Summary

This article describes the different types of notifications that can be configured as well as how to configure them. 

Table of Contents

With email notifications, specific recipients can be notified when changes related to metadata statuses, subject statuses, form flow, query modifications, randomization and inventory occur within the system. The recipients can be specified by role or email address. This page describes the different types of notifications that can be configured as well as how to configure them. To see how to customize the templates used in these notifications, review the design pages on email templates.

The notifications are sent to all users with the recipient role at the site where the change occurs as well as to all recipient roles at parent sites.

Example: A trial is configured with two sites shared by a parent site (All Sites, Site 1, Site 2). A monitor is given access to All Sites, a Coordinator is given access to Site 1 and a second Coordinator is given access to site 2. A notification is created to notify monitors and coordinators when the Demographics form is marked complete. When the Demographics form is marked complete at Site 1, the Monitor and Coordinator at site 1 will both receive the notification. The Coordinator at Site 2 will not receive that notification.

Each notification is set up with a type and a location. The type specifies the event or status that will trigger the notification. Location is used to designate where the change should occur in order for the email notification to trigger. The Location can correspond to a form within the study as well as other unique locations.

Status Email Notifications

Notifications can be sent to recipients when changes related to metadata statuses and query modifications occur at specified locations.

Metadata Statuses and Locations

Email notifications can be added for changes to the following metadata and query statuses.
Metadata Statuses

  • In Progress
  • Completed
  • SDVed
  • Data Reviewed
  • Frozen
  • Locked
  • Signed

Metadata Status Locations

  • Record – any metadata changes performed at the subject level
  • Form Type – a type of form; Locations of type Form Types are general and can be used to reduce the need for repeated creation of the same form
  • Form Instance – a specific instance of a Form Type that can be configured individually

Query Statuses and Locations

Query Statuses

  • Query Created
  • Query Confirmed
  • Query Answered
  • Query Closed
  • Query Reopened
  • Query Declined

Query Status Locations

  • Query Manager – any changes performed from the Query Manager
  • Query Workflow – any changes made in the Query Workflow

Form Flow Events

Form Flow Events
Form Flow notifications can be created for when a form changes to any of the form flow states configured for the study through the notification flow transition attribute.

Form Flow Locations

  • Form Type – a type of form

Subject Status Events

Subject Status Events
Email notifications can be created for when a subject’s status changes to any of the subject statuses configured for the study. All configured statuses will appear in the email type list.

Subject Status Locations

  • Site – The site at which the status for the subject changed

Adjudication User Task Events

User Task Events

Email notifications can be configured to send when a user is assigned a task in an Adjudication workflow. Notifications can be sent to designated system roles, specified email addresses, or to the ‘Appointee’ – the specific user assigned to the task.

User Task Locations

  • Record – Sends email when any user task is created for a subject
  • Form Type – Select the formType used to collect Adjudication resource assignments. The system sends an email when user tasks are created based on updates to the form.
  • Form Instance – Select the specific form instance used to collect Adjudication resource assignments. The system sends an email when user tasks are created based on updates to the form.

Randomization & Trial Supply Management Email Notifications

RTSM (Randomization & Trial Supply Management) email notifications that were historically configured in the Data Architect file can now be configured through the Email Notifications feature.

Note: Currently, custom context keys are not supported in the Email Notifications feature. Email notifications that require custom context keys must be configured in the Data Architect file.


Email triggers that have already been configured through the Data Architect file will continue function. This means that creating email notifications through the Manage Notifications screen for email notifications already configured on the Email Triggers tab of the DA will cause duplicate emails to be sent unless the email notifications configured in the DA are removed.


Randomization & Trial Supply Management events

Randomization Events

  • Randomize/Activate – when a subject is randomized
  • Derandomize – when a subject is derandomized
  • Drug Assignments – when a drug is assigned to a subject
  • Emergency Unblinding – when a subject is unblinded

Inventory Events

  • Inventory Empty – when the inventory is determined to be empty; the inventory check occurs after each drug is assigned
  • Inventory Threshold – when the inventory hits a current threshold as configured in the DA; an inventory check occurs in several different ways including after each drug is assigned, when shipments are created and when inventory is transferred
  • Inventory Transfer- when drug containers are sent to another location
  • Shipment Request – when an initial shipment or resupply request is made
  • Cancel Shipment – when a shipment enters the ‘Cancelled’ status; note that canceling a shipment is not the same as deleting a shipment
  • Restore Shipment – when a shipment is restored after deletion
  • Confirm Shipment – when a shipment is confirmed through the Confirm Shipment Widget on the study homepage

Locations

The Location field for Randomization & Trial Supply Management email notifications is used to specify the site or packaging company where the change should occur before the email notification is triggered.

