Oracle® User Management Tool

User's Guide

Release 12.0.1

E57087-01

December 2014

Oracle User Management Tool User’s Guide, Release 12.0.1

E57087-01

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Contents

List of Figures

List of Tables

Preface

- Audience

- Documentation Accessibility

- Related Documents

- Conventions

1 Introduction

- 1.1 Main Functions

- 1.2 How to Use Help

- 1.2.1 Navigational and Layout Features

2 Getting Started

- 2.1 Getting a New Password

- 2.2 Changing the Login Password

- 2.3 Accessing Support Help Desk

- 2.4 User Management Tool Interface

- 2.4.1 Navigation Elements

- 2.4.1.1 Menu

- 2.4.1.2 Page

- 2.4.1.3 Buttons

- 2.4.1.4 Links

- 2.4.1.5 Icons

- 2.4.2 Entry Fields

- 2.4.2.1 Text Boxes

- 2.4.2.2 Drop-down Lists

- 2.4.2.3 Check Boxes

- 2.4.2.4 Radio or Option Buttons

- 2.4.2.5 List Boxes

- 2.4.2.6 Date Boxes

- 2.5 Performing a Quick Search

- 2.6 Saving Details

- 2.7 Viewing Audit Trails

- 2.8 Logging out of the Application

3 Managing Users

- 3.1 User Types

- 3.2 InForm, IRT, and OLx Users

- 3.2.1 Viewing the List of InForm, IRT, or OLx Users

- 3.2.2 Creating InForm, IRT, or OLx Users

- 3.2.3 Viewing and Modifying InForm User Details

- 3.2.4 Viewing Multiple Association

- 3.2.5 Associating a User with a Site

- 3.2.6 Terminating InForm Users

- 3.2.7 Viewing Terminated InForm Users

- 3.2.8 Unterminating InForm Users

- 3.2.9 Approving or Rejecting InForm Users

- 3.2.10 Marking Users for Upload to InForm

- 3.2.11 Marking Users as Trained

- 3.2.12 Assigning IOL Classes

- 3.2.13 Sending InForm Account Details

- 3.2.14 Exporting InForm Users

- 3.2.15 Marking Users for Upload to IRT

- 3.2.16 Marking Users for Load to OLx

- 3.2.17 Marking Users for Updating User Name in Email Notifications

- 3.2.18 Updating Assessment Status

- 3.2.19 Assigning Preferred Study Locale

- 3.3 UMT Users

- 3.3.1 Viewing the List of UMT Users

- 3.3.2 Creating UMT Users

- 3.3.3 Viewing and Modifying UMT User Details

- 3.3.4 Activating UMT Users

- 3.3.5 Terminating UMT Users

- 3.3.6 Viewing Terminated UMT Users

- 3.3.7 Unterminating UMT Users

- 3.3.8 Resetting the Password for UMT Users

- 3.3.9 Resending UMT Login Details

- 3.4 Oracle Users

- 3.4.1 Viewing the List of Oracle Users

- 3.4.2 Creating Oracle Users

- 3.4.3 Viewing and Modifying Oracle User Details

- 3.5 Global Users

- 3.5.1 Viewing the List of Global Users

- 3.5.2 Creating Global Users

- 3.5.3 Assigning a Product

- 3.5.4 Viewing and Modifying Global User Details

- 3.5.5 Terminating a Global User

- 3.5.6 Viewing the Terminated User List

- 3.5.7 Unterminating Global Users

- 3.6 Merging Duplicate Users

- 3.7 Linking Users

4 Managing Trials

- 4.1 Viewing the List of Trials

- 4.2 Creating Trials

- 4.3 Viewing and Modifying Trial Details

- 4.4 Viewing and Resolving Duplicate Items

- 4.5 Bulk Copying

- 4.6 Selective Copying

- 4.7 Archiving Trials

- 4.8 Viewing Archived Trials

- 4.9 Exporting Trial Details

- 4.10 Exporting Trials

- 4.11 Importing Trials

- 4.12 Generating InForm XML

5 Managing Sites

- 5.1 Viewing the List of Sites

- 5.2 Creating Sites

- 5.3 Viewing and Modifying Site Details

- 5.4 Approving or Rejecting Sites

- 5.5 Marking Sites as Uploaded to InForm

- 5.6 Marking Sites as Not Participating

- 5.7 Viewing Not Participating Sites

- 5.8 Marking a Not Participating Site as Participating

- 5.9 Assigning or Updating the Study Version

- 5.10 Exporting Sites

- 5.11 Marking Upload to IRT

- 5.12 Updating Assessment Status for a Site

- 5.13 Sending Assessment Email

- 5.14 Stopping Assessment Process

- 5.15 Assigning Preferred Study Locale

6 Managing Roles

- 6.1 Managing InForm Roles

- 6.1.1 Viewing the List of InForm Roles

- 6.1.2 Creating InForm Roles

- 6.1.3 Viewing and Modifying InForm Role Details

- 6.1.4 Viewing and Modifying InForm User-Role Associations

- 6.1.5 Setting the Display Override Option

- 6.1.6 Approving or Rejecting InForm Roles

- 6.1.7 Transferring InForm Roles

- 6.2 Managing UMT Roles

- 6.2.1 Viewing the List of UMT Roles

- 6.2.2 Creating UMT Roles

- 6.2.3 UMT Roles and Rights

- 6.2.4 Viewing and Modifying UMT Role Details

- 6.2.5 Viewing and Modifying UMT User - Role Association

- 6.2.6 Deleting UMT Roles

- 6.3 Managing IRT Roles

- 6.3.1 Viewing the List of IRT Roles

- 6.3.2 Creating IRT Roles

- 6.3.3 Approving or Rejecting IRT Roles

7 Managing Groups

- 7.1 Viewing the List of Groups

- 7.2 Creating Groups

- 7.3 Viewing and Modifying User and Group Association

- 7.4 Validating AutoQuery Groups

- 7.5 Viewing and Modifying Group Details

- 7.6 Approving or Rejecting Groups

- 7.7 Creating PF Groups

8 Managing Reports

- 8.1 Viewing the List of Reports

- 8.2 Generating the Reports

- 8.2.1 Generating Assessment Reports

- 8.2.1.1 Generating the Assessment Summary Report at Sponsor Level

- 8.2.1.2 Generating the Assessment Summary Report at Trial Level

- 8.2.1.3 Generating the Assessment Detail Report at Trial Level

- 8.2.1.4 Generating the Assessment Summary Report at Site Level

- 8.2.1.5 Generating the Assessment Detail Report at Site Level

- 8.2.2 Generating Master Reports

- 8.2.2.1 Generating the Master Summary Report at Site Level

- 8.2.2.2 Generating the Master Detail Report at Site Level

- 8.2.3 Generating General Reports

- 8.2.3.1 Generating the Billing Report Details

- 8.2.3.2 Generating the Training Details Report

- 8.2.3.3 Generating the User Detail Report

- 8.2.3.4 Generating the WorkList-Site/User Report

- 8.2.3.5 Generating the Trial Archive Package (TAP) Report

9 Managing Worklists

- 9.1 Overview

- 9.2 Managing Worklist Generation

10 Worklist

- 10.1 Overview

- 10.2 Viewing Manual Worklist

- 10.3 Viewing Archived Records

11 Managing Assessment

- 11.1 Viewing the List of Assessed Users

- 11.2 Updating Assessment Status for an Assessed User

- 11.3 Viewing Assessment Comment History

- 11.3.1 Adding New Comments to the Assessment Comments History

- 11.3.2 Editing Comments

- 11.3.3 Deleting Comments

12 Managing Log Files

- 12.1 Viewing the List of Log Files

- 12.2 Viewing the List of Transferred Data

- 12.3 Archiving Log Files

- 12.4 Viewing Archived Log Files

13 InStruct Online Training

- 13.1 Overview

- 13.2 Assigning an IOL Class to a Trial

- 13.3 Managing Training

14 Configuring Settings

- 14.1 Configuring UMT Settings

- 14.1.1 Configuring Default Trials, Sites, and User Settings

- 14.1.2 Exporting UMT Configuration Settings

- 14.2 Configuring InForm Settings

- 14.2.1 Configuring Editable System Configuration Options for Trials on Trial Level

- 14.2.2 Configuring Editable System Configuration Options for New and Existing Trials on Sponsor Company Level

- 14.2.3 Configuring General Settings

- 14.2.4 Exporting InForm Configuration Settings

- 14.3 Configuring Custom Review State

- 14.4 Configuring Assessment

- 14.5 Configuring Assessment Benchmark

- 14.6 UMT Settings

- 14.6.1 Configuring UMT Settings

- 14.6.2 Managing ISD Codes and Time Zones for Countries

- 14.6.3 Viewing and Modifying Country Details

A UMT Field Information

- A.1 InForm, IRT, and OLx Users Field Information

- A.2 Create InForm, IRT, and OLX User Details

- A.3 Modify InForm and IRT User Details

- A.4 Multiple Association

- A.5 Global User List Page

- A.6 Create Global User

- A.7 Edit Global User

- A.8 InForm Roles

- A.9 Create InForm Role

- A.10 InForm Role Details

- A.11 User, Role Association

- A.12 Display and Change Override

- A.13 List of Groups

- A.14 Create Groups

- A.15 View and Modify User and Group Association

- A.16 Edit Groups

- A.17 Configuration Settings

- A.18 UMT Settings

- A.19 Country Details

- A.20 UMT Roles

- A.21 PF Roles

- A.22 Bulk Copy

- A.23 Create Sponsor Company

- A.24 Sponsor Company Details

- A.25 List of Sponsor Companies

- A.26 Log Files

- A.27 User, Role Association

- A.28 Study Variables

- A.29 Selective Copy

- A.30 PF User List Page

- A.31 List of Sites

- A.32 Selective Copy

- A.33 UMT Role Details

- A.34 UMT Users

- A.35 Create UMT Role

- A.36 Create PF Role

- A.37 Sponsor Company Details

- A.38 Create Sponsor Company

- A.39 Create Trial Details

- A.40 Create Oracle User

- A.41 Create Trial Details

- A.42 Edit PF User

- A.43 Create UMT User Details

- A.44 UMT User Details

- A.45 Create Site Details

- A.46 Site Details

- A.47 MUL Import - Error and Corrective Action Information

- A.48 Worklist Details

- A.49 Manage Worklists Generation

- A.50 Assessment Configuration Settings

- A.51 Assessment Benchmark Settings

- A.52 Generate Assessment Summary Report - Sponsor Level

- A.53 Generate Assessment Summary Report - Trial Level

- A.54 Generate Assessment Detail Report - Trial Level

- A.55 Generate Assessment Summary Report - Site Level

- A.56 Generate Assessment Detail Report - Site Level

- A.57 Generate Master Summary Report - Site Level

- A.58 Generate Master Detail Report - Site Level

- A.59 Generate Billing Details Report

- A.60 Generate Training Details Report

- A.61 Generate User Detail Report

- A.62 Generate Site-User Detail Report

- A.63 Generate Trial Archive Package (TAP) Report

- A.64 List of Oracle Users

- A.65 InForm Terminated User List

- A.66 List of Trials

- A.67 List of Archived Trials

- A.68 Managing Training

- A.69 Custom Review State Configuration Settings

Index

List of Figures

- 2-1 Navigation Elements

List of Tables

- 6-1 UMT Roles and Rights

- A-1 InForm, IRT Users, and OLx - Field Information

- A-2 InForm Users - Error Information

- A-3 Create InForm, IRT, and OLX User Details – Field Information

- A-4 Scenarios and Error Messages

- A-5 Modify InForm and IRT User Details – Field Information

- A-6 Scenarios and Error Messages

- A-7 Multiple Association – Field Information

- A-8 Multiple Association – Error Information

- A-9 Global User List Page – Field Information

- A-10 Create Global User - Field Information

- A-11 Create Global User - Error Information

- A-12 Edit Global User - Field Information

- A-13 Edit Global User - Error Information

- A-14 InForm Roles – Field Information

- A-15 Create InForm Role – Field Information

- A-16 Create InForm Role – Error Information

- A-17 InForm Role Details – Field Information

- A-18 InForm Role Details – Error Information

- A-19 User, Role Association – Field Information

- A-20 User - Role Association – Error Information

- A-21 Display Override – Field Information

- A-22 Change Display Override – Field Information

- A-23 Change Display Override – Error Information

- A-24 List of Groups – Field Information

- A-25 List of Groups – Error Information

- A-26 Create Groups - Field Information

- A-27 Create Group - Error Information

- A-28 View and Modify User and Group Association

- A-29 Edit Groups - Field Information

- A-30 Edit Group - Error Information

- A-31 Configuration Settings - Field Information

- A-32 Configuration Settings - Error Information

- A-33 UMT Settings - Field Information

- A-34 UMT Settings - Error Information

- A-35 Country Details – Field Information

- A-36 UMT Roles – Field Information

- A-37 PF Roles – Field Information

- A-38 Bulk Copy – Field Information

- A-39 Bulk Copy – Error Information

- A-40 Create Sponsor Company – Field Information

- A-41 Sponsor Company Details – Field Information

- A-42 List of Sponsor Companies – Field Information

- A-43 Log Files – Field Information

- A-44 User, Role Association – Field Information

- A-45 User, Role Association – Error Information

- A-46 Study Variable – Field Information

- A-47 Study Variables – Error Information

- A-48 Selective Copy – Field Information

- A-49 PF User List Page – Field Information

- A-50 List of Sites - Field Information

- A-51 Selective Copy – Field Information

- A-52 Selective Copy – Error Information

- A-53 UMT Role Details - Field Information

- A-54 UMT Role Details – Error Information

- A-55 UMT Users - Field Information

- A-56 UMT Users – Error Information

- A-57 Create UMT Role - Field Information

- A-58 Create UMT Role – Error Information

- A-59 Create PF Role - Field Information

- A-60 Create PF Role – Error Information

- A-61 Sponsor Company Details - Field Information

- A-62 Create Sponsor Company - Field Information

- A-63 Create Sponsor Company – Error Information

- A-64 Create Trial Details - Field Information

- A-65 Create Trial Details – Error Information

- A-66 Create Oracle User - Field Information

- A-67 Create PF User – Error Information

- A-68 Create Trial Details - Field Information

- A-69 Create Trial Details – Error Information

- A-70 Edit PF User - Field Information

- A-71 Edit PF User – Error Information

- A-72 Create UMT User Details - Field Information

- A-73 Create UMT User Details – Error Information

- A-74 UMT User Details - Field Information

- A-75 UMT User Details – Error Information

- A-76 Create Site Details - Field Information

- A-77 Create Site Details – Error Information

- A-78 Site Details - Field Information

- A-79 Site Details – Error Information

- A-80 MUL Import - Error and Corrective Action Information

- A-81 Worklist Details – Field Information

- A-82 Manage Worklists Generation – Field Information

- A-83 Assessment Configuration Settings – Field Information

- A-84 Assessment Benchmark Settings – Field Information

- A-85 Generate Assessment Summary Report at Sponsor Level – Field Information

- A-86 Generate Assessment Summary Report at Trial Level – Field Information

- A-87 Generate Assessment Detail Report at Trial Level - Field Information

- A-88 Generate Assessment Summary Report at Site Level - Field Information

- A-89 Generate Assessment Detail Report at Site Level - Field Information

- A-90 Master Summary Report at Site Level - Field Information

- A-91 Master Detail Report at Site Level - Field Information

- A-92 Billing Details Report - Field Information

- A-93 Training Details Report - Field Information

- A-94 User Detail Report - Field Information

- A-95 Site-User Detail Report - Field Information

- A-96 Trial Archive Package (TAP) Report - Field Information

- A-97 List of Oracle Users - Field Information

- A-98 InForm Terminated User List - Field Information

- A-99 List of Trials - Field Information

- A-100 List of Archived Trials - Field Information

- A-101 List of Archived Trials - Field Information

- A-102 List of Archived Trials - Field Information

Preface

This guide provides information about how to use User Management Tool (UMT).

Audience

This guide is intended for InForm, IRT, OLX, and IPMs Sponsor Users.

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 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.

Related Documents

For more information, see the following documents:

- Oracle User Management Tool User's Guide [this document]

- Oracle User Management Tool Release Notes

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

The Oracle User Management Tool (UMT) is an application for creating and managing user identity and access for Inform trials supported by Oracle. It also lets sponsor personnel enter, update, and confirm user and site details for their trials. It contains the following sections:

- Section 1.1, "Main Functions"

- Section 1.2, "How to Use Help"

1.1 Main Functions

The main functions of this application are:

- Delivers a robust, validated, secure, and intuitive user management environment that can be used across all InForm trials.

- Lets you import information to the UMT from external source files such as Excel spreadsheet and DAT files.

- Facilitates global updates to Oracle user information.

