Enable Localized Submissions and Translation Support

Learn how to update your vault's configuration to enable localized submissions and language translation support.

Last Updated

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About the Feature

Support for Localized Submissions was first added in 20R3. Vaults originally deployed in 20R3 or later include some of the required configurations by default.

However, additional changes to the Vault Safety template were introduced in 21R2 to address data model issues with localized objects introduced in 20R3. Throughout this article, sections are prepended with (21R2) to identify configuration added in 21R2.

Vaults deployed from 21R2 and later already have the necessary configuration for this feature.

(Optional) Navigation

Optionally, add a Localized Cases navigation tab.

Checklist Tasks
  • Add the Localized Cases Tab
    1. In Admin, go to Configuration > Tabs.
    2. Select Create.
    3. Create the Localized Cases tab with the following details:
      • Label: Localized Cases
      • Tab Type: Object
      • Object: Localized Cases
      • Creation Options: Prevent record creation
    4. Select Save.

Object Configuration

The following configurations are required for enabling localized submissions.

Localized Country

Checklist Tasks
  • Add the Localized Country Section to the Country Page Layout
    1. In Admin, go to Configuration > Objects > Country.
    2. On the Page Layouts tab, open the Country Detail Page Layout.
    3. Select Related Object from the Add Section drop-down menu.
    4. Complete the Add Related Object form with the following details:
      • Related Object: Localized Country
      • Create Option: Prevent Record Creation
    5. Select Edit Columns from the Localized Country related object section.
    6. Add the following columns:
      • Name
      • Localization
    7. Select Done.
    8. Select Save.

Localized Organization

Checklist Tasks
  • Add the Localized Organization Section to Organization Page Layouts
    1. In Admin, go to Configuration > Objects > Organization > Page Layouts.
    2. Add the Localized Organization related object section to the following page layouts:
      • CRO Detail Page Layout
      • Ethics Committee Detail Page Layout
      • Organization Detail Page Layout
      • Partner Detail Page Layout
      • Site Detail Page Layout
      • Sponsor Detail Page Layout
      • Vendor Detail Page Layout
    3. Select Related Object from the Add Section drop-down menu.
    4. Complete the Add Related Object form with the following details:
      • Related Object: Localized Organization
      • Create Option: Create record in new page
    5. Select Edit Columns from the Localized Organization related object section.
    6. Add the following columns:
      • Name
      • Localization
      • Official Name
    7. Select Done.
    8. Select Save.
  • Update the Agency Page Layout
    1. In Admin, go to Configuration > Objects > Organization.
    2. On the Page Layouts tab, open the Agency Detail Page Layout.
      If this layout does not exist, create a new layout with this name for the Agency object type.
    3. Add the Localization field to the Details section.
    4. Select Add Section > Related Object.
    5. Complete the Add Related Object form with the following details:
      • Related Object: Localized Organization
      • Create Option: Prevent Record Creation
    6. Select Edit Columns from the Localized Organization related object section.
    7. Add the following columns:
      • Name
      • Localization
      • Official Name
    8. Select Done.
    9. Select Save.

Localized Controlled Vocabulary

Checklist Tasks
  • Add the Localized Controlled Vocabulary Section to the Controlled Vocabulary Page Layout
    1. In Admin, go to Configuration > Objects > Controlled Vocabulary.
    2. On the Page Layouts tab, open the Base Controlled Vocabulary Records Page Layout.
    3. Select Related Object from the Add Section drop-down menu.
    4. Add theLocalized Controlled Vocabulary related object section.
    5. Select Edit Columns from the Localized Controlled Vocabulary related object section.
    6. Add the Localization column.
    7. Select Done.
    8. Select Save.

Localized Dose Form

Checklist Tasks
  • Add the Localized Dose Form Section to the Dose Form Page Layout
    1. In Admin, go to Configuration > Objects > Dose Form.
    2. On the Page Layouts tab, open the Dose Form Detail Page Layout.
    3. Select Related Object from the Add Section drop-down menu.
    4. Complete the Add Related Object form with the following details:
      • Related Object: Localized Dose Form
      • Create Option: Prevent Record Creation
    5. Select Edit Columns from the Localized Dose Form related object section.
    6. Add the following columns:
      • Name
      • Localization
    7. Select Done.
    8. Select Save.

Localized Study

Checklist Tasks
  • Add the Localized Study Section to the Study Page Layout
    1. In Admin, go to Configuration > Objects > Study.
    2. On the Page Layouts tab, open the Study Detail Page Layout.
    3. Select Related Object from the Add Section drop-down menu.
    4. Complete the Add Related Object form with the following details:
      • Related Object: Localized Study
      • Create Option: Create record in new page
    5. Select Edit Columns from the Localized Study related object section.
    6. Add the following columns:
      • Name
      • Localization
      • Study Name
    7. Select Done.
    8. Select Save.