Note: The name of the sites and packaging companies will depend on the study configuration.


Randomization Events

  • Site – The site at which the randomization event occurred

Inventory Events

  • Site – The site at which the inventory event occurred
  • Packaging Company – The name of the packaging company at which the inventory event occurred

Add New Notification

  1. On the Study homepage, hover your mouse over the ‘Actions’ tab and select ‘Manage Notifications’ from the drop down.
  2. Recipient: In the Recipient column, select:
    • The role that should be notified when a change is made
    • The option ‘Email Recipients(s)’ if the notification should be emailed to one or more email addresses
    • The option ‘Appointee’ if the notification should be emailed to only the assigned owner of the Adjudication User Task


Keep the following in mind when specifying recipients:

  • All recipients will receive the notification each time the criteria are met.
  • Email addresses are not shared across environments. Therefore, emails will not be sent in the design, test and approve environments if users do not have email addresses in those environments. To receive emails in each environment, users must add a primary email (electronic) address to their profile in each environment.


  1. If specifying the recipients by email address, enter the email address in the text field provided. To enter multiple email addresses, separate each address by a comma or enter each address on a new line.
  2. Type: In the Type column, select the event, transition, or state change that should cause an email notification to be sent.
    • Upon selecting a Type, the Email Subject will populate with a suggested subject.
  3. Location: In the Location column, select the site, form or location that when changed to the specified status, will trigger an email notification to the Recipient.
  4. Email Subject: Review the text in the Email Subject column and change the text as needed.
  5. Click the ‘Add’ button.
If a notification with the same Type and Location already exists for an email address and that email address is included in a subsequent addition, the system will inform you that the notification has already been added and no new notifications will be created for any email addresses included in the Recipient section. In such cases, the email address for which a notification already exists should be removed from the “Recipient” column or the email notification that already exists for the email address should be deleted.


The system will inform you that the Notification was added. The newly configured notification will appear in the list of Existing Notifications.

Delete Existing Notification

  1. Click the trashcan image in the Delete column for the notification that you want to delete.
  2. Confirm the deletion by clicking the ‘OK’ button.

The system will inform you that the notification was deleted. It will no longer appear in the Existing Notifications section.

Copy Existing Notification

By copying an existing notification, you can speed up the process of creating new notifications.

  1. Click the ‘copy’ image in the Copy column for the notification that you want to copy.
    • The notification information will be copied to the Manage Notifications section.
  2. Use the appropriate drop down menus to make changes to the new notification.
  3. Click the ‘Add’ button.
    • The new notification will be added to the Existing Notifications section.

Common Questions

Q: If the Coordinator is the recipient, and All Sites is the location, do all Coordinators receive the notification or just the users with the Coordinator role at the site that was associated with the triggering event?

  • A: Coordinators will only receive notifications for actions at their own site.

Q: What type of a notification scenario would require the location to be selected as the Packaging Company vs the Sites?

  • A: All events that involve a site (such as a shipment request or confirmation) can be set with a location of All Sites. If you want to create a notification for something like a transfer from one packaging company to another (where a site isn’t involved at all), you’d set the location as Packaging Company

Q: What is the difference between the event type of Randomize and Subject Status: Randomized for the purpose of Notifications. A randomization event would satisfy both of these event type trigger, correct?

  • A: Technically, the Subject Status designation of ‘Randomized’ can have its own rules or logic around it. However, 99.9999% of the time Subject status of Randomized is achieved once the Randomization action is executed. However, it is possible that a subject could achieve the status of randomized, then achieve the status of Complete or Early term due to a data entry error – then upon correction of the data entry error, be reassigned back to the status of Randomized. In this scenario, I would expect that a notification set up for the Subject Status: Randomized would be triggered twice – first, upon initially reaching the status, then again when returning to the status.

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