3 Alerts

This chapter contains the following topics:

• Introduction to Alerts

• Viewing Alerts

• Subscribing to an Alert

• Predefined Alerts

• Resetting Alerts

• Marking an Alert as Important

• Unmarking an Alert as Important

3.1 Introduction to Alerts

As a CRA 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 alert rules through the administrator user interface and then subscribe to one or more of them. These will then show up on the device as alert subscriptions, which you can then subscribe to. Once subscribed, you will receive notifications every time the subscription criteria is met. The Alert Rules run on the OCDA and external system for the triggering process. The alert inbox will display all the alerts. For more information on creating alerts in the administrator's 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. Alerts can be generated for a study or for a study-site.

The following is an example of an alert:

Figure 3-1 An Alert

Description of "Figure 3-1 An Alert"

An alert includes the following details, in order from top to bottom:

• The name of the alert

• The timestamp for when the alert was triggered

• The details and text of the alert

• Unread alerts will display a blue circle next to them in the list of alerts. Once you view the alert, the circle is removed as shown in Figure 3-2.

  Figure 3-2 Viewed Alerts

  
  Description of "Figure 3-2 Viewed Alerts"
  
  

3.2 Viewing Alerts

The Mobile CRA menu contains the Alerts icon with a badge to show the number of unread alerts in the list.

Figure 3-3 Alert Icon with Badge

Description of "Figure 3-3 Alert Icon with Badge"

The application icon also displays this badge.

Figure 3-4 CRA Launch Icon with Badge

Description of "Figure 3-4 CRA Launch Icon with Badge"

Perform the following steps to view alerts:

1. In the My Studies pane, tap a study to select it.

2. Tap a study-site to view its details.

   Figure 3-5 View an Alert

   
   Description of "Figure 3-5 View an Alert"
   
   

3. Tap Alerts. The following screen is displayed:

   Figure 3-6 Alerts Screen

   
   Description of "Figure 3-6 Alerts Screen"
   
   

4. In the Subscriptions pane, tap a notification to select it. The list of alerts for the study is displayed, with the most recent alerts on top.

   Figure 3-7 Alerts for a Study

   
   Description of "Figure 3-7 Alerts for a Study"
   
   

   Note:

   Swipe the Alerts panel, on the left, downwards as shown in Figure 3-8 to update the list of alerts.

   Figure 3-8 Update the Alerts List

   
   Description of "Figure 3-8 Update the Alerts List"
   
   

3.3 Subscribing to an Alert

Before subscribing to an alert, ensure that 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:

1. In the My Studies pane, tap a study to select it.

2. Tap a study-site to select it.

   Figure 3-9 Select a Study-Site

   
   Description of "Figure 3-9 Select a Study-Site"
   
   

3. Tap Subscription. The following screen is displayed:

   Figure 3-10 Subscriptions for a Study

   
   Description of "Figure 3-10 Subscriptions for a Study"
   
   

4. Select the alert category (Study Alerts, Site Alerts, and 3rd Party Alerts) to view the alerts in it. The details defined in the Configuration Utility will be displayed.

   Note:

   If Adaptive SAAG is not configured, the 3rd Party Alerts option will not be available.

   In the graphic below, Study Alerts have been selected.

   Figure 3-11 Category of Alerts

   
   Description of "Figure 3-11 Category of Alerts"
   
   

5. Select the alert you want to subscribe to.

   Figure 3-12 Select an Alert

   
   Description of "Figure 3-12 Select an Alert"
   
   

6. If necessary, modify the default threshold. For more details, refer to section Modifying an Alert Subscription.

7. Tap OFF on the top-right corner. It changes to ON and you will be subscribed to the alert.

   Figure 3-13 Subscribe to an Alert

   
   Description of "Figure 3-13 Subscribe to an Alert"
   
   

3.3.1 Unsubscribing from an Alert

Perform the following steps to unsubscribe from an alert from your mobile device:

1. Open the Mobile CRA application and log in with your user name and password.

2. In the My Studies tab, tap a study to view its details.

   Figure 3-14 Select a Study

   
   Description of "Figure 3-14 Select a Study"
   
   

3. Tap Subscription. The following screen is displayed:

   Figure 3-15 Alerts for a Study

   
   Description of "Figure 3-15 Alerts for a Study"
   
   

4. Select the alert category to view the alerts in it. In the graphic below, Study Alerts have been selected.

   Figure 3-16 Study Alerts

   
   Description of "Figure 3-16 Study Alerts"
   
   

5. Select the alert you want to unsubscribe from.

   Figure 3-17 Subscribe to an Alert

   
   Description of "Figure 3-17 Subscribe to an Alert"
   
   

6. Tap ON on the top-right corner. It changes to OFF and you will be unsubscribed from the alert.

   Figure 3-18 Select an Alert

   
   Description of "Figure 3-18 Select an Alert"
   
   

3.3.2 Modifying an Alert Subscription

Perform the following steps to modify an alert from your mobile device:

Modify an Alert Subscription for a Study-Site

1. Open the Mobile CRA application and log in with your user name and password.

2. In the My Studies tab, tap a study to select it.

   Figure 3-19 Select a Study

   
   Description of "Figure 3-19 Select a Study"
   
   

3. Tap Subscription. The following screen is displayed:

   Figure 3-20 Alerts for a Site

   
   Description of "Figure 3-20 Alerts for a Site"
   
   

4. Select Site Alerts to view a list of study-site alerts.

   Figure 3-21 Site Alerts

   
   Description of "Figure 3-21 Site Alerts"
   
   

5. Select the alert whose subscription you want to modify.

   Figure 3-22 Site Alerts

   
   Description of "Figure 3-22 Site Alerts"
   
   

6. Tap Threshold to edit it.

   Figure 3-23 Edit the Study-Site Alert Subscription

   
   Description of "Figure 3-23 Edit the Study-Site Alert Subscription"
   
   

7. After editing, tap Done on the top-right corner to save your changes.

   Figure 3-24 Threshold Modified

   
   Description of "Figure 3-24 Threshold Modified"
   
   

   Important:

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

   Similarly, you can modify the threshold value for a Study alert.

3.4 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>.

The following is a list of predefined alerts in the system:

Table 3-1 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

3.5 Resetting Alerts

Manual Reset

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 is displayed.

Note:

The Reset option is not available for external notifications.

Perform the following steps to reset an alert:

1. In the My Studies pane, tap a study to select it.

2. Tap a study-site to select it.

3. Tap Alerts to view a list of alerts for a study or study-site.

4. Tap the alert to view its details.

   Figure 3-25 Alert Details

   
   Description of "Figure 3-25 Alert Details"
   
   

5. Tap Reset. A reset message is sent to the mobile server and the alert will be reset.

   Figure 3-26 Alert Reset

   
   Description of "Figure 3-26 Alert Reset"
   
   

3.6 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. In the My Studies pane, tap a study to select it.

2. Tap a study-site to select it.

3. Tap Alerts to view a list of alerts for a study or study-site.

4. Tap an alert to view its details.

   Figure 3-27 Alert Details

   
   Description of "Figure 3-27 Alert Details"
   
   

5. Tap Mark Important on the top right. The alert will be marked as important and a red exclamation mark icon appears next to it.

   Figure 3-28 Alert Marked Important

   
   Description of "Figure 3-28 Alert Marked Important"
   
   

3.7 Unmarking an Alert as Important

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

1. In the My Studies pane, tap a study to select it.

2. Tap a study-site to select it.

3. Tap Alerts to view a list of alerts for a study or study-site.

4. Tap the alert marked important to view its details. Alerts marked important will display a red exclamation mark icon.

   Figure 3-29 Important Alert

   
   Description of "Figure 3-29 Important Alert"
   
   

5. Tap Unmark Important. The important flag for the alert will be cleared.

   Figure 3-30 Alert Marked Not Important

   
   Description of "Figure 3-30 Alert Marked Not Important"