2 Alert Notification and Study-Site Metrics

This chapter contains the following sections:

• Alerts

• Managing Alerts in OBIEE

• Mobile Alert Notification Configuration

• Parameter List

• Study-Site Metrics

2.1 Alerts

An Alert is a notification by which CRAs are notified about the various aspects of the studies that they are involved in. These Alerts may be about a site's performance, number of patients being enrolled in sites, visit dates, and so on.

Mobile CRA lets the users create subscriptions for such notifications. Mobile CRA sends Alerts to the CRAs who have subscribed to such Alerts as and when the thresholds (set against that particular Alert) are met.

2.1.1 Types of Alerts

Mobile CRA has two types of Alerts:

• Standard or System Alerts

• User Defined Alerts

2.1.1.1 Standard or System Alerts

Mobile CRA has 13 out-of-the-box Alerts. If need be, you can customize these Alerts using OBIEE. Following is the list of all 13 Alerts.

2.1.1.1.1 Out-of-the-Box Alerts

Following are the Standard Alerts:

• Count of Enrolled Patient is a Multiple of Five, No Reset—whenever the count of patients enrolled in a particular site reaches a number that is a multiple of 5. You do not need to reset the Alert to be triggered.

• First Patient has Enrolled at Site, No Reset—when the first patient has been enrolled in a site.

• Number of Active Sites is GT threshold, Manual—when the number of active sites they are assigned to exceeds the threshold set by the Administrator or User. ACTIVE_SITE_COUNT is the parameter associated with this Alert.

• Number of CRFs waiting for Verification, Auto—when the number of CRFs of a particular site, ready for source data verification, exceeds the threshold set by the Administrator or User. CRF_UNVERIFIED is the parameter associated with this Alert. This is an auto reset Alert where the site is pre-defined.

• Number of CRFs waiting for Verification, Manual—when the number of CRFs of a defined site, ready for source data verification, exceeds the threshold set by the Administrator or User. CRF_UNVERIFIED is the parameter associated with this Alert. This is a manual reset Alert where the site has to be defined.

• Number of Enrolled Patients is Greater Than Threshold, Auto—when the number of patients enrolled in a particular site exceeds the threshold set by the Administrator or User. ENROLLED_PATIENT is the parameter associated with this Alert.

• Number of Enrolled Patients since Last Site Visit, Manual—when the number of patients enrolled since the last visit in a particular site exceeds the threshold set by the Administrator or User. ENROLLED_SINCE_LAST_VISIT is the parameter associated with this Alert.

• Number of screen failures, Auto—when the number of failures in patient screening for enrollment exceeds the threshold set by the Administrator or User. SCREENING_DATE and SCREEN_FAILURE_COUNT are the parameters associated with this Alert.

• Number of Study Sites GT than Threshold, Manual—when the number studies assigned to the CRA exceeds the threshold set by the Administrator or User. STUDY_SITE_COUNT is the parameter associated with this Alert.

• Percentage of Closed Discrepancies, Auto—when the percentage of discrepancies during source data verification exceeds the threshold set by the Administrator or User. CLOSED_DISCREP_COUNT is the parameter associated with this Alert. This is an auto reset Alert.

• Percentage of Closed Discrepancies, Manual—when the percentage of discrepancies during source data verification exceeds the threshold set by the Administrator or User. CLOSED_DISCREP_COUNT is the parameter associated with this Alert. This is a manual reset Alert.

• Number of screen failures, Auto—when the number of patients who failed to pass the enrollment screening exceeds the threshold set by the Administrator or User. SCREENING_DATE and SCREEN_FAILURE_COUNT are the parameters associated with this Alert.

• Percentage of Open Queries, Manual—when the count of the open queries in a particular site exceeds the threshold set by the Administrator or User. OPEN_QUERY_COUNT is the parameter associated with this Alert.

2.1.1.2 User Defined Alerts

You can create new Alerts as per your specific needs.

