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).
Note: This feature is only available on Vaults that include the RIM Registrations application.
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:
- Download the MedDRA dictionary ZIP file of your choice and obtain the version-specific password for the ZIP file.
- Navigate to the RIM Maintenance tab.
- From the Action drop-down menu, choose Load MedDRA Dictionary.
- From the Action Type drop-down menu, choose Initial Load.
- Click Choose to browse and select your ZIP file.
- Enter the version-specific Password for the ZIP file.
- 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:
- Download the MedDRA dictionary ZIP file containing SeqAscii/llt.asc.
- Navigate to the RIM Maintenance tab.
- From the Action drop-down menu, choose Load MedDRA Dictionary.
- From the Action Type drop-down menu, choose Sequential Load.
- Click Choose to browse and select your ZIP file.
- Enter the version-specific Password for the ZIP file.
- 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.