(21R2) Localized Case Contact

Checklist Tasks
  • Update the Localized Case Contact Page Layout
    1. In Admin, go to Configuration > Objects > Localized Case Contact.
    2. On the Page Layouts tab, open the Localized Case Contact Detail Page Layout.
    3. Edit the Details section to match the following configuration in this order:
      • Case
      • Localized Case
      • Title
      • First Name
      • Middle Name
      • Last Name
      • Organization
      • Department
      • Facility Name
      4. Localized Case Contact Details Section
      Localized Case Contact Details Section
    4. Select Detail Form from the Add Section drop-down menu.
    5. Complete the Add Detail form with the following details:
      • Section Label: Address
      • Section Name: address__c
    6. Select Done.
    7. Add the following fields to the Address Detail section:
      • Street
      • Street Line 2
      • City
      • State / Province
      • Contact Country
      8. Localized Case Contact Address Section
      Localized Case Contact Address Section
    8. Select Save.
  • (Optional) Update the Localized Study Name Field
    1. In Admin, go to Configuration > Objects > Localized Study > Fields > Name.
    2. Select Edit.
    3. Select System manages field value (read-only).
    4. Enter “VV-{######}” in the Value Format field.
    5. Select Save.

(21R2) Case

Checklist Tasks

Localized Case

Checklist Tasks
  • (Optional) Enable “Display in Lists and Hovercards” for Fields
    1. In Admin, go to Configuration > Objects > Localized Case > Fields.
    2. Select Case.
    3. Select Edit.
    4. Select the checkbox beside “display in lists and hovercards.”
    5. Select Save.
    6. Go to Configuration > Objects > Localized Case > Fields > Organization.
    7. Select Edit.
    8. Select the checkbox beside “display in lists and hovercards.”
    9. Select Save.

(21R2) Configure the Localized Case Page Layout

Go to Configuration > Objects > Localized Case > Page Layouts and configure the Localized Case Detail Page Layout. Expand the following sections for detailed instructions for each section on the page layout:

Checklist Tasks
  • Details Section

    The Details section should include the following fields:

    • Case
    • Name (Required)
    • Localization
    • Local Awareness Date
    • Global Due Date
    • Localized Parent Information
    • NMPA Report Classification*

      This field should be added once local fields for NMPA have been enabled in your Vault.

    • CIOMS Remarks
    Details Section
    Details Section
  • Contacts Section

    The layout should have a Contacts related object section with the following settings:

    Related Object Section Label Section Name Creation Option Columns
    Localized Case Contact Contacts localized_case_contacts Prevent record creation
    • Name
    • Reporter Qualification
    • First Name
    • Last Name
    • Contact Type
    Contacts Section
    Contacts Section
  • Products Section

    The layout should have a Products related object section with the following settings:

    Related Object Section Label Section Name Creation Option Columns
    Localized Case Product Products localized_case_products Prevent record creation
    • Name
    • Product (Coded)
    • Product (Reported)
    Products Section
    Products Section
  • Product Registrations Section

    Once Japanese Localization Fields have been enabled in your Vault, the layout should have a Product Registrations related object section with the following settings:

    Related Object Section Label Section Name Creation Option Columns
    Case Product Registration Product Registration case_product_registrations Create record in new page
    • Name
    • Registration Country
    • PMDA Reporting Category*
    • Product Registration
    • Rank
    Product Registrations Section
    Product Registrations Section
  • Case Comments Section

    Once Japanese Localization Fields have been enabled in your Vault, the layout should have a Case Comments related object section with the following settings:

    Related Object Section Label Section Name Creation Option Columns
    Localized Case Comment Product Registration localized_case_comment Create record in new page
    • Name
    • Comments Label
    • Comments Text
    • Case Product Registration
    Case Comments Section
    Case Comments Section
  • Adverse Events Section

    The layout should have a Adverse Events related object section with the following settings:

    Related Object Section Label Section Name Creation Option Columns
    Localized Case Adverse Event Adverse Events localized_case_
    adverse_events    		 Prevent record creation
    • Name
    • Case Adverse Event
    • Event (Reported)
    Adverse Events Section
    Adverse Events Section
  • Assessments Section

    The layout should have a Assessments related object section with the following settings:

    Related Object Section Label Section Name Creation Option Columns
    Localized Case Assessment Assessments localized_assessments Prevent record creation
    • Name
    • Case Assessment
    • Expected
    • Expected (Status)
    Assessments Section
    Assessments Section
  • Assessment Results Section

    The layout should have a Assessment Results related object section with the following settings:

    Related Object Section Label Section Name Creation Option Columns
    Localized Case Assessment Result Assessment Results localized_case_
    assessment_results    		 Prevent record creation
    • Name
    • Case Assessment Result
    • Method (text)
    • Result (text)
    • Source (text)
    Assessment Results Section
    Assessment Results Section
  • Causes of Death Section

