Oracle Health Sciences Mobile Clinical Research Associate Server

Administrator's Guide

Release 2.0

E61210-01

November 2015

Oracle Health Sciences Mobile Clinical Research Associate Server Administrator's Guide, Release 2.0

E61210-01

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Contents

List of Figures

List of Tables

Preface

- Audience

- Documentation Accessibility

- Finding Information and Patches on My Oracle Support

- Finding Documentation on Oracle Technology Network

- Related Documents

- Conventions

1 Introduction

- 1.1 Overview

- 1.2 Logging In

2 Alert Notification and Study-Site Metrics

- 2.1 Alerts

- 2.1.1 Types of Alerts

- 2.1.1.1 Standard or System Alerts

- 2.1.1.2 User Defined Alerts

- 2.1.2 Alert Management

- 2.2 Managing Alerts in Oracle Business Intelligence Enterprise Edition

- 2.2.1 Customizing a Standard Alert

- 2.2.2 Creating a New Alert

- 2.3 Mobile Alert Notification Configuration

- 2.3.1 Rule Management in Administration User Interface

- 2.3.1.1 Rule Management Interface

- 2.3.1.2 Rule Management Operations

- 2.4 Parameter List

- 2.5 Study-Site Metrics

- 2.5.1 Changing the Display Order

3 Trip Reports

- 3.1 Configuring a Trip Report

- 3.1.1 Defining Trip Report Types

- 3.1.1.1 The Action Drop-down List

- 3.1.1.2 The View Drop-down List

- 3.1.1.3 Creating a Trip Report Type

- 3.1.1.4 Editing a Trip Report

- 3.1.1.5 Audit Details

- 3.1.2 Defining Attributes

- 3.1.2.1 Defining Picklist Sources

- 3.1.3 Defining Subitems

- 3.1.4 Defining the Category Order

- 3.1.5 Using EXtensible Stylesheet Language Transformations to Create a Trip Report

- 3.1.5.1 Defining Trip Report Styles

- 3.1.6 Source Data Verification

- 3.1.6.1 Linking a CTMS Study to an InForm Study

- 3.1.7 Sample Trip Report in the CTMS

4 Integrations and Configurations

- 4.1 Registering the Client

- 4.2 Registering Sources

- 4.2.1 Adding a Source

- 4.3 Adaptive Site-at-a-Glance

- 4.3.1 Registering Key Performance Indicators

- 4.3.1.1 Adding a KPI

- 4.3.1.2 Editing a KPI

- 4.3.1.3 Deleting a KPI

- 4.3.2 Trending Graphs and KPIs Displayed

- 4.3.3 Changing the Display Order

- 4.3.4 Pushing KPI Information to Mobile CRA

- 4.4 Alerts Registration

- 4.4.1 Adding an Alert

- 4.4.2 Editing an Alert

- 4.4.3 Deleting an Alert

Index

List of Figures

- 1-1 The Configuration Utility Login Screen

- 1-2 The Configuration Utility Home Screen

- 2-1 Catalog Link

- 2-2 Shared Folders

- 2-3 Mobile CRA Folder

- 2-4 Criteria Tab

- 2-5 Edit Filter

- 2-6 The New Tab

- 2-7 Subject Area

- 2-8 Filter for a Column

- 2-9 New Filter Condition

- 2-10 Alert Notification

- 2-11 Rule Management Screen

- 2-12 Rule Attributes Screen

- 2-13 Parameter List

- 2-14 The Study-Site Metrics Screen

- 2-15 Existing KPI Order

- 2-16 Corresponding Display Order on Ipad

- 2-17 Changed Display Order

- 2-18 Corresponding Changed Display Order in Ipad

- 3-1 The Mobile Trip Report Configuration Screen

- 3-2 The Action Drop-down List

- 3-3 View Drop-Down List

- 3-4 Create Trip Report Type Screen

- 3-5 Edit Trip Report Type Screen

- 3-6 Audit Details Screen

- 3-7 Selected Trip Report Type Screen

- 3-8 Add Type Attributes Screen

- 3-9 Editing an Attribute Type

- 3-10 Removing an Attribute Type

- 3-11 Defining Picklist Sources

- 3-12 Adding a Subitem

- 3-13 Saving a Subitem

- 3-14 Removing a Subitem

- 3-15 Existing Order in the iPad.

- 3-16 Re-arranged Order

- 3-17 Fetch from CTMS

- 3-18 New Order

- 3-19 Define Trip Report Styles Screen

- 3-20 Study Mapping

- 3-21 CTMS Study Mapping Attributes

- 3-22 Selecting the SDV Reporting Type

- 3-23 Mapping CTMS Sites to InForm Sites

- 3-24 Selecting Templates to Perform Source Data Verification

- 3-25 Sample Out-of-the-Box Trip Report in the CTMS

- 3-26 Sections within a Trip Report

- 3-27 CTMS Items Represented as Item Types on Mobile CRA Configuration Utility

- 3-28 Attributes for a Trip Report Type in MobileCRA Configuration Utility

- 3-29 Trip Report XSLT

- 3-30 Sample CTMS XML

- 3-31 Custom to Canonical XSL

- 3-32 Managing Status in XSL

- 3-33 Trip Report Item and its Attribute Conversion

- 3-34 Trip Report Item and its Attribute Conversion

- 3-35 Assigning a Picklist to an Attribute

- 3-36 The Trip Reports About Section

- 3-37 Trip Report on the IPad

- 4-1 The Client Registration Screen

- 4-2 Adding a Source

- 4-3 Adding a KPI

- 4-4 Editing a KPI

- 4-5 Deleting a KPI

- 4-6 The Trending Graphs

- 4-7 The 6 KPI Display

- 4-8 Selecting the 9 KPI Display Setting

- 4-9 The 9 KPI Display

- 4-10 Selecting the 12 KPI Display Setting

- 4-11 The 12 KPI Display

- 4-12 Existing Order in the Configuration Utility

- 4-13 Corresponding Display in the iPad.