- Provides easy-to-use interface and data exchange for the automated transfer of information to the InForm trial, Automated Site Assessment (ASA) used for end-user infrastructure assessments, and InStruct Online (IOL) end-user computer-based training application.

- Provides Dual Control functionality, where two users are required to perform a transaction, such as creating and managing sites, and creating users and configuration related records.

- Provides an integrated training log for updating and reviewing the training status of trial personnel.

- Provides a flexible environment for users to extract information from the UMT in a reportable format.

- Improves the user management experience for users and internal staff.

- Ensures full traceability.

- Ensures auditability.

1.2 How to Use Help

The Help system is divided into left and right panes. The left pane of the window is organized in the form of books and topics. Books contain related topics and topics contain information about performing a specific task. When you click a topic, the content is displayed in the right pane.

1.2.1 Navigational and Layout Features

- The and buttons on the navigation bar help you browse through all available topics.

- The X button lets you close the left pane. Click the Contents tab on the main help bar to open the left pane.

- The Index tab helps you search for a topic.

- The Search tab displays all the topics which contain the search text.

2 Getting Started

This section helps you use the Oracle User Management Tool (UMT) application. It gives you a description of the interface and its various elements. It contains the following sections:

- Section 2.1, "Getting a New Password"

- Section 2.2, "Changing the Login Password"

- Section 2.3, "Accessing Support Help Desk"

- Section 2.4, "User Management Tool Interface"

- Section 2.5, "Performing a Quick Search"

- Section 2.6, "Saving Details"

- Section 2.7, "Viewing Audit Trails"

- Section 2.8, "Logging out of the Application"

2.1 Getting a New Password

If you forget your login password, click the Forgot Your Password? link on the UMT login page to get your new password.

To get a new password:

1. On the login page, click the Forgot Your Password? link. The Forgot Your Password? page is displayed.

2. Enter your user name in the Please Enter Your Username field and click Submit.

3. You are prompted to enter the answer for your hint question. Enter the answer for the question and click Send New Password.
Your new password is sent to the email address, specified during user creation and in the UMT settings.

4. To view the login page, click Return.

2.2 Changing the Login Password

Every user is assigned a unique password. This password expires or becomes invalid after the password expiration period or if you exceed the maximum login attempts (specified in the UMT settings). If the password has expired, the system prompts you to change the password. Oracle recommends that you periodically change your password.

Note:
Contact the UMT system administrator for details on the current setting for maximum number of login attempts.

To change the login password:

1. Click the CHANGE PASSWORD link on the top-right corner of the page. The Change Your Password page is displayed.

2. Enter your new password and password hint.
When you change your password, the new password is validated based on the settings selected in the UMT Settings page.

3. Click Submit to submit the changes. To discard the changes, click Return.

2.3 Accessing Support Help Desk

The Oracle UMT home page has links that let you access the support link and e-mail the customer support team.

To access the Oracle UMT support help desk:

1. On the Oracle UMT login page, click the http://www.oracle.com/us/corporate/Acquisitions/phaseforward/support-176416.html in the Help Desk Information section. The Support Overview page is displayed. The page has links that have various support information.

2. Click the Help Desk E-mail link in the Help Desk Information section to send an email to the customer support team.

2.4 User Management Tool Interface

This section introduces you to the different elements on the UMT interface. It also explains how you can use these elements to navigate and perform tasks.

2.4.1 Navigation Elements

The main navigation elements in the UMT application are menus, links, and buttons, which in turn display pages where you can define or modify existing details. The following figure illustrates the navigation elements:

Figure 2-1 Navigation Elements

Viewing Data on List Pages

Sorting: When viewing records on list pages, click the required column header to sort the list in alphanumeric order.

Filters: The filter criteria at the top of a list page lets you filter the list based on the criteria you select.

2.4.1.1 Menu

UMT is a web-based application that consists of a menu with several submenus. Each menu opens a page enabling you to perform various tasks.

Note:
The menu items displayed on the menu vary depending upon your access rights.

2.4.1.2 Page

Each menu item takes you to a new page. Each of these pages may contain icons, buttons, and links that may open other pages or perform tasks such as delete or save.

2.4.1.3 Buttons

Buttons let you access a new page where you can define, change, or view details.

2.4.1.4 Links

Most of the pages in this application contain links. Links are used for various purposes. On clicking a link, the view or edit page is displayed. For example, on clicking the Trial Name link on the List of Trials page, the Trial Details page is displayed.

2.4.1.5 Icons

An icon is a small graphic symbol that represents an action. When clicked, the action associated with the icon is executed. For example, on clicking the icon, the corresponding user-role association is displayed.

2.4.2 Entry Fields

2.4.2.1 Text Boxes

Text boxes let you enter or type information specific to a field. Depending on the kind of information that is required, these fields let you enter either alphabetical or numeric values. For example, entering a name in the First Name text box. In specific cases, alphanumeric values may be required.

2.4.2.2 Drop-down Lists

Drop-down lists let you select a value from the list that is displayed on clicking the drop-down arrow beside it. Most of the drop-down lists display all the items defined in the system for that particular field.

The options available in the drop-down list may vary depending upon your access rights.

2.4.2.3 Check Boxes

Check boxes let you select more than one option. Click a blank check box to select it. Click a selected check box to clear or deselect it. Click the top select box in the select box column to select all records.

2.4.2.4 Radio or Option Buttons

Option buttons usually, though not always, appear in pairs and give you an either-or option. One of the options is always selected by default. Selecting one of the other option buttons deselects the default option.

2.4.2.5 List Boxes

List boxes usually appear in pairs. The left list box contains a list of all available items. You can select individual items from it and click the >> and > buttons provided between the two list boxes. The items move to the right list box. To remove an item or all items from the selected list, select the item and click the < or << button.

2.4.2.6 Date Boxes

Date boxes are basically text boxes provided with the date picker beside it. Clicking this icon opens up a calendar, letting you select a date.

2.5 Performing a Quick Search

The Quick Search feature is available on the List of Countries page (located in the right corner).

Using this feature, you can search for sites and users, and directly access the required page.

For details on the List of Countries page, see Section 14.6.2.

To perform quick search:

1. In the Quick Search section, select the search item (such as sites or users) from the Find drop-down list.

2. Enter the search keyword in the with name as text box and click Submit. Based on your search criteria, the corresponding page is displayed.

2.6 Saving Details

The Submit button lets you save the changes made to the current page. You are prompted to save the changes made on a page if you are navigating to another page without saving the changes on the current page.

Oracle recommends you not to use the Back button of the browser. The pages are not displayed most of the time or you may lose the changes you have made. To navigate, use the menu or the Return button of the application.

Using any of the browser buttons such as, Refresh takes you to the home page of the application.

2.7 Viewing Audit Trails

Any changes made to a field item are captured and the reasons for change are tracked and audited. You can view the changes made to a particular field by viewing its corresponding audit trail.

To view audit trails:

1. Click the icon corresponding to a field item. On the Audit Trail page that appears, the audit details for corresponding field item are displayed.

2. To view the previous screen, click Return.

2.8 Logging out of the Application

You can log out of the application any time.

Oracle recommends you not to close your browser window to close the application without logging off from the UMT system. The connection with the server is disconnected properly only when you log out of the application.

To log out of the application:

- Click the LOG OUT link on the top-right corner of this application. You are logged out of the application and the login page is displayed.

Note:
The UMT system automatically logs you off when your session is inactive. You need to re-login to continue working.

3 Managing Users

This chapter contains the following topics:

- Section 3.1, "User Types"

- Section 3.2, "InForm, IRT, and OLx Users"

- Section 3.3, "UMT Users"

- Section 3.4, "Oracle Users"

- Section 3.5, "Global Users"

- Section 3.6, "Merging Duplicate Users"

- Section 3.7, "Linking Users"

3.1 User Types

The following are the types of users:

- InForm, IRT, and OLx Users

- UMT Users

- Oracle Users

- Global Users

The InForm, Oracle, and Global users can be enabled for single sign-on (SSO), which is a user authentication process. It lets users use single user name and password to access multiple trials and applications within a sponsor or a clinical research organization (CRO). It also lets users to switch from one application or trial to another without re-signing.

3.2 InForm, IRT, and OLx Users

This section contains the following topics:

- Section 3.2.1, "Viewing the List of InForm, IRT, or OLx Users"

- Section 3.2.2, "Creating InForm, IRT, or OLx Users"

- Section 3.2.3, "Viewing and Modifying InForm User Details"

- Section 3.2.4, "Viewing Multiple Association"

- Section 3.2.5, "Associating a User with a Site"

- Section 3.2.6, "Terminating InForm Users"

- Section 3.2.7, "Viewing Terminated InForm Users"

- Section 3.2.8, "Unterminating InForm Users"

- Section 3.2.9, "Approving or Rejecting InForm Users"

- Section 3.2.10, "Marking Users for Upload to InForm"

- Section 3.2.11, "Marking Users as Trained"

- Section 3.2.12, "Assigning IOL Classes"

- Section 3.2.13, "Sending InForm Account Details"

- Section 3.2.14, "Exporting InForm Users"

- Section 3.2.15, "Marking Users for Upload to IRT"

- Section 3.2.16, "Marking Users for Load to OLx"

- Section 3.2.17, "Marking Users for Updating User Name in Email Notifications"

- Section 3.2.18, "Updating Assessment Status"

- Section 3.2.19, "Assigning Preferred Study Locale"

3.2.1 Viewing the List of InForm, IRT, or OLx Users

The InForm Users page lets you manage InForm, IRT, and OLx users. You can view the list of InForm users and their details on this page. Additionally, it lets you filter the users based on the filter criteria.

To view the list of InForm users:

1. Select Users from the menu bar. The InForm Users page is displayed.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm users for the selected sponsor company and trial is displayed.

3. To filter users, enter the filter criteria, and click Find. The list of InForm users that satisfy the specified filter criteria is displayed.
For more details on how to filter and view InForm, IRT, and OLx users, see Section A.1.

4. To clear the filter criteria, click Clear.
While specifying the filter criteria, you can use the full name or part of the name.

Note:
To navigate through the user list, click the First, Previous, Next, or Last links.
To view a particular page, select the page from the drop-down list.

To view all the users on a single page, select All from the drop-down list.

Click the column name link to sort users either in the ascending or descending order, based on the column name. On the first click, the users are sorted in the ascending order. To sort them in descending order, click the column name link again.

3.2.2 Creating InForm, IRT, or OLx Users

The Create InForm Details page lets you create three types of InForm users, that is, PF users, sponsor users, and site users. Only PF users (Administrators) can create both PF and sponsor users, and associate with any sponsor. Sponsor users can create only sponsor users within that sponsor. Enter the user details and user association to create a new InForm user.

To create InForm users:

1. Select Users from the menu bar. The InForm Users page is displayed.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm users for the selected sponsor company and trial is displayed.

3. Click the Create InForm User link. The Create InForm User Details page is displayed.

4. Enter the user details and user association.
For more details on how to create InForm, IRT, and OLX users, see Section A.1.

Note:
The User Association section, on the Create InForm User Details page, varies depending upon the selected User Type.

5. Click Submit to save the user details.

Note:
To save the current user details and create another user, click Submit and Add Another.
To discard the changes, click Return.

3.2.3 Viewing and Modifying InForm User Details

The InForm User Details page lets you view and modify InForm user details. If the user details are modified, the reason for change is captured and the changes are tracked and audited. You can view the changes made to a particular field by viewing its corresponding audit trails.

To view and modify InForm user details:

1. Select Users from the menu bar. On the InForm Users page that appears, select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm users for the selected sponsor company and trial is displayed.

2. Click the Username link. On the InForm User Details page that appears, the user details for the selected user are displayed.

3. Modify the user details.
For more details on how to modify InForm, IRT, and OLX user details, see Section A.3.

Note:
If you modify the current sponsor company or the trial displayed in the Current Sponsor Company and Trial drop-down lists, the InForm Users page is displayed.

4. Enter the reason for modifying the user details in the Reason for Change text box and click Submit.

Note:
To cancel the changes made to the InForm user details, click Return.
To view the list of audit trails for a particular field, click the corresponding icon.

3.2.4 Viewing Multiple Association

The Multiple Association icon lets you view the sites associated with the user. You can also request equipment assessment for the site or mark the site as assessed or request immediate provisioning.

To view multiple associations:

1. Select Users from the menu bar. The InForm Users page is displayed.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm users for the selected sponsor company and trial is displayed.

3. Click the icon in the Site(s) column. On the page that appears, the list of users and their associated sites are displayed.

Note:
The icon is active only for non-ZPF users.

4. Select a user from the Select Username list box and click Go. The list of sites to which the user is associated is displayed.
For more details on multiple associations, see Section A.4.

Note:
To navigate through the user list, click the First, Previous, Next, or Last links.
To view a particular page, select the page from the drop-down list.

To view all the users on a single page, select All from the drop-down list.

Click the column name to sort the sites either in the ascending or descending order, based on the column name. On the first click, the sites are sorted in the ascending order. To sort the sites in descending order, click the column name again.

To view the list of InForm users, click Return.

3.2.5 Associating a User with a Site

You can associate a user with all sites located within a country and time zone. Only sponsor users can be associated with sites within a country and/or a time zone.

To automatically associate a user to a site:

1. Select Users from the menu bar. The InForm Users page is displayed.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm users for the selected sponsor company and trial is displayed.

3. Click the required sponsor user name link in the grid. The Edit InForm User Details page displays the details of the sponsor user.

4. Select Country or Country & TimeZone from the Filter By drop-down list.

5. Select the required country or country and time zone from the drop-down list.

6. Select the Automatic Association check box.

7. Enter the reason for modifying the user details in the Reason for change text box and click Submit.
The sponsor user is automatically associated with all the sites of the selected country and time zone.

3.2.6 Terminating InForm Users

The InForm Users page lets you terminate InForm users. You can also view the list of terminated users.

To terminate InForm users:

1. Select Users from the menu bar. The InForm Users page appears.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm users for the selected sponsor company and trial is displayed.

3. Select the check box corresponding to the user you want to terminate.

4. Select Terminate User from the Select drop-down list.

5. Enter the details in the Comments check box and click Go.

6. On the confirmation dialog box that appears, click OK to terminate the selected InForm user.

Note:
To cancel termination of the InForm user, click Cancel.

7. Click OK on the dialog box that appears on successful termination of the InForm user.

3.2.7 Viewing Terminated InForm Users

The InForm Terminated User List page displays the list of terminated InForm users. You can view the user name, first name, last name, and country of the terminated users.

To view terminated InForm users:

1. Select Users from the menu bar. The InForm Users page is displayed.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm users for the selected sponsor company and trial is displayed.

3. Click the Terminated User List link. The InForm Terminated User List page is displayed, which shows the list of terminated users.
For more details on InForm terminated user list, see Section A.65.

Note:
To go back to the previous page, click Return.

3.2.8 Unterminating InForm Users

The Terminated User List page lets you revoke the termination of InForm users. You can either revoke the termination of all users or a particular user.

To unterminate InForm users:

1. Select Users from the menu bar. The InForm Users page is displayed.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm users for the selected sponsor company and trial is displayed.

3. Click the Terminated User List link. The InForm Terminated User List page is displayed.

4. Select the check box corresponding to the user whose termination you want to revoke and click Unterminate.

5. Click OK in the dialog box that appears on revoking the termination of the InForm user.

Note:
To go back to the previous page, click Back.

3.2.9 Approving or Rejecting InForm Users

The Approve and Reject options available on the InForm Users page let you approve and reject InForm users. You can approve or reject a user, only if the user status is pending. If user details or association are changed, the approved or rejected status is changed to Pending or Approved based on the approval rights of the user logged in.

To approve or reject InForm users:

1. Select Users from the menu bar. The InForm Users page is displayed.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm users for the selected sponsor company and trial is displayed.

3. Select the check box corresponding to the user you want to approve or reject.

4. Select Approve or Reject from the Select drop-down list.

- If you select Reject, enter the reason for rejecting the user in the Comments text box.

- If you select Approve, the Electronic Signature Affidavit page is displayed. Enter your password and click Submit. To cancel approval, click Cancel.

The Approval Status for the selected user changes based on the action performed.

5. Click Go.

3.2.10 Marking Users for Upload to InForm

The InForm user details created in UMT can be uploaded into the InForm system. The Load to InForm option on the InForm Users page lets you mark users for upload.

To mark users for upload to InForm:

1. Select Users from the menu bar. The InForm Users page is displayed.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm users for the selected sponsor company and trial is displayed.

3. Select the check box corresponding to the user you want to upload to InForm.

4. Select Mark Upload To InForm from the Select drop-down list.

5. Enter the reasons in the Comments text box and click Go.

3.2.11 Marking Users as Trained

The InForm user created may already be trained or may require training. The InForm Users page lets you mark a user as trained. You can also enter this information while creating or modifying the InForm user details.