    The layout should have a Causes of Death related object section with the following settings:

    Related Object Section Label Section Name Creation Option Columns
    Localized Case Cause of Death Causes of Death localized_case_
    causes_of_death    		 Prevent record creation
    • Name
    • Cause of Death (Reported)
    • Case Cause of Death
    Causes of Death Section
    Causes of Death Section
  • Medical History Section

    The layout should have a Medical History related object section with the following settings:

    Related Object Section Label Section Name Creation Option Columns
    Localized Case Medical History Medical History localized_medical_History Prevent record creation
    • Name
    • Condition/Procedure (Reported)
    • Comments
    Medical History Section
    Medical History Section
  • Drug History Section

    The layout should have a Drug History related object section with the following settings:

    Related Object Section Label Section Name Creation Option Columns
    Localized Case Drug History Drug History localized_drug_History Prevent record creation
    • Name
    • Drug (Coded)
    • Drug (Reported)
    Drug History Section
    Drug History Section
  • Test Results Section

    The layout should have a Test Results related object section with the following settings:

    Related Object Section Label Section Name Creation Option Columns
    Localized Case Test Result Test Results localized_
    test_results    		 Prevent record creation
    • Name
    • Test Name (Reported)
    • Test Result
    • Comments
    Test Results Section
    Test Results Section
  • Narrative Section

    The Narrative section should include the following fields:

    • Case Narrative
    • Narrative Preview
    • Medical History Text
    • Reporter’s Comments
    • Company Comments
    • Additional Pregnancy Related Information*
      • This field should be added once local fields for NMPA have been enabled in your Vault.
    Narrative Section
    Narrative Section
  • Study Section

    The Study section should include the following fields:

    • Study Name
    • Study Name (Continued)
    • Reporting Summary
    • Study Type
    • MFDS Other Study Type*
      This field should be added once local fields for MFDS have been enabled in your Vault.
    Study Section
    Study Section
  • Reference Numbers Section

    The layout should have a Reference Numbers related object section with the following settings:

    Related Object Section Label Section Name Creation Option Columns
    Localized Case Identifier Reference Numbers localized
    _case_identifiers    		 Prevent record creation
    • Name
    • Case Identifier
    • Source
    Reference Numbers Section
    Reference Numbers Section
  • Submissions & Distributions Section

    The layout should have a Submissions & Distributions related object section with the following settings:

    Related Object Section Label Section Name Creation Option Columns
    Transmission Submissions & Distributions submissions_distributions Prevent record creation
    • Name
    • Lifecycle State
    • Transmission Type
    • Transmission Date
    • Reason
    • Origin
    • Destination
    • Due Date
    • File
    Submissions & Distributions Section
    Submissions & Distributions Section

(21R2) Localized Case Product

In Admin, go to Configuration > Objects > Localized Case Product > Page Layout > Localized Case Product Detail Page Layout and configure the following sections on the page layout.

Checklist Tasks
  • Details Section
    1. Localized Case
    2. Case Product
    3. Product (Reported)
    4. Product (Coded)
    5. Local MPID
    6. Registration Holder/Applicant
    7. Related Device Information*

      This field should be added once local fields for NMPA have been enabled in your Vault.

    8. Other Additional Information
    Details Section
    Details Section
  • Dosages Section

    The layout should have a Dosages related object section with the following settings:

    Related Object Section Label Section Name Creation Option Columns
    Localized Case Product Dosage Dosages localized_case_
    product_dosage    		 Prevent record creation
    • Name
    • Dose Text
    • Dose (unit text)
    • Dose Form Text
  • Indications Section

    The layout should have an Indications related object section with the following settings:

    Related Object Section Label Section Name Creation Option Columns
    Localized Case Product Indication Indications localized_case_
    product_indication    		 Prevent record creation
    • Name
    • Name (Reported)
    Indications Section
    Indications Section
  • Substances Section

    The layout should have an Substances related object section with the following settings:

    Related Object Section Label Section Name Creation Option Columns
    Localized Case Product Substance Substances localized_case_
    product_substance    		 Prevent record creation
    • Name
    • Substance Name
    Substances Section
    Substances Section

(21R2) Localized Case Assessment

Checklist Tasks
  • Configure the Localized Case Assessment Page Layout
    1. In Admin, go to Configuration > Objects > Localized Case Assessment > Page Layout > Localized Case Assessment Detail Page Layout.
    2. Select Add from the Related Objects section.
    3. Complete the Add Related Object form with the following details:
      • Related Object: Localized Case Assessment Result
      • Section Label: Assessment Results
      • Create Option: Prevent Record Creation
    4. Select Done.
    Localized Case Assessment Page Layout
    Localized Case Assessment Page Layout

(21R2) Transmission

We recommend that you configure the Transmission object by adding the Localization lookup field to the object and adding the Hide Localized Case layout rule to the Transmission page layout.