- 4-14 Changed Display Order in the Configuration Utility

- 4-15 Corresponding Changed Display Order in the iPad

- 4-16 Adding an Alert

- 4-17 Editing an Alert

- 4-18 Deleting an Alert

List of Tables

- 2-1 Out-of-the-Box Alerts

- 2-2 Alert Management Activities

- 2-3 Field Descriptions - Rule

- 2-4 Rule Parameter Fields

- 2-5 Permitted Status Changes

- 3-1 Field Descriptions

- 3-2 Add Type Attribute Field Descriptions.

- 3-3 SDV Reporting Options

Preface

This guide provides information about how to use Oracle Health Sciences Mobile Clinical Research Associate Server (Mobile CRA) Configuration Utility application.

This preface contains the following topics:

- Audience

- Documentation Accessibility

- Finding Information and Patches on My Oracle Support

- Finding Documentation on Oracle Technology Network

- Related Documents

- Conventions

Audience

This guide is intended for the following job classifications:

- Mobile CRA Configuration Utility Administrators

Documentation Accessibility

For information about Oracle's commitment to accessibility, visit the Oracle Accessibility Program website at http://www.oracle.com/pls/topic/lookup?ctx=acc&id=docacc.

Access to Oracle Support

Oracle customers that have purchased support have access to electronic support through My Oracle Support. For information, visit http://www.oracle.com/pls/topic/lookup?ctx=acc&id=info or visit http://www.oracle.com/pls/topic/lookup?ctx=acc&id=trs if you are hearing impaired.

Finding Information and Patches on My Oracle Support

Your source for the latest information about Oracle Health Sciences Mobile Clinical Research Associate is Oracle Support's self-service Web site, My Oracle Support (formerly MetaLink).

Before you install and use an Oracle software release, always visit the My Oracle Support Web site for the latest information, including alerts, release notes, documentation, and patches.

Creating a My Oracle Support Account

You must register at My Oracle Support to obtain a user name and password account before you can enter the Web site.

To register for My Oracle Support:

1. Open a Web browser to http://support.oracle.com.

2. Click the Register here link to create a My Oracle Support account. The registration page opens.

3. Follow the instructions on the registration page.

Signing In to My Oracle Support

To sign in to My Oracle Support:

1. Open a Web browser to http://support.oracle.com.

2. Click Sign In.

3. Enter your user name and password.

4. Click Go to open the My Oracle Support home page.

Searching for Knowledge Articles by ID Number or Text String

The fastest way to search for product documentation, release notes, and white papers is by the article ID number.

To search by the article ID number:

1. Sign in to My Oracle Support at http://support.oracle.com.

2. Locate the Search box in the upper right corner of the My Oracle Support page.

3. Click the sources icon to the left of the search box, and then select Article ID from the list.

4. Enter the article ID number in the text box.

5. Click the magnifying glass icon to the right of the search box (or press the Enter key) to execute your search.
The Knowledge page displays the results of your search. If the article is found, click the link to view the abstract, text, attachments, and related products.

In addition to searching by article ID, you can use the following My Oracle Support tools to browse and search the knowledge base:

- Product Focus — On the Knowledge page, you can drill into a product area through the Browse Knowledge menu on the left side of the page. In the Browse any Product, By Name field, type in part of the product name, and then select the product from the list. Alternatively, you can click the arrow icon to view the complete list of Oracle products and then select your product. This option lets you focus your browsing and searching on a specific product or set of products.

- Refine Search — Once you have results from a search, use the Refine Search options on the right side of the Knowledge page to narrow your search and make the results more relevant.

- Advanced Search — You can specify one or more search criteria, such as source, exact phrase, and related product, to find knowledge articles and documentation.

Finding Patches on My Oracle Support

Be sure to check My Oracle Support for the latest patches, if any, for your product. You can search for patches by patch ID or number, or by product or family.

To locate and download a patch:

1. Sign in to My Oracle Support at http://support.oracle.com.

2. Click the Patches & Updates tab.
The Patches & Updates page opens and displays the Patch Search region. You have the following options:

- In the Patch ID or Number is field, enter the primary bug number of the patch you want. This option is useful if you already know the patch number.

- To find a patch by product name, release, and platform, click the Product or Family link to enter one or more search criteria.

3. Click Search to execute your query. The Patch Search Results page opens.

4. Click the patch ID number. The system displays details about the patch. In addition, you can view the Read Me file before downloading the patch.

5. Click Download. Follow the instructions on the screen to download, save, and install the patch files.

Finding Documentation on Oracle Technology Network

The Oracle Technology Network Web site contains links to all Oracle user and reference documentation. To find user documentation for Oracle products:

1. Go to the Oracle Technology Network at
http://www.oracle.com/technetwork/index.html and log in.

2. Mouse over the Support tab, then click the Documentation hyperlink.
Alternatively, go to Oracle Documentation page at

http://www.oracle.com/technology/documentation/index.html

3. Navigate to the product you need and click the link.
For example, scroll down to the Applications section and click Oracle Health Sciences Applications.

4. Click the link for the documentation you need.

Related Documents

For more information, see the following documents:

Oracle Business Intelligence Enterprise Edition (OBIEE) Documentation

The Oracle Business Intelligence Suite Enterprise Edition Online Documentation Library documentation set includes:

- Oracle® Fusion Middleware User's Guide for Oracle Business Intelligence Enterprise Edition 11g Release 1 (11.1.1.7.0)

- Oracle® Fusion Middleware Metadata Repository Builder's Guide for Oracle Business Intelligence Enterprise Edition 11g Release 1 (11.1.1.7.0)

- Oracle® Fusion Middleware System Administrator's Guide for Oracle Business Intelligence Enterprise Edition 11g Release 1 (11.1.1.7.0)

- Oracle® Fusion Middleware Scheduling Jobs Guide for Oracle Business Intelligence Enterprise Edition 11g Release 1 (11.1.1.7.0)

- Oracle® Fusion Middleware Security Guide for Oracle Business Intelligence Enterprise Edition 11g Release 1 (11.1.1.7.0)

- Oracle® Fusion Middleware Developer's Guide for Oracle Business Intelligence Enterprise Edition 11g Release 1 (11.1.1.7.0)

- Oracle® Fusion Middleware Integrator's Guide for Oracle Business Intelligence Enterprise Edition 11g Release 1 (11.1.1.7.0)

Siebel Clinical Documentation

The Siebel Clinical documentation set includes:

- Siebel Life Sciences Guide

- Siebel Data Model Reference for Industry Applications

Conventions

The following text conventions are used in this document:

Convention

Meaning

boldface

Boldface type indicates graphical user interface elements associated with an action, or terms defined in text or the glossary.

italic

Italic type indicates book titles, emphasis, or placeholder variables for which you supply particular values.

monospace

Monospace type indicates commands within a paragraph, URLs, code in examples, text that appears on the screen, or text that you enter.

