# Enable Clinical Trials: Isolate Blinded Product Information

With the 24R1 release, the Clinical Trials: Isolate Blinded Product Information feature laid the foundation for Veeva Safety's most advanced approach to protecting blinded information for Clinical Trial Study Cases. In 24R2, Vault Safety fully isolates blinded Product information, so that unblinded Case Products can be independently assessed.

We recommend adopting this feature to ensure optimal processing of your blinded Clinical Trial Study Cases from start to finish. This feature offers the following significant advantages over other methods of managing Case blinding:

* Dual records preserve all of the information from before and after unblinding for all global and localized records
* Support for independent assessments of unblinded Case Products during the Medical Review process
* Blind protection supports overall clinical trial integrity when distributing SUSARs to ethics committees and study sites
* Accurate reporting to both regulatory and non-regulatory health authorities
* A clear user interface to help users easily differentiate blinded from unblinded information

For more information about using this feature, see <a href="/en/gr/691317/">Isolate Blinded Clinical Trial Information</a>.

## Enablement Overview

The following list outlines the procedures for enabling Clinical Trials: Isolate Blinded Product Information in your Vault:

1. Review the [Prerequisites][1] and [Recommendations][2].
2. [Update Safety General Settings][3].
3. [Update Object Lifecycle Application Roles and Atomic Security][4].
4. [Update the Case Lifecycle][5].
5. [Add Layouts and a Layout Profile][6].

## Prerequisites {#prereqs}

Before enabling the Clinical Trials: Isolate Blinded Product Information feature in your Vault, you must contact Veeva Managed Services. Based on your organization's needs, our team will consult with you on the following:

* Generating the _Blinding Type_ and _Blinded Reference_ details on existing Clinical Trial Study Cases
* Reviewing custom reports and existing _Case_ object layouts for potential impact.

In addition, consider these other prerequisites for using this feature:

* Your Vault must use <a href="/en/gr/01308/">Inbox Items</a>.
* Your Vault must have <a href="/en/gr/01304/">Case Access Group Security</a> configured.
* Your Vault must use <a class="external-link " href="https://rn.veevavault.help/en/lr/archive/24r1/new-in-24r1/#action-layouts" target="_blank" rel="noopener">Action Layouts<i class="fa fa-external-link" aria-hidden="true"></i></a>.

## Recommendations {#recommends}

In addition to the prerequisites, we recommend the following setup for working with the Clinical Trials: Isolate Blinded Product Information feature:

* Configure <a href="/en/gr/01216/#studies-without-study-arms">Studies without Study Arms</a>.
* Enable the <a href="/en/gr/15057/#object-record-deletion--relationships">Cascade delete children records</a> option in your Vault.

## Update Safety General Settings {#general-settings}

Complete the following steps to turn on the Clinical Trials: Isolate Blinded Product Information feature.

1. Go to **Admin > Settings > Safety General Settings**.
2. Select **Edit**.
3. In the **Other Options** section, select **Enable Isolation of Blinded Product Information**.
4. On the **Warning** dialog, select **Continue**.
5. Select **Save**.

## Update Object Lifecycle Application Roles and Atomic Security {#update-roles-security}

For any lifecycle configured with the _Study Unmasked_ application role, update the <a href="/en/gr/47850/#how-to-set-atomic-security-on-fields">Atomic Security</a> for blind-sensitive fields from _Hide_ to _Edit_ or _Read_ as needed.

## Update the Case Lifecycle {#update-case-lc}

You must add a conditional entry action to the _Unblinding_ state of the _Case Lifecycle_ so that Vault does not set Open Label Products to the _Unblinding_ lifecycle state. Optionally, you may also update the label of the _Start Unblinding_ user action to "Complete Unblinding".

To complete these procedures, go to **Admin > Configuration > Object Lifecycles > Case Lifecycle > States > Unblinding**.