Checklist Tasks
  • Add the Lookup Field to the Transmission Object
    1. In Admin, go to Configuration > Objects > Transmission > Fields.
    2. Select Create.
    3. Create the field with the following details:
      • Field Type: Lookup
      • Label: Localization
      • Lookup Relationship: Localized Case
      • Lookup Source Field: Localization
    4. Select Save.
    5. Go to Transmission > Object Types.
    6. On the Fields view, select Edit.
    7. Ensure the Localization field lookup field is selected for the Submission object type.
    Localization Lookup Field
    Localization Lookup Field
  • Create the Hide Localized Case Page Layout Rule
    1. In Admin, go to Configuration > Objects > Transmission > Page Layout > Submission Detail Page Layout > Layout Rules.
    2. Select Create.
    3. Create a Layout Rule with the following properties:
      • Label: Hide Localized Case
      • Hide the Following Page Layout Items:
        • Type: Fields
        • Values: Localized Case, Localization
      • IF this Layout Rule Expression is TRUE: isblank(localized_case__vr.name__v)
    4. Select Save.

(21R2) Case Product Registration

Checklist Tasks

(21R2) All Localized Objects (Non-Case)

If your Vault’s localization object details page layout has a system-related field in the Details section and it is NOT a Case child-object, add the System Information section and move those fields to that section.

Verify this configuration is done on the following objects:

  • Localization
  • Localized Controlled Vocabulary
  • Localized Country
  • Localized Dose Form
  • Localized Organization
  • Localized Product
  • Localized Route of Administration
  • Localized Study
  • Localized Substance
  • Localized Transmission
  • Localized Unit of Measurement
Checklist Tasks
  • (Optional) Add the System Information Section
    1. In Admin, go to Configuration > Objects > [Localized Object] > Page Layout > [Localized Object] Detail Page Layout.
    2. Select Add Section.
    3. Select Detail Form.
    4. Add the section with the following properties:
      • Section Label: System Information
      • Section Name: system__c
      • Detail Form - Two Columns
    5. Select Done.
    6. Move any system-related fields to this section.
    7. Add the section with the following properties:
      • Status
      • Created By
      • Created Date
      • Last Modified By
      • Last Modified Data
  • (Optional) Remove Fields from the Details Section

    If any of the following fields are in the Details section of any of the Localized Objects Detail Page Layouts, remove them from the section using the "x" next to the field:

    • Lifecycle
    • Lifecycle State
    • Lifecycle Stage
    • Lifecycle State Stage ID

(21R2) All Localized Case Child-Objects

Certain Localized Case child object page layouts may contain system-related fields in the Details section.

Verify this configuration is done on the following objects:

  • Localized Case Cause of Death
  • Localized Case Contact
  • Localized Case Identifier
  • Localized Case Product Substance
Checklist Tasks
  • (Optional) Add the System Information Section
    1. In Admin, go to Configuration > Objects > [Localized Object] > Page Layout > [Localized Object] Detail Page Layout.
    2. Select Add Section.
    3. Select Detail Form.
    4. Add the section with the following properties:
      • Section Label: System Information
      • Section Name: system__c
      • Detail Form - Two Columns
    5. Select Done.
    6. Move any system-related fields to this section.
    7. Add the section with the following properties:
      • Status
      • Created By
      • Created Date
      • Last Modified By
      • Last Modified Data
  • (Optional) Remove Fields from the Details Section

    If any of these fields appear in the Details section, move them to the System Information Section:

    • Name
    • Status
    • Created By
    • Created Date
    • Last Modified By
    • Last Modified Data
    • Lifecycle
    • Lifecycle State
    • Lifecycle Stage
    • Lifecycle State Stage ID

Object Lifecycles and Workflows

(21R2) Updates to Approved State in Localized Case Lifecycle

Checklist Tasks
  • (Optional) Rename the Approved State

    The 21R2 release includes a new system-managed Approved state for the Localized Case Lifecycle. The previously used Approved (approved_state__c) state can be relabelled and repurposed as a Revision state.

    1. In Admin, go to Configuration > Object Lifecycles > Localized Case Lifecycle.
    2. Select Approved (approved_state__c) from the States section.
      Ensure to select the custom (__c) state, not the system-managed (__v) Approved state.
    3. Select Edit from the Details section.
    4. Enter “Revision” in the State Label field.
    5. Enter “revision” in Name
    6. Select Save.
  • Configure the Approved State in the Localized Workflows
    1. In Admin, go to Configuration > Workflows.
    2. Open the following workflows for editing:
      • Localized Case Workflow
      • Localized Case Translation Workflow
    3. Select State Change: Approved.
    4. Select Edit.
    5. Under State Change Options, change the Next State field to the system-managed Approved (approved__v) state.
    6. Select Save.

