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 page layouts and layout rules on the Study object. To edit the Study object, in the Admin area, go to Configuration > Objects > Study.
Page Layout
On the Study > Page 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
Add 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
Add 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
Page Layout Rules
In Configuration > Objects > Study, open the Page Layouts tab, and then add the following layout rules to the Study Detail Page Layout:
Rule Label | Hide the following Page Layout Items | IF this Layout Rule Expression is TRUE |
---|---|---|
Study Doesn't Have Arms |
|
study_has_arms__v = false |
Download Dosage to Case |
|
study_has_arms__v = false ||
blinded__v != true |
Update the Study Product Object
You must update page 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.
Page Layouts
On the Study Product > Page Layouts tab, make the following updates to each page layout.
Details Section
Update the Details section in each Study Product page layout to reorder the existing fields to place the Name field below Study.
Dosage Section
Add a Dosage section to each Study Product page 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
Page Layout Rules
Go to Study Product > Page Layout > Layout Rules, and then add the following layout rules to each Study Product page layout:
Rule Label | Hide the following Page Layout Items | IF this Layout Rule Expression is TRUE |
---|---|---|
New Record |
|
status__v != 'active__v' && status__v != 'inactive__v' |
Configure the Study Arm Object
The Study Arm object is new for this feature. You must configure the fields, page layout, and page 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
Page Layouts
On the Study Arm > Page 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
Add 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
Add 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
Page Layout Rules
Go to Study Arm > Page Layouts > Study Arm Detail Page Layout > Layout Rules, and then add the following layout rules:
Rule Label | Hide the following Page Layout Items | IF this Layout Rule Expression is TRUE |
---|---|---|
New Record |
|
status__v != 'active__v' && status__v != 'inactive__v'
|
Workflow Timeline |
|
not(isBlank(name__v)) |
Indication |
|
blinded__v = true |
Blinded |
|
study_blinded__c != true |
Configure the Study Arm Product Object
The Study Arm Product object is new for this feature. You must configure the fields, page layout, page 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 |
Page Layouts
On the Study Arm Product > Page 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
Add 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
Page Layout Rules
Go to Study Arm Product > Page Layouts > Study Arm Product Detail Page Layout > Layout Rules, and then add the following layout rules:
Rule Label | Hide the following Page Layout Items | IF this Layout Rule Expression is TRUE |
---|---|---|
New Record |
|
status__v != 'active__v' && status__v != 'inactive__v'
|
Workflow Timeline |
|
not(isBlank(name__v)) |
Study Arm is Blinded |
|
study_arm_blinded__v = true |
Study Arm is Open |
|
study_arm_blinded__v != true |
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 page layout and page layout rules for this object.
To edit the Study Product Placeholder object, in the Admin area, go to Configuration > Objects > Study Product Placeholder.
Page Layouts
On the Study Product Placeholder > Page 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
Page Layout Rules
Go to Study Product Placeholder > Page Layouts > Study Product Placeholder Detail Page Layout > Layout Rules, and then add the following layout rule:
Rule Label | Hide the following Page Layout Items | IF this Layout Rule Expression is TRUE |
---|---|---|
Workflow Timeline |
|
not(isBlank(name__v)) |
Configure the Study Product Group Object
The Study Product Group object is new for this feature. You must configure the page layout and page layout rules for this object.
To edit the Study Product Group object, in the Admin area, go to Configuration > Objects > Study Product Group.
Page Layouts
On the Study Product Group > Page Layouts tab, configure the Study Product Group Detail Page Layout to add the following section.
Details Section
Update the Details section with the following settings:
- Layout: Single Column
- Fields:
- Organization
- Study
- Name
- space
Page Layout Rules
Go to Study Product Group > Page Layouts > Study Product Group Detail Page Layout > Layout Rules, and then add the following layout rule:
Rule Label | Hide the following Page Layout Items | IF this Layout Rule Expression is TRUE |
---|---|---|
Workflow Timeline |
|
not(isBlank(name__v)) |
Update the Case Object
You must update the Case page layout and page 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
Page Layouts
On the Case > Page 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
Page Layout Rules
Go to Case > Page 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
- Hide the following Page Layout Items:
- Type: Fields
- Value: Study Arm
- IF this Layout Rule Expression is TRUE:
study_has_arms__v != true
Product (Study) Rule v2
- Rule Label: Product (Study) Rule v2
- Hide the following Page Layout Items:
- Type: Fields
- Value: Study Product
- 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)) ) )
Permission Sets
On the Users & Groups > Permission Sets page, configure the following Object Permissions:
-
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
-
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)
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:
- Add the following SUSAR verdict:
- Verdict: SUSAR
- Prompt for Fields: Study (required)
Study Arm (unblinded) (required)
- Add the following Not SUSAR verdict:
- Verdict: Not SUSAR
- Prompt for Fields: Study (required)
Study Arm (unblinded) (required)
- Add the following SUSAR verdict:
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?
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 |