Enable Study Arms and Blinded Product Names

Learn how to update your Vault’s configuration to enable Study Arms, including blinded product names.

About the Feature

Study site reporters were added in Vault Safety 20R1. Upgraded Vaults must perform the following configuration changes to enable this feature.

Manage Studies describes how to set up Study Arms and blinded Study Product names, once you enable this feature.

Update the Study Object

You must update layouts and layout rules on the Study object. To edit the Study object, in the Admin area, go to Configuration > Objects > Study.

Layout

On the Study > Layouts tab, open the Study Detail Page Layout, and then make the following updates.

Details Section

Update the Details section with the following settings:

  • Section Layout: Two Columns
  • Fields:
    • Organization
    • Study Number
    • Masking
    • Start Date
    • Completion Date
    • space
    • MedDRA Version
    • Study Name
    • Blinded
    • Study Has Arms
    • Download Dosage to Case
    • space

Study Products Section

Update the Study Products section with the following settings:

  • Creation Option: Popup Dialog
  • Columns:
    • Name
    • Study Product Role
    • Dose (number)
    • Dose (unit)
    • Frequency
    • Frequency (unit)
    • Dose Form (text)
    • RoA

Study Arms Section

Insert a Study Arms related object section with the following settings:

  • Related Object: Study Arm
  • Creation Option: Popup Dialog
  • Columns:
    • Name
    • Blinded
    • Description

Study Arm Products Section

Insert a Study Arms Products related object section with the following settings:

  • Related Object: Study Arm Product
  • Creation Option: New Page
  • Columns:
    • Name
    • Study Arm
    • Blinded Name (Placeholder)

Indications Section

Update the Indications section with the following change:

Creation Option: Popup Dialog

Layout Rules

In Configuration > Objects > Study, open the Layouts tab, and then add the following layout rules to the Study Detail Page Layout:

Rule Label IF this Layout Rule Expression is TRUE Apply the following display effects
Study Doesn't Have Arms study_has_arms__v = false
  • Effect: Hide
  • Type: Sections
  • Value: Study Arms, Study Arm Products
Download Dosage to Case study_has_arms__v = false || blinded__v != true
  • Effect: Hide
  • Type: Fields
  • Value: Download Dosage to Case

Update the Study Product Object

You must update layouts and layout rules on the Study Product object. To edit the Study Product object, in the Admin area, go to Configuration > Objects > Study Product.

Layouts

On the Study Product > Layouts tab, make the following updates to each layout.

Details Section

Update the Details section in each Study Product layout to reorder the existing fields to place the Name field below Study.

Dosage Section

Insert a Dosage section on each Study Product layout with the following settings, with the exception of the Device Detail Page Layout:

  • Layout: Single Column
  • Fields:
    • Dose
    • Frequency
    • Frequency (unit)
    • Dose Form (text)
    • RoA
    • Dosage Notes
    • space

Layout Rules

Go to Study Product > Layout > Layout Rules, and then add the following layout rules to each Study Product layout:

Rule Label IF this Layout Rule Expression is TRUE Apply the following display effects
New Record status__v != 'active__v' && status__v != 'inactive__v'
  • Effect: Hide
  • Type: Sections
  • Value: System Information

Configure the Study Arm Object

The Study Arm object is new for this feature. You must configure the fields, layout, and layout rules for this object. To edit the Study Arm object, in the Admin area, go to Configuration > Objects > Study Arm.

Fields

On the Study Arm > Fields tab, configure the following field:

  • Label: Study Blinded
  • Type: Lookup
  • Lookup Object: Study
  • Lookup Field: Blinded

Layouts

On the Study Arm > Layouts tab, configure the Study Arm Detail Page Layout to add the following sections:

Details Section

Update the Details section with the following settings:

  • Layout: Single Column
  • Fields:
    • Organization
    • Study
    • Name
    • Blinded
    • Indication
    • Description

Study Arm Products Section

Insert a Study Arm Products related object section with the following settings:

  • Related Object: Study Arm Product
  • Creation Option: Popup Dialog
  • Fields:
    • Name
    • Blinded Name

System Information Section

Insert a System Information section with the following settings:

  • Layout: Two Columns
  • Fields:
    • Last Modified Date
    • Last Modified By
    • Study Blinded
    • Created Date
    • Created By
    • Study Product Group

Layout Rules

Go to Study Arm > Layouts > Study Arm Detail Page Layout > Layout Rules, and then add the following layout rules:

Rule Label IF this Layout Rule Expression is TRUE Apply the following display effects
New Record status__v != 'active__v' && status__v != 'inactive__v'
  • Effect: Hide
  • Type: Sections
  • Value: System Information
Workflow Timeline not(isBlank(name__v))
  • Effect: Hide
  • Type: Sections
  • Value: Workflow Timeline
Indication blinded__v = true
  • Effect: Hide
  • Type: Fields
  • Value: Indication
Blinded study_blinded__c != true
  • Effect: Hide
  • Type: Fields
  • Value: Blinded

Configure the Study Arm Product Object

The Study Arm Product object is new for this feature. You must configure the fields, layout, layout rules, and validation rules for this object.

