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

Set up and manage the International Medical Device Regulators Forum (IMDRF) dictionary for coding device-specific adverse events.

## About the IMDRF Dictionary Feature

Starting in 22R3, Veeva Safety supports the International Medical Device Regulators Forum (IMDRF) dictionary with the latest device-specific adverse event codes. The system-managed dictionary will be available when the new central IMDRF dictionary is released each year. Administrators control when to upgrade to the newest version and can transition to the latest codes quickly and easily.

The IMDRF Dictionary object supports all seven annexes from the IMDRF dictionary, which includes the following:

* Annex A: Medical Device Problem
* Annex B: Type of Investigation
* Annex C: Investigation Findings
* Annex D: Investigation Conclusion
* Annex E: Health Effects - Clinical signs and Symptoms or Conditions
* Annex F: Health Effects: Health Impact
* Annex G: Medical Device Component

To enable IMDRF Dictionary maintenance and device-specific adverse event coding, complete the configuration on this page.

Once enabled, <a href="/en/gr/01185/">Manage the IMDRF Dictionary</a> describes how to manage the dictionary.

## 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** (<img class="inline" src="https://platform.veevavault.help/assets/images/saf-app-control.png" alt="slider" style="" />) icon.
5. In the _Details_ section, <a href="/en/gr/26387/#how-to-add-object-fields">add</a> the _Active IMDRF Version_ control field with the **Slider** (<img class="inline" src="https://platform.veevavault.help/assets/images/saf-app-control.png" alt="slider" style="" />) icon.
6. Insert a <a href="/en/gr/26387/#how-to-add-detail-forms">_Detail Form_ section</a> **Section**:
      * **Section Label**: Enter `System Information`.
      * **Section Layout**: From the drop-down, select **Detail Form - Two Columns**.
7. In the _System Information_ section, <a href="/en/gr/26387/#how-to-add-object-fields">add</a> 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**.

## 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** <a href="/en/gr/26387/#how-to-add-sections">related object section</a>.
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, <a href="/en/gr/26387/#how-to-add-object-fields">add</a> the **Device Code** control field with the **Slider** (<img class="inline" src="https://platform.veevavault.help/assets/images/saf-app-control.png" alt="slider" style="" />) icon and arrange the section fields as follows:
   * _Name_
   * _Case Product_
   * _Case_
   * _Device Code Type_
   * <img class="inline" src="https://platform.veevavault.help/assets/images/saf-app-control.png" alt="slider" style="" /> _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, <a href="/en/gr/26387/#how-to-add-object-fields">add</a> 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:

<table>
    <thead>
        <tr>
            <th>Object</th>
            <th>Permission Type</th>
            <th>Recommended Access</th>
        </tr>
    </thead>
        <tbody>
        <tr>
            <td>Case Product Device Code</td>
            <td>Object Control Permissions</td>
            <td><strong>View</strong> access for <strong>Device Code</strong></td>
        </tr>
        <tr>
            <td>Dictionary</td>
            <td>Object Permissions</td>
            <td><strong>Read</strong> access for <strong>IMDRF Device Code</strong></td>
        </tr>
        <tr>
            <td>IMDRF Device Code</td>
            <td>Object Field Permissions</td>
            <td><strong>Read</strong> access for:<ul>
                <li><strong>Device Code Type</strong></li>
                <li><strong>IMDRF Version</strong></li>
            </ul></td>
        </tr>
    </tbody>
</table>

#### 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**.