9 Alerts

This chapter provides details on alerts. It contains the following topics:

• Section 9.1, "Introduction to Alerts"

• Section 9.2, "Viewing Alerts"

• Section 9.3, "Searching for Alerts"

• Section 9.4, "Alerts Subscription"

• Section 9.5, "Predefined Alerts"

• Section 9.6, "Resetting Alerts"

• Section 9.7, "Marking an Alert as Important"

• Section 9.8, "Alerts while Application is Closed"

9.1 Introduction to Alerts

When on the move, you will have to be notified about various aspects of studies and site visits, including their progress, performance, and so on. Mobile CRA lets you create alerts through the administrator user interface and then subscribe to one or more of them. Once subscribed, you will receive notifications every time the subscription criteria is met. The alert inbox will display all the alerts logically categorized based on the site. For more information on creating alerts in the Administrator user interface, refer to the Oracle Health Sciences Mobile Clinical Research Associate Server Administrator's Guide.

You can also flag an alert as 'Important'. This ensures that alerts carrying important information of your interest or those requiring your attention are flagged.

9.1.1 Alert Views

Alerts can be generated for a study, study-site, or 3rd party. Alerts are displayed in the following two views:

Alert List View

Figure 9-1 Alert List View

Description of "Figure 9-1 Alert List View"

For each alert, the following information is displayed:

• The alert name

• The site name

• The study name

• The timestamp for the alert. If the alert was triggered in the last 12 hours the time the alert was triggered is shown. If the alert was triggered more than 7 days earlier, the date is shown in localized format taken from a global setting on the Smartphone.

• If an alert has been marked important, a red exclamation mark icon is also present.

Alert Details View

The Alert Detail View displays a single alert that has been selected through the Alert List View. Perform the following steps to view the alert details:

1. Tap the alert in the list to display its details.

   Figure 9-2 Alert Details View

   
   Description of "Figure 9-2 Alert Details View"
   
   

For each alert, the following information is displayed:

• The site name

• The study name

• The alert title

• The timestamp for the alert

• The details and text of the alert

• The importance of the alert

You can scroll up or down to view all details of the alert. When alert details are viewed, its receipt is confirmed. The Mark as important button lets you mark an alert as important. For more information on marking alerts as important, refer to Section 9.7.

9.2 Viewing Alerts

Perform the following steps to view alerts:

1. Navigate to the Mobile CRA menu.

   Figure 9-3 Mobile CRA Menu

   
   Description of "Figure 9-3 Mobile CRA Menu"
   
   

2. Tap Alerts. The list of alerts will be displayed. The 50 most recent alerts available from the Mobile CRA Server will be listed.

   Figure 9-4 Alerts List

   
   Description of "Figure 9-4 Alerts List"
   
   

9.3 Searching for Alerts

A search bar is provided at the top of the alerts list view. When the search field is tapped, a keyboard is displayed and the search bar occupies the title bar space as shown below. You can then enter your search text in the search bar. The list is updated with the search results as you type in the search text.

Figure 9-5 Search for Alerts

Description of "Figure 9-5 Search for Alerts"

You can search for an alert based on the following:

• Site name

• Study name

• Alert title

9.4 Alerts Subscription

9.4.1 Subscribing to an Alert

Before subscribing to an alert, ensure that Oracle Health Sciences Mobile CRA has been downloaded, registered, and all administrative tasks have been completed. Perform the following steps to subscribe to an alert from your mobile device:

Subscribing to an Alert for a Study

1. In the Mobile CRA menu, tap Subscriptions. A list of studies is displayed.

   Figure 9-6 Mobile CRA Menu

   
   Description of "Figure 9-6 Mobile CRA Menu"
   
   

2. Tap the study you want to subscribe alerts from.

   Figure 9-7 List of Alerts

   
   Description of "Figure 9-7 List of Alerts"
   
   

3. Tap Study Alerts.

   A list of alerts for the study is displayed.