To edit the Study Arm Product object, in the Admin area, go to Configuration > Objects > Study Arm Product.

Fields

On the Study Arm Product > Fields tab, update the following fields:

Field Change
Study Delete the existing Criteria VQL
Study Arm Add the following Criteria VQL: study__v = {{this.study__v}}
Blinded Name (Placeholder) Change the Label to Blinded Name

Layouts

On the Study Arm Product > Layouts tab, configure the Study Arm Product Detail Page Layout to match the following sections.

Details Section

Update the Details section with the following settings:

  • Layout: Single Column
  • Fields:
    • Organization
    • Study Arm
    • Study Product
    • Name
    • Blinded Name (Placeholder)
    • Dose
    • Dose (unit)
    • Frequency
    • Frequency (unit)

System Information Section

Insert a System Information section with the following settings:

  • Layout: Two Columns
  • Fields:
    • Last Modified Date
    • Last Modified By
    • Study
    • Created Date
    • Created By
    • Study Arm Blinded

Layout Rules

Go to Study Arm Product > Layouts > Study Arm Product Detail Page Layout > Layout Rules, and then add the following layout rules:

Rule Label IF this Layout Rule Expression is TRUE Apply the following display effects
New Record status__v != 'active__v' && status__v != 'inactive__v'
  • Effect: Hide
  • Type: Sections
  • Value: System Information
Workflow Timeline not(isBlank(name__v))
  • Effect: Hide
  • Type: Sections
  • Value: Workflow Timeline
Study Arm is Blinded study_arm_blinded__v = true
  • Effect: Hide
  • Type: Fields
  • Value: Dose, Dose (unit), Frequency, Frequency (unit)
Study Arm is Open study_arm_blinded__v != true
  • Effect: Hide
  • Type: Fields
  • Value: Blinded Name

Validation Rule

On the Study Arm Product > Validation Rules tab, configure the following Validation Rule:

  • Label: Blinded Name is Mandatory
  • Error Message: Blinded Name is Mandatory for products in a blinded arm.
  • Location: Blinded Name

  • Validation: Add the following VQL:

    not (

    study_arm_blinded__v = true &&

    isBlank(study_product_placeholder__vr.name__v)

    )

Configure the Study Product Placeholder Object

The Study Product Placeholder object is new for this feature. You must configure the layout and layout rules for this object.

To edit the Study Product Placeholder object, in the Admin area, go to Configuration > Objects > Study Product Placeholder.

Layouts

On the Study Product Placeholder > Layouts tab, configure the Study Product Placeholder Detail Page Layout to match the following section.

Details Section

Update the Details section with the following settings:

  • Layout: Single Column
  • Fields:
    • Organization
    • Study
    • Name
    • space

Layout Rules

Go to Study Product Placeholder > Layouts > Study Product Placeholder Detail Page Layout > Layout Rules, and then add the following layout rule:

Rule Label IF this Layout Rule Expression is TRUE Apply the following display effects
Workflow Timeline not(isBlank(name__v))
  • Effect: Hide
  • Type: Sections
  • Value: Workflow Timeline

Configure the Study Product Group Object

The Study Product Group object is new for this feature. You must configure the layout and layout rules for this object.

To edit the Study Product Group object, in the Admin area, go to Configuration > Objects > Study Product Group.

Layouts

On the Study Product Group > Layouts tab, configure the Study Product Group Detail Page Layout to update the following section.

Details Section

Update the Details section with the following settings:

  • Layout: Single Column
  • Fields:
    • Organization
    • Study
    • Name
    • space

Layout Rules

Go to Study Product Group > Layouts > Study Product Group Detail Page Layout > Layout Rules, and then add the following layout rule:

Rule Label IF this Layout Rule Expression is TRUE Apply the following display effects
Workflow Timeline not(isBlank(name__v))
  • Effect: Hide
  • Type: Sections
  • Value: Workflow Timeline

Update the Case Object

You must update the Case layout and layout rules.

To edit the Case object, go to Configuration > Objects > Case.

Fields

On the Case > Fields tab, configure the following fields.

  • Identifiable Company Product: Add the following formula:

Or(
    not(isBlank(product__vr.name__v)),
    Or (
            And(
                And(not(isBlank(study__vr.name__v)), study_has_arms__v != true),
                study_blinded__v = true
            ),
    Or (
            And(
                And(not(isBlank(study__vr.name__v)), study_has_arms__v != true),
                And(study_blinded__v != true,not(isBlank(study_product__vr.name__v)))
            ),
            And(
                And(not(isBlank(study__vr.name__v)), study_has_arms__v = true),
                not(isBlank(study_product_group__vr.name__v))
            )
    )
    )
)

  • Products (Group): Change the Label to Study Arm
  • Products (Arm): Change the Label to Study Arm (Unblinded)
  • Study Blinded: Change the Object Types to AER, Case, and Imported Case

Layouts

On the Case > Layouts tab, edit the AER Detail Page Layout to match the following sections.

