Veeva Safety can automatically send and track questionnaires and reminders to the primary reporter by email depending on the preconfigured settings for product, country, language, and watchlist. This feature was introduced in Vault Safety 20R3 and requires configuration to be made available.
Note: We recommend enabling Follow-Up Questionnaires instead of the feature described in this article. You can only configure one method of generating questionnaires configured in your Vault.
The steps required to enable this feature depend on the release during which your Vault deployed. Depending on when your Vault was provisioned, it may have certain configurations already, such as security and object layouts. Follow the appropriate checklist to enable this feature:
- Vaults Deployed from 22R3 or Earlier
- Vaults Deployed from 20R3 or Earlier
- Vaults Deployed from 20R2 or Earlier
Note: Vault limits document templates to 500 per document hierarchy. If your Vault uses more than 500 templates, contact your Veeva Representative about supporting high-volume document template questionnaires for this feature.
Vaults Deployed from 22R3 or Earlier
The following configuration to enable this feature is for Vaults initially deployed in 22R3 or an earlier release.
Update Constraints on Transmission Object
You must update the constraints on the Transmission object as follows:
- Navigate to Admin > Configuration > Objects > Transmission > Object Types > Correspondence > Organization.
- Select Edit.
- Clear the Criteria VQL field.
- Select Save.
- Navigate to the Transmission object’s Fields tab.
- Select Organization.
- Clear the Default Value field.
- Navigate to the Transmission object’s Object Types tab and complete the following steps for the Distribution, Inbound Transmission, and Submission object types:
- Select an object type.
- Select the Organization field.
- Select Edit.
- Update the Default Value to
case_version__vr.organization__v. - Select Save.
Update the Inbox Item Layout
Update the Inbox Item object layout:
- Navigate to Admin > Configuration > Objects > Inbox Item > Layouts > Inbox Item Detail Page Layout.
- Insert a Related Object section for the Transmission object with the following parameters:
- Section Label:
Correspondence - Creation Option: Prevent record creation
- Section Help:
Inbox Item Correspondence are tracked in this section. - Criteria VQL:
object_type__vr.api_name__v = 'correspondence__v' - Select Apply on Create.
- Section Label:
- Add the following columns to this Correspondence section:
- Lifecycle State
- Transmission Date
- Due Date
- Correspondence Method
- Recipient (Person)
- Recipient (User)
- Destination Email
- Reply-To
- For the Inbound Transmission section, update the Criteria VQL value to
object_type__vr.api_name__v != 'correspondence__v'.
Update the Inbox Item Lifecycle
Update the Inbox Item’s lifecycle:
- Add a Correspondence state to the Inbox Item Lifecycle and configure the following:
- Add an entry action to always update the Follow-Up Rule field to
invalid_case__vand the Send Follow-Up field totrue. - Add a user action to always change the state to New. We recommend labeling this
Missing Information Received.
- Add an entry action to always update the Follow-Up Rule field to
- Add a user action to the New lifecycle state to always change the state to Correspondence. We recommend labeling this
Create Follow-up Questionnaire for Invalid Case.
Vaults Deployed from 20R3 or Earlier
You must perform the following configuration to enable this feature on a Vault that was initially deployed off of Vault Safety 20R3 or an earlier release.
Note: Before you enable this feature, contact Veeva Support to turn on PHI Protection on Person records. We recommend that you request this as soon as possible, as this flag cannot be turned on once records exist.
Configure Object Layouts
Update the following object layouts.
Case Object
Update the Case object layout:
- Add the following fields to the Details section:
- Follow-Up Rule
- Send Follow-Up
- Insert a Related Object section for the Transmission object with the following parameters:
- Section Label:
Correspondence - Creation Option: Prevent record creation
- Section Help:
Inbox Item Correspondence are tracked in this section. - Criteria VQL:
object_type__vr.api_name__v = 'correspondence__v' - Select Apply on Create.
- Section Label:
- Add a layout rule so that if Send Follow-Up is
True, the Follow-Up Rule must not be blank.
Watchlist Object
Update the Watchlist object layout:
- Insert a Related Documents section with the following parameters:
- Section Label:
Questionnaire Templates - Select Columns to Display:
- Name
- Doc Number
- Country
- Language
- Lifecycle State
MedDRA Criteria Object
Update the MedDRA Criteria object layout:
- Insert a Related Documents section with the following parameters:
- Section Label:
Term Specific Questionnaire Templates - Select Columns to Display:
- Name
- Doc Number
- Country
- Language
- Lifecycle State
- Section Label:
Vaults Deployed from 20R2 or Earlier
You must perform the following configuration to enable this feature on a Vault that was initially deployed off of Vault Safety 20R2 or an earlier release.