2.1.2 Alert Management

You can perform Alert management activities as follows:

Table 2-1 Alert Management Activities

Application Where Activity is performed	Activity
Oracle Business Intelligence Enterprise Edition (OBIEE)	Create, modify, or delete an Alert.
Mobile CRA Server Admin UI	Register an Alert created in OBIEE. Create an Alert rule. Update status of an Alert to either active or inactive.
Mobile CRA Application (on either an iPhone or iPad)	Subscribe to Alerts. Set threshold for an Alert. View an Alert.

2.2 Managing Alerts in OBIEE

You can perform the following in OBIEE for Alerts:

2.2.1 Customizing a Standard Alert

To customize a standard Alert:

1. Sign in to Oracle BI Enterprise Edition.

2. In the global header, click Catalog to display the Catalog page.

   Figure 2-1 displays the Catalog link.

   Figure 2-1 Catalog Link

   
   Description of "Figure 2-1 Catalog Link"
   
   

3. Click Shared Folders.

   Figure 2-2 displays the Shared Folders folder.

   Figure 2-2 Shared Folders

   
   Description of "Figure 2-2 Shared Folders"
   
   

4. Click the Mobile CRA Folder.

   Figure 2-3 displays the Mobile CRA folder.

   Figure 2-3 Mobile CRA Folder

   
   Description of "Figure 2-3 Mobile CRA Folder"
   
   

5. You see all the standard Alerts in the right-hand pane. Navigate to an Alert you want to edit and click the Edit link. The Alert is displayed in the Analysis Editor.

6. Navigate to the Criteria tab.

   On the left hand side Subject Area pane displays OCDA subject area and its hierarchical columns.

   On the right hand side upper section Selected Columns pane shows the name of the column's folder, for example, Site-Name and name of the column, for example, Site_Name.

   On the right hand side lower section Filters pane shows filters to create or edit filters for the Alert.

   Figure 2-4 displays the Criteria tab.

   Figure 2-4 Criteria Tab

   
   Description of "Figure 2-4 Criteria Tab"
   
   

7. Drag and Drop columns from the left hand side Subject Area pane to the Selected Columns pane to set modify the Alert.

8. Edit filters of the Alert by clicking the Filter option for the specific column or by clicking the filter button in the Filter pane header.

   Figure 2-5 displays the Edit Filter.

   Figure 2-5 Edit Filter

   
   Description of "Figure 2-5 Edit Filter"
   
   

9. Click OK to save the filter.

2.2.2 Creating a New Alert:

Creating a new Alert:

1. Sign in to Oracle BI Enterprise Edition.

2. In the global header, click New, then Analysis.

   Figure 2-6 displays the New tab.

   Figure 2-6 The New Tab

   
   Description of "Figure 2-6 The New Tab"
   
   

3. Click OCDA in Select Subject Area menu.

   Figure 2-7 displays the Select Subject Area menu.

   Figure 2-7 Subject Area

   
   Description of "Figure 2-7 Subject Area"
   
   

4. Navigate to the Criteria tab.

5. Drag and drop columns from the left hand side Subject Area pane to the Selected Columns pane to specify criteria for the Alert.

6. Add filters to the Alert by clicking the Filter option for the specific column or by clicking on the filter button in the Filter pane header.

   Figure 2-8 displays the Filter option for a column.

   Figure 2-8 Filter for a Column

   
   Description of "Figure 2-8 Filter for a Column "
   
   

7. Specify filter condition in New Filter dialog box.

   Figure 2-9 displays the New Filter dialog box.

   Figure 2-9 New Filter Condition

   
   Description of "Figure 2-9 New Filter Condition"
   
   

8. Click OK to save the filter.

9. To see the results, if any, click the Results tab.

10. In the Analysis editor, click the Save Analysis toolbar button to display the dialog to save the analysis.

11. If you want to save the analysis to a personal or shared folder:

    1. In the Save In box, select the personal or shared folder in which to save the analysis.

    2. In the Name field, enter a name for the analysis, such as Site Names by Study.

    3. Click OK.

12. Click OK. The new Alert is created.

For the CDA Adapter, the Admin UI server lets a System Administrator maintain two key areas of the Mobile CRA system:

• Rule Management in Admin UI

• Parameter List

2.3 Mobile Alert Notification Configuration

Getting to the Mobile Alert Notification Screen:

Click Alert Notification in left pane of the Home page to reach the Mobile Alert Notification Configuration Screen.