To mark a user as trained:

1. Select Users from the menu bar. The InForm Users page is displayed.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm users for the selected sponsor company and trial is displayed.

3. Select the check box corresponding to the user you want to mark as trained.

4. Select Mark as Trained from the Select drop-down list.

Note:
You can mark a user as trained only if the user is approved.

5. Enter the reason for marking the user as trained in the Comments text box and click Go.
The selected user is marked as trained.

3.2.12 Assigning IOL Classes

This feature is only usable for trials for which the Switchoff IOL option (on the Configuration Settings page) is not selected, that is, the UMT-IOL integration is enabled for the trials. For more details on configuration settings, see Chapter 14.

To assign an IOL class to a user:

1. Select Users from the menu bar. The InForm Users page is displayed.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm users for the selected sponsor company and trial is displayed.

3. Select the check box corresponding to the user you want to assign the IOL class to.

4. Select Assign IOL Class from the Select drop-down list.

5. Enter the reason in the Comments text box and click Go. The Request Training page is displayed.

6. Move the appropriate IOL class into the Selected window and click Submit.

3.2.13 Sending InForm Account Details

The Send InForm Account Details option lets you send the InForm account details to the selected users in the form of an email. This email contains the study URL of a particular trial. Additionally, emails containing the InForm user name and password are sent by the UMT system. However, these actions take place only if the Upload to InForm status is complete and the trial is in a golive state.

To send InForm account details:

1. Select Users from the menu bar. The InForm Users page is displayed.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm users for the selected sponsor company and trial is displayed.

3. Select the check box corresponding to the user you want to send the InForm account details.

4. Select Send InForm Account Details from the Select drop-down list and click Go.

5. Click Go on the confirmation dialog box.

3.2.14 Exporting InForm Users

The Export to Excel and Export to File links available on the InForm Users page let you export InForm users. You can export the InForm user details either to an Excel spreadsheet or to a flat file.

To export InForm users:

1. Select Users from the menu bar. The InForm Users page is displayed.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm users for the selected sponsor company and trial is displayed.

3. Select the check box corresponding to the user you want to export.

4. Click the Export to Excel or Export to File link. On the dialog box that appears, click Open to open the file or click Save to save the file.

3.2.15 Marking Users for Upload to IRT

The Load to IRT option on the InForm Users page lets you mark users for upload to IRT.

To mark users for upload to IRT:

1. Select Users from the menu bar. The InForm Users page is displayed.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm users for the selected sponsor company and trial is displayed.

3. Select the check box corresponding to the user you want to upload to IRT.

4. Select Mark Upload To IRT from the Select drop-down list.

5. Enter the reasons in the Comments text box and click Go.

3.2.16 Marking Users for Load to OLx

The Load to OLx option on the InForm Users page lets you mark users for upload to OLx.

To mark users for upload to OLx:

1. Select Users from the menu bar. The InForm Users page is displayed.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm users for the selected sponsor company and trial is displayed.

3. Select the check box corresponding to the user you want to upload to OLx.

4. Select Mark Upload To OLx from the Select drop-down list.

5. Enter the reasons in the Comments text box and click Go.

3.2.17 Marking Users for Updating User Name in Email Notifications

The Update User Name in Email Notifications option on the InForm Users page lets you mark users for updating user name in email notifications.

To mark users for updating user name in email notifications:

1. Select Users from the menu bar. The InForm Users page is displayed.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm users for the selected sponsor company and trial is displayed.

3. Select the check box corresponding to the user you want to mark for updating the user name in email notifications.

4. Select Update User Name in Email Notifications from the Select drop-down list.

5. Select the corresponding option from the User Name Order drop-down list.

6. Click Go.

3.2.18 Updating Assessment Status

The Update Assessment Status option on the InForm Users page lets you update the assessment status of the InForm users.

To update the assessment status of InForm users:

1. Select Users from the menu bar. The InForm Users page is displayed.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm users for the selected sponsor company and trial is displayed.

3. Select the check box corresponding to the user whose assessment status you want to update.

4. Select Update Assessment Status from the Select drop-down list.

5. Enter the reasons in the Comments text box and click Go.
The Update Assessment Status page is displayed.

6. Select the check box corresponding to the status you want to update.

7. Enter the reasons in the Assessment Summary Box and click Update.

Note:
Click Return to go back to the InForm Users page.

3.2.19 Assigning Preferred Study Locale

The Edit Oracle User Details page lets you assign a preferred study locale to InForm users.

To assign a preferred study locale to an InForm user:

1. Select Users from the menu bar. The InForm Users page is displayed.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm users for the selected sponsor company and trial is displayed.

3. Select the check box corresponding to the user whose preferred study locale you want to update.

4. Select Assign Preferred Study Locale from the Select drop-down list.

5. Select the preferred language from the Language drop-down list.

6. Enter the reason in the Comments text box and click Go.

Note:
To cancel the changes made to the user details, click Return.

3.3 UMT Users

This section contains the following topics:

- Section 3.3.1, "Viewing the List of UMT Users"

- Section 3.3.2, "Creating UMT Users"

- Section 3.3.3, "Viewing and Modifying UMT User Details"

- Section 3.3.4, "Activating UMT Users"

- Section 3.3.5, "Terminating UMT Users"

- Section 3.3.6, "Viewing Terminated UMT Users"

- Section 3.3.7, "Unterminating UMT Users"

- Section 3.3.8, "Resetting the Password for UMT Users"

3.3.1 Viewing the List of UMT Users

The UMT Users page lets you view the list of UMT users and their details. It also lets you filter the UMT users based on the filter criteria.

To view the list of UMT users:

1. Select Users from the menu bar. On the page that appears, click the UMT Users link.

2. On the UMT Users page, select the sponsor company from the Current Sponsor Company drop-down list. The list of UMT users for the selected sponsor company is displayed.

3. To filter UMT users, enter the filter criteria and click Find. The list of UMT users that satisfy the specified filter criteria is displayed.
While specifying the filter criteria, you can either use the full name or the first few letters of the name.

For more details on how to filter and view UMT users, see Section A.34.

4. To clear the filter criteria, click Clear.

Note:
To navigate through the user list, click the First, Previous, Next, or Last links.
To view a particular page, select the page from the drop-down list.

To view all the users on a single page, select All from the drop-down list.

Click the column name link to sort the UMT users in the ascending or descending order, based on the column name. On the first click, the UMT users are sorted in the ascending order. To sort the UMT users in descending order, click the column name link again.

3.3.2 Creating UMT Users

The Create UMT User Details page lets you create following UMT users:

- PF users - Only PF users (Administrators) can create both PF and sponsor users and associate UMT users with any sponsor. PF users have access to all sponsors.

- Sponsor users - A sponsor user can create only sponsor users within that sponsor. Sponsor users can access only their own data and cannot view other sponsor details.

To create UMT users:

1. Select Users from the menu bar. On the page that appears, click the UMT Users link.

2. On the UMT Users page, select the sponsor company from the Current Sponsor Company drop-down list. The list of UMT users for the selected sponsor company is displayed.

Note:
To create a user for all sponsors, select All from the drop-down list.

3. Click the Create UMT User link. The Create UMT User Details page is displayed.

4. Enter the user details and assign a role for the user.
For more details on how to create UMT users, see Section A.34.

Note:
To override, click OK in the dialog box that appears. Click Cancel to change the email address.

5. Click Submit to save the user details.

6. To save the current user details and create another UMT user, click Submit and Add Another.

7. To discard the changes, click Return.
On successful creation of the UMT user, the user name and temporary password are sent to the email address specified on the Create UMT User Details page.

3.3.3 Viewing and Modifying UMT User Details

The UMT User Details page lets you view and modify UMT user details. If the user details are modified, the reason for change is captured, and the changes are tracked and audited. You can view the changes made to a particular field by viewing its corresponding audit trails.

To view and modify UMT user details:

1. Select Users from the menu bar. On the page that appears, click the UMT Users link.

2. On the UMT Users page, select the sponsor company from the Current Sponsor Company drop-down list. The list of UMT users for the selected sponsor company is displayed.

3. Click the user name link. The UMT User Details page is displayed, which shows the details for the selected user.

4. Modify the user details.
For more details on how to modify UMT user details, see Section A.34.

Note:
If the sponsor company in the Current Sponsor Company drop-down list is changed to another sponsor company, the UMT Users page is displayed.

5. Enter the reason for modifying the user details in the Reason for Change text box and click Submit.

6. To cancel the changes made to the UMT user details, click Return.

7. To view the list of audit trails for a particular field, click the corresponding icon.

3.3.4 Activating UMT Users

The UMT Users page also lets you activate UMT users.

To activate UMT users:

1. Select Users from the menu bar. On the page that appears, click the UMT Users link.

2. On the UMT Users page, select the sponsor company from the Current Sponsor Company drop-down list. The list of UMT users for the selected sponsor company is displayed.

3. Select the check box corresponding to the user you want to activate or inactivate.

4. Select Activate from the Select drop-down list and enter the reason for activating the user in the Comments text box. Click Go.

5. Click OK on the dialog box that appears on successful activation of the UMT user.

Note:
The status for the selected user changes based on the action performed.

3.3.5 Terminating UMT Users

The UMT Users page lets you terminate UMT users. You can also view the list of terminated users.

To terminate UMT users:

1. Select Users from the menu bar. On the page that appears, click the UMT Users link.

2. On the UMT Users page, select the sponsor company from the Current Sponsor Company drop-down list. The list of UMT users for the selected sponsor company is displayed.

3. Select the check box corresponding to the user you want to terminate.

4. Select Terminate from the Select drop-down list.

5. Enter the reason for terminating the user in the Comments text box and click Go.

6. On the confirmation dialog box that appears, click OK to terminate the selected UMT user.

Note:
To cancel termination of the UMT user, click Cancel.

7. Click OK on the dialog box that appears on successful termination of the UMT user.

3.3.6 Viewing Terminated UMT Users

The Terminated User List page displays the list of terminated UMT users. You can view the user name, first name, last name, and country of the terminated users.

To view terminated UMT users:

1. Select Users from the menu bar. On the page that appears, click the UMT Users link.

2. On the UMT Users page, select the sponsor company from the Current Sponsor Company drop-down list. The list of UMT users for the selected sponsor company is displayed.

3. Click the Terminated User List link. The list of terminated users is displayed.

Note:
To go back to the previous page, click Return.

3.3.7 Unterminating UMT Users

The Terminated User List page lets you revoke the termination of UMT users. You can either revoke the termination of all users or a particular user.

To unterminate UMT users:

1. Select Users from the menu bar. On the page that appears, click the UMT Users link.

2. On the UMT Users page, select the sponsor company from the Current Sponsor Company drop-down list. The list of UMT users for the selected sponsor company is displayed.

3. Click the Terminated User List link. The Terminated User List page is displayed.

4. Select the check box corresponding to the user you want to revoke the termination and click Unterminate.

5. Click OK on the dialog box that appears on revoking the termination of the UMT user.

Note:
To go back to the previous page, click Return.

3.3.8 Resetting the Password for UMT Users

The login password for an UMT user can be reset in case the password is blocked or expired.

To reset password for UMT users:

1. Select Users from the menu bar. On the page that appears, click the UMT Users link.

2. On the UMT Users page, select the sponsor company from the Current Sponsor Company drop-down list. The list of UMT users for the selected sponsor company is displayed.

3. Select the check box corresponding to the user you want to reset the password.

4. Select Reset Password from the Select drop-down list.

5. Enter the reason for resetting the password in the Comments text box.

6. Click Go. Click OK on the dialog box that appears.

3.3.9 Resending UMT Login Details

The UMT Users page also lets you resend UMT login details to a user.

To resend login details of UMT users:

1. Select Users from the menu bar. On the page that appears, click the UMT Users link.

2. On the UMT Users page, select the sponsor company from the Current Sponsor Company drop-down list. The list of UMT users for the selected sponsor company is displayed.

3. Select the check box corresponding to the user whose login details you want to resend.

4. Select Resend UMT Login Details from the Select drop-down list.

5. Enter the reason for resending the details in the Comments text box.

6. Click Go.

7. Click OK on the dialog box that appears.

3.4 Oracle Users

This section contains the following topics:

- Section 3.4.1, "Viewing the List of Oracle Users"

- Section 3.4.2, "Creating Oracle Users"

- Section 3.4.3, "Viewing and Modifying Oracle User Details"

3.4.1 Viewing the List of Oracle Users

The Oracle Users page lets you view the list of Oracle users and their details. This page also lets you filter Oracle users based on the filter criteria.

To view the list of Oracle users:

1. Select Users from the menu bar. On the page that appears, click the Oracle Users link.

2. Set the Current Sponsor Company and Trial drop-down lists to Select by default.
The list of Oracle users is displayed on the Oracle Users page.

3. To filter users, enter the filter criteria and click Find. The list of Oracle users that satisfy the specified filter criteria is displayed. For more details on how to filter and view Oracle users, see Section A.64.

Note:
While specifying the filter criteria, you can either use the full name or part of the name.

4. To clear the filter criteria, click Clear.

Note:
To navigate through the user list, click the First, Previous, Next, or Last links.
To view a particular page, select the page from the drop-down list.

To view all the users on a single page, select All from the drop-down list.

Click the column name link to sort the users either in the ascending or descending order, based on the column name. On the first click, the users are sorted in the ascending order. To sort the users in descending order, click the column name link again.

Oracle users having Modify Oracle Rights can approve or reject users on the Oracle Users list page.

Select Mark upload to InForm from the action item drop-down list. The Sponsor and Trial drop-down lists are displayed.

- Set sponsor and trial to All for the user to be associated with all sponsors and trials.

- Set trial to All for the user to be associated with all trials of the selected sponsor.

- Select a sponsor and trial for the user to be associated with only that trial and sponsor.

Use the + icon for associating a site with each user record. The site association popup is displayed on the basis of the site selected.

You can download the Excel template.

3.4.2 Creating Oracle Users

The Create Oracle User page lets you create an Oracle user. To create an Oracle user, you must have the Create Oracle User rights. You can create only Oracle user type users.

To create Oracle users:

1. Select Users from the menu bar. On the page that appears, click the Oracle Users link.

2. Set the Current Sponsor Company and Trial drop-down lists to Select by default.
The list of Oracle users is displayed on the Oracle Users page.

3. Click the Create Oracle User link. The Create Oracle User Details page is displayed.

4. Enter the Oracle user's details.
For more details on how to create Oracle users, see Section A.40.

5. On the Create Oracle User Details page, associate the user with a sponsor and trial.

- To associate a user with all sponsors and trials, select All from the Select Sponsor and Select Trial drop-down lists.

- To associate a user with one sponsor and all trials, select the sponsor from the Select Sponsor drop-down list, and select All from the Select Trial drop-down list.

- To associate a user with all sponsors and one trial, select All from the Select Sponsor drop-down list, and select a trial from the Select Trial drop-down list.

Note:
To save the current Oracle user details and create another Oracle user, click Submit and Add Another.
To discard the changes, click Return.

3.4.3 Viewing and Modifying Oracle User Details

The PF User Edit page lets you view and modify the PF user details. If the user details are modified, the reason for change is captured and the changes are tracked and audited. You can view the changes made to a particular field by viewing its corresponding audit trails.

To view and modify PF user details:

1. Select Users from the menu. On that page, click the Oracle Users link. The list of Oracle Users is displayed.

Note:
The Sponsor and Trial drop-down lists should be set by default to Select.

2. Click the required username link in the grid. The Edit Oracle User Details page appears that displays the user details for the selected user.

3. Modify the user details as required.
For more details on how to create Oracle users, see Section A.40.

4. Enter the reason for modifying the user details in the Reason for change text box and click Submit.

5. On the Edit Oracle User Details page, associate the user to sponsor and trial.

- If sponsor and trial are set to All, the user is associated with all sponsors and trials.

- If trial is set to All and one sponsor is selected, the user is associated with all trials of the selected sponsor.

- If one sponsor and trial are selected, the user is associated only with that selected trial and sponsor.

Note:
To cancel the changes made to the user details, click Return.
To view the list of audit trails for a particular field, click the corresponding icon.

3.5 Global Users

A Global user is a user managed by Oracle Identity Management suite. You can assign Global user to multiple InForm trials and applications within a sponsor or a CRO. A Global user that has access to applications for multiple sponsors or CROs will have a unique identity per sponsor or CRO. You can update the Global users' details, assign them to trials, or globally de-provision.

This section contains the following topics:

- Section 3.5.1, "Viewing the List of Global Users"

- Section 3.5.2, "Creating Global Users"

- Section 3.5.3, "Assigning a Product"

- Section 3.5.4, "Viewing and Modifying Global User Details"

- Section 3.5.5, "Terminating a Global User"

- Section 3.5.6, "Viewing the Terminated User List"

- Section 3.5.7, "Unterminating Global Users"

Note:
Global Users feature is enabled only if Switchoff Global User option (on the Configuration Settings page) is not selected.