4. Figure 9-8 List of Alerts for a Study

   
   Description of "Figure 9-8 List of Alerts for a Study"
   
   

5. Tap the alert you want to subscribe to and view its details.

   Figure 9-9 Alert Details

   
   Description of "Figure 9-9 Alert Details"
   
   

6. If you want, modify the threshold value by tapping Threshhold.

   Figure 9-10 Modify the Threshold

   
   Description of "Figure 9-10 Modify the Threshold"
   
   

7. If the alert is set to OFF on the top right, tap it to turn it on and subscribe to it.

   Important:

   To propagate the threshold changes to CTMS, reset the alert by switching it OFF, and then ON again (if it was originally ON).

   Figure 9-11 A Subscribed Alert

   
   Description of "Figure 9-11 A Subscribed Alert"
   
   

Subscribing to an Alert for a Site

1. In the Mobile CRA menu, tap Subscriptions. A list of studies is displayed.

   Figure 9-12 Mobile CRA Menu

   
   Description of "Figure 9-12 Mobile CRA Menu"
   
   

2. Tap the study you want to subscribe alerts from.

   Figure 9-13 List of Alerts

   
   Description of "Figure 9-13 List of Alerts"
   
   

3. Tap Site Alerts.

   Figure 9-14 Site Alerts

   
   Description of "Figure 9-14 Site Alerts"
   
   

4. A list of alerts is displayed.

   Figure 9-15 List of Alerts for a Site

   
   Description of "Figure 9-15 List of Alerts for a Site"
   
   

5. Tap the alert you want to subscribe to and view its details.

   Figure 9-16 Alert Details

   
   Description of "Figure 9-16 Alert Details"
   
   

6. If you want, modify the threshold value by tapping on Threshold.

   Figure 9-17 Modify the Threshold

   
   Description of "Figure 9-17 Modify the Threshold"
   
   

7. If the alert is set to OFF on the top right, tap it to turn it on and subscribe to it.

   Important:

   To propagate the threshold changes to CTMS, reset the alert by switching it OFF, and then ON again (if it was originally ON).

   Figure 9-18 Turn an Alert ON

   
   Description of "Figure 9-18 Turn an Alert ON"
   
   

9.4.2 Unsubscribing an Alert

Before unsubscribing from an alert, ensure that Oracle Health Sciences Mobile CRA has been downloaded, registered and all administrative tasks have been completed. Perform the following steps to unsubscribe from an alert from your mobile device:

Unsubscribe an Alert for a Study

1. In the Mobile CRA menu, tap Subscriptions.

   Figure 9-19 Mobile CRA Menu

   
   Description of "Figure 9-19 Mobile CRA Menu"
   
   

2. A list of alerts is displayed. Tap the study for which you want to unsubscribe an alert.

   Figure 9-20 List of Studies

   
   Description of "Figure 9-20 List of Studies"
   
   

3. Tap Study Alerts. A list of alerts is displayed.

   Figure 9-21 Alerts for Study

   
   Description of "Figure 9-21 Alerts for Study"
   
   

4. Tap the alert that you want to modify.

5. Tap ON on the top right hand corner. It switches off the alert and you will be unsubscribed.

   Figure 9-22 Turn an Alert OFF

   
   Description of "Figure 9-22 Turn an Alert OFF"
   
   

   Figure 9-23 Alert Details

   
   Description of "Figure 9-23 Alert Details"
   
   

Unsubscribe an Alert for a Site

1. In the Mobile CRA menu, tap Subscriptions. A list of studies is displayed.

   Figure 9-24 Mobile CRA Menu

   
   Description of "Figure 9-24 Mobile CRA Menu"
   
   

2. Tap the study you want to unsubscribe alerts from.

   Figure 9-25 List of Alerts

   
   Description of "Figure 9-25 List of Alerts"
   
   

3. Tap Site Alerts.

4. A list of alerts is displayed.

   Figure 9-26 List of Alerts for a Site

   
   Description of "Figure 9-26 List of Alerts for a Site"
   
   

5. Tap the alert you want to unsubscribe and view its details.

   Figure 9-27 Alert Details

   
   Description of "Figure 9-27 Alert Details"
   
   

6. Tap ON on the top right, to switch off the alert. You will be unsubscribed.

   Figure 9-28 Alert Details

   
   Description of "Figure 9-28 Alert Details"
   
   

9.4.3 Modifying an Alert Subscription

Before modifying a subscription, ensure that Oracle Health Sciences Mobile CRA has been downloaded, registered, and all administrative tasks have been completed. Perform the following steps to modify an alert from your mobile device:

1. Navigate to the Mobile CRA menu.

   Figure 9-29 Mobile CRA Menu

   
   Description of "Figure 9-29 Mobile CRA Menu"
   
   

2. Tap Alerts. The list of alerts will be displayed. The 50 most recent alerts available from the Mobile CRA Server will be listed.