1 Introduction

This chapter contains the following sections:

- Section 1.1, "Overview"

- Section 1.2, "Logging In"

1.1 Overview

Oracle Health Sciences Mobile Clinical Research Associate Server (Mobile CRA) integrates with Oracle Clinical Development Analytics (CDA) and Oracle Siebel Clinical Trial Management System (CTMS) with the help of integration adapters.

The Mobile CRA Server Configuration Utility is a Web-based application that lets you manage the configuration of these integration adapters. The Configuration Utility supports the following integration adapters:

- CDA Alert Notifications

- CTMS Mobile Trip Reports

The application can support new adapters from different systems, if required.

1.2 Logging In

Figure 1-1 displays the Configuration Utility Login screen.

Figure 1-1 The Configuration Utility Login Screen

Figure 1-2 displays the Configuration Utility Home screen.

Figure 1-2 The Configuration Utility Home Screen

2 Alert Notification and Study-Site Metrics

This chapter contains the following sections:

- Section 2.1, "Alerts"

- Section 2.2, "Managing Alerts in Oracle Business Intelligence Enterprise Edition"

- Section 2.3, "Mobile Alert Notification Configuration"

- Section 2.4, "Parameter List"

- Section 2.5, "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. These alerts may be a site's performance, number of patients enrolled in sites, visit dates, and so on.

Mobile CRA lets you create subscriptions for such notifications. It 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:

- Section 2.1.1.1, "Standard or System Alerts"

- Section 2.1.1.2, "User Defined Alerts"

2.1.1.1 Standard or System Alerts

Mobile CRA has 13 out-of-the-box alerts. If required, you can customize these alerts using OBIEE. The following is the list of all 13 alerts.

2.1.1.1.1 Out-of-the-Box Alerts

The following are the Standard Alerts:

Table 2-1 Out-of-the-Box Alerts

Alerts

Description

Count of Enrolled Patient is a Multiple of Five, No Reset

When 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 parameters associated with this alert.

Number of Study Sites GT than Threshold, Manual

When the number of 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 2-2 Alert Management Activities

Application where activity is performed

Activity

Oracle Business Intelligence Enterprise Edition (OBIEE)

Create, modify, or delete an alert

Mobile CRA Server Configuration Utility

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 Oracle Business Intelligence Enterprise Edition

You can perform the following in Oracle Business Intelligence Enterprise Edition (OBIEE) for alerts:

2.2.1 Customizing a Standard Alert

To customize a standard Alert:

1. Sign in to Oracle Business Intelligence Enterprise Edition.

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

Figure 2-1 Catalog Link

3. Click Shared Folders.

Figure 2-2 Shared Folders

4. Click the Mobile CRA folder.

Figure 2-3 Mobile CRA Folder

5. All the standard alerts are displayed in the right-hand pane. Navigate to the 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, the Subject Area pane displays OCDA subject area and its hierarchical columns.

On the right-hand side upper section, the 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, the Filters pane shows filters to create or edit filters for the alert.

Figure 2-4 Criteria Tab

7. Drag and drop columns from the left-hand side Subject Area pane to the Selected Columns pane to modify the alert.

8. Click the Filter option to edit filters of the alert for the specific column or click Filter in the Filter pane header.

Figure 2-5 Edit Filter

9. Click OK to save the filter.

2.2.2 Creating a New Alert

To create a new alert, perform the following steps:

1. Sign in to Oracle Business Intelligence Enterprise Edition.

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

Figure 2-6 The New Tab

3. Click OCDA in Select Subject Area menu.

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. Click the Filter option to add filters to the alert for the specific column or click Filter in the Filter pane header.

Figure 2-8 Filter for a Column

7. Specify the filter condition in New Filter dialog box.

Figure 2-9 New Filter Condition

8. Click OK to save the filter.

9. Click the Results tab to see the results, if any.

10. In the Analysis editor, click Save Analysis 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 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 Configuration Utility server lets a system administrator maintain two key areas of the Mobile CRA system:

- Section 2.3.1, "Rule Management in Administration User Interface"

- Section 2.4, "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 Alert Notification

This section contains the following topics:

- Section 2.3.1, "Rule Management in Administration User Interface"

2.3.1 Rule Management in Administration User Interface

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:

- Section 2.3.1.1, "Rule Management Interface"

- Section 2.3.1.2, "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 toolbar icons are for specific Create, Edit, and Remove operations.

Figure 2-11 Rule Management Screen

The following fields of rules are displayed in the Rule Details pane:

Table 2-3 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 are:

STUDY_ID - when the scope is for a study.

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 creates the alert.

Create Date

The alert creation date.

Last Updated

The date on which the alert was last modified, updated, edited, and saved.

The following fields of rule parameters are displayed in Rule parameters pane:

Table 2-4 Rule Parameter Fields

Field Name

Field Description

Rule ID

Reference to primary key of the HSM_Rules table.

TypOrd

This column is created for de-normalized threshold table (HSM_OBI_THRESHS). It defines the position (that is, column) in the HSM_OBI_THRESHS table, and represents the data type and the position of the parameter. The valid values are:

For string columns - STR1, STR2,STR3, STR4, and STR5

For date columns - DT1, DT2, DT3, DT4, and DT5

For numeric columns - NUM1,NUM2, NUM3, NUM4, and 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 the 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:

- Section 2.3.1.2.1, "Creating a Rule"

- Section 2.3.1.2.2, "Editing a Rule"

- Section 2.3.1.2.3, "Removing a Rule"

- Section 2.3.1.2.4, "Rule Statuses"

2.3.1.2.1 Creating a Rule

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

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 the Rules Attributes screen.