3.5.1 Viewing the List of Global Users

The Global Users page lets you view the list of Global users and their details. It lets you filter the Global users based on the filter criteria. You can also associate the product to the user here.

To view the list of Global users:

1. Select Users from the menu bar. On the page that appears, click the Global Users link.

2. On the Global Users page, select the sponsor company from the Current Sponsor Company drop-down list. The list of Global users for the selected sponsor company is displayed.

3. To filter users, enter the filter criteria and click Find. The list of Global users that satisfy the specified filter criteria is displayed.
For more details on how to filter and view Global Users, see Section A.5.

Note:
To clear the filter criteria, click Clear.
While specifying the filter criteria, you can either use the full name or the first few letters of the name.

To navigate through the user list, click the First, Previous, Next, or Last links.

To view a particular page, select the page from the drop-down list.

To view all the users on a single page, select All from the drop-down list.

Click the column name link to sort the Global users either in the ascending or descending order, based on the column name. On the first click, the users are sorted in the ascending order. If you want to sort the users in descending order, click the column name link again.

A new link Import on Global User List page is displayed. On clicking this menu, a new page Import is available.

You can download the Excel template and use it to perform bulk import of Global Users.

3.5.2 Creating Global Users

The Create Global User page lets you create a global user. To create a global user, you must have the Manage Global User rights. You can create two types of global users, that is site users and sponsor users.

To create Global users:

1. Select Users from the menu bar.

2. On the Global Users page, select the sponsor company from the Current Sponsor Company drop-down list.

3. Click the Global Users link. The list of users for the selected sponsor company is displayed.

4. Click the Create Global User link. The Create Global User page is displayed.

5. Enter the global user details.
For more details on how to create Global Users, see Section A.6.

6. To save the current Global User details and create another, click Submit and Add Another.

Note:
To create a Global User, the values entered in the UserName, First Name, Last Name, and E-mail ID fields must be unique.

- If you try creating a Global user with duplicate values in the First Name, Last Name, User Name, or Email Address fields, an error message User already exists is displayed and the user is not created.

- If you try creating a Global user with duplicate values in the First Name, Last Name, and Email ID fields, with a different User Name, an error message First Name, Last Name and Email ID combination already exists in the sponsor is displayed and the user is not created.

To discard the changes, click Return.

3.5.3 Assigning a Product

The Assign Product action item on Global Users page lets you assign global users to a product.

To assign global users to a product:

1. Select Users from the menu bar. On the page that appears, click the Global User link.

2. On the Global Users page, select the sponsor company from the Current Sponsor Company drop-down list. The list of Global Users for the selected sponsor company is displayed.

3. Select the check boxes corresponding to the user you want to assign a product and click Assign Product.

4. Select the product type from the Product drop-down list.

5. Select the trial version from the Trial Version drop-down list that appears.

6. Select the trial from the Trial drop-down list that appears.
The trial gets populated based on the selected trial version and product. On selecting the trial, the user information associated with that trial is displayed.

Note:
You can add new users to the selected product and can also edit existing users.
IRT roles are displayed on selecting only the IRT trial.

InForm roles are displayed on selecting only InForm trial.

Both IRT and InForm roles are displayed for joint IRT and InForm trials.

7. Select the InForm Role, IRT Role, User name in Email Notification, Preferred study locale, Product Locale, Load To InForm, and Load To IRT details from their respective drop-down lists.

8. To associate a site with a user:

1. Click the + icon. The site association list based on the trial selected is displayed.

2. Select the site you want to associate with a user and use the navigational keys to the Selected text box.

3. Click Save and click OK on the confirmation dialog box.

9. Enter the reasons in the Comments text box and click Submit.

10. Click OK on the confirmation dialog box that appears.

11. Click Return to go back to the Global Users page.

3.5.4 Viewing and Modifying Global User Details

The Global User page lets you view and modify Global user details. If the user details are modified, the reason for change is captured and the changes are tracked and audited. You can view the changes made to a particular field by viewing its corresponding audit trails.

To view and modify Global user details:

1. Select Users from the menu bar. Select the sponsor company and click the Global Users tab. The list of Global users for that selected sponsor company is displayed.

2. Click the Username link in the grid. The Global User Details page is displayed, which shows the user details for the selected user.

3. Modify the user details.
For more details on how to filter and view Global Users, see Section A.7.

On changing the current sponsor company in the drop-down list, the users belonging to that sponsor are displayed.

4. Enter the reason for modifying the user details in the Reason for Change text box and click Submit.
When editing a Global user, ensure the User Name, First Name, Last Name, and E-mail ID are unique.

Note:
If a user is assigned to trials and the Global User record is modified, the changes are reflected across all trials the user is associated to.

Note:
If you try to edit a Global user record with already existing First Name, Last Name, Email ID and User Name, an error message User already exists is displayed on clicking Submit.
If you try to edit a Global user record with an already existing First Name, Last Name, and Email ID, which already exists but with a different User Name, an error message First Name, Last Name and Email Id combination already exists in the sponsor is displayed on clicking Submit.

If you try to edit a Global user record with a different First Name, Last Name, and Email ID, but with an existing User Name, an error message User Name already Exists is displayed on clicking Submit.

5. To cancel the changes made to the user details, click Return.

6. To view the list of audit trails for a particular field, click the corresponding icon.

3.5.5 Terminating a Global User

The Global Users page lets you terminate a global user.

Note:
Terminating a Global User will terminate the user across all products the user is assigned to.

To terminate a global user:

1. Select Users from the menu bar. On the page that appears, click the Global User link.

2. On the Global Users page, select the sponsor company from the Current Sponsor Company drop-down list. The list of Global Users for the selected sponsor company is displayed.

3. Select the check boxes corresponding to the user you want to terminate and select Terminate User from the Select drop-down list.

4. Enter the reasons in the Comments text box and click Submit.

5. Click OK on the confirmation dialog box that appears.

3.5.6 Viewing the Terminated User List

The Terminated User List page displays the list of terminated global users. You can view the user name, first name, last name, country, and email address of the terminated users.

To view terminated Global users:

1. Select Users from the menu bar. The Global Users page is displayed.

2. Select the sponsor company from the Current Sponsor Company drop-down list. The list of Global users for the selected sponsor company is displayed.

3. Click the Terminated User List link. The Global User Terminated List page is displayed, which shows the list of terminated users.

4. To go back to the previous page, click Return.

3.5.7 Unterminating Global Users

The Terminated User List page lets you revoke the termination of Global users. You can either revoke the termination of all users or a particular user.

To unterminate Global users:

1. Select Users from the menu bar. The Global Users page is displayed.

2. Select the sponsor company from the Current Sponsor Company drop-down list. The list of Global users for the selected sponsor company is displayed.

3. Click the Terminated User List link. The Global User Terminated List page is displayed.

4. Select the check box corresponding to the user whose termination you want to revoke and click Unterminate.

5. Click OK in the dialog box that appears on revoking the termination of the InForm user.

6. To go back to the previous page, click Back.

3.6 Merging Duplicate Users

You may have the same user registered with a different user name for a different trial under the same sponsor. This results in many duplicate users. The Merge Duplicate Users page lets you merge these duplicate users under one master user. After you select one record as the master user, the others are automatically terminated.

To view and merge duplicate users:

1. Select Users from the menu bar. On the page that appears, select the sponsor company from the Current Sponsor Company drop-down list.

2. Click Merge Duplicate Users.

3. To filter duplicate users, enter the filter criteria and click Find. The list of users that satisfy the specified filter criteria is displayed.

4. Select the check boxes corresponding to the users you want to merge and click Merge.

5. The Merge Duplicate users page is displayed.

6. Select the record you want as the Master User.

7. Select the check boxes corresponding to the users you want to merge. Select Merge Selected Users from the Select drop-down list.

8. Enter the reasons for change in the Comments text box. Click Save to merge the changes.

9. Click OK on the dialog box that appears on successfully merging the duplicate records.

10. Click Return to go back to the Merge Duplicate Users page.

Note:
Click Group Duplicate Users to display possible duplicate users without entering any filter criteria.

3.7 Linking Users

The Link Users functionality also lets you manage duplicate users by linking one or more users with similar details. However, after the linking process is complete, the remaining users are not automatically terminated.

To view and link duplicate users:

1. Select Users from the menu bar. On the page that appears, select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists.

2. Click Link Users.

3. The list of users that satisfy the specified linking criteria is displayed.

4. Click the Link User link corresponding to the user you want to link to another user. The Updating Link Users page is displayed.

5. Select the check boxes corresponding to the user you want to link the selected user to and enter the reasons for change in the Comments text-box.

6. Click Update to link the users.

7. Click OK on the dialog box that appears on successfully linking the duplicate users.

8. Click Return to go back to the Link Users page.

4 Managing Trials

This chapter contains the following sections:

- Section 4.1, "Viewing the List of Trials"

- Section 4.2, "Creating Trials"

- Section 4.3, "Viewing and Modifying Trial Details"

- Section 4.4, "Viewing and Resolving Duplicate Items"

- Section 4.5, "Bulk Copying"

- Section 4.6, "Selective Copying"

- Section 4.7, "Archiving Trials"

- Section 4.8, "Viewing Archived Trials"

- Section 4.9, "Exporting Trial Details"

- Section 4.10, "Exporting Trials"

- Section 4.11, "Importing Trials"

- Section 4.12, "Generating InForm XML"

4.1 Viewing the List of Trials

The List of Trials page lets you view the list of trials and their details. It also lets you filter the trials based on the filter criteria.

To view the list of trials:

1. Select Trials from the menu bar. The List of Trials page is displayed.

2. Select the sponsor company from the Current Sponsor Company drop-down list. The list of trials for the selected sponsor company is displayed.

3. To filter trials, enter the filter criteria in the filter section and click Find. The list of trials that satisfy the specified filter criteria is displayed.
When you specify the filter criteria, you can use the full name or part of the name.

For more details on how to filter and view trials, see Section A.66.

4. To clear the filter criteria, click Clear.

Note:
To navigate through the trial list, click the First, Previous, Next, or Last links.
To view a particular page, select the page from the drop-down list.

To view all the trials on a single page, select All from the drop-down list.

Click the column name link to sort the trials in the ascending or descending order, based on the column name. On the first click, the trials are sorted in the ascending order. To sort the trials in descending order, click the column name link again.

4.2 Creating Trials

The Create Trial Details page lets you create a main trial, training trial, and UAT trial. Enter the trial and association details to create a trial. You can also copy the sites, roles, groups, and configuration settings from another trial. You cannot create production trials.

To create trials:

1. Select Trials from the menu bar. The List of Trials page is displayed.

2. Select the sponsor company from the Current Sponsor Company drop-down list. The list of trials for the selected sponsor company is displayed.

3. Click the Create Trial link. The Create Trial Details page is displayed.

4. Enter the trial details.
For more details on how to create trials, see Section A.41.

5. To copy the details of an existing trial, click Copy From. In the confirmation dialog box that appears, click OK to continue. In the pop-up window that appears, select the sites, roles, groups, users, and configuration that you want to copy and click Copy.

6. Click Submit to save the trial details.

Note:
To save the current trial details and create another trial, click Submit and Add Another.
To discard the changes, click Cancel.

4.3 Viewing and Modifying Trial Details

The Trial Details page lets you view and modify the trial details. If the trial details are modified, the reason for change is captured and the changes are tracked and audited. You can view the changes made to a particular field by viewing its corresponding audit trails.

To view and modify trial details:

1. Select Trials from the menu bar. The List of Trials page is displayed.

2. Select the sponsor company from the Current Sponsor Company drop-down list. The list of trials for the selected sponsor company is displayed.

3. Click the trial name link in the grid. The Trial Details page is displayed, which shows the selected trial details.

4. Modify the trial details.
For more details on how to modify trial details, see Section A.41.

Note:
If you modify the current sponsor company displayed in the Current Sponsor Company drop-down list, the List of Trials page is displayed.

5. Enter the reason for modifying the trial details in the Reason for Change text box and click Save.

6. To cancel the changes made to the trial details, click Cancel.

7. To view the list of audit trails for a particular field, click the corresponding icon.

4.4 Viewing and Resolving Duplicate Items

When you import trials, records or trial items may be duplicated. The List of Duplicate Items page displays the list of duplicate items and lets you resolve the duplicate trial items.

To view and resolve duplicate items:

1. Select Trials from the menu bar. The List of Trials page is displayed.

2. Select the sponsor company from the Current Sponsor Company drop-down list. The list of trials for the selected sponsor company is displayed.

3. Click the icon corresponding to a trial.
The List of Duplicate Items page is displayed, which shows the list of duplicate trial items.

4. Select the check box corresponding to the item you want to resolve and click Resolve.

5. On the confirmation dialog box that appears, select OK. All unchecked items are deleted.

4.5 Bulk Copying

You can copy all or selected modules entirely (such as sites, users, and so on) from a trial to another.

To bulk copy trial details:

1. Select Trials from the menu bar. The List of Trials page is displayed.

2. Select the sponsor company from the Current Sponsor Company drop-down list. The list of trials for the selected sponsor company is displayed.

3. Click the icon corresponding to a trial.

4. On the page that appears, click the Bulk Copy link. The Bulk Copy page is displayed.
For more details on selective trials copy, see Section A.22.

5. Select the source trial from the Source Trial drop-down list.

6. Select the check boxes of the modules you want to copy.

7. Click Submit to create a copy of the trial.

4.6 Selective Copying

You can selectively copy trial details from a module onto another trial.

To copy selective trial details:

1. Select Trials from the menu bar. The List of Trials page is displayed.

2. Select the sponsor company from the Current Sponsor Company drop-down list. The list of trials for the selected sponsor company is displayed.

3. Click the icon corresponding to a trial. The Selective Copy page is displayed.

4. Select the source trial and type of detail from the Source Trial and Select Type drop-down lists. The Selective Copy page displays the details according to the selected type in the Available text box.
For more details on selective trials copy, see Section A.29.

Note:
Depending on the details type you select from the Select Type drop-down list, the User Management Tool gives you an option to copy additional details. For instance, if you select Roles, you can copy the details of all associated sponsor users and associated site users, in addition to the regular details of the roles.

5. Use >> or > to move all or selected details to the Selected field.

Note:
Press and hold the Ctrl key to select multiple choices.
Use the << or < button to move all or selected details back to the Available field.

6. Click Submit to create a copy of the trial.

4.7 Archiving Trials

The Archive option available on the List of Trials page lets you archive inactive trials.

To archive trials:

1. Select Trials from the menu bar. The List of Trials page is displayed.

2. Select the sponsor company from the Current Sponsor Company drop-down list. The list of trials for the selected sponsor company is displayed.

3. Select the check box corresponding to the trial you want to archive.

4. Select Archive from the Select drop-down list.

5. Enter the reason for archival in the Comments text box and click Go.

6. To view the archived sponsors, click the View Archive of Trials link.

4.8 Viewing Archived Trials

The List of Archived Trials page lets you view the archived trials. You can view the trial name, reference, protocol number, therapeutic area, and status. This page also displays the date and time of archival.

To view archived trials:

1. Select Trials from the menu bar. The List of Trials page is displayed.

2. Select the sponsor company from the Current Sponsor Company drop-down list. The list of trials for the selected sponsor company is displayed.

3. Click the Archived Trials link. The List of Archived Trials page is displayed, which shows the list of archived trials.
For more details on archived trials, see Section A.67.

Note:
To navigate through the trial list, click the First, Previous, Next, or Last links.
To view a particular page, select the page from the drop-down list.

To view all the trials on a single page, select All from the drop-down list.

Click the column name link to sort the trials in the ascending or descending order, based on the column name. On the first click, the trials are sorted in the ascending order. To sort the trials in descending order, click the column name link again.

To go back to the list of trials, click Back.

4.9 Exporting Trial Details

The Export to Excel and Export to File links available on the List of Trials page let you export trial details. You can export the trial details either to an Excel spreadsheet or to a flat file.

To export trial details:

1. Select Trials from the menu bar. The List of Trials page is displayed.

2. Select the sponsor company from the Current Sponsor Company drop-down list. The list of trials for the selected sponsor company is displayed.

3. Select the check box corresponding to the trial you want to export.

4. Click the Export to Excel or Export to File link. On the dialog box that appears, click Open to open the file or click Save to save the file.

4.10 Exporting Trials

Clicking Export on the List of Trials page lets you export trials and their associated sites, site users, sponsor users, roles, and groups.

To export trials:

1. Select Trials from the menu bar. The List of Trials page is displayed.

2. Select the sponsor company from the Current Sponsor Company drop-down list. The list of trials for the selected sponsor company is displayed.