Figure 2-10 displays the Mobile Alert Notification Configuration screen.

Figure 2-10 Alert Notification

Description of "Figure 2-10 Alert Notification"

This section contains the following topics:

• Rule Management in Admin UI

2.3.1 Rule Management in Admin UI

The Rule management module lets you manage Rule definitions and corresponding thresholds. To manage a Rule, select the Alert name from the navigation panel. When you select a Rule, the right pane displays the Rule definition form, which consists of the Rule parameters and Rule thresholds.

The Rule definition form lets an Administrator create, update, or delete a Rule based on the business Rules defined for the Rule category.

This section contains the following topics:

• Rule Management Interface

• Rule Management Operations

2.3.1.1 Rule Management Interface

Figure 2-11 represents the basic UI layout for Rules and Alerts. The left pane displays a list of all Rules (which can be sorted). The right upper pane displays Rule details and right lower pane displays Rule Parameters with default values.

When you select a Rule in the left pane, the right pane displays the information for that particular Rule. The tool bar icons are for specific Create, Edit, and Remove operations.

Figure 2-11 displays the user interface design for the Rule Management screen.

Figure 2-11 Rule Management Screen

Description of "Figure 2-11 Rule Management Screen"

Following fields of rules are displayed in Rule Details pane:

Table 2-2 Field Descriptions - Rule

Field Name	Field Description
Alert Name	The Alert Name as defined in the CDA.
Description	The details or summary. This is displayed in the Description field of Subscriptions.
Re Trigger Type	This lets you specify how the Alert triggers after the first time. The re-trigger types available are Manual Alert, Auto Alert, and One time Alert.
Rule Function	This column includes the name of the function associated with the Rule.For an OBIEE Rule, it includes the name of the OBIEE Rule. For an SQL based Rule it includes the SQL statement representing the Rule.
Scope	The valid scope of the Alert. The valid values for the current release are: STUDY_ID when the scope is for a Study, and STUDY_SITE_ID when the scope is for a particular Site within a Study.
Full Text Notification	This is the notification template. It includes the text that is sent as a message to the mobile device. The text includes tags which are replaced by the actual values before being sent.
Status	Defines whether the Rule is active or not. A Rule is in the DRAFT status while it is being configured or tested. The available options are ACTIVE, INACTIVE, and DRAFT.
Created By	The login name of the user who has created the Alert.
Create Date	The Alert creation date.
Last Updated	The date on which the Alert was last modified, updated, edited, and saved.

Following fields of Rule Parameters are displayed in Rule parameters pane:

Table 2-3 Rule Parameter Fields

Field Name	Field Description
Rule ID	Reference to primary key of HSM_RuleS table.
TypOrd	This column is created for the purpose of de-normalized threshold table (HSM_OBI_THRESHS). It defines the position (i.e. column) in HSM_OBI_THRESHS table and represents the data type and the position of the parameter. The valid values for String columns are STR1, STR2,STR3, STR4, STR5, for Date columns DT1, DT2, DT3, DT4, DT5, and for Numeric columns NUM1,NUM2, NUM3, NUM4, NUM5.
Default Value	The default value of the parameter at the Rule level.
Parameter Name	The Parameter name.
Re-Evaluation Type	Determines how the parameter is re-evaluated. It is used in combination with RE_EVALUATE_FUNC column, which includes the name of the function. The valid values are SYSTEM (implementations are provided by Oracle), and USER (user provides the implementation).
Re-Evaluation Function	Includes the name of the function which is executed to calculate the new value of the parameter at the time of reset. These functions can be provided by Oracle or the client depending on the re-evaluate type column.