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 and subscription threshold values.

To edit a rule and its thresholds, perform the following steps:

1. Click a rule in the List of Rules pane.

2. Click Edit Rule in the Rule Details pane.

3. Modify requisite fields in the 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, and 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 steps:

1. Click a rule in the List of Rules pane.

2. Click Remove Rule in the Rule Details pane.

3. Click Yes in the Remove Rule dialog box.

2.3.1.2.4 Rule Statuses

A rule can have three statuses, DRAFT, ACTIVE, and INACTIVE.

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

Table 2-5 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 the Rule definitions. The interface lets you create and remove existing parameter definitions.

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, ia confirmation dialog box is displayed 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 three are used for the trending graphs. You can also change the display order of these KPIs.

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 Existing KPI Order

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

Figure 2-16 Corresponding Display Order on Ipad

Figure 2-17 displays the changed order in the Configuration Utility.

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

3 Trip Reports

The trip report you see on mobile devices such as the iPhone or iPad is called a Canonical trip report. The Canonical trip reports' generic trip report structure can accommodate different kinds of configurations for Trip Reports in the CTMS.

Different implementations configure CTMS differently, either by extending the default trip report shipped out-of-the-box in CTMS or by completely replacing the default trip report with one of their own.

You must transform the out-of-the-box CTMS trip report to the Canonical trip report by extending the default transformation. You can make this transformation through Extensible Stylesheet Language Transformations (XSLT), a unique but flexible XML transformation language.

A Canonical trip report is simple in its structure. It is composed of two basic components:

- Attributes

- Items

Each item can have attributes and (or) items nested inside. It supports multi-level nesting. This generic structure lets you create any kind of trip report. For example, a trip report can have a checklist item, follow-up item, and attendee apart from its attributes. The checklist item may have a nested follow-up item underneath it. Thus, you may have a 3 level nested Trip Report structure.

To extend the configurations of the default CTMS trip report to your mobile device:

1. Understand the CTMS trip report structure by inspecting the XML coming out of the CTMS trip report web service.

2. Come up with a Canonical trip report structure that may or may not be same as the CTMS trip report depending on their needs. For example, a user may default certain values in the web service so that they can come up with a minimal trip report structure to make it easy for the Mobile CRA to quickly fill in or they can design it to accommodate all the fields in CTMS.

3. Transform the CTMS trip report to Canonical trip report using XSLT.

4. Define the display characteristics for those transformed attributes in the Configuration Utility. The Configuration Utility is where the user defines the attributes, the item types, and their relationship along with the display characteristics. The items, attributes, and relationship must mirror the transformation structure in the XSLT. For example, if a trip report is defined to have two items types such as checklist.

3.1 Configuring a Trip Report

Getting to the Mobile Trip Report Configuration Screen:

Click Trip Reports in right pane of the Home page to reach the Configuration Screen.

This section contains the following topics:

- Section 3.1.1, "Defining Trip Report Types"

- Section 3.1.2, "Defining Attributes"

- Section 3.1.3, "Defining Subitems"

- Section 3.1.4, "Defining the Category Order"

- Section 3.1.5, "Using EXtensible Stylesheet Language Transformations to Create a Trip Report"

- Section 3.1.6, "Source Data Verification "

- Section 3.1.7, "Sample Trip Report in the CTMS"

3.1.1 Defining Trip Report Types

This module lets you define how a trip report is displayed on the device. You can define the various sections, attributes, and associated checks of the trip report type. You can also define the order of display.

Figure 3-1 represents the Mobile Trip Report Configuration screen. The left pane displays a list of all tasks. The right pane displays the corresponding default types in the top pane and the details of the type selected in the bottom pane.

Figure 3-1 The Mobile Trip Report Configuration Screen

When you select a task from the left pane, the right pane displays the screens related to that particular task. The toolbar buttons are Action, View, Create, Edit, Remove, and Audit.

You can define the various sections, sub-sections, the fields among these sections and sub sections, the date type, and rules around each of these fields.

Mobile CRA has the following report types:

- Trip Report

- Attendees

- Checklist Items

- Follow-up Items

- Assignees

The star icon denotes that this is a standard trip report type. You cannot delete the standard trip report types.

This section contains the following sub sections:

- Section 3.1.1.1, "The Action Drop-down List"

- Section 3.1.1.2, "The View Drop-down List"

- Section 3.1.1.3, "Creating a Trip Report Type"

- Section 3.1.1.4, "Editing a Trip Report"

- Section 3.1.1.5, "Audit Details"

3.1.1.1 The Action Drop-down List

Figure 3-2 represents the Action drop-down list:

Figure 3-2 The Action Drop-down List

When you select Action, it displays the options, Create, Edit, Remove, and Audit.

3.1.1.2 The View Drop-down List

Figure 3-2 represents the View drop-down list:

Figure 3-3 View Drop-Down List

When you click View, it lets you control the display, and the order in which the columns are displayed.

When you click Columns, it lets you define what columns are to be displayed, and what columns are to be hidden. To do this:

1. Click View.

2. Select Columns.

3. Select the columns that you want to display.

Reorder lets you rearrange the order of the columns. To do this:

1. Click View.

2. Select Reorder Columns.

3. You can view the list of Visible columns. Use the arrow keys on the right to rearrange the order of the columns displayed.

3.1.1.3 Creating a Trip Report Type

To create a trip report type:

1. Click Create to create a Trip Report Type.

Figure 3-4 Create Trip Report Type Screen

The screen displays the list of attributes required for creating a new trip report type.

2. Enter requisite fields in the Create Trip Report Type screen.

Table 3-1 Field Descriptions

Serial Number

Field Name

Description

1

Type Name

Provide a name for the trip report type.

2

Caption

Enter the name for an attribute within a section.

3

Category

Enter the heading title.

4

Order

Enter a number between 1 to 5.