3. Click Export. The Export page is displayed.

4. Select the trial name from the Trial Name drop-down list.

5. Select the modules to be exported by clicking the corresponding check boxes.

6. Click the Export to Excel or Export to File links to export the file to an Excel spreadsheet or to a flat file or Export IRT CSV (which exports only the IRT trial in CSV format).

7. To cancel the export, click Return.

4.11 Importing Trials

Clicking Import on the List of Trials page lets you import trial details and their associated sites, site users, sponsor users, roles, and groups. This facility is available only to users having the Import Data right.

To import trials:

1. Select Trials from the menu bar. The List of Trials page is displayed.

2. Select the sponsor company from the Current Sponsor Company drop-down list. The list of trials for the selected sponsor company is displayed.

3. Click Import. The Import page is displayed.

4. Enter the path of the file in the Filename text box or click Browse to select the path of the file.

Note:
The selected path is copied in the Filename text box.

5. Select the trial name from the Trial Name drop-down list.

6. Select the modules to be imported by clicking the corresponding check boxes.

7. Select the import template from the Excel Template For All Products and Version drop-down list.

Note:
Composite Template is the default import template.

8. Click Validate and Import.

9. To cancel import, click Cancel.

For Import Error Information and Trouble shooting, see Section A.47.

4.12 Generating InForm XML

You can export the details of a trial to an XML file. However, you can export the details of only one trial to an XML file at a time.

To generate InForm XML:

1. Select Trials from the menu bar. The List of Trials page is displayed.

2. Select the sponsor company from the Current Sponsor Company drop-down list. The list of trials for the selected sponsor company is displayed.

3. Select the check box corresponding to the trial you want to generate.

4. Click the Generate InFormXML link. On the dialog box that appears, click Open to open the file or click Save to save the file.

5 Managing Sites

This chapter contains the following topics:

- Section 5.1, "Viewing the List of Sites"

- Section 5.2, "Creating Sites"

- Section 5.3, "Viewing and Modifying Site Details"

- Section 5.4, "Approving or Rejecting Sites"

- Section 5.5, "Marking Sites as Uploaded to InForm"

- Section 5.6, "Marking Sites as Not Participating"

- Section 5.7, "Viewing Not Participating Sites"

- Section 5.8, "Marking a Not Participating Site as Participating"

- Section 5.9, "Assigning or Updating the Study Version"

- Section 5.10, "Exporting Sites"

- Section 5.11, "Marking Upload to IRT"

- Section 5.12, "Updating Assessment Status for a Site"

- Section 5.13, "Sending Assessment Email"

- Section 5.14, "Stopping Assessment Process"

- Section 5.15, "Assigning Preferred Study Locale"

5.1 Viewing the List of Sites

The List of Sites page lets you view the list of sites and site details. This page also lets you filter the sites based on the filter criteria.

To view the list of sites:

1. Select Sites from the menu bar. The List of Sites page is displayed.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of sites for the selected sponsor company and trial is displayed.

3. To filter the sites, enter the filter criteria in the filter section and click Find. The list of sites that satisfy the specified filter criteria is displayed.
While specifying filter criteria, you can use the full name or part of the name.

For more details on how to filter and view sites, see Section A.31.

4. To clear the filter criteria, click Clear.

Note:
To navigate through the site list, click the First, Previous, Next, or Last links.
To view a particular page, select the page from the drop-down list.

To view all the sites on a single page, select All from the drop-down list.

Click the column name link to sort the sites in the ascending or descending order, based on the column name. On the first click, the sites are sorted in the ascending order. To sort the sites in descending order, click the column name link again.

5.2 Creating Sites

The Create Site Details page lets you create sites. Enter the site and user association details to create a new site.

To create sites:

1. Select Sites from the menu bar. The List of Sites page is displayed.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of sites for the selected sponsor company and trial is displayed.

3. Click the Create Site link. The Create Site Details page is displayed.

4. Enter the site and user association details.
For more details on how to create sites, see Section A.45.

5. Click Submit to save the details.

6. To save the current site details and create another site, click Submit and Add Another.

7. To discard the changes, click Return.

5.3 Viewing and Modifying Site Details

The Site Details page lets you view and modify site details. When the site details are modified, the reason for change is captured and the changes are tracked and audited. You can view the changes made to a particular field by viewing its corresponding audit trail.

To view and modify site details:

1. Select Sites from the menu bar. The List of Sites page is displayed.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of sites for the selected sponsor company and trial is displayed.

3. Click the site name link. The Site Details page is displayed, which shows the selected site details.

4. Modify the site details.
For more details on how to modify site details, see Section A.46.

Note:
If you modify the current sponsor company or the trial displayed in the Current Sponsor Company and Trial drop-down lists, the List of Sites page is displayed.

5. Enter the reason for modifying the site details in the Reason for Change text box and click Submit.

6. To cancel the changes made to the site details, click Return.

7. To view the list of audit trails for a particular field, click the corresponding icon.

5.4 Approving or Rejecting Sites

The List of Sites page lets you approve and reject sites. A site must be approved before you carry out any clinical trials. Once you approve a site, you cannot approve it again unless the site details are modified. You can approve or reject sites depending on your access rights.

To approve or reject sites:

1. Select Sites from the menu bar. The List of Sites page is displayed.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of sites for the selected sponsor company and trial is displayed.

3. Select the check box corresponding to the site you want to approve or reject.

4. Select Approve or Reject from the Select drop-down list. If you select Reject, enter the reason for rejection in the Comments text box.

5. Click Go.

6. If you select Approve, the Electronic Signature Affidavit page is displayed. Enter your password and click Submit. To cancel approval, click Cancel.

The Status for the selected site changes based on the action performed.

5.5 Marking Sites as Uploaded to InForm

Site information is uploaded to the InForm system if the applicable sites are marked as Uploaded to InForm in UMT.

To mark a site as uploaded to InForm:

1. Select Sites from the menu bar. The List of Sites page is displayed.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of sites for the selected sponsor company and trial is displayed.

Note:
You can also search for the site you want to mark by specifying at least one search criteria.

3. Select the check box corresponding to the site you want to mark as uploaded to InForm.

4. Select Mark Upload to InForm from the Select drop-down list.

5. Enter the reasons in the Comments text box and click Go.

6. Click OK on the confirmation dialog box.

5.6 Marking Sites as Not Participating

Sites which no longer participate in a study can be marked as not participating, making them inactive in the study. The site user accounts associated only with the non-participating site are marked as terminated.

To mark sites as non-participating:

1. Select Sites from the menu bar. The List of Sites page is displayed.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of sites for the selected sponsor company and trial is displayed.

Note:
You can also search for the site you want to mark by specifying at least one search criteria.

3. Select the check box corresponding to the site you want to mark as non participating.

4. Select Mark as Not Participating from the Select drop-down list and enter your comments in the Comments text box.

5. Click Go.

6. Click OK on the confirmation dialog box.

5.7 Viewing Not Participating Sites

You can view the list of not participating sites under the trial of a sponsor company.

To view not participating sites:

1. Select Sites from the menu bar. The List of Sites page is displayed.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of sites for the selected sponsor company and trial is displayed.

3. Click the View Not Participating Sites link. The List of Not Participating Sites page appears.

4. The list of not participating sites for the selected sponsor company and trial is displayed.

Note:
To view not participating sites from a different trial of the same sponsor company, select the trial from the Trial drop-down list.
To view not participating sites for a different sponsor company, select the sponsor company and the trial from the Current Sponsor Company and Trial lists.

To view the list of sites again, click Back.

5.8 Marking a Not Participating Site as Participating

You can mark a not participating site as participating again. Users associated with such sites are no longer considered terminated.

To mark a not participating site as participating:

1. Open the list of not participating sites.
The List of Not Participating Sites page is displayed.

2. Select the check box corresponding to the site you want to mark as participating.

3. Click Mark as Participating.

4. Click OK on the confirmation dialog box.

5.9 Assigning or Updating the Study Version

You can assign a study version to a site or update the study version after you have modified a site.

To assign or update study version:

1. Select Sites from the menu bar. The List of Sites page is displayed.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of sites for the selected sponsor company and trial is displayed.

Note:
You can also search for the site whose study version you want to update by specifying at least one search criteria.

3. Select the check box corresponding to the site you want to mark as assigned or update study version.

4. Select Assign study version from the Select drop-down list.

5. Select the version from the study version drop-down list.

6. Enter the reasons in the Comments text box and click Go.

7. Click OK on the confirmation dialog box.

5.10 Exporting Sites

The Export to Excel and Export to File links available on the List of Sites page let you export site details to an Excel spreadsheet or a flat file.

To export sites:

1. Select Sites from the menu bar. The List of Sites page is displayed.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of sites for the selected sponsor company and trial is displayed.

3. Select the check box corresponding to the site you want to export.

4. Click the Export to Excel or Export to File link.

5. On the dialog box that appears, click Open to open the file or click Save to save the file.

5.11 Marking Upload to IRT

The List of Sites page lets you mark sites as uploaded to IRT.

To mark a site as uploaded to IRT:

1. Select Sites from the menu bar. The List of Sites page is displayed.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of sites for the selected sponsor company and trial is displayed.

Note:
You can also search for the site you want to mark by specifying at least one search criteria.

3. Select the check box corresponding to the site you want to mark as uploaded to IRT.

4. Select Mark Upload to IRT from the Select drop-down list.

5. Click Go.

6. Click OK on the confirmation dialog box.

5.12 Updating Assessment Status for a Site

The List of Sites page also lets you update the assessment status for a site.

To update the assessment status for a site:

1. Select Sites from the menu bar. The List of Sites page is displayed.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of sites for the selected sponsor company and trial is displayed.

Note:
You can also search for the site you want to mark by specifying at least one search criteria.

3. Select the check box corresponding to the site whose assessment status you want to update.

4. Select Update Assessment Status from the Select drop-down list.

5. Enter the reasons in the Comments text box and click Go.

6. Click OK on the confirmation dialog box.

5.13 Sending Assessment Email

The List of Sites page lets you send an assessment email for a site.

To send an assessment email for a site:

1. Select Sites from the menu bar. The List of Sites page is displayed.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of sites for the selected sponsor company and trial is displayed.

Note:
You can also search for the site you want to mark by specifying at least one search criteria.

3. Select the check box corresponding to the site for which you want to send an assessment email.

4. Select Send Assessment Email from the Select drop-down list.

5. Enter the reasons in the Comments text box and click Go.

6. Click OK on the confirmation dialog box.

5.14 Stopping Assessment Process

The List of Sites page lets you stop the assessment process for a site.

To stop the assessment process for a site:

1. Select Sites from the menu bar. The List of Sites page is displayed.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of sites for the selected sponsor company and trial is displayed.

Note:
You can also search for the site you want to mark by specifying at least one search criteria.

3. Select the check box corresponding to the site for which you want to stop the assessment process.

4. Select Stop Assessment Process from the Select drop-down list.

5. Enter the reasons in the Comments text box and click Go.

6. Click OK on the confirmation dialog box.

5.15 Assigning Preferred Study Locale

The List of Sites page lets you assign a preferred study locale for a site.

To assign a preferred study locale for a site:

1. Select Sites from the menu bar. The List of Sites page is displayed.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of sites for the selected sponsor company and trial is displayed.

Note:
You can also search for the site you want to mark by specifying at least one search criteria.

3. Select the check box corresponding to the site for which you want to assign a preferred study locale.

4. Select Assign Preferred Study Locale from the Select drop-down list.

5. Enter the reasons in the Comments text box and click Go.

6. Click OK on the confirmation dialog box.

6 Managing Roles

This chapter contains the following topics:

- Section 6.1, "Managing InForm Roles"

- Section 6.2, "Managing UMT Roles"

- Section 6.3, "Managing IRT Roles"

6.1 Managing InForm Roles

This section describes the following:

- Section 6.1.1, "Viewing the List of InForm Roles"

- Section 6.1.2, "Creating InForm Roles"

- Section 6.1.3, "Viewing and Modifying InForm Role Details"

- Section 6.1.4, "Viewing and Modifying InForm User-Role Associations"

- Section 6.1.5, "Setting the Display Override Option"

- Section 6.1.6, "Approving or Rejecting InForm Roles"

- Section 6.1.7, "Transferring InForm Roles"

6.1.1 Viewing the List of InForm Roles

The InForm Roles page lets you view the list of InForm roles and its details. It also lets you filter roles based on the filter criteria.

To view the list of InForm roles:

1. Select Roles from the menu bar. The InForm Roles page is displayed.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm roles for the selected sponsor company and trial is displayed.

Note:
The trial selected must be an InForm trial else the InForm users tab is not displayed.

3. To filter roles, enter the filter criteria and click Find. The list of InForm roles that satisfy the specified filter criteria is displayed.
To specify the filter criteria, use the full name or the first few letters of the name.

For more details on how to filter and view InForm roles, see Section A.8.

4. To clear the filter criteria, click Clear.

Note:
To navigate through the InForm roles list, click the First, Previous, Next, or Last links.
To view a particular page, select the page from the drop-down list.

To view all the InForm roles on a single page, select All from the drop-down list.

Click the column name link to sort the InForm roles in the ascending or descending order, based on the column name. On the first click, the InForm roles are sorted in the ascending order. To sort the InForm roles in descending order, click the column name link again.

6.1.2 Creating InForm Roles

The Create InForm Role page lets you create a role and assign rights under various categories such as User administration, CRF rights, Case Book rights, Query rights, Rule rights, and System Administration rights. You can assign the roles to each user, which defines the access level of the account to the system.

To create InForm roles:

1. Select Roles from the menu bar. The InForm Roles page is displayed.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm roles for the selected sponsor company and trial is displayed.

3. Click the Create InForm Role link. The Create InForm Role page is displayed.

4. Enter the InForm role details. You can select the role type as Site, Sponsor, or both.
For more details on how to create InForm roles, see Section A.9.

5. Click Submit to save the details.

Note:
To save the current InForm role details and create another InForm role, click Submit and Add Another.
To go back to the List of InForm Roles page, click Return.

6.1.3 Viewing and Modifying InForm Role Details

The InForm Role Details page lets you view the rights associated with a role and modify the details, if required. When role details are modified, the reason for change is captured and the changes are tracked and audited. You can view the changes made to a particular field by viewing its corresponding audit trails.

To view and modify InForm role details:

1. Select Roles from the menu. On the InForm Roles page that appears, select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm roles for the selected sponsor company and trial is displayed.

2. Click the role name link within the grid. On the InForm Roles page that appears, the details for the selected InForm role are displayed.

3. Modify the InForm role details.
The Associate users icon beside the Roles field displays user-role association. The icon is displayed only when a user is associated to a role.

For more details on how to modify the InForm role details, see Section A.10.

Note:
If you modify the current sponsor company or the trial displayed in the Current Sponsor Company and Trial drop-down lists, the InForm Roles page is displayed.

4. Enter the reason for modifying the details of the InForm role in the Reason For Change text box and click Go.

5. To cancel the changes made to the trial details, click Cancel.

6. To view the list of audit trails for a particular field, click the corresponding icon.

6.1.4 Viewing and Modifying InForm User-Role Associations

The User-Role Association page lets you view the list of users associated with the selected role. You can also add or remove users for the selected role.

To view and modify InForm user-role association:

1. Select Roles from the menu bar. The InForm Roles page is displayed.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm roles for the selected sponsor company and trial is displayed.

3. Click the icon corresponding to a role. The User-Role Association page is displayed, which shows the list of users for the selected role.

4. Modify the user-role association.
For more details on how to view and modify user-role association, see Section A.11.

5. Click Submit to save the changes.

6. To go back to the List of InForm Roles page, click Return.

6.1.5 Setting the Display Override Option

The Change Display Overrides page lets you set the display override option for an item group.

To set a display override option:

1. Select Roles from the menu bar. The InForm Roles page is displayed.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm roles for the selected sponsor company and trial is displayed.

3. Click the icon corresponding to a role.
You can set the display override option for item group as read only, editable, or hidden. Based on the option assigned to the role, a user can view or modify the item group.

The Change Display Overrides page is displayed, which shows the list of available and selected Item groups.

4. Modify the details.
For more details on how to view and modify the Display Override option, see Section A.12.

5. Click Submit to save the changes.

6. To go back to the List of InForm Roles page, click Return.

6.1.6 Approving or Rejecting InForm Roles

The InForm Roles page lets you approve and reject InForm roles. You can either approve or reject InForm roles depending on your access rights.

You can approve or reject only those roles which are in the Pending status.

To approve or reject InForm roles:

1. Select Roles from the menu bar. The InForm Roles page is displayed.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm roles for the selected sponsor company and trial is displayed.

3. Select the check box corresponding to the role you want to approve or reject.

4. Select Approve or Reject from the Select drop-down list. If you select Reject, enter the reason for rejection in the Comments text box.