2.3.1.2 Rule Management Operations

The Rule Management module supports the following key operations:

• Creating a Rule

• Editing a Rule

• Removing a Rule

• Rule Statuses

2.3.1.2.1 Creating a Rule

To create a new Rule and its thresholds, perform the following:

The default category for a new user-defined Rule is User Alert.

1. Click Create Rule in Rule Details pane.

2. Enter requisite fields in Rules Attributes screen.

   Figure 2-12 displays the Rules Attributes screen.

   Figure 2-12 Rule Attributes Screen

   
   Description of "Figure 2-12 Rule Attributes Screen"
   
   

3. Click OK to create the rule.

2.3.1.2.2 Editing a Rule

You can edit an existing user-defined Rule.

You can edit subscription threshold values.

To edit a Rule and its thresholds, perform the following:

1. Click a rule in List of Rules pane.

2. Click Edit Rule in Rule Details pane.

3. Modify requisite fields in Rules Attributes screen.

4. Click OK to save the rule.

2.3.1.2.3 Removing a Rule

You can only remove user-defined rules. You can remove a rule only if no Rule thresholds or user subscriptions exist.

Note:

If any Rule Parameters exist for a rule, Remove Rule will be disabled. You must first delete all rule parameters, before you delete a rule.

To remove a Rule, perform the following:

1. Click a rule in List of Rules pane.

2. Click Remove Rule in Rule Details pane.

3. Click Yes in Remove Rule dialog.

2.3.1.2.4 Rule Statuses

A Rule can have three statuses: DRAFT, ACTIVE, and INACTIVE.

You can change status of a rule through Edit Rule operation. The Permitted status changes are:

Table 2-4 Permitted Status Changes

Current Status	Permitted Statuses
DRAFT	ACTIVE AND INACTIVE
ACTIVE	INACTIVE
INACTIVE	DRAFT

When a system administrator creates the Rule, the default status is DRAFT.

2.4 Parameter List

Parameters List lets you manage the standardized list of parameters that are used in Rule definitions. The interface lets you create and remove existing parameter definitions.

Figure 2-13 displays the Parameter List screen.

Figure 2-13 Parameter List

Description of "Figure 2-13 Parameter List"

The Rule Parameters list supports the following key operations:

• Create: The Create icon lets you create a new Rule Parameter definition. When you click it, it displays the list of attributes required for creating a new Rule Parameter definition.

• Delete: The Delete icon lets you delete a parameter definition from the Rule Parameters table. When you select a parameter for removal, and click Delete, it presents you with a confirmation dialog box to remove the Rule.

  When you click OK, the parameter record is deleted and the Select Columns table is refreshed.

2.5 Study-Site Metrics

Earlier versions of Mobile CRA displayed only 6 KPIs in the application. Now, there are 27 KPIs which can be configured, the first 3 of which are used for the trending graphs. You can also change the display order of these KPIs.

Figure 2-14 displays the Study-Site Metrics screen.

Figure 2-14 The Study-Site Metrics Screen

Description of "Figure 2-14 The Study-Site Metrics Screen"

2.5.1 Changing the Display Order

You can change the order of the KPIs displayed. Perform the following steps:

1. Select the KPI whose display order you want to change. Click Edit.

2. Enter the new display order number in Display Order. Click OK.

Figure 2-15 displays the existing KPI order in the Admin UI.

Figure 2-15 Existing KPI Order

Description of "Figure 2-15 Existing KPI Order"

Figure 2-16 displays the corresponding display on the Ipad.

Figure 2-16 Corresponding Display Order on Ipad

Description of "Figure 2-16 Corresponding Display Order on Ipad"

Figure 2-17 displays the changed order in the Admin UI.

Figure 2-17 Changed Display Order

Description of "Figure 2-17 Changed Display Order"

Figure 2-18 displays the changed display in the Ipad.

Figure 2-18 Corresponding Changed Display Order in Ipad

Description of "Figure 2-18 Corresponding Changed Display Order in Ipad"