(21R2) Configure the Localized Case Close Workflow

Checklist Tasks
  • Create the Localized Case Close Workflow
    1. In Admin, go to Configuration > Workflows.
    2. Select Create.
    3. Select Object Workflow from the drop-down menu.
    4. Select Continue.
    5. Create the workflow with the following details:
      • Label: Localized Case Workflow
      • Lifecycle: Localized Case Translation Workflow
    6. Create the workflow with the following steps:
      • Workflow Task: Task: Case Close
      • State Change: State Change: Closed
    7. Select Save.
    Localized Case Close Workflow
    Localized Case Close Workflow
  • Configure the Start Workflow: Start Workflow Step
    1. Add the Start Step.
    2. Select Add Control.
    3. Configure the Start Options with the following properties:
      • Control 1: Participants
        • Participation Label: Distribution Manager
        • Add Participants: Use roles as participants
          • Roles allowed to participate: Distribution Manager
    Start Workflow: Start Workflow Step
    Start Workflow: Start Workflow Step
  • Configure the Task: Case Close Workflow Step
    1. Add a Workflow Task after the Start step, labelled Task: Case Close in the Localized Case Close Workflow.
    2. Configure the General Settings with the following properties:
      • Task Label: Review Submissions
      • Assign Task To: Distribution Manager
        • Make available to users in participant group
      • Instructions: “Ensure localized case has been submitted to all required regulatory authorities.”
      • Task Requirement: Required
    3. Configure the Due Date:
      • Task Creation Date: + 1 Days
    4. Select Prompt for Verdicts from the Prompts section.
    5. Configure the Verdicts section with the following properties:
      • Verdict Label: Submissions Complete
      • Capacity Label: Signed by
        • Required
      • Capacity Values:
        • ICSR Approver
        • Distribution Manager
    Task: Case Close Workflow Step
    Task: Case Close Workflow Step
    Verdict
    Verdict

Configure the Localized Case Translation Workflow

The following configuration was originally provided in the 20R3 template.

Checklist Tasks
  • Create the Localized Case Translation Workflow
    1. In Admin, go to Configuration > Workflows.
    2. Select Create.
    3. Select Object Workflow from the drop-down menu.
    4. Select Continue.
    5. Create the workflow with the following details:
      • Label: Localized Case Translation
      • Lifecycle: Localized Case
    6. Create the workflow with the following steps:
      • Workflow Task: Task: Case Close
      • State Change: State Change: Closed
    7. Select Save.
    Localized Case Translation Workflow
    Localized Case Translation Workflow
  • Configure the Start Workflow: Start Workflow Step
    1. Add the Start Step.
    2. Select Add Control.
    3. Configure the Start Options with the following properties:
      • Control 1: Participants
        • Participation Label: Distribution Manager
        • Add Participants: Use roles as participants
          • Roles allowed to participate: Distribution Manager, ICSR Approver
      • Control 2: Participants
        • Participation Label: Translators
        • Add Participants: Use roles as participants
          • Roles allowed to participate: Data Entry, Translator
    Start Workflow: Start Workflow Step
    Start Workflow: Start Workflow Step
  • Configure the Task: Translation Entry Workflow Step
    1. Add a Workflow Task after the State Change: Case Translation step, labelled Task: Translation Entry in the Localized Case Translation Workflow.
    2. Configure the General Settings with the following properties:
      • Task Label: Translation Entry
      • Assign Task To: Translators
        • Make available to users in participant group
      • Instructions: “Please ensure all necessary fields are translated.”
      • Task Requirement: Required
    3. Configure the Due Date:
      • Task Creation Date: + 2 Days
    4. Select Include verdicts and comments from previous tasks from the Notifications section.
    5. Select Review Translation from the Select Tasks drop-down menu.
    6. Select Save.
    Task: Translation Entry Workflow Step
    Task: Translation Entry Workflow Step
  • Configure the Task: Review Translation Workflow Step
    1. Add a Workflow Task after the State Change: Translation Review step, labelled Task: Review Translation in the Localized Case Translation Workflow.
    2. Configure the General Settings with the following properties:
      • Task Label: Review Translation
      • Assign Task To: Approvers
        • Make available to users in participant group
      • Instructions: “Please ensure all necessary fields are translated.”
      • Task Requirement: Required
    3. Configure the Due Date:
      • Task Creation Date: + 2 Days
    4. Select Prompt for Verdicts from the Prompts section.
    5. Create two Verdicts with the following properties:
      • Verdict Label: Approve Revision
      • Verdict Label: Reject Revision
        • Prompt for Comments: "Comments"
        • Required
    6. Select Save.
    Task: Review Translation Workflow Step
    Task: Review Translation Workflow Step
    Verdict
    Verdict
  • Configure the Decision: Approve Translation Workflow Step
    1. Add a Workflow Task after the Workflow Task: Translation Review step, labelled Decision: Approve Translation in the Localized Case Translation Workflow.
    2. Create a Rule with the following properties:
      • IF: Task - Review: Translation - at least one label equals - Approve Translation
      • Then: Approved
      • Else:
        • Then: Case Translation
    3. Select Save.
    Decision: Approve Translation Workflow Step
    Decision: Approve Translation Workflow Step