Note:
If you select Approve, the Electronic Signature Affidavit page is displayed. Enter your password and click Submit. To cancel approval, click Cancel.
The Approval Status for the selected InForm role changes based on the action performed.

5. Click Go.

6.1.7 Transferring InForm Roles

The InForm Roles page also lets you transfer InForm roles.

To transfer InForm roles:

1. Select Roles from the menu bar. The InForm Roles page is displayed.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm roles for the selected sponsor company and trial is displayed.

3. Click the icon corresponding to the role you want to transfer.

4. Select the user from the User(s) Available (Role Name) text box and transfer to the Transfer to text box using the navigational buttons.

5. Select the required role from the drop-down list and click Submit.

6. Click OK on the dialog box that appears.

7. Click Return to go back to the List of InForm roles page.
The change is reflected in the Member Count and on the Users page.

6.2 Managing UMT Roles

This section contains the following topics:

- Section 6.2.1, "Viewing the List of UMT Roles"

- Section 6.2.2, "Creating UMT Roles"

- Section 6.2.3, "UMT Roles and Rights"

- Section 6.2.4, "Viewing and Modifying UMT Role Details"

- Section 6.2.5, "Viewing and Modifying UMT User - Role Association"

- Section 6.2.6, "Deleting UMT Roles"

6.2.1 Viewing the List of UMT Roles

The UMT Roles page lets you view the list of UMT roles and role details. This page also lets you filter the UMT roles based on the filter criteria.

To view the list of UMT roles:

1. Select Roles from the menu bar. On the page that appears, click the UMT Roles link. The UMT Roles page is displayed.

2. Select the sponsor company from the Current Sponsor Company drop-down list. The list of UMT roles for the selected sponsor company is displayed.

3. To filter the role, enter the role name in the Role Name text box and click Find. The list of UMT roles that satisfy the filter criteria is displayed.
To specify the filter criteria, use the full name or the first few letters of the name.

For more details on how to filter and view roles, see Section A.20.

4. To clear the filter criteria, click Clear.

Note:
To navigate through the UMT roles list, click the First, Previous, Next, or Last links.
To view a particular page, select the page from the drop-down list.

To view all the UMT roles on a single page, select All from the drop-down list.

Click the column name link to sort the UMT roles in the ascending or descending order, based on the column name. On the first click, the UMT roles are sorted in the ascending order. To sort the UMT roles in descending order, click the column name link again.

6.2.2 Creating UMT Roles

The Create UMT Role page lets you create a role and assign rights under various categories such as UMT Admin, Import, Export, User, Sponsor, Site Details, Log Files, Approval, InForm Rights, and Miscellaneous. You can assign all or some of the rights under each category to a user.

To create UMT roles:

1. Select Roles from the menu bar. On the page that appears, click the UMT Roles link.

2. On the UMT Roles page that appears, select the sponsor company from the Current Sponsor Company drop-down list. The list of UMT roles for the selected sponsor company is displayed.

3. Click the Create UMT Role link. The Create UMT Role page is displayed.

4. Enter the UMT role details.
For more details on how to create UMT roles, see Section A.35.

5. Click Submit to save the details.

6. To save the current UMT role details and create another UMT role, click Submit and Add Another.

7. To discard the changes, click Return.

6.2.3 UMT Roles and Rights

UMT roles are assigned certain rights and privileges that help them perform different tasks. Table 6-1 provides a list of various rights and privileges that are typically assigned to a UMT role.

Table 6-1 UMT Roles and Rights

Rights

Description

UMT Admin

Create UMT User

Create a UMT user.

Modify UMT User

Edit UMT user details.

View UMT User

View UMT user details.

Manage UMT User

Edit UMT user country details and user association with trials.

Create UMT Role

Create a UMT role.

Modify UMT Role

Sponsor Role Users: Modify sponsor role user details.

PF Role Users: Update default role settings of PF role.

View UMT Role

View UMT user role details.

Manage UMT Role

Edit the association between a user and a role.

Modify UMT Configurations (PF Only)

Configure and edit UMT settings.

Modify Provisioned by (PF only),

Configure and edit provisioning Settings.

Manage IOL Training

Configure and edit IOL settings.

Import/Export

Import/Export

Import and export trial details.

Import Form and Items Ref Names

Import XML forms and item ref names.

Manage Auto Import Duplicates

Resolve automatically duplicated trial items.

User/Sponsor/Site Details

Create Sponsor

Create a sponsor.

Modify Sponsor Details

Edit sponsor details.

View Sponsor Details

View sponsor details.

Create Trial

Create a trial.

Modify Trial Details

Edit trial details.

Create InForm User

Create InForm user.

Modify InForm User

Edit InForm user details.

View InForm User

View InForm user details.

Manage InForm User

Associate a group and a role.

Create Site

Create a site.

Modify Site

Edit site details.

View Site Details

View site details.

Manage Site Details

Create and modify user and site association.

Load to InForm

Load user and site details to InForm.

Request InStruct account (IOL) (PF Only)

Request IOL training for PF users.

Copy Between Trials

Copy trial.

Manage Mass Associations

Enable mass association.

Lock Trial

Rights to lock trials.

View/Edit Pivotal Fields

Rights to view or edit Pivotal details.

Create/Edit UAT details

Rights to create or edit UAT details.

View Terminated User Details

Rights to view the terminated User Details.

View IRT User Details

Rights to view the IRT user details.

View IRT Site Details

Rights to view the IRT site details.

View IRT Right and Roles

Rights to view the IRT right and roles.

Manage IRT User Details

Rights to edit the IRT user details.

Manage IRT Site Details

Rights to edit the IRT site details.

Manage IRT Right and Roles

Rights to edit the IRT right and roles.

Load to IRT

Load user and site details to IRT.

Create OLx User

To create an OLx user.

View OLx User

To view OLx user.

Modify OLx user

Modify existing OLx user.

Manage OLx user

To manage OLx users.

Load to OLx

Load user and site details to OLx.

Log Files

View Import/Export Log File

View MUL application log files.

View Data Transfer Log to Pivotal (PF Only)

View Pivotal application log files.

View Data Transfer Log to InForm (PF Only)

View InForm application log files.

View Data Transfer Log to eCS (PF Only)

View eCS application log files.

View Data Transfer Log to IOL* (PF Only)

View IOL application log files.

View Training Log (PF Only)

Enable the training logs menu.

Approval

Approve Site Details

Approve or reject site details.

Approve InForm User Details

Approve, reject or terminate InForm user.

Approve InForm Rights and Role

Approve or reject InForm role.

Approve InForm Groups

Approve or reject InForm group.

Approve InForm Configuration

Approve or reject InForm settings.

Approve IRT Rights and Role

Approve or reject IRT role.

InForm Rights

Edit InForm Config Settings

Edit the InForm configuration settings.

Create InForm Rights and Role

Create InForm rights and roles.

Modify InForm Rights and Role

Edit InForm rights and roles.

Manage InForm Rights and Role

Manage the user-role associations.

Create InForm Groups

Create InForm group details.

Modify InForm Groups

Edit InForm group details.

Manage InForm Groups

To enable user, role association with groups. Associate an InForm group with a user and a group.

View InForm Config

View InForm configuration details.

View InForm Rights and Roles

View InForm rights and roles.

View InForm Groups

View InForm groups.

Create OLx Rights and Role

To create OLx rights and role.

Modify OLx Rights and Role

To modify OLx rights and role.

Manage OLx Rights and Role

To manage OLx roles and rights.

View OLx Roles and Rights

To view OLx roles and rights.

Miscellaneous

View Reports

To view billing details report, training report, and assessment detail report.

6.2.4 Viewing and Modifying UMT Role Details

The UMT Role Details page lets you view the rights associated with a role and modify the details, if required. If the role details are modified, the reason for change is captured and the changes are tracked and audited. You can view the changes made to a particular field by viewing its corresponding audit trail.

To view and modify UMT role details:

1. Select Roles from the menu bar. On the page that appears, click the UMT Roles link. The UMT Roles page is displayed.

2. Select the sponsor company from the Current Sponsor Company drop-down list. The list of UMT roles for the selected sponsor company is displayed.

3. Click the role name link in the grid. The UMT Role Details page is displayed, which shows the selected UMT role details.

4. Modify the UMT role details.
For more details on how to modify the UMT role details, Section A.33.

Note:
If the sponsor company in the Current Sponsor Company drop-down list is changed to another sponsor company, the UMT Roles page is displayed.

5. Enter the reason for modifying the details of the UMT role in the Reason For Change text box and click Submit.

6. To cancel the changes made to the UMT role details, click Cancel.

7. To view the list of audit trails for a particular field, click the corresponding icon.

6.2.5 Viewing and Modifying UMT User - Role Association

The User - Role Association page lets you view the list of users associated with the selected role. You can also add or remove users for the selected role.

To view and modify UMT user-role association:

1. Select Roles from the menu bar. On the page that appears, click the UMT Roles link. The UMT Roles page is displayed.

2. Select the sponsor company from the Current Sponsor Company drop-down list. The list of UMT roles for the selected sponsor company is displayed.

3. Click the icon corresponding to a role. The User-Role Association page is displayed, which shows the list of users for the selected role.

4. Modify the user-role association.
For more details on how to view and modify the user-role associations, see Section A.11.

5. Click Submit to save the changes.

6. To cancel the changes, click Return.

6.2.6 Deleting UMT Roles

The UMT Roles page lets you delete roles. However, you must specify the reason for deleting the UMT role.

To delete UMT roles:

1. Select Roles from the menu bar. On the page that appears, click the UMT Roles link. The UMT Roles page is displayed.

2. Select the sponsor company from the Current Sponsor Company drop-down list. The list of UMT roles for the selected sponsor company is displayed.

3. Select the check box corresponding to the role you want to delete.

4. Enter the reason for deleting the role in the Comments text box and click Delete.

6.3 Managing IRT Roles

This section contains the following topics:

- Section 6.3.1, "Viewing the List of IRT Roles"

- Section 6.3.2, "Creating IRT Roles"

- Section 6.3.3, "Approving or Rejecting IRT Roles"

6.3.1 Viewing the List of IRT Roles

The IRT Roles page lets you view the list of IRT roles and role details. This page also lets you filter the IRT roles based on the filter criteria.

To view the list of IRT roles:

1. Select Roles from the menu bar. On the page that appears, click the IRT Roles link. The IRT Roles page is displayed.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of IRT roles for the selected sponsor company is displayed.

3. To filter the role, enter the role name in the Role Name text box and click Find. The list of IRT roles that satisfy the filter criteria is displayed.
To specify the filter criteria, use the full name or the first few letters of the name.

4. To clear the filter criteria, click Clear.

Note:
To navigate through the IRT roles list, click the First, Previous, Next, or Last links.
To view a particular page, select the page from the drop-down list.

To view all the IRT roles on a single page, select All from the drop-down list.

Click the column name link to sort the IRT roles in the ascending or descending order, based on the column name. On the first click, the IRT roles are sorted in the ascending order. To sort the IRT roles in descending order, click the column name link again.

6.3.2 Creating IRT Roles

The Create IRT Role page lets you create a role and assign rights under various categories such as Subject Related, Study Admin Activities, Site Admin Activities, User Related Activities, Drug Related Activities, Reports, Ad-Hoc Reports, and Instructions and Forms. You can assign all or some of the rights under each category to a user.

To create IRT roles:

1. Select Roles from the menu bar. On the page that appears, click the IRT Roles link. The IRT Roles page is displayed.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of IRT roles for the selected sponsor company is displayed.

3. Click the Create IRT Role link. The Create IRT Role page is displayed.

4. Enter the IRT role details.

5. Click Submit to save the details.

6. To save the current IRT role details and create another IRT role, click Submit and Add Another.

7. To discard the changes, click Return.

6.3.3 Approving or Rejecting IRT Roles

The IRT Roles page lets you view approve or reject IRT roles.

To approve or reject IRT roles:

1. Select Roles from the menu bar. On the page that appears, click the IRT Roles link. The IRT Roles page is displayed.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of IRT roles for the selected sponsor company is displayed.

3. Select the check box corresponding to the role you want to approve or reject.

4. Enter the reasons in the Comments text box and click Go.

7 Managing Groups

This chapter contains the following topics:

- Section 7.1, "Viewing the List of Groups"

- Section 7.2, "Creating Groups"

- Section 7.3, "Viewing and Modifying User and Group Association"

- Section 7.4, "Validating AutoQuery Groups"

- Section 7.5, "Viewing and Modifying Group Details"

- Section 7.6, "Approving or Rejecting Groups"

- Section 7.7, "Creating PF Groups"

7.1 Viewing the List of Groups

The List of Groups page lets you view the list of groups and their details. It also lets you filter groups based on the filter criteria.

To view the list of groups:

1. Select Groups from the menu bar. The List of Groups page is displayed.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of groups for the selected sponsor company and trial is displayed.

3. To filter the groups, enter the filter criteria in the filter section and click Find. The list of groups that satisfy the specified filter criteria is displayed.
When you specify the filter criteria, you can use either the full group name or the first few letters of the group name.

For more details on how to filter and view groups, see Section A.13.

4. To clear the filter criteria, click Clear.

Note:
To navigate through the group list, click the First, Previous, Next, or Last links.
To view a particular page, select the page from the drop-down list.

To view all the groups on a single page, select All from the drop-down list.

Click the column name link to sort the groups in the ascending or descending order, based on the column name. On the first click, the groups are sorted in the ascending order. To sort the groups in descending order, click the column name link again.

7.2 Creating Groups

To create groups:

1. Select Groups from the menu bar. The Sponsor and Trial drop-down lists must be set to Select. The List of PF Groups page is displayed.

2. Click the Create PF Group link. The Create PF Groups page is displayed.

3. Enter the group details.
For more details on how to create groups, see Section A.14.

Note:
The groups created here are not copied to other trials until they are assigned to a user.

4. Click Submit to save the group details.

5. To save the current group details and create another group, click Submit and Add Another.

6. To discard the changes, click Return.

7.3 Viewing and Modifying User and Group Association

You can view users associated with a group and modify the number of users associated with it.

To view and modify group and user association:

1. Select Groups from the menu bar. The List of Groups page is displayed.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of groups for the selected sponsor company and trial is displayed.

3. Click the icon corresponding to the group for which you want to view and modify the user and group association. The User-Group Association page displays the users that are associated with the group.

4. Modify the user and group association.
For more details on how to modify user and group association, see Section A.15.

5. Click Submit.

6. Click OK on the confirmation dialog box.

7. To cancel all changes and return to the List of Groups page, click Return.

7.4 Validating AutoQuery Groups

You can validate approved autoquery groups for the purpose of uploading XML forms into the InForm system.

To validate autoquery groups:

1. Select Groups from the menu bar. The List of Groups page is displayed.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of groups for the selected sponsor company and trial is displayed.

3. Click the AutoQuery or CTValidation link. The autoquery dialog box is displayed.

4. Select the autoquery user and CT Validation User from the AutoQuery User drop-down lists respectively.

5. Click Submit.

6. Click OK on the confirmation dialog box.

7.5 Viewing and Modifying Group Details

The Edit Groups page lets you view and modify group details. If the group details are modified, the reason for change is captured and the changes are tracked and audited. You can view the changes made to a particular field by viewing its corresponding audit trails.

To view and modify group details:

1. Select Groups from the menu bar. The List of Groups page is displayed.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of groups for the selected sponsor company and trial is displayed.

3. Click the group name link in the grid. The Edit Groups page is displayed, which shows the selected group details.

4. Modify the group details.
For more details on how to modify group details, see Section A.16.

Note:
If you modify the current sponsor company or the trial displayed in the Current Sponsor Company and Trial drop-down lists, the List of Groups page is displayed.

5. Enter the reason for modifying the group details in the Reason For Change text box and click Submit.

6. To go back to the List of Groups page, click Return.

7. To view the list of audit trails for a particular field, click the corresponding icon.

7.6 Approving or Rejecting Groups

The List of Groups page lets you approve and reject groups. You can approve or reject groups depending on your access rights. All changes made to the group must be approved. You must provide your password on the Electronic Signature Affidavit page that appears during the process.

To approve or reject a group:

1. Select Groups from the menu bar. The List of Groups page is displayed.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of groups for the selected sponsor company and trial is displayed.

3. Select the check box corresponding to the group you want to approve or reject.

4. Select Approve or Reject from the Select drop-down list.
If you select Reject, enter the reason in the Comments text box.

If you select Approve, the Electronic Signature Affidavit page is displayed. Enter your password and click Submit. The Approval Status for the selected group changes based on the action performed.

To cancel approval, click Cancel.

