Configure Email Transmissions

To allow users to send Submissions and Distributions using email, configure Email Transmissions.

Sections in This Article

Overview

Vault Safety supports sending Transmissions over email. This feature is useful for both sending distributions to partner organizations and sending submissions to regulatory authorities. You can also set up cover letter templates using Vault’s controlled document management capabilities.

Purpose

This page provides instructions for Administrators to configure their vaults to automatically generate Email Transmissions when a Case matches the reporting rules. For information on sending Email Transmissions for distribution manager users, see Send an Email Transmission.

Configuration Checklist

The following list outlines the high-level steps to configuring Email Transmissions:

Prerequisites

Consider the following prerequisites before you configure Email Transmissions:

Configure an Email Transmission Profile and Recipients

To configure an Email Transmission Profile, you must set up the Email Profile and add email destinations.

Add an Email Profile

You must add an Email Profile, which is a type of Transmission Profile, to use Email Transmissions. Manage Transmission Profiles provides instructions on setting up Transmission Profiles.

Once complete, the system creates the Email Profile and uses the Origin and Destination settings to match Cases with this Email Profile when evaluating reporting obligations.

Next, add Email Destinations to specify the email addresses that receive the email transmissions.

Add Email Recipients

You can add up to ten Email Destinations per Email Profile.

Prerequisite: Add Person Records

Before you can add Email Destinations, you must add a Person record for each recipient with the appropriate email address. Manage Person records from Business Admin > Persons.

Add Email Destinations to Email Profile

  1. On the Email Profile, expand Email Destinations, and then select Create.
  2. In the Destination Person field, select the preconfigured Person record with the appropriate email address.
  3. In the Recipient Type field, specify the type of recipient.

    Note An Email Profile can contain only one Destination Person with the Recipient Type of To.

Result

The Person is added as an email destination for this Email Profile. Add additional recipients as required.

Supported Tokens for Email Message Subject and Body

Only certain tokens are supported for use in the Message Subject and Message Body fields. Unsupported tokens are not generated.

Note If a token causes the Message Subject or Message Body to exceed the character limit, the text will be truncated at the character limit without a vault notification.

The following table lists the supported tokens:

Field Token
Case Number ${Custom.case_number}
Date of Birth (normalized) ${Custom.dob}
Date of Death (normalized) ${Custom.dod}
Due Date ${Custom.due_date}
Receipt Date ${Custom.receipt_date}
Name ${Custom.name}
New Info Date ${Custom.new_info_date}
Patient Initials ${Custom.patient_id}
Study Name ${Custom.study_name}
UID ${Custom.uid}
Worldwide UID ${Custom.worldwide_uid}
Report Type ${Custom.report_type}
CIOMS Remarks ${Custom.cioms_remarks}
Company Comments ${Custom.sender_comments}

Configure Reporting Rules

There are two types of reporting rules that you can use with Email Transmissions:

  • Partner Distribution List: You can set up a Reporting Family of the type Partner Distribution List to assign a reporting ruleset and add the Products and Studies that should trigger email transmission generation.
  • MAH Distribution List: You can assign an MAH reporting obligation to a Product or Study Registration for Email Distributions in place of regulatory submissions.

The system matches reporting rules with the appropriate Transmission Profile, including Email Profiles, using the Origin and Destination pair.

Email Cover Letter Templates

You can create email cover letter templates using vault’s controlled document template functionality.

Vault Online Help provides more information on controlled document templates.

About Cover Letter Templates

You can add cover letter templates using the Template › Cover Letter (Template) › Email Cover Letter (Template) document type.

When an Email Profile references a cover letter template, any Email Transmissions created from that profile generate and attach a cover letter using that template. Generated cover letters use the Case › Cover Letter › Email Cover Letter document type.

You can use Vault merge field tokens within email cover letter templates. Vault Online Help provides information on using merge fields.

Note Do not include merge field tokens for sensitive information that should be blinded or masked. Blind protection is not available for email cover letters.

Add an Email Cover Letter Template

  1. From the primary navigation bar, select Create > Document > Upload.
  2. Select Classify documents now.
  3. Set the Choose document type field to:
    Template › Cover Letter (Template) › Email Cover Letter (Template)
    You may need to activate this template document type before it is available for use.
  4. On the Upload Files (Step 2) page, set the Template Document Type to Email Cover Letter.
    Email Cover Letter Template General Settings
    Email Cover Letter Template General Settings
  5. Complete additional fields on the Upload Files (Step 2) page as required.
  6. Move the document to a Steady-state, such as Approved.
    The method to move the document to a steady-state depends on your vault's configuration. We recommend configuring a document workflow for approval. The document must be in a steady-state to be used as a controlled template.

Result

The steady-state email cover template document is saved to the Library and available for selection on an Email Profile.

Note Merge field tokens are not replaced on the template document. The tokens will be replaced with the appropriate field values when a cover letter is generated for an Email Transmission using the template.


Manage Transmission Profiles
Configure FDA Gateway
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