### Add an Entry Action

Complete the following steps to add a conditional entry action to the _Unblinding_ state:

1. In the **Entry Actions** section, select **Edit** and configure the following Entry Action:
   * **Perform with conditions**
   * If **Study Blinded** > **equals** > **Yes**
   * If **Single Arm Selection on Inbox** (formerly labeled _Study Has Arms_) > **equals** > **No**
     * **perform actions:** Change related object lifecycle state asynchronously (no limit)
     * **Related Object:** Case Products
     * **Change State To:** Unblinding
     * Select **Conditions On Related Records**
     * **Condition:** Exclude related records in the following lifecycle states
     * **Related Record's State:** Open, Active, Inactive
2. Select **Save**.

### Optional: Change the User Action Label

You can change the label of the _Start Unblinding_ user action to "Complete Unblinding".

1. In the **User Actions** section, select **Edit**.
2. On the existing user action with the **Action Label** set to "Start Unblinding", change the label to "Complete Unblinding".
3. Select **Save**.

## Add Layouts and a Layout Profile {#add-layouts}

You must create or update the _Blinded Medical Review_, _Unblinded Medical Review_, and _Case_ layouts, and then add them to a _Medical Review_ layout profile.

### Create Layouts

On the _Case_ object, add the _Blinded Medical Review_ and _Unblinded Medical Review_ layouts. Configure both layouts for the _Case_ object type.

Go to **Admin > Configuration > Objects > Case > Layouts**.

For more information on how to create an object layout, see <a href="/en/gr/26387/#how-to-create-an-object-layout">Configuring Object Layouts</a>.

#### Create the Blinded Medical Review Layout

Create the _Blinded Medical Review_ layout and add pages, sections, and fields as described in the following table.

The _Slider_ (<img class="inline" src="https://platform.veevavault.help/assets/images/saf-app-control.png" alt="app-control" style="" />) icon indicates a control section or field.