5. Click Go.

7.7 Creating PF Groups

To create PF groups, see Section 7.2

8 Managing Reports

This chapter contains the following topics:

- Section 8.1, "Viewing the List of Reports"

- Section 8.2, "Generating the Reports"

8.1 Viewing the List of Reports

To view the list of reports:

1. Select Reports from the menu bar. The List of Reports page is displayed.

8.2 Generating the Reports

The section contains the following topics:

- Section 8.2.1, "Generating Assessment Reports"

- Section 8.2.2, "Generating Master Reports"

- Section 8.2.3, "Generating General Reports"

8.2.1 Generating Assessment Reports

You can generate the following assessment reports:

- Assessment Report - Sponsor Level: It displays the assessment details for all trials of a sponsor.

- Assessment Summary Report - Trial Level: It displays the summary of assessment details for a trial.

- Assessment Detail Report - Trial Level: It displays the complete details of the assessment for a trial.

- Assessment Summary Report - Site Level: It displays the summary of assessment details for a site.

- Assessment Detail Report - Site Level: It displays the complete details of the assessment for a trial.

8.2.1.1 Generating the Assessment Summary Report at Sponsor Level

To generate the Assessment Summary Report at sponsor level:

1. Select Reports from the menu bar. The List of Reports page is displayed.

2. Click the Assessment Report - Sponsor Level link. The Generate Assessment Report - Sponsor Level page is displayed.

3. For more details on how to generate the Assessment Summary Report at Sponsor Level, see Section A.52.

4. Click Generate. The Assessment Summary Report at sponsor level is generated. You can export the report to an Excel spreadsheet or print the report.

1. To export the report to an Excel spreadsheet, click the Export To Excel link.
On the dialog box that appears, click Open to open the file or click Save to save the file.

2. To print the report, click the Print link.
On the dialog box that appears, click Print.

5. Click Return to go back to the List of Reports page.

8.2.1.2 Generating the Assessment Summary Report at Trial Level

To generate the Assessment Summary Report at trial level:

1. Select Reports from the menu bar. The List of Reports page is displayed.

2. Click the Assessment Summary Report - Trial Level link. The Generate Assessment Summary Report - Trial Level page is displayed.

3. For more details on how to generate the Assessment Summary Report at trial level, see Section A.53.

4. Click Generate. The Assessment Summary Report at trial level is generated. You can export the report to an Excel spreadsheet or DAT file, or print the report.

1. To export the report to an Excel spreadsheet, click the Export To Excel link.
On the dialog box that appears, click Open to open the file or click Save to save the file.

2. To export the report to a DAT file, click the Export To File link.
On the dialog box that appears, click Open to open the file or click Save to save the file.

3. To print the report, click the Print link.
On the dialog box that appears, click Print.

5. Click Return to go back to the List of Reports page.

8.2.1.3 Generating the Assessment Detail Report at Trial Level

To generate the Assessment Detail Report at trial level:

1. Select Reports from the menu bar. The List of Reports page is displayed.

2. Click the Assessment Detail Report - Trial Level link. The Generate Assessment Detail Report - Trial Level page is displayed.

3. For more details on how to generate the Assessment Detail Report at Trial Level, see Section A.54.

4. Click Generate. The Assessment Detail Report at trial level is generated. You can export the report to an Excel spreadsheet or DAT file, or print the report.
For more details, see Section 8.2.1.2.

5. Click Return to go back to the List of Reports page.

8.2.1.4 Generating the Assessment Summary Report at Site Level

To generate the Assessment Summary Report at site level:

1. Select Reports from the menu bar. The List of Reports page is displayed.

2. Click the Assessment Summary Report - Site Level link. The Generate Assessment Summary Report - Site Level page is displayed.

3. For more details on how to generate the Assessment Summary Report at Site Level, see Section A.55.

4. Click Generate. The Assessment Summary Report at site level is generated. You can export the report to an Excel spreadsheet or DAT file, or print the report.
For more details, see Section 8.2.1.2.

5. Click Return to go back to the List of Reports page.

8.2.1.5 Generating the Assessment Detail Report at Site Level

To generate the Assessment Detail Report at site level:

1. Select Reports from the menu bar. The List of Reports page is displayed.

2. Click the Assessment Detail Report - Site Level link. The Generate Assessment Detail Report - Site Level page is displayed.

3. For more details on how to generate the Assessment Detail Report at Site Level, see Section A.56.

4. Click Generate. The Assessment Summary Report at site level is generated. You can export the report to an Excel spreadsheet or DAT file, or print the report.
For more details, see Section 8.2.1.2.

5. Click Return to go back to the List of Reports page.

8.2.2 Generating Master Reports

You can generate the following master reports:

- Master Summary Report - Site Level

- Master Detail Report - Site Level

8.2.2.1 Generating the Master Summary Report at Site Level

To generate the Master Summary Report at site level:

1. Select Reports from the menu bar. The List of Reports page is displayed.

2. Click Master Reports and then click Master Summary Report - Site Level link. The Generate Master Summary Report - Site Level page is displayed.
For more details on how to generate the Master Summary Report at Site Level, see Section A.57.

3. Click Generate. The Master Summary Report at site level is generated. You can export the report to an Excel spreadsheet or DAT file, or print the report.
For more details, see Section 8.2.1.2.

4. Click Return to go back to the List of Reports page.

8.2.2.2 Generating the Master Detail Report at Site Level

To generate the Master Detail Report at site level:

1. Select Reports from the menu bar. The List of Reports page is displayed.

2. Click Master Reports and then click Master Detail Report - Site Level link. The Generate Master Detail Report - Site Level page is displayed.
For more details on how to generate the Master Detail Report at Site Level, see Section A.57.

3. Click Generate. The Master Detail Report at site level is generated. You can export the report to an Excel spreadsheet or DAT file, or print the report.
For more details, see Section 8.2.1.2.

4. Click Return to go back to the List of Reports page.

8.2.3 Generating General Reports

You can generate the following general reports:

- Billing Report Details

- Training Report

- User Detail Report

- Worklist-Site/User Report

- Trial Archive Package (TAP) Report

8.2.3.1 Generating the Billing Report Details

To generate the Billing Report details:

1. Select Reports from the menu bar. The List of Reports page is displayed.

2. Click General Reports and then click Billing Details Report link. The Generate Billing Details page is displayed.
For more details on how to generate the Billing Details Report, see Section A.59.

3. Click Generate. The Billing Details Report is generated. You can export the report to an Excel spreadsheet or DAT file, or print the report.
For more details, see Section 8.2.1.2.

4. Click Return to go back to the List of Reports page.

8.2.3.2 Generating the Training Details Report

To generate the Training Report:

1. Select Reports from the menu bar. The List of Reports page is displayed.

2. Click General Reports and then click Training Report link. The Training Details Report page is displayed.
For more details on how to generate the Training Details Report, see Section A.60.

3. Click Generate. The Training Details Report is generated. You can export the report to an Excel spreadsheet or DAT file, or print the report.
For more details, see Section 8.2.1.2.

4. Click Return to go back to the List of Reports page.

8.2.3.3 Generating the User Detail Report

To generate the User Detail Report:

1. Select Reports from the menu bar. The List of Reports page is displayed.

2. Click General Reports and then click User Detail Report link. The Generate User Detail Report page is displayed.
For more details on how to generate the User Detail Report, see Section A.61.

3. Click Generate. The User Detail Report is generated. You can export the report to an Excel spreadsheet or DAT file, or print the report.
For more details, see Section 8.2.1.2.

4. Click Return to go back to the List of Reports page.

8.2.3.4 Generating the WorkList-Site/User Report

To generate the WorkList-Site/User Report:

1. Select Reports from the menu bar. The List of Reports page is displayed.

2. Click General Reports and then click WorkList-Site/User Reports link. The Site-User Detail Report page is displayed.
For more details on how to generate the Site-User Detail Report, see Section A.62.

3. Click Generate. The Site Detail Report is generated. You can export the report to an Excel spreadsheet.

1. To export the report to an Excel spreadsheet, click the Export To Excel link.

2. On the dialog box that appears, click Open to open the file or click Save to save the file.

4. Click Return to go back to the List of Reports page.

8.2.3.5 Generating the Trial Archive Package (TAP) Report

To generate the Trial Archive Package (TAP) Report:

1. Select Reports from the menu bar. The List of Reports page is displayed.

2. Click General Reports and then click Trial Archive Package (TAP) Report link. The Trial Archive Report (TAP) page is displayed.

3. Select the sponsor company and trial.

4. Click Generate Report.

5. On the dialog box that appears, click Open to open the file or click Save to save the file.
The Trial Archive Report is generated in the form of an Excel spreadsheet.

6. Click Return to go back to the List of Reports page.

9 Managing Worklists

This chapter contains the following topics:

- Section 9.1, "Overview"

- Section 9.2, "Managing Worklist Generation"

9.1 Overview

The Manage Workslists Generation page lets you assign trials to manual worklists or automatic worklists as required. It also lets you set the default worklist type for all the new trials you create. Assignment to automatic worklists must be initiated by a Support ticket. For more details on manual worklists and automated worklists, see Chapter 10.

Note:
Only Oracle administrator users and third party Tier-I help desk users with required access rights can access the Manage Worklists tab.

9.2 Managing Worklist Generation

To manage worklist generation:

1. Select Manage Worklists from the menu bar. The Manage Worklists Generation page is displayed.
For more details on how to manage worklist generation, see Section A.49.

2. Select the sponsor company from the Sponsor drop-down list.

3. To assign a trial to a manual worklist:
Select the required trial from the Disabled box and click the right arrow. The selected trial is moved to the Manual Worklists box.

4. To assign a trial to an automatic worklist, Oracle support team has to create a support ticket.

5. Enter the reason for modification in the Reason for change text box.

6. Click Submit to save the changes. To discard the changes, click Return.

10 Worklist

This chapter contains the following topics:

- Section 10.1, "Overview"

- Section 10.2, "Viewing Manual Worklist"

- Section 10.3, "Viewing Archived Records"

10.1 Overview

The worklist details page lets you track the transactions carried out in UMT for a trial at user, site, role, and group levels, after the trial goes live. There are two types of worklists, such as Manual and Automated.

Note:
Only UMT users and third party Tier-I help desk users with required access rights can access the Worklists tab.

10.2 Viewing Manual Worklist

You can view manual worklist details at user, site, role, group, and configuration levels. You can assign a manual worklist to User Manager (UM), User Approver (UA), and Quality Control (QC), and complete the worklist. The completed worklists are archived.

To view a manual worklist:

1. Select Worklist from the menu bar. By default, the manual worklist details page is displayed.
For more details on worklist details, see Section A.48.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of worklists at user level for the selected sponsor company and trial is displayed.

Note:
To view the worklist details at site, role, group, and configuration levels, click the corresponding links.

3. To filter worklists based on user, site, role, group, or configuration levels, enter the filter criteria, and click Find. The list of worklists that satisfy the specified filter criteria is displayed.
For more details on how to filter and view worklist details, see Section A.48.

4. Select the required worklist from the list by clicking the corresponding check box.

5. Select the user to assign the worklist to, for approval from the Select drop-down list.

Note:
You should assign a worklist to User Manager (UM), User Approver (UA), and Quality Control (QC), in the sequence, for approval.

6. Select Mark as Pending or Archive Records as required from the Select drop-down list.

7. Enter the reasons in the Comments text box and click Go.
The worklist record is updated successfully.

10.3 Viewing Archived Records

After a worklist is approved and processed completely, it will be archived in UMT.

To view the archived worklists:

1. Select Worklist from the menu bar. By default, the manual worklist details page is displayed.

2. Click the View Archived Records link. The list of archived worklists is displayed.

3. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of archived worklists for the selected sponsor company and trial is displayed.

11 Managing Assessment

This chapter contains the following sections:

- Section 11.1, "Viewing the List of Assessed Users"

- Section 11.2, "Updating Assessment Status for an Assessed User"

- Section 11.3, "Viewing Assessment Comment History"

11.1 Viewing the List of Assessed Users

The List of Assessed Users page lets you view the list of assessed users and their details. Additionally, it lets you filter the users based on the filter criteria.

To view the list of assessed users:

1. Select Assessments from the menu bar. The List of Assessed Users page is displayed.

2. Select the sponsor company, trial, and site from the Current Sponsor Company, Trial and Site drop-down lists. The list of assessed users for the selected sponsor company, trial, and site is displayed.
An error message No User Details Found is displayed when there are no assessed users in the selected sponsor company, trial, and site.

3. To filter users, enter the filter criteria and click Find. The list of assessed users that satisfy the specified filter criteria is displayed.

Note:

Filtering options cannot be used unless you specify a current sponsor company, a trial, and a site.

While specifying the filter criteria, you can use the full name or part of the name.

An error message No Result found for the Selected Criteria is displayed when there are no users who meet the search criteria.

1. To navigate through the user list, click the First, Previous, Next, or Last links.

2. To view a particular page, select the page from the drop-down list.

3. To view all the users on a single page, select All from the drop-down list.

4. Click the column name link to sort the users either in the ascending or descending order, based on the column name. On the first click, the users are sorted in the ascending order. To sort them in descending order, click the column name link again.

5. To clear the filter criteria, click Clear.

11.2 Updating Assessment Status for an Assessed User

The List of Assessed Users page lets you update the assessment status of assessed users.

To update the assessment status of an assessed user:

1. Select Assessments from the menu bar. The List of Assessed Users page is displayed.

2. Select the sponsor company, trial, and site from the Current Sponsor Company, Trial, and Site drop-down lists. The list of assessed users for the selected sponsor company, trial, and site is displayed.

3. To filter users, enter the filter criteria and click Find. The list of assessed users that satisfy the specified filter criteria is displayed.

Note:
To clear the filter criteria, click Clear.

4. Select the check box corresponding to the user whose status you want to update.

5. Select Update Assessment Status from the Select drop-down list.

6. Enter the reason for updating in the Comments text box and click Go.
The Update Assessment Status page is displayed.

7. Select the check box corresponding to the status you want to update.

8. Enter a summary of updating in the Assessment Summary Box text box and click Update.
The assessment status of the user is updated successfully.

9. Click OK on the dialog box that appears.

10. Click Return to go back to the List of Assessed Users page.

11.3 Viewing Assessment Comment History

The List of Assessed Users page also lets you view the Assessment Comment History for an assessed user.

To view the Assessment Comment History for an assessed user:

1. Select Assessments from the menu bar. The List of Assessed Users page is displayed.

2. Select the sponsor company, trial, and site from the Current Sponsor Company, Trial, and Site drop-down lists. The list of assessed users for the selected sponsor company, trial, and site is displayed.

3. To filter users, enter the filter criteria and click Find. The list of assessed users that satisfy the specified filter criteria is displayed.

Note:
To clear the filter criteria, click Clear.

4. Click corresponding to the user whose Assessment Comment History you want to display.

5. The Assessments Comment History page displays the comments history of the selected user.

Note:
Click Return to go back to the List of Assessed Users page.

11.3.1 Adding New Comments to the Assessment Comments History

The Add New Comments link on the Assessments Comments History Page lets you add new comments to an assessed user's comments history.

To add new comments to an assessed user's comments history:

1. Click the Add New Comments link on the Assessment Comments History page. The Add Assessment Comments page is displayed.

2. Enter your comments in the Public Comments and Private Comments text boxes and click Submit.

Note:
You must enter comments in both text boxes.

3. Click OK on the dialog box that appears.

4. Click Return to go back to the Assessment Comments History page.

5. Click Clear to clear the comments entered.

11.3.2 Editing Comments

The Edit or Delete link on the Assessment Comments History page lets you edit comments from an assessed user's assessments comments history.

To edit an assessed user's assessments comments history:

1. Click the Edit or Delete link for the corresponding user.

2. The Comments tab is highlighted and the Comment type radio button displays whether it is a public or private comment.

3. Edit the comments as required and enter the reasons for change in the Comments text box. Click Update.

4. Click OK on the dialog box that appears.

5. Click Return to go back to the List of Assessed Users page.

11.3.3 Deleting Comments

The Edit or Delete link on the Assessment Comments History page lets you delete comments from an assessed user's assessments comments history.

To delete an assessed user's assessments comments history:

1. Click the Edit or Delete link for the corresponding user.

2. The Comments tab is highlighted and the Comment type radio button displays whether it is a public or private comment.

3. Enter the reasons for deletion in the Comments text box and click the delete icon.

4. Click OK on the dialog box that appears.

Note:
Click Return to go back to the List of Assessed Users page.

12 Managing Log Files

This chapter contains the following topics:

- Section 12.1, "Viewing the List of Log Files"

- Section 12.2, "Viewing the List of Transferred Data"

- Section 12.3, "Archiving Log Files"

- Section 12.4, "Viewing Archived Log Files"

12.1 Viewing the List of Log Files

The Log Files page displays the list of log files and its details. You can view the details of the import such as application name, batch ID, name of the user who initiated the import, date and time of the import, and status of the import.