Note: Before you enable this feature, contact Veeva Support to turn on PHI Protection on Person records. We recommend that you request this as soon as possible, as this flag cannot be turned on once records exist.
Update Security Profiles
- Grant the appropriate user roles permissions on the following new object types:
- Transmission: Correspondence type
- Transmission Message: Email Event type
- Grant field-level access to the new Case object fields.
Configure Object Layouts
Update the following object layouts.
Case Object
Update the Case object layout:
- Add the following fields to the Details section:
- Follow-Up Rule
- Send Follow-Up
- Insert a Related Object section for the Transmission object with the following parameters:
- Section Label:
Correspondence - Creation Option: Prevent record creation
- Section Help:
Inbox Item Correspondence are tracked in this section. - Criteria VQL:
object_type__vr.api_name__v = 'correspondence__v' - Select Apply on Create.
- Section Label:
- Add a layout rule so that if Send Follow-Up is
True, the Follow-Up Rule must not be blank.
Transmission Object
Configure a layout for the Correspondence type of Transmission object with the following parameters:
- Insert a Details section with the following fields:
- Case
- Recipient (Case Contact)
- Recipient (Person)
- Correspondence Method
- Destination Email
- Reply-to
- Case Identifier
- Organization
- Due Date
- Transmission Date
- Insert a Related Documents section for the Transmission field.
- Insert a Related Object section for the Transmission Message object with the following parameters:
- Label:
Correspondence Events - Creation Option: Prevent record creation
- Select Columns to Display:
- Name
- Event Type
- Event Time
- Label:
- Insert an eSignature section with the default settings.
- Insert an Attachments section with the default settings.
- Add the following layout rule:
- Label: Hide Email Addresses
- Fields to Hide:
- Destination Email
- Reply-to
- Expression:
correspondence_method_c != 'email_c'
Transmission Message
Configure a layout for the Email Event type of Transmission Message object with the following parameters:
- Insert a Details section with the following fields:
- Name
- Transmission
- Organization
- Message Type
- Event Type
- Event Time
- Body
- Insert an Attachments section with the default settings.
Case Contact
Update the layout for the Reporter type of Case Contact object with the following parameters:
- Add include the following fields:
- Reporter Email
- Reporter Email Consent
- Update the Related Documents section to include the following columns:
- Products
- Countries
- Language
Watchlist
Update the Watchlist object layout:
- Insert a Related Documents section for the Questionnaire Templates field with the following columns:
- Name
- Doc Number
- Country
- Language
- Lifecycle State
MedDRA Criteria
Update the MedDRA Criteria object layout:
- Insert a Related Documents section for the Term Specific Questionnaire Templates field with the following columns:
- Name
- Doc Number
- Country
- Language
- Lifecycle State
Configure Document Types
Update document types as follows:
- Activate the Template document type and update the document field order as needed.
- Delete the Case > Correspondence (
correspondence__c) document type.- If any existing documents in your Vault use this type, either reclassify those documents or inactivate the Correspondence (correspondence__c) document type instead of deleting it.
Activate the Reporter Notification for Followup Job
You must activate the Reporter Notification for Followup job definition for Vault to to send automated email questionnaires.
Optional Lifecycle and Workflow Updates
We recommend the following optional configurations:
- Configure a document lifecycle for templates.
- Add a workflow to approve template documents
- Add security so that only certain groups can edit the template documents. There is no security by default.
- Add a new user group, such as Administrators or Global Administrators, who can edit the template documents.
- Configure a workflow to update Questionnaires that enter the Ready state for manual follow-ups to ensure the user is notified when the questionnaire should be manually sent to the reporter if an email address is unavailable.
- For example, add an entry action for Type=Correspondence && Method=Manual.
- Consider adding a step to capture the transmission date as well.
- Configure a workflow or State Change action to handle email transmission errors.
- Update the Transmission object lifecycle to move to Complete state when a reply is received. This action should be added to the Sent and Opened states if Type = Correspondence.
- Configure security to the new states:
- Sent
- Error
- Ready
Customize the Questionnaire Email Notification
You can change the Questionnaire Email notification template to fit the needs of your organization. This notification supports only tokens included in the default notification.