   Figure 9-30 List of Alerts

   
   Description of "Figure 9-30 List of Alerts"
   
   

3. Tap the alert you want to modify.

4. Tap Threshhold to modify the threshold value.

5. Tap Done on the top right. If you do not want to save your changes, tap Cancel to go back to the alert details.

9.5 Predefined Alerts

Oracle Health Sciences Mobile CRA system will ship with a set of predefined alerts for data available from CDA. All predefined alerts will generate a notification in the following format:

You have received an alert for <Study X> regarding <Site Y>.

Following is a list of predefined alerts in the system:

Table 9-1 Predefined Alerts

Predefined Alert	Description
Number of CRFs waiting for verification	Number of CRF pages ready for source verification at the site
First patient has enrolled at site	The first patient has been enrolled at site
Number of enrolled patients is greater than threshold	The number of enrolled patients at a study site is greater than the preset threshold value
Count of enrolled patient is a multiple of five	Number of patients enrolled in list
Percent of open queries	The number of open queries at a study site is greater than the preset threshold percentage
Percent of closed discrepancies	Percent of discrepancies that are closed as Irresolvable is greater than the preset threshold percentage
Number of screen failures	Screen failures is greater than the preset threshold value
Number of enrolled patients since last site visit	Count of enrolled patients since last site visit
Visit reports waiting approval	The number of trip reports pending approval
Number of active sites is greater than threshold	Count of active sites is greater than the threshold
Number of sites greater than planned	The number of study sites that exceed the planned sites
Number of study sites is greater than threshold	Count of study sites is greater than the threshold

9.6 Resetting Alerts

You can manually reset an alert to trigger again on the same conditions. Before resetting an alert, ensure that you are connected to the server. If you try to reset an alert when offline, an error will be displayed. Perform the following steps to reset an alert:

Note:

The Reset option is not available for external notifications.

1. Tap the alert to view its details.

   Figure 9-31 Alert Details

   
   Description of "Figure 9-31 Alert Details"
   
   

2. Click Reset. A reset message is sent to the mobile server and the reset option is not visible.

   Figure 9-32 Reset an Alert

   
   Description of "Figure 9-32 Reset an Alert"
   
   

9.7 Marking an Alert as Important

You can also mark an alert as important. An important alert is indicated by a red exclamation mark icon. Perform the following steps to mark an alert as important:

1. Tap an alert to view its details.

   Figure 9-33 Alert Details

   
   Description of "Figure 9-33 Alert Details"
   
   

2. Tap Mark important. The alert will be marked as important and the button changes to Mark unimportant.

   Figure 9-34 Alert Marked Important

   
   Description of "Figure 9-34 Alert Marked Important"
   
   

3. In the alerts list, a red exclamation mark icon will be displayed next to the alert.

   Figure 9-35 Important Alerts in the List

   
   Description of "Figure 9-35 Important Alerts in the List"
   
   

9.7.1 Clearing the Important Flag for an Alert

Perform the following steps to clear the importance flag on an alert:

1. Tap the alert, marked important, to view its details.

   Figure 9-36 Mark Alert Unimportant

   
   Description of "Figure 9-36 Mark Alert Unimportant"
   
   

2. Tap Unmark Important.

3. The important flag will be cleared in the list of alerts.

   Figure 9-37 Important Icon Removed

   
   Description of "Figure 9-37 Important Icon Removed"
   
   

9.8 Alerts while Application is Closed

When the application is closed or running in the background, the Android system sends a notification when an alert is triggered.

Figure 9-38 Alert Signal in the Android Notification Menu

Description of "Figure 9-38 Alert Signal in the Android Notification Menu"

Tapping on the Mobile CRA notification proceeds to open the application and then the alerts to view.