With the Disclose application, you can stay on top of important information about the study you're involved in. The application can send you email alerts about changes to the study's processes or data. This article will guide you on how to subscribe to these email notifications and how you can adjust their frequency to make sure you're getting updates at a frequency that suits you.

Table of Contents

TYPES OF EMAIL NOTIFICATIONS

INCOMPLETE TASK NOTICE

Prerequisites: All users can subscribe to receive notifications for incomplete tasks via email.
Description: This email notification sends a list of the user's incomplete tasks.
Email Format:
To: a user with assigned tasks that are not yet marked complete
From: [config: emailer, EmailFromAddress]
Reply to [config: emailer, EmailReplyToAddress]
Subject: [config: Emailer, EmailAppName] Tasks Needing Action (e.g. PharmaCM Tasks Needing Action)
Content:
Dear [User First Name User Last Name],
You have incomplete or overdue tasks in [config: Emailer, EmailAppName] that need action.
[Heading] Overdue tasks [list of tasks assigned to user where the task due date < today] in a table format with the following headers (each task is a new row in the table) (sorted by Due Date ascending)
1. [Task Name - hyperlink to task] (e.g. Complete Edit of Protocol Registration Form)
2. [Compliance Event] (e.g. ClinicalTrials.gov Initial Protocol Registration)
3. [Unique Study ID - hyperlink to study]
4. [Assigned Date] (e.g. date task was assigned)
5. [Due Date] (e.g. date task is due)
6. [Assigned To] (e.g. user assigned the task)
7. [Process Cycle] (e.g. Upload)
[Heading] Assigned but not overdue tasks [list of tasks assigned to user where the task due date >= today] (in the same table as for overdue tasks)
[insert table of tasks]

STUDY HEALTH ISSUES NOTIFICATIONS

Prerequisites: Global Study Owner or Compliance Authority Manager
Description: This email notification sends studies with study health issues.
Email Format:

To: each user with GSO or CA Manager role assigned on a study
From: [config: emailer, EmailFromAddress]
Reply to [config: emailer, EmailReplyToAddress]
Subject: [config: Emailer, EmailAppName] Outstanding Study Health Issues on your Studies as of [date] (e.g. PharmaCM Outstanding Study Health Issues on your Studies as of 04/02/2014)
Content:
Dear [User First Name User Last Name],
You are the Global Study Owner or CA Manager for the following Study Health Issues in [config: Emailer, EmailAppName] that need action.
[Heading] Outstanding Study Health Issues [list of Study Monitor Issues which are Flagged as a problem in Study Health see WI-6587] (in a table format with the following headers) (each issue is a new row in the table) (sorted by Severity descending, then by Unique Study ID ascending, then by Study Monitor)
1. [Unique Study ID - hyperlink to study]
2. [Section] (CtGov.A.2) (if applicable)
3. [Issue Description] (e.g. The EMA Initial Pan-European CTA is overdue)
4. [Study Monitor] (e.g. Compliance, Dates, Assessment..)
5. [Severity] (e.g. Critical, High, Medium)
6. [Date Issued] (date when issue was created) - For later release (after 2.1)

STUDY OWNER INCOMPLETE TASKS

Prerequisites: Global Study Owner or Compliance Authority Manager
Description: This email notification sends a list of incomplete tasks.
Email Format:

To: each user with GSO/CA Manager role assigned on a study
From: [config: emailer, EmailFromAddress]
Reply to [config: emailer, EmailReplyToAddress]
Subject: [config: Emailer, EmailAppName] Outstanding Tasks on your Studies (e.g. PharmaCM Outstanding Tasks on your Studies)
Content:
Dear [User First Name User Last Name],
You are the Global Study Owner and/or CA Manager for the following overdue and/or incomplete tasks in [config: Emailer, EmailAppName] that need action.
[Heading] Overdue tasks [list of tasks assigned to user where the task due date < today] (in a table format with the following headers) (each task is a new row in the table) (sorted by Due Date ascending, then by Assigned To, then by Unique Study ID)
1. [Assigned To] (e.g. user assigned the task)
2. [Task Name - hyperlink to task] (e.g. Complete Edit of Protocol Registration Form)
3. [Compliance Event] (e.g. ClinicalTrials.gov Initial Protocol Registration)
4. [Unique Study ID - hyperlink to study]
5. [Assigned Date] (e.g. date task was assigned)
6. [Due Date] (e.g. date task is due)
7. [Process Cycle] (e.g. Upload)
[Heading] Assigned but not overdue tasks [list of tasks assigned to user where the task due date >= today] (in the same table as for overdue tasks)
[insert table of tasks]

STUDY DATA CHANGE NOTIFICATION

Prerequisites: Global Study Owner or Compliance Authority Manager
Description: This email notification sends a list of changes to selective properties for owned studies. You may change selective properties in the Administrator Data Dictionary.
Email Format:

To: [each user with GSO/CA Manager role assigned on a study]
From: [config: emailer, EmailFromAddress]
Reply to [config: emailer, EmailReplyToAddress]
Subject: [config: Emailer, EmailAppName] Important Changes on your Studies as of [date] (e.g. PharmaCM Important Changes on your Studies as of 04/02/2014)
Dear [User First Name User Last Name],
You are the Global Study Owner and/or CA Manager for the following changes in [config: Emailer, EmailAppName] which are of importance.
[Heading] Important Study Changes [list of property changes captured from WI-4186] (in a table format with the following headers) (each change is a new row in the table) (sorted by Date ascending, then by Property Name, then by Changed By)
1. [Unique Study ID - hyperlink to study]
2. [Property Name] (e.g. Study Start Date)
3. [Change Details] (e.g. Old Value: 03/05/2014, New Value: 04/04/2014)
4. [Date Modified] (e.g. 04/02/2014 3:16 PM)
5. [Changed Version] (e.g. if a change is from 0.27 to 0.28, then display 0.28 here)