5

Description

Add comments, details, or description around the trip report type.

6

Category Order

Specify the order in which the various sections appear within a trip report type. Each section has to be separated by a comma.

7

Caption Attribute

Defines the field from which the value is picked up by the system as a header for the Trip Report Type.

8

Overview Attribute 1

Define the option that comes up for a particular attribute. You can choose the value from the list of options.

9

Overview Attribute 2

Defines the pick list applicable for a particular trip report type. For example, for checklist items, status is defined as an Overview Attribute, and this brings in the values as a pick list for the user to choose a value.

11

Order Attribute

Defines the sequence ordering for the trip report type

3. Click OK to create a trip report type.

3.1.1.4 Editing a Trip Report

To edit a trip report type:

1. Click Edit to edit a trip report.

Figure 3-5 Edit Trip Report Type Screen

2. The Edit Trip Report Type screen displays the list of attributes that can be edited in a Trip Report type. Click Show More on the screen to display additional attributes.

3. Click OK to save the changes.

3.1.1.5 Audit Details

Click Audit to view the timestamp of when the trip report component was last created and (or) modified along with the user details.

Figure 3-6 Audit Details Screen

3.1.2 Defining Attributes

When you select a trip report in the top Trip Report Types pane, it displays the Selected Type Trip Report screen in the bottom pane.

Figure 3-7 Selected Trip Report Type Screen

The screen has two tabs: Attributes and Subitems. By default, the Attributes tab is displayed.

The toolbar displays the Actions, View, Add, Edit, and Remove icons.

The Action Drop-down List

When you click Action, it lets you view the options, Add, Edit, and Remove.

The View Drop-down List

When you click View, it lets you control the display and the order in which the columns are displayed.

When you click Columns it lets you define what columns are to be displayed and what columns are to be hidden. To do this:

1. Click View.

2. Select Columns.

3. Select the columns that you want to display.

Reorder lets you rearrange the order of the columns. To do this:

1. Click View.

2. Select Reorder Columns.

3. You can view the list of Visible columns. Use the arrow keys on the right to rearrange the order of the columns displayed.

Adding Attributes

When you click Add, it lets you add an attribute type. The Add attributes screen displays the list of attributes required for creating a new attribute type. Fields marked with a star (*) are mandatory fields.

Figure 3-8 Add Type Attributes Screen

Table 3-2 describes the Add Type Attribute field descriptions.

Table 3-2 Add Type Attribute Field Descriptions.

Serial Number

Field Name

Descriptions

4

Order

Enter the number that is used by the system to order the attribute.

5

Data Type

Select the data type from the available options, Text, Number, Date, and Boolean.

6

Max Length

Enter the number that is used by the system to determine the maximum length of the text input on the mobile application.

7

Default Value

Enter any default value that needs to be displayed.

8

Picklist Field

Select the source of values, in case the attribute is a Picklist.

9

Hidden

Specify if the attribute has to be hidden or displayed. The values are True and False.

10

Required

Specify if the attribute has to be mandated or optional. The values are Yes and No.

11

Read Only

Specify if the attribute has to be display only or the user can type in an input. The values are Yes and No.

1

Attribute Name

Enter the name of the attribute.

2

Caption

Enter the caption for the attribute.

3

Category

Specify the sub-section under which the particular attribute shall be displayed.

Editing a Type Attribute

When you click Edit, it lets you edit an attribute type. The Edit Attribute Type screen displays the list of attributes that can be edited in an attribute type.

Figure 3-9 Editing an Attribute Type

Removing an Attribute Type

When you click Remove, it deletes the selected attribute type.

Figure 3-10 Removing an Attribute Type

3.1.2.1 Defining Picklist Sources

Some of the fields in the trip reports need to display a list of values. The Define Picklists Sources section lets you define the picklists and the source of values for such fields. Once defined, these can be attached to the required and relevant attributes in the trip report types.

Figure 3-11 Defining Picklist Sources

Click Define Picklist Sources to view the Picklists screen.

When you select a picklist from the top pane, the bottom pane displays the selected Picklist details. The toolbar icons are Action, View, Create, Edit, Remove, and Audit.

The primary function of the picklist source table is to define the picklist items used for the Choice field in the Group Attribute field definition. Each picklist item is created with an associated type that corresponds to the available Web service based options, which are key-value pairs.

Define Picklist Source Operation:

To create a picklist for a Metadata field, define a Picklist Source Item:

1. Enter the name, description, and picklist type in the Picklist Item table.

2. The Picklist Type item is either a key-value pair value or a URL-based web service.

3. After creating the picklist item, select the corresponding Type tab for entering values.

4. Use constraints to prevent items from being created with different types for same item

Picklist Types:

- Key-Value - Defines a list of key-value pairs.

- External - Defines a web service for retrieving Picklist items.

Entity Objects:

- HSM_CTMS_PICKLIST

View Object Fields:

- PICKLIST_NAME is the name of Picklist source.

- PICKLIST_TYPE is the type of Picklist (Key-Value or External).

- PICKLIST_DESCR is the description of the Picklist item.

Defining Picklist Source Values:

The Picklist item values tabs primary function is to define the values associated with each Picklist source name. The values for a Picklist Item can be different based on the Picklist type.

Defining the Picklist Source Value Operation:

1. Select a picklist name and type row from the Picklist Source table.

2. Select the corresponding picklist type from either the Key-Value or Web Service tab.

3. A new record is created with required attributes pertaining to type within designated tab.

4. The Key-value type may contain multiple records per picklist source item.

5. The external web service type contains one record per Picklist source item.

Entity Objects:

- HSM_ CTMS_PICKLIST_KEYVAL

- HSM_ CTMS_PICKLIST_EXT

View Object Fields—Key-Value Type

- PICKLIST_TYPE is the name of type (key-value).

- PICKLIST_KEY is the name of the picklist value to display.

- PICKLIST_VALUE is the data value of the picklist name.

- PICKLIST_DESCR is the description of the Picklist name.

- DISPLAY_ORDER is the sequence of items to display.