(21R2) (Optional) Configure the Localized Case Revision Workflow

Checklist Tasks
  • Create the Localized Case Revision Workflow
    1. In Admin, go to Configuration > Workflows.
    2. Select Create.
    3. Select Object Workflowfrom the drop-down menu.
    4. Select Continue.
    5. Create the workflow with the following details:
      • Label: Localized Case Revision
      • Lifecycle: Localized Case
    6. Select Save.
    7. Select Createfrom the Workflow Steps section.
    8. Add the following workflow steps:
      1. State Change: State Change: Revision
      2. Workflow Task: Task: Revision
      3. Workflow Task: Task: Review
      4. Decision: Approved?
      5. State Change: State Change: Approved
    9. Select Save.
    Localized Case Revision Workflow
    Localized Case Revision Workflow
  • Configure the Start Workflow: Start Workflow Step
    1. Add the Start Step.
    2. Select Add Control.
    3. Configure the Start Options with the following properties:
      • Control 1: Instructions
        • Instructions: “You are starting a translation revision. Please provide instructions to the translators.”
      • Control 2: Date
        • Label: Revision Due Date
      • Control 3: Participants
        • Participation Label: Approvers
        • Add Participants: Use roles as participants
          • Roles allowed to participate: Distribution Manager, ICSR Approver
      • Control 4: Participants
        • Participation Label: Translators
        • Add Participants: Allow workflow initiator to select participants
          • Roles allowed to participate: Translator
          • Allow task instructions for these participants
            • Required
          • Default users from sharing settings
    Start Workflow: Start Workflow Step
    Start Workflow: Start Workflow Step
  • Configure the Task: Revision Workflow Step
    1. Navigate to Task: Revision in the Localized Case Revision Workflow.
    2. Select Edit.
    3. Configure the General Settings with the following properties:
      • Task Label: Revise Translation
      • Assign Task To: Translators
        • Make available to users in participant group
      • Instructions: “Revise case translations based on instructions.”
      • Task Requirement: Required
    4. Configure the Due Date:
      • Task Creation Date: - 1 Days
    5. Select Prompt for Comments from the Prompts section.
    6. Select Save.
    Task: Revision Workflow Step
    Task: Revision Workflow Step
  • Configure the Task: Review Workflow Step
    1. Navigate to Task: Review in the Localized Case Revision Workflow.
    2. Select Edit.
    3. Configure the General Settings with the following properties:
      • Task Label: Review Translation
      • Assign Task To: Approvers
        • Make available to users in participant group
      • Instructions: “Please review revised translations.”
      • Task Requirement: Required
    4. Configure the Due Date:
      • Task Creation Date: + 0 Days
    5. Select Prompt for Verdicts from the Prompts section.
    6. Create two Verdicts with the following properties:
      • Verdict Label: Approve Revision
      • Verdict Label: Reject Revision
        • Prompt for Comments: "Comments"
        • Required
    7. Select Save.
    Task: Review Workflow Step
    Task: Review Workflow Step
    Verdict
    Verdict
  • Configure the Decision: Approved? Workflow Step
    1. Navigate to Decision: Approved? in the Localized Case Revision Workflow.
    2. Select Edit.
    3. Create a Rule with the following properties:
      • IF: Task - Task: Review - at least one label equals - Reject Revision
      • Then: Task: Revision
      • Else:
        • Then: State Change: Approved
    4. Select Save.
    Decision: Approved? Workflow Step
    Decision: Approved? Workflow Step