<table>
    <tr>
        <th>Page</th>
        <th>Sections and Section Settings</th>
        <th>Fields</th>
    </tr>
    <tr>
        <td rowspan="4">Case Summary</td>
        <td><ul>
                <li><strong>Section Type:</strong> Detail Form</li>
                <li><strong>Section Label:</strong> Case Summary</li>
                <li><strong>Section Layout:</strong> Detail Form - Two Columns</li>
            </ul>
        </td>
        <td><ul>
            <li><em>Name</em></li>
            <li><em>Case Number</em></li>
            <li><em>Report Type</em></li>
            <li><em>Study</em></li>
            <li><em>Study Arm</em></li>
            <li><em>Case Blinded</em></li>
            <li><em>Case Tags</em></li>
            <li><em>Expedited</em></li>
            <li><em>Primary Event Seriousness</em></li>
            <li><em>Relatedness</em></li>
            <li><em>Receipt Date</em></li>
            <li><em>New Info Date</em></li>
            <li><em>Due Date</em></li>
            <li><em>Event Country</em></li>
            <li><em>Reporter Country</em></li>
            <li><em>Reporter Language</em></li>
        </ul></td>
    </tr>
    <tr>
        <td><ul>
                <li><strong>Section Type:</strong> Detail Form</li>
                <li><strong>Section Label:</strong> Patient Summary</li>
                <li><strong>Section Layout:</strong> Detail Form - Two Columns</li>
            </ul>
       </td>
       <td><ul>
            <li><img class="inline" src="https://platform.veevavault.help/assets/images/saf-app-control.png" alt="app-control" style="" /> <em>Sex</em></li>
            <li><img class="inline" src="https://platform.veevavault.help/assets/images/saf-app-control.png" alt="app-control" style="" /> <em>Date of Birth</em></li>
            <li><img class="inline" src="https://platform.veevavault.help/assets/images/saf-app-control.png" alt="app-control" style="" /> <em>Age at Onset</em></li>
            <li><img class="inline" src="https://platform.veevavault.help/assets/images/saf-app-control.png" alt="app-control" style="" /> <em>Age Group</em></li>
            <li><img class="inline" src="https://platform.veevavault.help/assets/images/saf-app-control.png" alt="app-control" style="" /> <em>Date of Death</em></li>
            <li>Pregnancy</li>
        </ul></td>
    </tr>
    <tr>
        <td><ul>
                <li><strong>Section Type:</strong> Detail Form</li>
                <li><strong>Section Label:</strong> Narrative</li>
                <li><strong>Section Layout:</strong> Detail Form - Two Columns</li>
            </ul>
       </td>
       <td><ul>
            <li><img class="inline" src="https://platform.veevavault.help/assets/images/saf-app-control.png" alt="app-control" style="" /> <em>Narrative Preview</em></li>
            <li><em>space</em></li>
            <li><img class="inline" src="https://platform.veevavault.help/assets/images/saf-app-control.png" alt="app-control" style="" /> <em>Reporter's Comments</em></li>
            <li><img class="inline" src="https://platform.veevavault.help/assets/images/saf-app-control.png" alt="app-control" style="" /> <em>Company Comments</em></li>
        </ul></td>
    </tr>
    <tr>
        <td><ul>
                <li><strong>Section Type:</strong> <img class="inline" src="https://platform.veevavault.help/assets/images/saf-app-control.png" alt="app-control" style="" /> Timeline</li>
                <li><strong>Section Label:</strong> Timeline</li>
            </ul>
       </td>
       <td><ul>
            <li>N/A</li>
        </ul></td>
    </tr>
    <tr>
        <td rowspan="3">Assessments & Relatedness</td>
        <td><ul>
                <li><strong>Section Type:</strong> <img class="inline" src="https://platform.veevavault.help/assets/images/saf-app-control.png" alt="app-control" style="" /> Case Assessments</li>
                <li><strong>Section Label:</strong> Case Assessments</li>
                <li><strong>Blinding Type:</strong> Blinded and Open Label</li>
            </ul>
        </td>
        <td><ul>
            <li>N/A</li>
        </ul></td>
    </tr>
    <tr>
        <td><ul>
                <li><strong>Section Type:</strong> <img class="inline" src="https://platform.veevavault.help/assets/images/saf-app-control.png" alt="app-control" style="" /> Case Assessment Expectedness</li>
                <li><strong>Section Label:</strong> Case Assessment Expectedness</li>
                <li><strong>Blinding Type:</strong> Blinded and Open Label</li>
            </ul>
        </td>
        <td><ul>
            <li>N/A</li>
        </ul></td>
    </tr>
    <tr>
        <td><ul>
                <li><strong>Section Type:</strong> <img class="inline" src="https://platform.veevavault.help/assets/images/saf-app-control.png" alt="app-control" style="" /> Case Assessment Results</li>
                <li><strong>Section Label:</strong> Case Assessment Results</li>
                <li><strong>Blinding Type:</strong> Blinded and Open Label</li>
            </ul>
        </td>
        <td><ul>
            <li>N/A</li>
        </ul></td>
    </tr>
    <tr>
        <td rowspan="2">Case Products & Adverse Events</td>
        <td><ul>
                <li><strong>Section Type:</strong> Related Object</li>
                <li><strong>Related Object:</strong> Case Product</li>
                <li><strong>Section Label:</strong> Case Products</li>
                <li><strong>Criteria VQL:</strong> <code>blinding_type__v != 'unblinded__v'</code></li>
            </ul>
        </td>
        <td><ul>
            <li>Adjust columns if needed</li>
        </ul></td>
    </tr>
    <tr>
        <td><ul>
                <li><strong>Section Type:</strong> Related Object</li>
                <li><strong>Related Object:</strong> Case Adverse Event</li>
                <li><strong>Section Layout:</strong> Case Adverse Events</li>
            </ul>
        </td>
        <td><ul>
            <li>Adjust columns if needed</li>
        </ul></td>
    </tr>
      <tr>
        <td>Analysis of Similar Events</td>
        <td><ul>
                <li><strong>Section Type:</strong> Related Object</li>
                <li><strong>Related Object:</strong> Case Relationship</li>
                <li><strong>Section Label:</strong>Linked Cases</li>
            </ul>
        </td>
        <td><ul>
            <li>Adjust columns if needed</li>
        </ul></td>
    </tr>
      <tr>
        <td rowspan="3">System</td>
        <td><ul>
                <li><strong>Section Type:</strong> Workflow Timeline</li>
                <li><strong>Section Label:</strong> Workflow Timeline</li>
            </ul>
        </td>
        <td><ul>
            <li>N/A</li>
        </ul></td>
    </tr>
    <tr>
        <td><ul>
                <li><strong>Section Type:</strong> Related Object</li>
                <li><strong>Related Object:</strong> Case Signature</li>
                <li><strong>Section Label:</strong> Signatures</li>
            </ul>
        </td>
        <td><ul>
            <li>Adjust columns if needed</li>
        </ul></td>
    </tr>
    <tr>
        <td><ul>
                <li><strong>Section Type:</strong> Detail Form</li>
                <li><strong>Section Label:</strong> Details</li>
                <li><strong>Section Layout:</strong> Detail Form - Two Columns</li>
            </ul>
        </td>
        <td><ul>
            <li>Adjust columns if needed</li>
        </ul></td>
    </tr>
</table>