View Object Fields—External Type

- PICKLIST_TYPE is the name of type (external).

- URL_PATH – external REST URL to fetch data from an external source.

- DATA_PATH is the path within the received data structure that points to array of options to display.

- KEY_PATH is the path within the received data structure that points to a unique option key.

- VALUE_PATH is the path within the received data structure that points to unique option displayable value.

3.1.3 Defining Subitems

The tool bar displays the Actions, View, Add, Save, and Remove icons.

The Action Drop-down List

When you click Action, it lets you view the three options: Add, Delete, and Save.

The View Drop-down List

When you click View, it lets you control the display and the order in which the columns are displayed.

When you click Columns it lets you define what columns are to be displayed and what columns are to be hidden. To do this:

- Click View.

- Select Columns.

- Select the columns that you want to display.

Reorder lets you rearrange the order of the columns. To do this:

- Click View.

- Select Reorder Columns.

- You can view the list of Visible columns. Use the arrow keys on the right to rearrange the order of the columns displayed.

Adding a Subitem

When you click Add, it lets you add a Subitem type. The Add Subitem screen displays the list of attributes required for creating a new Subitem type. Fields marked with a star (*) are mandatory fields.

Figure 3-12 Adding a Subitem

Saving a Subitem Type

Figure 3-13 Saving a Subitem

When you click Save it saves the Subitem type.

Removing a Subitem

Figure 3-14 Removing a Subitem

1. When you click Remove, the Remove Subitem Type dialog box is displayed.

2. Click Yes to delete the selected Subitem type.

3.1.4 Defining the Category Order

Order is a text field to key in the number that is used by the system to order the Category attribute.

The standard application on the iDevice comes with a default category order.

Figure 3-15 Existing Order in the iPad.

You can re-arrange the order categories per your requirements.

Figure 3-16 Re-arranged Order

Click Fetch from CTMS to view the re-arranged order.

Figure 3-17 Fetch from CTMS

You can now view the new order on the iPad.

Figure 3-18 New Order

3.1.5 Using EXtensible Stylesheet Language Transformations to Create a Trip Report

The four XSLTs that are needed for the creation of the trip report are:

- Canonical to Custom Insert - Converts the canonical trip report from the client to the custom trip report creation XML for invoking web service on the CTMS. Since the result from the CTMS is a true or false response depending on whether the insert operation is successful or not, you do not need an XSLT for Custom to Canonical Insert.

- Canonical to Custom Query - Converts the canonical trip report query request to a custom CTMS request. Since the result is the CTMS XML, another XSLT is needed to convert it back to canonical.

- Custom to Canonical Query - Converts the XML that was recovered as a result from the CTMS into the canonical trip report.

- Canonical to Custom Update - Converts the canonical trip report from the client to custom trip report update XML for invoking web service on the CTMS. Since the result from the CTMS is a true or false response depending on whether the update operation is successful or not, you do not need an XSLT for Custom to Canonical Update.

3.1.5.1 Defining Trip Report Styles

Click Define Trip Report Style to view the Define Trip Report Style screen.

When you select a trip report style from the top pane, the bottom pane displays the selected trip report style details mode. You can visually inspect the contents of the uploaded file. You must modify and validate the style sheet structure and data outside the Configuration Utility server. If you want to make changes in the selected style type, use the File Upload icon to re-upload a new style sheet file. See data model specifications for additional information on entity attributes.

Figure 3-19 Define Trip Report Styles Screen

View Contents Operation

- Use the Inline Frame component to display the Style Sheet file contents.

- Use the Servlet applet to read the contents from the CLOB database field.

- Servlet transforms XML content into HTML markup representation for display.

- The contents are displayed in Inline Frame component in the read-only mode.

Entity Objects

- HSM_ CTMS_STYLE

View Object Fields

- CONTENT (read-only) – contents of field that contains XSLT data

3.1.6 Source Data Verification

Mobile CRA now supports Source Data Verification (SDV) for InForm enabled studies. You must ensure the following:

- InForm must be 6.0 or above

- InForm must have the data adapter and data discrepancy services installed

- The CTMS site must be mapped to the InForm sites from the Mobile CRA Administration Console.

CRAs will not conduct SDV at every type of site visit. The Mobile CRA Administration Console permits the selection of which CTMS site visit template can access InForm. For example, CRAs may conduct a site visit initiation visits. A specific trip report template is created to support this type of visit. However, it is not required to conduct SDV activities during this type of visit. Mobile CRA permits the administrator to select which templates permit SDV.

3.1.6.1 Linking a CTMS Study to an InForm Study

All CTMS studies are pre-populated into the Study Mapping table as shown in Figure 3-20.

Figure 3-20 Study Mapping

Additionally, the list of CTMS sites are automatically populated.

Enabling InForm Source Data Verification for a Study

To enable InForm SDV for a study in Mobile CRA, perform the following steps:

1. Enter the InForm URLs for the study enabled against the CTMS Study Name or ID.

Figure 3-21 CTMS Study Mapping Attributes

1. Enter the main InForm URL, the InForm Adapter URL, and the InForm Discrepancies adapter.

2. Select the type of SDV reporting that will be returned from SDV sessions to the trip report.

Figure 3-22 Selecting the SDV Reporting Type

Table 3-3 SDV Reporting Options

Reporting Type

Behavior

List of Issues

One checklist item is created for each form where query is created.

Text for Checklist - '<Patient ID> had form for Visit <#>, <Form Name> with an issue'

Text for Comment - '<Query Text>'

Summarized

One checklist item is created for each SDV session.

Text for Checklist - 'SDV Completed for <x> number of forms'.

Text for Comment - ' Forms SDV Complete:< # forms> : Forms Partial Verify: <# Forms> : Forms with Issues: <# Forms>

List of Forms

One checklist item is created for each form that are fully verified or partially verified.

Text for Checklist - 'SDV ["Completed" or "Partial"] for Visit <#>, <Form Name>'

Text for Comment - ''Record Status <Verified/Partial Verified/Issue) : <If Issue, record query text in comment>'

Summarized/Finding Detail

One checklist item is created.

