Sending Email Notifications with Rules

You can use a Rule to send an email notification to a group of users when certain conditions occur. For example, you could send a notification to medical monitors in your Study when a new Adverse Event is added to a Casebook.

Prerequisites

Required Permissions

By default, users with the CDMS Study Designer study role can perform the actions described below. If your organization uses custom Study Roles, your role must grant the following permissions:

Type Permission Label Controls
Standard Tab Studio Tab

Ability to access the Studio tab
Functional Permission Design Study

Ability to create study design definitions and a study schedule from Studio

If your Study contains restricted data, you must have the Restricted Data Access permission to view it.

Learn more about Study Roles.

Creating an Email Group

Before you can fully configure a Send Email rule action, you must first create an Email Group.

  1. Navigate to Studio > Email Groups.

  2. Click + New Email Group. New Email Group button

  3. Enter a Name for the Email Group. This is the value that displays in the Email Group dropdown during rule creation and in EDC Tools > Email Group Assignment. New Email Group dialog

  4. Optional: Enter a Description of your Email Group.
  5. Click Save.
  6. Optional: Click Save and New to save your Email Group and begin creating another one without closing the New Email Group dialog.

A lead data manager can now add users to your Email Group from EDC Tools > Email Group Assignment.

Creating a Send Email Rule

To create a Send Email rule:

  1. Create a new Rule from Studio > User Defined Rules, fill in the required fields, and create your Rule Expression.
  2. Select the Send Email Rule Action and make the required selections.
  3. Click Save.

Creating the Subject & Message Template

Once you select the Send Email action, Vault opens the Message Template Editor. From here, you can select an Email Group to receive the notification, create a template Subject, and a template Message, using text, dynamic and static tokens, and HTML formatting.

Send Email rule action configuration

Tokens are pieces of text with a specific format that Vault replaces with the values the tokens represent. They use the format ${Custom.tokenName}. Vault includes a dynamic token for every Item on the Form you selected in the Rule Details panel. (Note that you can’t include item tokens for any Items within a repeating Item Group). When Vault sends the email notification, this token is replaced with the value of the Item.

To insert a token, locate the token in the list. Hover over the token and then click Add (). Vault adds the token at your last cursor location within either the Subject or Message fields.

Static Tokens

Vault also includes static tokens for various metadata for the Form and Subject:

Name Token Description
Event Date ${Custom.@Event.event_date__v} The Event Date for the Event containing the Form
Visit Method ${Custom.@Event.visit_method__v} The Visit Method associated with the Event
Site Number ${Custom.@Site.name__v} The Site Number of the Site
Event Group Sequence ${Custom.@EventGroup.sequence__v} The Sequence number of the Event Group instance, for repeating Event Groups (cycles)
Subject Name ${Custom.@Subject.name__v} The Subject ID of the Subject
Site Name ${Custom.@Site.site_name__v} The Name of the Site
Site Study Country ${Custom.@Site.study_country__v} The Study Country of the Site
Study Name ${Custom.@Study.name__v} The Name of the Study
Event Sequence ${Custom.@Event.sequence__v} The Sequence number of the Event instance, for Events within repeating Event Groups (cycles)
Subject Status ${Custom.@Subject.subject_status__v} The Subject Status of the Subject at the time of form submission
Site Principal Investigator ${Custom.@Site.principal_investigator__v} The name of the Principal Investigator assigned to the subject’s Site
Casebook Version ${Custom.@Casebook.version__v} The Casebook Version assigned to the subject’s Casebook
Form Sequence ${Custom.@Form.sequence__v} The Sequence number of the Form instance, for repeating forms

HTML Tags for Text Formatting

Vault allows a limited set of HTML tags for you to format text in your Message template.

The following tags are available:

Tag Description Allowed Attributes Example 
<b></b>
 Bold None 
<b>Bolded text</b>
 
<em></em>
 Emphasis None 
<em>Emphasized text</em>
 
<i></i>
 Italics None 
<i>Italicized text</i>
 
<p></p>
 Paragraphs None 
<p>A new Serious Adverse Event was submitted for Subject: ${Custom.@Subject.name__v}.<p>
 
<ol>
  <li></li>
</ol>
 Ordered lists and list items (numbered lists) None 
<ol>
  <li>Review the form</li>
  <li>Perform an assessment</li>
</ol>
 
<ul>
  <li></li>
</ul>
 Unordered lists and list items (bulleted list) None 
<ul>
  <li>${Custom.@Study.name__v}</li>
  <li>${Custom.@Site.site_name__v}</li>
  <li>${Custom.@Subject.name__v}</li>
</ul>
 
<blockquote></blockquote>
 Indented blockquotes None 
<blockquote>
  blockquote
</blockquote>
 
<img>
 Image files "src", "alt", "width", "height" 
<img src="http://www.veeva.com/images/veeva_logo.png" alt="Veeva Systems logo" height="50" width="200">
 
<span></span>
 Span tag for styling "style" 
<span style="color: red; font-weight: bold;">span</span>
 
<a></a>
 Links "href", "target", "title", "rel" 
<a target="_blank" href="http://www.veeva.com/" title="Veeva Systems Inc." rel="noopener">Explore Veeva.com!</a>

Versioning & Deployments

Email Groups and related records are not subject to casebook versioning. Like rules, review plans, and other versionless objects, you can create and edit Email Groups at any time, whether or not the Casebook Definition is published.

For studies using automated deployments, the deployment process will automatically migrate all email group configuration from environment to environment. For studies using manual deployments (studies created prior to the 19R3 release), you must configure your Email Group and message template in each vault.