Enable the IMDRF Dictionary for Maintenance, Case Processing, and Submissions

With the 22R3 release, Veeva Safety supports the International Medical Device Regulators Forum (IMDRF) dictionary, providing the latest device-specific adverse event codes. Veeva updates Vault’s IMDRF dictionary annually, in line with the IMDRF maintenance schedule. When new versions are released, they become available in your Vault. You control which version of the IMDRF dictionary your Vault uses for coding.

Once enabled, Manage the IMDRF Dictionary describes how to maintain the dictionary.

26R3 Update: Automatic Adverse Event Device Code Creation

With the 26R3 release, Safety saves time when coding device products related to adverse events by automating the creation of Case Product Device Codes and the coding of IMDRF data. When a Case Assessment Result is evaluated as related to a Device-type Case Product, Vault generates a Case Product Device Code on the Case Product and maps its IMDRF data based on the MedDRA term coded to the related Case Adverse Event. To configure this feature in your Vault, see Configure Automatic Adverse Event Device Code Creation.

Overview

To enable this feature in your Vault:

• Create an IMDRF Dictionary object layout
• Configure the Active Version field on the Dictionary object
• Create the IMDRF Device Code Dictionary record
• Enable the Fetch Dictionary Releases action for the IMDRF Device Code Dictionary
• Configure the Case Product object layout to support Case Product Device Codes
• Configure the Case Product Device Code object layout
• Configure the Localized Case Product Device Code object layout
• Grant permissions

Add the IMDRF Dictionary Layout

1. Navigate to Admin > Configuration > Objects > Dictionary > Layouts.
2. Select Create.
3. On the Add Layout page, select IMDRF Device Code from the Object Type picklist, and then select Create.
4. On the Dictionary: Record Name page, in the Details section, replace the Active IMDRF Version field with the Active IMDRF Version control field, denoted by a Slider () icon.
5. In the Details section, add the Active IMDRF Version control field with the Slider () icon.
6. Insert a Detail Form section Section:
   • Section Label: Enter System Information.
   • Section Layout: From the drop-down, select Detail Form - Two Columns.
7. In the System Information section, add the following fields:
   • Last Modified Date
   • Last Modified By
   • Created Date
   • Created By
8. Select Save.

Configure the IMDRF Active Version Field

1. Navigate to Admin > Configuration > Objects > Dictionary > Fields.
2. In the Field column, select Active Version, and then select Edit.
3. Edit the Formula Expression to match the following: if(not(IsBlank(active_meddra_version__v)), text(active_meddra_version__v), if(not(IsBlank(active_imdrf_version__v)), text(active_imdrf_version__v), if(not(IsBlank(active_whodrug_version__v)), text(active_whodrug_version__v), '')))
4. Select Save.
5. If an Alert message appears, select OK.

Create the IMDRF Device Code Dictionary

To make the IMDRF dictionary available for use in your Vault:

1. Navigate to Business Admin > Objects > Dictionaries.
2. Select Create.
3. On the Create Dictionary page, select IMDRF Device Code from the Select Dictionary Type picklist.
4. On the Create IMDRF Device Code page, in the Name field, enter IMDRF Device Code Dictionary.
5. Select Save.

Enable Fetch Dictionary Releases for the IMDRF Device Code Object Type

1. Navigate to Admin > Configuration > Objects > Dictionary > Object Types.
2. On the right side of the page, toggle to Actions.
3. In the All Actions menu, select Edit Object Type Actions.
4. In the IMDRF Device Code column, select the Fetch Dictionary Releases checkbox.
5. Select Save.

Configure the Case Product Layout for Device Codes

1. Navigate to Admin > Configuration > Objects > Case Product > Layouts.
2. Select Device Detail Page Layout.
3. Insert the Case Product Device Code related object section.
4. In the Case Product Device Code section, select Edit Columns, and then add the Device Code Type and Device Code columns.
5. Delete the Device Problem and Evaluation Codes related object section.
6. Optional: Drag and drop to rearrange the sections.
7. Select Save.

Configure the Case Product Device Code Object

1. Navigate to Admin > Configuration > Objects > Case Product Device Code > Layouts.
2. Select the Case Product Device Code Detail Page Layout.
3. In the Details section, add the Device Code control field with the Slider () icon and arrange the section fields as follows:
   • Name
   • Case Product
   • Case
   • Device Code Type
   • Device Code
4. Select Save.

(Optional) Recommended Configuration for Case Product Device Code

1. Navigate to Admin > Configuration > Objects > Case Product Device Code.
2. On the Fields tab, for both Device Code and Device Code Type, edit the fields and then select the Display in default lists and hovercards checkbox.
3. Select Save.
4. On the List Layout tab, select Reorder and then configure the list in the following order:
   • Device Code Type
   • Device Code
5. Select Save.

Configure the Localized Case Product Device Code Layout

1. Navigate to Admin > Configuration > Objects > Localized Case Product Device Code > Layouts.
2. Select the Localized Case Product Device Code Detail Page Layout.
3. In the Details section, add the following fields:
   • Name
   • Case
   • Case Product
   • Case Product Device Code
   • Localized Case
   • Localized Case Product
   • Device Code Type
   • Local Code
4. Select Save.

(Optional) Recommended Configuration for Localized Case Product Device Code

1. Navigate to Admin > Configuration > Objects > Localized Case Product Device Code.
2. On the Fields tab, select Device Code Type, edit the field and then select the Display in default lists and hovercards checkbox.
3. Select Save.

Grant Permissions

Ensure your permission sets are granted the appropriate level of access to objects and fields according to your organization’s process.

1. Navigate to Admin > Users & Groups > Permission Sets > [Permission Set] > Objects.
2. Select Case Product Device Code.
3. In Object Permissions, grant Read or Edit permissions for Case Product Device Code as appropriate to the user group.
4. In Object Field Permissions, grant Read or Edit permissions for All Object Fields as appropriate to the user group.

(Optional) Grant View or Edit Permissions for Case Processors

Depending on your organization’s processes, you may choose to grant View or Edit permissions to Case Processors. If so, update the Case Entry Actions permission set and the Case Product Device Code Lifecycle as described in the following sections.

Case Entry Actions Permissions

Navigate to Admin > Users & Groups > Permission Sets > Case Entry Actions > Objects and complete the configuration summarized in the following table:

Object	Permission Type	Recommended Access
Case Product Device Code	Object Control Permissions	View access for Device Code
Dictionary	Object Permissions	Read access for IMDRF Device Code
IMDRF Device Code	Object Field Permissions	Read access for: Device Code Type IMDRF Version

Case Product Device Code Lifecycle Permissions

To add Edit permissions to the Case Product Device Code Lifecycle:

1. Navigate to Admin > Configuration > Object Lifecycles > Case Product Device Code Lifecycle.
2. In the States section, select Active.
3. In the Atomic Security: Fields section, select Edit and then set the following fields to Edit:
   • Device Code
   • Device Code Type
4. Select Save.

(26R3) Configure Automatic Adverse Event Device Code Creation

To configure this feature in your Vault:

• Copy the standard layout for the following objects:
  • Case Product Device Code
  • Device Code
• Assign the Fetch MedDRA Mappings action to the Dictionary object
• Add a user action to the applicable states of the Dictionary Lifecycle object lifecycle as follows:
  • Condition Type: Select All conditions are met
  • If: Select Dictionary Type > equals > IMDRF Device Code
  • Allow the following actions: Select Fetch MedDRA Mappings
    • Action Label: Enter Fetch MedDRA Mappings