |

## Related Permissions

The following permissions are needed for using RIM Maintenance:

|        Type                  |        Permission Label                       |        Controls                                                                                                                         |
|------------------------------|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
|        Security Profile      |        Application: RIM: RIM Maintenance      |        Ability to use RIM Maintenance.                                                                                                  |
|        Security Profile      |        Tabs: RIM Maintenance                  |        Ability to access the **RIM Maintenance** tab.                                                                                       |
|        Security Profile      |        Object: Coded Indication: Create       |        Ability to create records in the Coded Indication object. This is required to use **Import MedDRA Dictionary > Initial Load**.       |
|        Security Profile      |        Object: Coded Indication: Edit         |        Ability to edit records in the Coded Indication object. This is required to use **Import MedDRA Dictionary > Sequential Load**.      |

## Limitations & Additional Considerations

### Inactive MedDRA Versions

Values in the _MedDRA Versions_ picklist can be set to inactive. We recommend using the MedDRA Dictionary Loader only to load data referencing active versions in this picklist, as the _Load MedDRA Job_ fails when attempting to reference inactive versions.

### Coded Indication Object

We recommend that you no longer use the following legacy fields within the _Coded Indication_ object:

  * _Preferred Term Code_ (`preferred_term__rim`)
  * _Preferred Term Code Status_ (`preferred_term_code_status__rim)`

Vault does not reference either of these fields when you use the MedDRA Dictionary Loader feature. These fields are unnecessary for most immediate use cases.

We also recommend that you do not apply an object lifecycle to the _Coded Indication_ object. Adding a lifecycle disrupts functionality that renders an object record _Active_ or _Inactive_ as its currency changes in the MedDRA dictionary.