APPROVED STUDY INFORMATION

Prerequisites: Global Study Owner, Compliance Authority Manager, or Approver
Description: An email notification when study information has been approved and may be made public soon
Email Format:

From: [config: emailer, EmailFromAddress]
Reply to [config: emailer, EmailReplyToAddress]
Subject: [config: Emailer, EmailAppName] Study information that is approved since [date email is sent] (e.g. PharmaCM Study information that is approved as of 20-Oct-2015)
Dear [User First Name User Last Name],
You have requested notification when study information has been approved and may be ready to be published in the public domain.
(Table heading in bold)
Approved Study Information
[Insert content in a table format]

UPLOADED STUDY INFORMATION

Prerequisites: User must be assigned a task in the workflow
Description: An email notification that study information has been uploaded to a registry and may be made public soon.
Email Format:

From: [config: emailer, EmailFromAddress]
Reply to [config: emailer, EmailReplyToAddress]
Subject: [config: Emailer, EmailAppName] Study information that is approved as of [date email is sent] (e.g. PharmaCM Study information that is approved as of 20-Oct-2015)
Dear [User First Name User Last Name],
You have requested notification when study information has been uploaded to an external site, such as a registry, and may be published in the public domain.
(Table heading in bold)
ClinicalTrials.gov Uploads
[Insert Table 1 content in a table format]
EudraCT Uploads
[Insert Table 2 content in a table format]
Uploaded to Sponsor Trial Site
[Insert Table 3 content in a table format]

STUDY OWNER UNASSIGNED TASKS NOTIFICATION

Prerequisites: Global Study Owner or Compliance Authority Manager
Content: An email notification about unassigned tasks on studies that a user is managing.
Email Content:
To: each user with GSO/CA Manager role assigned on a study
From: [config: emailer, EmailFromAddress]
Reply to [config: emailer, EmailReplyToAddress]
Subject: [config: Emailer, EmailAppName] Tasks Missing User Assignments on your Studies (e.g. PharmaCM Tasks Missing User Assignments on your Studies)
Content:
Dear [User First Name User Last Name],
You are the Global Study Owner and/or CA Manager for the following tasks that are missing users and awaiting immediate assignment [config: Emailer, EmailAppName] that need action.
[Heading] Awaiting Immediate User Assignment [list of tasks task status = Awaiting Assignment AND no user is assigned] (in a table format with the following headers) (each task is a new row in the table) (sorted by Due Date ascending, then by Assigned To, then by Unique Study ID)
1. [Assigned To] (e.g. user assigned the task) - NULL is this case
2. [Task Name - hyperlink to task] (e.g. Complete Edit of Protocol Registration Form)
3. [Compliance Event] (e.g. ClinicalTrials.gov Initial Protocol Registration)
4. [Unique Study ID - hyperlink to study]
5. [Assigned Date] (e.g. date task was assigned or expected to be assigned)
6. [Due Date] (e.g. date task is due)
7. [Process Cycle] (e.g. Upload)
[Heading] Planned tasks missing user assignment [list of tasks task status = Planned AND no user is assigned] (in the same table as tasks awaiting immediate assignment)
[insert table of tasks]

CTIS EMAILS

Prerequisites: The email will go to users with a specific "CTIS Notification Email" role who are subscribed to receive the emails. This allows notifications to be sent to both system users and non-system users via created user accounts.
Content: An email notification to notify users when CTIS Notification compliance event is completed

The Email template will be as follows:
An email will be received with the Subject:
"CTIS Member [CE title] ([Country]) is ([Date in mm/dd/yy format]), [Unique Study Id]"

The Email Body will be as follows:
Dear Team,

The [CE title] of [Date in mm/dd/yy] for member state [Country] has been approved to enter in the CTIS portal.

Kind Regards,
CTT Team
If the date is not populated in email due to error, the email will look like:-

An email will be received with the Subject:
"CTIS Member (Actual) [Activity_Type] ([[Region Name or Global]]), [Unique Study Id]"

The Email Body will be:
Dear Team,

The [Activity_Type] (Actual) for Member state ([[Region Name or Global]]) has been approved to enter in the CTIS portal.

Kind Regards,
CTT Team

HOW TO SUBSCRIBE TO EMAIL NOTIFICATIONS

Navigate to the ‘User Profile’ tab from the upper System Navigation ribbon by clicking on your username initials.

On the Settings panel, click on the ‘Subscriptions’ option

The Subscriptions page will list the eight E-mail Subscriptions currently available and a brief description of each (shown below). To subscribe, simply check the corresponding box in the ‘Check to Subscribe’ column.

Users can also adjust the ‘Number of Days between Emails’ to set the exact frequency at which they’ll receive these Subscription E-mails.

Once box is checked and frequency is specified, click ‘Save’. The user will now receive the specified subscriptions via e-mail.

NOTE: These E-mail Subscriptions will be sent to the e-mail address associated with the username.

How to Receive ‘Study Data Change Notification’ Emails

Pre-requisite

Repeat steps 1-4

On the User Subscriptions list, highlight the ‘Study Data Change Notification’ option and click on the checkbox located under ‘Check to Subscribe’ column