(21R2) Configure Entry Actions and Criteria in the Localized Case Lifecycle

Checklist Tasks
  • Add Entry Actions on the Approved State
    1. In Admin, go to Configuration > Object Lifecycles > Localized Case Lifecycle > Approved.
    2. Select Edit from the Entry Actions section.
    3. Add the “Change related object lifecycle state” action and Change the State to Locked for the following objects:
      • Localized Case Adverse Events
      • Localized Case Assessment Results
      • Localized Case Assessments
      • Localized Case Causes of Death
      • Localized Case Comment
      • Localized Case Contacts
      • Localized Case Drug History
      • Localized Case Identifiers
      • Localized Case Medical History
      • Localized Case Product Dosage
      • Localized Case Product Indications
      • Localized Case Product Substances
      • Localized Case Products
      • Localized Case Test Results
      • Case Product Registration
    4. Add the “Change related Document lifecycle state” action to the following:
      • Document Reference Field: Case Narrative
      • State Type: Document Workflow: Approved
    5. Select Save.
  • Add Entry Actions on the Closed State
    1. In Admin, go to Configuration > Object Lifecycles > Localized Case Lifecycle > Closed.
    2. Select Edit from the Entry Actions section.
    3. Add the “Change related object lifecycle state” action and Change the State to Locked for the following objects:
      • Localized Case Adverse Events
      • Localized Case Assessment Results
      • Localized Case Assessments
      • Localized Case Causes of Death
      • Localized Case Comment
      • Localized Case Contacts
      • Localized Case Drug History
      • Localized Case Identifiers
      • Localized Case Medical History
      • Localized Case Product Dosage
      • Localized Case Product Indications
      • Localized Case Product Substances
      • Localized Case Products
      • Localized Case Test Results
    4. Add the “Change related Document lifecycle state” action to the following:
      • Document Reference Field: Case Narrative
      • State Type: Steady State
    5. Select Save.
  • Add Entry Actions on the Revision State
    1. In Admin, go to Configuration > Object Lifecycles > Localized Case Lifecycle > Revision.
    2. Select Edit from the Entry Actions section.
    3. Add the “Change related object lifecycle state” action and Change the State to Locked for the following objects:
      • Localized Case Adverse Events
      • Localized Case Assessment Results
      • Localized Case Assessments
      • Localized Case Causes of Death
      • Localized Case Comment
      • Localized Case Contacts
      • Localized Case Drug History
      • Localized Case Identifiers
      • Localized Case Medical History
      • Localized Case Product Dosage
      • Localized Case Product Indications
      • Localized Case Product Substances
      • Localized Case Products
      • Localized Case Test Results
    4. Add the “Change related Document lifecycle state” action to the following:
      • Document Reference Field: Case Narrative
      • State Type: Starting State
    5. Select Save.
  • Add Entry Criteria on the Closed State
    1. In Admin, go to Configuration > Object Lifecycles > Localized Case Lifecycle > Closed.
    2. Select Edit from the Entry Criteria section.
    3. Add Validate That criteria with the following properties:
      • State of Related Record
      • Transmissions
      • No Records Equal
      to each of the following states:
      • Pending
      • E2B ACK Rejected
      • Error
      • E2B ACK Accepted
      • MDN Received
      • Sending Attachments
      • E2B ACK Warning
      • MDN Failure
      • Ready for Submission
      • Sending ICSR
    4. Select Save.
    Entry Criteria on the Closed State
    Entry Criteria on the Closed State

(21R2) Configure Lifecycle Stage Groups for the Localized Case Lifecycle

Checklist Tasks

Security and Permissions

(21R2) Configure Atomic Security on the Localized Case Lifecycle

Checklist Tasks
  • Add Atomic Relationship Security Read Permissions to the Closed and Approved States

    The objects must have Secure Relationships enabled before you can configure the Atomic Security: Relationship permissions.

    1. In Admin, go to Configuration > Object Lifecycles > Localized Case Lifecycle > [Approved/Closed].
    2. Select Edit from the Atomic Security: Relationships section.
    3. Change Atomic Security: Relationship permissions to Read on the following objects:
      • Localized Case Adverse Events
      • Localized Case Assessment Results
      • Localized Case Assessments
      • Localized Case Causes of Death
      • Localized Case Comment
      • Localized Case Contacts
      • Localized Case Drug History
      • Localized Case Identifiers
      • Localized Case Medical History
      • Localized Case Product Dosage
      • Localized Case Product Indications
      • Localized Case Product Substances
      • Localized Case Products
      • Localized Case Test Results
      • Case Product Registration
    4. Select Save.
    Atomic Relationship Security Read Permissions
    Atomic Relationship Security Read Permissions
  • Add Read Access to Roles in the Localized Case Objects

    You must add read access to all roles in all of the Localized Case objects:

    • Localized Case
    • Localized Case Adverse Events
    • Localized Case Assessment Results
    • Localized Case Assessments
    • Localized Case Causes of Death
    • Localized Case Comment
    • Localized Case Contacts
    • Localized Case Drug History
    • Localized Case Identifiers
    • Localized Case Medical History
    • Localized Case Product Dosage
    • Localized Case Product Indications
    • Localized Case Product Substances
    • Localized Case Products
    • Localized Case Test Results
    1. In Admin, go to Configuration > Objects > [Localized Case Object].
    2. Select Edit from the Roles section.
    3. Add Read permissions to all roles.
    Read Access to Localized Case Objects
    Read Access to Localized Case Objects

(21R2) Configure Matching Sharing Rules

Matching Sharing Rules must be enabled on every Localized object, the Transmission object, and the Case Product Registration object in your Vault. The list of localization objects are:

  • Localized Case
  • Localized Case Adverse Events
  • Localized Case Assessment Results
  • Localized Case Assessments
  • Localized Case Causes of Death
  • Localized Case Comment
  • Localized Case Contacts
  • Localized Case Drug History
  • Localized Case Identifiers
  • Localized Case Medical History
  • Localized Case Product Dosage
  • Localized Case Product Indications
  • Localized Case Product Substances
  • Localized Case Products
  • Localized Case Test Results
  • Localized Controlled Vocabulary
  • Localized Country
  • Localized Dose Form
  • Localized Organization
  • Localized Product
  • Localized Reason Omitted
  • Localized Route of Administration
  • Localized Study
  • Localized Substance
  • Localized Unit of Measurement
  • Transmission
  • Case Product Registration
Checklist Tasks
  • Create Matching Sharing Rules on All Localized Objects
    1. In Admin, go to Configuration > Objects > [Object].
    2. Go to the Sharing Rules tab.
    3. Select Create from the Matching Sharing Rules section.
    4. Add the following Sharing Rules:
      Label Application Role
      [Object] - Data Entry Data Entry
      [Object] - Dist Manager Distribution Manager
      [Object] - Translator Translator
      [Object] - ICSR Approver ICSR Approver

      For example: Localized Case Comments - Dist Manager

    5. For each sharing rule, configure the matching criteria to use the Organization (organization__v) field:
      Rule Criteria
      Rule Criteria
    Matching Sharing Rules
    Matching Sharing Rules
  • Create Matching Sharing Rules for the Localized Organization Object
    1. In Admin, go to Configuration > Objects > Localized Organization.
    2. Go to the Sharing Rules tab.
    3. Select Create from the Matching Sharing Rules section.
    4. Add the following Sharing Rules:
      Label Application Role
      Organization - Data Entry Data Entry
      Organization - Distribution Manager Distribution Manager
      Organization - Editor Editor
      Organization - Head of Safety Head of Safety
      Organization - Intake Intake
      Organization - Medical Coder Medical Coder
      Organization - Medical Reviewer Medical Reviewer
      Organization - QC QC
      Organization - Safety Operations Safety Operations
      Organization - Safety Writer Safety Writer
    5. For each sharing rule, configure the matching criteria to use the Organization (organization__v) field:
      Rule Criteria
      Rule Criteria
    6. Select Save.

(21R2) Configure Permissions on the Transmission Lifecycle

Checklist Tasks
  • Hide the Localized Organization Object in Business Admin
    1. In Admin, go to Configuration > Object Lifecycles > Transmission Lifecycle.
    2. Select Add from the Roles section.
    3. Ensure the following roles are added:
      • Data Entry
      • Distribution Manager
      • ICSR Approver
      • Intake
      • Medical Coder
      • Medical Reviewer
      • Quality Controller
      • Safety Operations
      • Safety Writer
    4. Select Save.
    Role Permissions on Transmission Lifecycle
    Role Permissions on Transmission Lifecycle

(21R2) Configure Permissions for the Translator Role on Document Lifecycles

You must add the Translator role and permissions to the following document lifecycles:

  • Narrative Lifecycle
  • Case Generated Document Lifecycle
  • Case Source Document Lifecycle

Perform the configuration described in the following sections on each of the above lifecycles.

Checklist Tasks
  • Add the Translator Role
    1. In Admin, go to Configuration > Document Lifecycles > [Document Lifecycle] > Roles.
    2. Select Create.
    3. Create the Translator role with the following properties:
      • Label: Translator
      • Application Role: Translator
    4. Select Enable Dynamic Access Control.
    5. Select Save.
  • Add the Translator Sharing Rule
    1. Go to the Sharing Rules tab.
    2. Select Create.
    3. Create the Sharing Rule with the following properties
      • Label: [Document Lifecycle Name] - Translator
        • For example: Narrative - Translator
      • Rule Criteria: Translator
        • Organization (organization__v)
        • Blind Protection (blind_protection__v)
    4. Select Save.
  • Add Translator Permissions
    1. In Admin, go to Configuration > Document Lifecycles > [Document Lifecycle] > States.
    2. Select [State].
    3. Go to the Security Settings Tab.
    4. Select Edit.
    5. Configure permissions for each lifecycle state, according to the following table:
      Lifecycle State Permissions Granted for Translator Role
      Case Source Lifecycle Imported
      • View Document
      • Edit Fields
      Narrative Lifecycle Draft
      • View Document
      • View Content
      • Download Source
      • Edit Document
      Review
      • View Document
      • View Content
      • Download Source
      Approved
      • View Document
      • View Content
      • Download Source
      Closed
      • View Document
      • View Content
      • Download Source
      Case Generated Document Lifecycle Generated
      • View Document
      • View Content
      • Download Source
      Closed
      • View Document
      • View Content
      • Download Source
    Example: Translator Permissions for Narrative Lifecycle Draft State
    Example: Translator Permissions for Narrative Lifecycle Draft State

Next Steps: Agency-Specific Configuration

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