Text for Checklist - 'SDV completed for # forms: <#> issues found'

Text for Comment - Forms with Issues: <# Forms>

By Patient

One checklist item is created for each patient that are verified for each SDV Session.

Text for Checklist - 'SDV on Patient <Patient ID>: <#> of forms verified. <#> issues found'

Text for Comment - ' Forms SDV Complete:< # forms> : Forms Partial Verify: <# Forms> : Forms with Issues: <# Forms>

The system differentiates between CRF pages that are fully verified (all fields verified) and pages that are partially verified, (some fields are verified).

Since various studies operate under different SDV reporting rules, the system lets the administrator select a reporting type on a study by study basis. For example, Study 1 may be operating under strict controls, requiring individual report for each form verified, while Study 2 is operating under less strict business rules (that is, a post marketing study), which only requires a summary report.

2. Map the CTMS site to the InForm sites.

Figure 3-23 Mapping CTMS Sites to InForm Sites

Once the Inform URLs are in place, the system selects all CTMS sites and names for the study, and displays them in the CTMS Studies tab.

The InForm Study site names that maps to the CTMS study site must be entered into the appropriate field.

3. Select templates where SDV will be performed.
SDV may not be performed for every template. For example, a template designed to support a Site Initiation visit may not require SDV, because patients have not yet enrolled at the site.

In the second tab, Templates, the administrator can select the templates where SDV will be accessible.

Figure 3-24 Selecting Templates to Perform Source Data Verification

Click Yes or No for each template.

When the trip report is saved, the SDV results are automatically mapped to the default checklist section in the out-of-the-box CTMS trip report, with a Sub Activity of SDV Activity.

Note:
In CTMS, if the Sub Activity field does not permit the value of SDV Activity, add this to the picklist.

If required, the XSLT mappings can be modified to direct the SDV records to CTMS applet other than checklist. For details on altering the mappings, see Section 3.1.5.

3.1.7 Sample Trip Report in the CTMS

Figure 3-25 describes a sample out-of-the-box trip report in CTMS:

Figure 3-25 Sample Out-of-the-Box Trip Report in the CTMS

Figure 3-26 shows a trip report in the out-of-the-box CTMS with the trip report header section and its various subitems highlighted. This trip report has the following items:

- Attendees

- Check list items

- Follow-up items

- Comments summary

- The checklist and the follow up items have the assignee items within.

These items have various attributes:

Figure 3-26 Sections within a Trip Report

Figure 3-27 displays the sections within a trip report.

Figure 3-27 CTMS Items Represented as Item Types on Mobile CRA Configuration Utility

The above items in the CTMS can be represented as various item types on the Mobile CRA Configuration Utility screen.

These items are represented as five different items in the Configuration Utility, including the trip report container element, and the assignee item, which are present under both checklist item and follow up item. All hierarchical items are represented as flat items in the Configuration Utility.

The attributes under each of these elements are defined in the hierarchical order. All the attributes under the trip report element go under trip report, all the attributes under checklist items go under checklist items, and so on.

The attributes contain various properties which control the behavior of those attributes on the mobile screen. These attributes include editable, hidden, and so on.

Figure 3-28 displays the attributes for a trip report type in the Configuration Utility.

Figure 3-28 Attributes for a Trip Report Type in MobileCRA Configuration Utility

You can display each of the attributes and items in a separate display category. You can use this functionality for representing the elements in the UI using certain logical grouping. For example, all attributes in the header section are displayed under a single display section called About. However, if you want, you can place them in different groupings. For example, Assigned To, Approver, and Reviewer in a workflow section, and all the other fields in the About section.

Figure 3-29 represents the sample canonical form. The canonical form has two basic elements, that is, items and attributes. An item can have attributes and (or) items in a hierarchical structure at any number of levels. The figure represents the out-of-the-box trip report with three levels, the trip report at the top level, the checklist, follow up, attendees at the second level with assigned to at the third level inside the checklist and follow up item.

Figure 3-29 Trip Report XSLT

Figure 3-30 represents the sample CTMS XML that is dispatched as part of the trip report web service XML. It mirrors the hierarchy of the trip report in the CTMS. The mobile trip report can follow the same hierarchy or a completely different hierarchy.

Figure 3-30 Sample CTMS XML

Figure 3-31 shows how the XSLT coding is done to transform the XML from one form to another.

In the example below, the CTMS XML that was returned is converted. As a result the CTMS web service XML is converted back to canonical XML.

For example, for every occurrence of a trip report element in the CTMS trip report, a Trip Report element is created in the canonical trip report. Also, the example below shows how to create a canonical element attribute from a CTMS attribute. In this case, whenever there is a protocol number attribute in the trip report header, an attribute is created in the canonical form, whose name is Protocol Number, and whose value is the same as the value in the CTMS.

Figure 3-31 Custom to Canonical XSL

The example below shows a special handling for trip report status attribute, which is, again, an attribute inside the trip report. Here, whenever you query the trip report from CTMS in Submitted or Submitted for Approval, it is put in the In Review status in the Mobile CRA. This is one of the normalized Trip Report statuses in the mobile client. To accommodate all kinds of workflow, the mobile client has the following recognized statuses:

- Editable status - The CTMS status can be retained as is except for the below status values, which have a special meaning. In this case, the trip report is editable in the mobile client.

- In Review status - The status in the CTMS for which the Mobile CRA will not update the update the trip report in the client.

- Submitted status - CTMS must have a Submitted status if it wants to submit the Trip Report for approval or review workflow. Also, during the submission, the client asks for the electronic signature.

- Approved status - CTMS must have an approved status. The status must be passed as is to the client. When the client sees any trip report in the approved status, it does not let the mobile client update any further. This is assumed as the final state in the mobile client.

Figure 3-32 represents the Managing Status in XSL.

Figure 3-32 Managing Status in XSL

Figure 3-33 shows an example similar to the trip report item and its attribute conversion, where the checklist items can be converted from the CTMS to the canonical form. The example also includes the attributes under the checklist items.

Figure 3-33 Trip Report Item and its Attribute Conversion

Figure 3-34 displays a trip report item and its attribute conversion.

