Enable Clinical Trials: Isolate Blinded Product Information

Learn how to configure your Vault to isolate blinded Product information.

About the Feature

In 24R1, the Clinical Trials: Isolate Blinded Product Information feature laid the foundation for Vault 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

This feature also introduces an option to turn off blind protection on Narrative documents. When blind protection is turned on, the Case Narrative Preview does not display any sensitive information. When Narratives are generated for Follow-up Cases, the new Narrative copies the blind protection setting from the Narrative on the previous Case version. If blind protection is turned off, any information in the Narrative document may be included in the Narrative Preview. When Narratives are generated for Follow-up Cases, blind protection remains off. Regardless of blind protection, if the initial Narrative contained merge fields, the tokens are regenerated using the new information in the Follow-up Case.

For more information about using this feature, see Isolate Blinded Clinical Trial Information.

Enablement Overview

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

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

Prerequisites

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
• Updating Narrative templates with merge fields or tokens that return blinded information so that the Blinding Type returns in the same merge field or token.
• 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 Inbox Items.
• Your Vault must have Case Access Group Security configured.
• Your Vault must use Action Layouts.

Recommendations

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

• Configure Studies without Study Arms.
• Enable the Cascade delete children records option in your Vault.

Update Safety General Settings

Complete the following steps to turn on the Clinical Trials: Isolate Blinded Product Information feature. You also have the option to turn off blind protection on Narratives generated for Study Cases.

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. Optional: Select Turn off Blind Protection on Narrative.
6. Select Save.

Update Object Lifecycle Application Roles and Atomic Security

For any lifecycle configured with the Study Unmasked application role, remove the application role and then define the default Atomic Security for blind-sensitive fields as Edit or Read as needed.

For more information on setting Atomic Security on fields, see Configuring Atomic Security for Objects.

Update the Case Lifecycle

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 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

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 Configuring Object Layouts.

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 () icon indicates a control section or field.

Page	Sections and Section Settings	Fields
Case Summary	Section Type: Detail Form Section Label: Case Summary Section Layout: Detail Form - Two Columns	Name Case Number Report Type Study Study Arm Case Blinded Case Tags Expedited Primary Event Seriousness Relatedness Receipt Date New Info Date Due Date Event Country Reporter Country Reporter Language
	Section Type: Detail Form Section Label: Patient Summary Section Layout: Detail Form - Two Columns	Sex Date of Birth Age at Onset Age Group Date of Death Pregnancy
	Section Type: Detail Form Section Label: Narrative Section Layout: Detail Form - Two Columns	Narrative Preview space Reporter's Comments Company Comments
	Section Type: Timeline Section Label: Timeline	N/A
Assessments & Relatedness	Section Type: Case Assessments Section Label: Case Assessments Blinding Type: Blinded and Open Label	N/A
	Section Type: Case Assessment Expectedness Section Label: Case Assessment Expectedness Blinding Type: Blinded and Open Label	N/A
	Section Type: Case Assessment Results Section Label: Case Assessment Results Blinding Type: Blinded and Open Label	N/A
Case Products & Adverse Events	Section Type: Related Object Related Object: Case Product Section Label: Case Products Criteria VQL: blinding_type__v != 'unblinded__v'	Adjust columns if needed
	Section Type: Related Object Related Object: Case Adverse Event Section Layout: Case Adverse Events	Adjust columns if needed
Analysis of Similar Events	Section Type: Related Object Related Object: Case Relationship Section Label:Linked Cases	Adjust columns if needed
System	Section Type: Workflow Timeline Section Label: Workflow Timeline	N/A
	Section Type: Related Object Related Object: Case Signature Section Label: Signatures	Adjust columns if needed
	Section Type: Detail Form Section Label: Details Section Layout: Detail Form - Two Columns	Adjust columns if needed

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: state__v= 'medical_review_state__v' || state__v='unblinding_state__v'
• Apply the following display effects: Focus On > Layout

For information on creating layout rules, see Configuring Layout Rules.

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 blinding_type__v != 'blinded__v' 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: state__v= 'unblinded_state__v' || state__v= 'unblinding_state__v'|| state__v= 'in_approval_state__c'
• Apply the following display effects: Focus On > Layout

For information on creating layout rules, see Configuring Layout Rules.

Configure the Medical Review Layout Profile

Complete the following steps to configure a Medical Review layout profile:

1. Create a layout profile called “Medical Reviewer”.
2. Add users to the Medical Reviewer layout profile.
3. Add the following layouts to the layout profile for the Case object:
   • Case Page Layout
   • Blinded Medical Review
   • Unblinded Medical Review