Product Section

Update the Product section to include the following fields:

  • Study Arm
  • Product

System Information Section

Update the System Information section to include the following fields:

  • Name
  • space
  • Status
  • Study Has Arms

Layout Rules

Go to Case > Layouts > AER Detail Page Layout > Layout Rules, and then add the following layout rules.

Study Doesn’t Have Arms

  • Rule Label: Study Doesn’t Have Arms
  • IF this Layout Rule Expression is TRUE:
    study_has_arms__v != true
  • Apply the following display effects:
    • Effect: Hide
    • Type: Fields
    • Value: Study Arm

Product (Study) Rule v2

  • Rule Label: Product (Study) Rule v2
  • IF this Layout Rule Expression is TRUE:
    Or(
            report_type__vr.name__v != "Study",
            Or(
                    study_has_arms__v = true,
                    If(IsBlank(blinded__v), study_blinded__v, And(study_blinded__v, blinded__v))
            )
    )
  • Apply the following display effects:
    • Effect: Hide
    • Type: Fields
    • Value: Study Product

Permission Sets

On the Users & Groups > Permission Sets page, configure the following Object Permissions:

  1. Enable the permission to Read the Study Arm, Study Arm Product, Study Product Group, and Study Product Placeholder objects on the following permission sets:
    • Case Distribution Actions
    • Case Entry Actions
    • Case Intake Actions
    • Case Review Actions
    • Safety Operations Actions
    • Safety Writer
    • Submission Actions
  2. Enable the permission to Read, Create, Edit, and Delete the Study Arm, Study Arm Product, Study Product Group, and Study Product Placeholder objects on the following permission set:
  • Administration Actions

Update the Case Review Workflow

Go to Configuration > Object Workflows > Case Review, and then configure the following steps.

Decision: Case Unblinded?

Update the Decision: Case Unblinded? step to add the following Else rule:

  • Type: Decision
  • Next Steps: Determined by Rules
  • Rule 1: Leave the existing rule as-is
  • Else: then Open Arm?

Decision: Open Arm?

Add the following Decision: Open Arm? step after the Decision: Case Unblinded? step:

  • Type: Decision
  • Next Steps: Determined by Rules
  • Rule 1:
    If Study Has Arms equals Yes and
    Study Arm (unblinded) is not blank
    then Medical Review (Not Blinded)
  • Else: then Medical Review (Blinded)

alt-text

Update the Case Unblinding Workflow

Go to Configuration > Object Workflows > Case Unblinding, and then configure the following steps.

Start

Update the Start step to make the following change:

  • Next Steps: Study Arms?

Decision: Study Arms?

Add the Decision: Study Arms step with the following settings:

  • Type: Decision
  • Next Steps: Determined by Rules
  • Rule 1: If Study Has Arms equals Yes
    then Unblinding (Study Arm)
  • Else: then Unblinding

Workflow Task: Unblinding (Study Arm)

Add the Workflow Task: Unblinding (Study Arm) step with the following settings:

  • Type: Workflow Task
  • Next Steps: SUSAR?
  • Prompts: Copy the same Prompts and Verdicts as the Workflow Task: Unblinded step in the same workflow, and then add the following additions:
    1. Add the following SUSAR verdict:
      • Verdict: SUSAR
      • Prompt for Fields:
        • Study (required)
        • Study Arm (unblinded) (required)
    2. Add the following Not SUSAR verdict:
      • Verdict: Not SUSAR
      • Prompt for Fields:
        • Study (required)
        • Study Arm (unblinded) (required)

Decision: Unblinded

Update the Decision: Unblinded step to match the following settings:

  • Type: Decision
  • Next Steps: Determined by the rules below
  • Rule 1: If task Unblinding, Unblinding (Study Arm) at least one label equals SUSAR and
    If field Case Blinded equals No
    then Set State Unblinded
  • Rule 2: Else if all task Unblinding labels equal Not SUSAR and
    If field Case Blinded equals No
    then Set State Unblinded
  • Rule 3: Else if all task Unblinding labels equal Keep Blind then Set State Blinded
  • Else: then Study Arms?

alt-text

Update the Case Lifecycle

Go to Object Lifecycles > Case Lifecycle, and then update the Unblinded state to add the following Entry Criteria rules:

State Rule Type If Validate that
Unblinded Entry Criteria Study Has Arms equals No Case Products: No records equal Blinded
Case Products: No records equal Unblinding
Unblinded Entry Criteria Study Has Arms is blank Case Products: No records equal Blinded
Case Products: No records equal Unblinding

Update the Case Product Lifecycle

Go to Object Lifecycles > Case Product Lifecycle, and then update the Unblinding state to add the following Entry Action rules:

State Rule Type If Validate that
Unblinding Entry Action Case Product Type equals Study Product Set field Blinded to: No
Unblinding Entry Action Case Product Type equals Study Product and
Blinded Name (Placeholder) is blank		 Start Workflow: Unblind Case Product