Figure 3-34 Trip Report Item and its Attribute Conversion

Figure 3-35 displays assigning a picklist to the status attribute in the CRA Configuration Utility.

Figure 3-35 Assigning a Picklist to an Attribute

Figure 3-36 displays the Trip Reports About Section screen in the Ipad.

Figure 3-36 The Trip Reports About Section

Figure 3-37 shows a Trip Report on the Ipad.

Figure 3-37 Trip Report on the IPad

4 Integrations and Configurations

Mobile CRA lets you register, define, and manage key performance indicators (KPIs) either from OCDA or from other external sources. You can use the site-at-a-glance (SaaG) feature of Mobile CRA to view analytical data and metrics even if you do not use OCDA.

This chapter contains the following topics:

- Section 4.1, "Registering the Client"

- Section 4.2, "Registering Sources"

- Section 4.3, "Adaptive Site-at-a-Glance"

- Section 4.4, "Alerts Registration"

4.1 Registering the Client

You must provision the client in the Adaptive SaaG through WebLogic Server configuration. Use the Client Name and your credentials to receive the Client ID and Client Key.

You must procure (offline activity) and submit the Client ID and the Client Key through the Mobile CRA Configuration Utility application.

Figure 4-1 The Client Registration Screen

Note:
The Client ID and Client Key are sent to the Mobile CRA Configuration Utility user through offline communication such as an e-mail.

4.2 Registering Sources

You must register the various external sources (such as labs, imagery services, and so on) within the system before they can start sending information.

The Configuration Utility has the following enhancements for registering KPIs:

The Source Registration on the Configurations page. Send the Source Name and Source Type to the SaaG server. The returned information, Source ID and Source Key, is displayed.

4.2.1 Adding a Source

To add a source, perform the following:

1. Click Add. The Add Source window is displayed.

2. From the Source Type drop-down list, select KPI for a source that sends KPIs. Select ALERT for a source that sends alerts.

3. Enter the details and click OK.

Figure 4-2 Adding a Source

4.3 Adaptive Site-at-a-Glance

Mobile CRA's SaaG is a key feature as it assists CRAs in monitoring sites.

Earlier, Mobile CRA pulled in data only from the OCDA system. To let you use non-OCDA systems with this feature, Mobile CRA is re-designed to make SaaG an open feature by exposing APIs using which any system can push in KPI information, once registered into the system. This feature is now called the Adaptive SaaG.

The Mobile CRA Configuration Utility Web application now includes multiple enhancements for setting up KPIs from external systems.

4.3.1 Registering Key Performance Indicators

After the sources for KPIs are defined, you must define and manage the KPIs to be displayed on the mobile application.

Clicking Site-at-a-glance opens up the Register KPIs table on the right side of the page.

The system assigns the display order for the KPIs. However, you can add, edit, or delete a KPI as needed. There is no restriction on the number of KPIs that you can register.

4.3.1.1 Adding a KPI

To add a KPI, perform the following steps:

1. Click Add. The Add KPI window is displayed.

2. Enter the details and click OK.

Figure 4-3 Adding a KPI

4.3.1.2 Editing a KPI

To edit a KPI, perform the following steps:

1. Click Edit. The Edit KPI window is displayed.

2. Edit the required details and click OK.

Figure 4-4 Editing a KPI

4.3.1.3 Deleting a KPI

To delete a KPI, perform the following steps:

1. Click Delete. The Remove KPI confirmation message is displayed.

2. Click Yes.

Figure 4-5 Deleting a KPI

4.3.2 Trending Graphs and KPIs Displayed

Any number of KPIs can be registered and defined here. The first three KPIs are used for the trending graphs in the mobile application. You can define the order in which these KPIs are displayed here. The order can be changed and the mobile application reflects the change accordingly, including the KPIs for the trending graphs.

Figure 4-6 The Trending Graphs

You can choose the number of KPIs you want to view on a page: 6, 9, or 12.

Figure 4-7 The 6 KPI Display

Figure 4-8 illustrates selecting the 9 KPI display setting.

Figure 4-8 Selecting the 9 KPI Display Setting

Figure 4-9 illustrates the 9 KPI display.

Figure 4-9 The 9 KPI Display

Figure 4-10 illustrates selecting the 12 KPI display setting.

Figure 4-10 Selecting the 12 KPI Display Setting

Figure 4-11 illustrates the 12 KPI Display

Figure 4-11 The 12 KPI Display

4.3.3 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 4-12 Existing Order in the Configuration Utility

Figure 4-13 displays the corresponding display on the iPad.

Figure 4-13 Corresponding Display in the iPad.

Figure 4-14 displays the changed order in the Configuration Utility.

Figure 4-14 Changed Display Order in the Configuration Utility

Figure 4-15 displays the changed display in the iPad.

Figure 4-15 Corresponding Changed Display Order in the iPad

4.3.4 Pushing KPI Information to Mobile CRA

External sources (such as labs, drug companies, and imagery services) must use the Source ID and Source Key to push information such as KPI ID, KPI Name, Study Site ID or Study ID or General, and KPI Value.

The external source can send information in bulk or for a KPI at a time. In case of errors, appropriate error messages are sent back to the external source.

4.4 Alerts Registration

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 from non-OCDA sources create subscriptions for such notifications here. CRAs who have subscribed to such alerts receive these as and when the thresholds (set against that particular Alert) are met.

4.4.1 Adding an Alert

To add an alert, perform the following steps:

1. Click Add. The Add Alert window is displayed.

2. Enter the details and click OK.

Note:
Only those sources registered as alerts (as type) are displayed.

Figure 4-16 Adding an Alert

4.4.2 Editing an Alert

To edit an Alert, perform the following steps:

1. Click Edit. The Edit Alert window is displayed.

2. Edit the required details and click OK.

Figure 4-17 Editing an Alert

4.4.3 Deleting an Alert

To delete an alert, perform the following steps:

1. Click Delete. The Delete Alert window is displayed.

2. Delete the required alert and click OK.

Figure 4-18 Deleting an Alert

Index
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P

patches, Preface

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