##### Add a Blinded Medical Review Layout Rule

Create a layout rule to focus the _Blinded Medical Review_ layout on the desired Case lifecycle state as follows:

* **Label:** "Focus"
* **IF this Layout Rule Expression is TRUE:** <code>state__v= 'medical_review_state__v' || state__v='unblinding_state__v'</code>
* **Apply the following display effects:** Focus On > Layout

For information on creating layout rules, see <a href="/en/gr/51632/#creating-layout-rules">Configuring Layout Rules</a>.

### Create the Unblinded Medical Review Layout

To create the _Unblinded Medical Review_ layout, first copy the _Blinded Medical Review_ layout and then make configuration changes:

1. Select the **Blinded Medical Review** layout's **Action** menu, and then select **Save As**.
2. In the **Layout Label** field, enter "Unblinded Medical Review".
3. Select **Done**.
4. On the **Assessments & Relatedness** page, change the **Blinding Type** to **Unblinded and Open Label** in the following sections:
   * **Case Assessments**
   * **Case Assessment Expectedness**
   * **Case Assessment Results**
5. On the **Case Products & Adverse Events** page, change the **Criteria VQL** to <code>blinding_type__v != 'blinded__v'</code> on the **Case Products** section.

#### Add an Unblinded Medical Review Layout Rule

Create a layout rule to focus the _Unblinded Medical Review_ layout on the desired Case lifecycle state as follows:

* **Label:** "Focus"
* **IF this Layout Rule Expression is TRUE:** <code>state__v= 'unblinded_state__v' || state__v= 'unblinding_state__v'|| state__v= 'in_approval_state__c'</code>
* **Apply the following display effects:** Focus On > Layout

For information on creating layout rules, see <a href="/en/gr/51632/#creating-layout-rules">Configuring Layout Rules</a>.

### Configure the Medical Review Layout Profile

Complete the following steps to configure a _Medical Review_ layout profile:

1. <a href="/en/gr/582159/#how-to-create-layout-profiles">Create a layout profile</a> called "Medical Reviewer".
2. <a href="/en/gr/582159/#how-to-add-users">Add users</a> to the Medical Reviewer layout profile.
3. <a href="/en/gr/582159/#how-to-add-layouts">Add the following layouts</a> to the layout profile for the _Case_ object:
   * _Case Page Layout_
   * _Blinded Medical Review_
   * _Unblinded Medical Review_

[1]: #prereqs
[2]: #recommends
[3]: #general-settings
[4]: #update-roles-security
[5]: #update-case-lc
[6]: #add-layouts