You can send Individual Case Safety Reports (ICSRs) from Safety to email destinations.
Note: Depending on your Admin’s configuration, object, field, and section labels, lifecycle states, and workflows may differ from the general information on this page. Refer to your organization’s business processes for guidance.
About Email Transmissions
Distribution Managers can send ICSRs over email to multiple recipients. The email contains the ICSR document and appropriate transmission documents, including a cover letter, if applicable. The relevant Email Profile determines the Transmission’s mailing list, ICSR format, email content, and appropriate transmission documents, such as a cover letter. You can track and monitor when recipients receive and open the emails.
When the Safety Reporting Rule Engine determines that a Case meets reporting criteria for an organization and matches an Email Profile, Vault generates an ICSR Transmission in the Ready state and associates it with the Case.
Note: Total attachment size cannot exceed 15 MB.
Prerequisites
- Your Admin must configure this feature with email settings, including the destinations in an Email Profile.
- To send emails from Vault using a custom domain instead of
@veevavault.com, your Admin must configure custom outbound email domains. - To send email Transmissions for Early Notifications, your Admin must configure the Transmission object.
- To validate E2B XML files generated for email Distributions to regional destinations, your Admin must set the Always Evaluate value of the Validation Criteria to Yes.
- You must have permission to manage Transmission object records. Typically, these permissions are reserved for Distribution Manager users.
View Email Contents
You can view the email contents and attachments from the following fields on the ICSR Transmission:
- Message Subject
- Message Body
- Cover Letter
- File
Send Email Transmissions
Use the Send Email Transmission action to send email Transmissions. Depending on your Vault’s configuration, this action may be available as a user action or triggered as part of a workflow.
Note: If Strict Transmission Version Enforcement is enabled in your Vault and the Case has a previous version with an open Transmission to the same Destination and Transmission Profile (or Destination ID for the PMDA), Vault asks for confirmation before sending the new Transmission.
For auto-submissions, the Send to Gateway action on the Case supports sending email Transmissions with auto-submissions enabled.
Transmission Lifecycle States for Email Transmissions
Email Transmissions may enter the following lifecycle states:
- Sent: When the email has been sent to all recipients.
- Complete: When the email has been delivered to all recipients.
- Error: When the email could not be delivered to one or more recipients.
Track and Monitor Emails
Vault tracks certain key events for reach Transmission and logs events for each recipient. You can review the events log to view the following events:
- Initial Message Sent: The initial email was sent to a recipient.
- Message Delivered: An email was successfully delivered to a recipient.
- Message Opened: An email was opened by a recipient.
- Error: An email could not be delivered to a recipient.
Note: Consider the following when tracking email events:
- Not all email addresses support full event tracking, depending on the recipient email server security settings.
- Email receipt status updates may be delayed up to one hour.
- Vault cannot guarantee the delivery of email event messages due to the possibility of temporary recipient email server outages.