To view the list of log files:

1. Select Log Files from the menu bar. The Log Files page is displayed. Select the sponsor company from the Current Sponsor Company drop-down list.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists.

3. Enter the filter criteria and click Find. The list of log files for the specified filter criteria is displayed.
For more details on viewing log files, see Section A.26.

Note:
Click the column name link to sort the log files in the ascending or descending order, based on the column name. On the first click, the log files are sorted in the ascending order. To sort the log files in the descending order, click the column name link again.
To view list of transferred data, click the module name link.

12.2 Viewing the List of Transferred Data

The Data Transferred page displays the list of transferred data in the corresponding module.

To view the list of transferred data:

1. Select Log Files from the menu bar. The Log Files page is displayed.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists.

3. Enter the filter criteria and click Find. The list of log files for the specified filter criteria is displayed.

4. Click the HTML Log View link. The Data Transferred page is displayed, which shows the list of transferred data for the corresponding module.

5. To view the previous page, click Back.

12.3 Archiving Log Files

The Archive option available on the Log Files page lets you archive inactive log files.

To archive log files:

1. Select Log Files from the menu bar. The Log Files page is displayed.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists.

3. Enter the filter criteria and click Find. The list of log files for the specified filter criteria is displayed.

4. Select the check box corresponding to the log file you want to archive and enter the reason for archival in the Comments text box.

5. Click Archive.

6. To view the archived log files, click the View Archive of Log Files link.

12.4 Viewing Archived Log Files

The List of Archived Log Files page lets you view archived log files. You can view the application name, module name, name of the user who initiated the import, date and time of the import, and status of the import.

To view archived log files:

1. Select Log Files from the menu bar. The Log Files page is displayed.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists.

3. Enter the filter criteria and click Find. The list of log files for the specified filter criteria is displayed.

4. Click the View Archive of Log Files link. The List of Archived Log Files page is displayed, which shows the list of archived log files.

5. To view the archived log files of a particular sponsor company, select the sponsor company from the Current Sponsor Company drop-down list.

6. To view list of transferred data, click the Batch ID link.

7. To view the previous page, click Back.

13 InStruct Online Training

This chapter contains the following topics:

- Section 13.1, "Overview"

- Section 13.2, "Assigning an IOL Class to a Trial"

- Section 13.3, "Managing Training"

13.1 Overview

InStruct Online (IOL) lets you assign training classes to trials and manage the training classes. You can assign IOL classes for trials for which the Swithchoff IOL option is disabled.

13.2 Assigning an IOL Class to a Trial

To assign an IOL class to a trial:

1. Select IOL Training from the menu bar.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of classes available for the selected sponsor company and trial is displayed.

3. Select the classes you want to assign to the trial and specify the number of seats.
You can select either Unlimited or enter the required number of seats.

4. Click Submit.

13.3 Managing Training

The Manage Training page lets you view the list of classes assigned to the users and their statuses. You can reassign the classes to the users and download the class completion certificates.

To manage the training classes:

1. Select IOL Training from the menu bar.

2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists.

3. Click Manage Training. The list of training records is displayed.

4. Enter the filter criteria and click Find. The list of training records that satisfy the filter criteria is displayed.
For more details on how to assign, filter, and view training records, see Section A.68.

5. To clear the filter criteria, click Clear.

14 Configuring Settings

14.1 Configuring UMT Settings

The Configuration settings page lets you configure UMT settings such as trial configuration, site configuration, and user configuration.

14.1.1 Configuring Default Trials, Sites, and User Settings

The Trial Configurations, Site Configurations, and User Configurations sections let you configure settings. New sites and InForm users created under a selected trial reflect these settings.

To configure default trial, site, and user settings:

1. Select Configuration from the menu bar. The Configuration settings page is displayed.

2. Select the current sponsor company and trial from the Current Sponsor Company and Trial drop-down lists.

3. Enter the settings in the Trial Configurations, Site Configurations, and User Configurations sections.
For more information on how to configure the default trial, site, and user settings, see Section A.17.

4. Enter the reason for modifying the settings in the Comments text box and click Submit.

5. To discard the changes, click Return.

14.1.2 Exporting UMT Configuration Settings

The Export to Excel and Export to File links available on the Configuration settings page lets you export UMT configuration settings. You can export the settings to an Excel spreadsheet or to a flat file.

To export UMT configuration settings:

1. Select Configuration from the menu bar. The Configuration settings page is displayed.

2. Select the current sponsor company and trial from the Current Sponsor Company and Trial drop-down lists.

3. Click the Export to Excel or Export to File link.

4. On the dialog box that appears, click Open to open the file or click Save to save the file.

14.2 Configuring InForm Settings

The Configuration settings page lets you configure InForm settings such as editable system configuration and general settings.

14.2.1 Configuring Editable System Configuration Options for Trials on Trial Level

The Editable System Config Options section lets you configure editable system configuration options for a selected trial.

To configure editable system configuration options for trials:

1. Select Configuration from the menu bar. The Configuration settings page is displayed.

2. Select the current sponsor company and trial from the Current Sponsor Company and Trial drop-down lists.

3. Enter the settings required.
For more details on how to configure the editable system configuration options for a trial, see Section A.17

4. Enter the reason for modifying the settings in the Comments text box and click Submit.

5. To discard the changes, click Return.

14.2.2 Configuring Editable System Configuration Options for New and Existing Trials on Sponsor Company Level

You can also configure the editable system configuration options for a new trial and update the settings for all existing trials under the selected sponsor company in the Editable System Config Options section.

To configure editable system configuration options for new and existing trials:

1. Select Configuration from the menu bar. The Configuration settings page is displayed.

2. Select the current sponsor company from the Current Sponsor Company drop-down list and All from the Trial drop-down list.

3. Enter the settings in the Editable System Configuration Options section.
For more details on how to configure the editable system configuration options for new trials, see Section A.17.

4. Select the check boxes corresponding to the setting items under Editable System Config Options section. This updates all existing trials and sets the default value for new trials to be created under the selected sponsor company.

5. Enter the reason for modifying the settings in the Comments text box and click Submit.

6. To discard the changes, click Return.

14.2.3 Configuring General Settings

Only PF users can modify the general settings available in the Settings section of the Configuration settings page. You can update the settings for existing trials and also set the default settings for new trials.

To configure general settings:

1. Select Configuration from the menu bar. The Configuration settings page is displayed.

2. Select the current sponsor company from the Current Sponsor Company drop-down list and All from the Trial drop-down list.

3. Enter the settings.
For more details on how to configure the general settings, see Section A.17.

4. Select the check boxes corresponding to the settings item to update the settings for all existing trials and set the default settings for new trials.

5. Enter the reason for modifying the settings in the Comments text box and click Submit.

6. To discard the changes, click Return.

14.2.4 Exporting InForm Configuration Settings

The Export to Excel and Export to File links available on the Configuration settings page lets you export configuration settings. You can export the settings to an Excel spreadsheet or to a flat file.

To export UMT configuration settings:

1. Select Configuration from the menu bar. The Configuration settings page is displayed.

2. Select the current sponsor company and trial from the Current Sponsor Company and Trial drop-down lists.

3. Click the Export to Excel or Export to File link.

4. On the dialog box that appears, click Open to open the file or click Save to save the file.

14.3 Configuring Custom Review State

The Custom Review settings page lets you configure custom review states and custom review stages for InForm 5.5 trials only.

To add a review state and a review stage:

1. Select Configurations from the menu bar. The Configuration settings page is displayed.

2. Click the Custom Review State Config link. The Custom Review settings page is displayed.

3. Select the current sponsor company and trial from the Current Sponsor Company and Trial drop-down lists.

Note:
You should select an InForm 5.5 trial.

4. Enter the settings.
For more details on Custom Review State configuration settings, see Section A.69.

5. Enter the comments for modifying the configurations in the Comments text box.

6. Click Submit to save the changes.

7. Click Remove Review Stage to delete the custom review stages.

14.4 Configuring Assessment

The Assessment Configuration Settings page lets you configure the assessment settings at sponsor level and trial level.

To configure the assessment settings:

1. Select Configurations from the menu bar. The Configuration settings page is displayed.

2. Click the Assessment Config link. The Assessment Configuration Settings page is displayed.

3. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists.
For more details on Assessment Configuration Settings, see Section A.50.

4. Enter the comments for modifying the configurations in the Comments text box.

5. Click Submit to save the changes. To discard the changes, click Return.

14.5 Configuring Assessment Benchmark

The Assessment Benchmark Settings page lets you configure the benchmark settings for assessment.

To configure the assessment benchmark:

1. Select Configuration from the menu bar. The Configuration Settings page is displayed.

2. Click the Assessment Benchmark link. The Assessment Benchmark Settings page is displayed.

3. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists.

Note:
You can configure the benchmark settings for assessment on sponsor company level by not selecting a trial.

For more details on Assessment Benchmark Settings, see Section A.51.

4. Enter the comments for modifying the configurations in the Comments text box.

5. Click Submit to save the changes. To discard the changes, click Return.

14.6 UMT Settings

14.6.1 Configuring UMT Settings

The UMT Settings page lets you view and configure the password and login settings, worklist schedule and staging schedule settings. The password assigned to the UMT users during creation is based on the settings configured on the UMT Settings page.

To configure UMT settings:

1. Select UMT Settings from the menu bar. The UMT Settings page appears.

2. Modify the UMT configuration settings.
For more information on how to configure the UMT settings, see Section A.18.

3. Enter the reason for modification in the Reason for change text box and click Submit to save the changes.

4. To discard the changes, click Return.

14.6.2 Managing ISD Codes and Time Zones for Countries

The List of Countries page lets you manage ISD codes and time zones for countries. You can view list of countries and corresponding ISD codes.

To view list of countries:

1. Select UMT Settings from the menu bar. The UMT Settings page is displayed.

2. Click the Manage Countries List link. The List of Countries page is displayed that displays the list of countries and the corresponding ISD codes.

3. To filter the countries, enter the country name in the Country Name text box and click Find.
While specifying the filter criteria, you can use the full name or use the first few letters of the name.

You can use the Quick Search feature to search for sites and users and directly access the required page. For more details on the Quick Search feature, see Section 2.5.

Note:
To navigate through the country list, click the First, Previous, Next, or Last links.
To view a particular page, select the page from the drop-down list.

To view all the countries on a single page, select All from the drop-down list.

To view the country details, click the country name link.

To view the UMT Settings page, click Cancel.

14.6.3 Viewing and Modifying Country Details

The Country Details page lets you view and modify the country details and the Time Zone Association.

To view and modify the country details:

1. Select UMT Settings from the menu bar. The UMT Settings page is displayed.

2. Click the Manage Countries List link. The List of Countries page is displayed.

3. Click the country name link. The Country Details page is displayed, which shows the selected country details.

4. Modify the country details.
For more details on how to modify the country details, see Section A.19.

5. Enter the reason for modifying the sponsor details in the Reason for change text box and click Submit.

6. To discard the changes, click Return.

A UMT Field Information

Note:
All fields marked with * are mandatory.

A.1 InForm, IRT, and OLx Users Field Information

Table A-1 InForm, IRT Users, and OLx - Field Information

Field Name

Description

Field Size (In Character)

Username

Enter the name of the user.

32

First Name

Enter the first name of the user.

127

Last Name

Enter the last name of the user.

127

User Status

Select the status of the user from the drop-down list.

NA

User Type

Select the user type from the drop-down list.

NA

Role

Select the role from the drop-down list.

NA

Approval Status

Select the approval status from the drop-down list.

NA

Training Status

Select the training status from the drop-down list.

NA

Site(s)

Enter the site number.

255

Assessment Status

Select the assessment status from the drop-down list.

NA

Uploaded to InForm

Select the option from the drop-down list.

NA

Country

Select the country from the drop down.

NA

User ID

Enter the user ID.

NA

InForm/IRT User Details:

-

-

Displays the icon:

if the user is marked Upload to InForm.

if the user is marked Upload to IRT.

if the user is marked Upload to InForm/IRT.

NA

Username

Displays the user name. Click the hyperlink to view the corresponding user details.

NA

First Name

Displays the first name of the user.

NA

Last Name

Displays the last name of the user.

NA

User Status

Displays the status of the user.

NA

User Type

Displays the user type.

NA

Role

Displays the role of the user.

NA

Approval Status

Displays the approval status. The approval status can be Approved, Rejected, or Pending.

NA

Training Status

Displays the training status. The training status can be Trained or Not Trained.

NA

Site(s)

Displays the sites associated with the user. If the user is associated to multiple sites, the icon is displayed. Click the icon to view the association details. The icon is disabled for the user type Sponsor.

NA

Assessment Status

Displays the assessment status of the latest site assessment performed by the user. Click the icon to view the list of provisioning details.

NA

User ID

Displays the user ID of the IRT user.

NA

IRT Roles

Displays the IRT roles.

NA

Trained Date

Displays the trained date of the user.

NA

Country

Displays the country name of the user.

NA

Pass/Fail

Displays the pass or fail status of the user.

NA

Provisioning Status

Displays the provisioning status of the user.

NA

Table A-2 InForm Users - Error Information

Field Name/ Action

Scenario

Error Message

Role

When you click the role drop- down list without selecting the User Type.

Select User Type to load Role.

Check Box

When you click Go without selecting a user.

Select a User.

Check Box

When you click Go without checking a user.

Please check at least one User and then proceed.

Select Drop-down LIst

When you click Go without selecting any option in Select drop down list.

Select an action.

Pending User

When the pending user is assigned to Request for Equipment Assessment.

Pending User(s) cannot be requested for Equipment Assessment.

Request For Equipment Assessment

When the PF user is assigned to Request for Equipment Assessment.

PF users are not allowed for Assessment.

Request For Equipment Assessment

When the user who do not have site or multiple sites assigned to Request for Equipment Assessment.

Users associated to no sites or multiple sites cannot be requested for Equipment Assessment on this page.

Request For Equipment Assessment

Error occurs when the user status is not approved and the user is assigned to Request Equipment Assessment.

One or more of the site(s) are not approved. Please approve to Request Equipment Assessment.

Immediate Provisioning

Error occurs when the user is already marked for Immediate Provisioning.

One or more of the selected users is already marked for Immediate Provisioning - Equipment Assessment is not available.

Immediate Provisioning

Error occurs when the user is already marked for Immediate Provisioning.

One or more of the selected users is already marked for Equipment Assessment.

Active user

Error occurs when you try to change the user status to Active who is locked for QC.

User is locked for QC.

Active user

Error occurs when you try to change the user status to Active whose status is already in the Active status.

You have selected active users.

Inactivate User

Error occurs when you try to change the status of an inactive user.

You have selected inactive users.

Reject

Error occurs when you reject the user whose status is not pending.

You have selected users whose approval status is not pending.

Comment

Error occurs when you click Go button without entering a comment.

Enter a comment.

Comment

Error occurs when the character limit of the comments text exceed 255 characters.

Comments text should not exceed 255 characters.

Approve

Error occurs when you change the status of the user who is already approved.

You have selected users whose approval status is not pending.

Requires IOL Training

Error occurs when an enrolled user is requested for Requires for IOL.

You have selected enrolled users.

Mark as Assessed

Error occurs when you mark the PF user as Assessed.

PF users are not allowed for Assessment.

Pending Users

Error occurs when you mark the pending user as site Assessed.

Pending Users cannot be marked as Site Assessed.

User Site Association

Error occurs when you mark the user as Assessed who have association with no sites or multiple sites.

Users associated to no sites or multiple sites cannot be marked as site Assessed on this page.

Marked as Assessed

Error occurs when you mark the user as Assessed who is already marked as assessed.

One or more of the selected users is already marked as Assessed.

Mark as Trained

Error occurs when you change the training status of the user as Trained whose status is already trained.

You have selected Users whose Training status is Completed/Trained.

Terminate User

Error occurs when you try to terminate the user who is locked for QC.

User is locked for QC.

Mark Upload To InForm

Error occurs when you mark pending user as Upload to InForm.

Pending User(s) cannot be Marked Upload to InForm.

Mark Upload To InForm

Error occurs when you mark Upload the User who do not have a Role association.

Selected Users do not have a Role association.

Send Welcome Pack

Error occurs when you send welcome pack to the user who are not uploaded to InForm.

You have selected users who are not uploaded to InForm (second column icon).

Request Immediate Provisioning

Error occurs when you request immediate provisioning to the user whose status is pending.

Pending Users cannot be requested for Immediate Provisioning.

Request Immediate Provisioning

Error occurs when you request immediate provisioning to PF user.

PF users are not allowed for Provisioning.

Request Immediate Provisioning

Error occurs when you request immediate provisioning to the user who have no association or multiple association with the sites.

Users associated to no sites or multiple sites cannot be marked as Immediate provisioning started on this page.

Request Immediate Provisioning

Error occurs when you request immediate provisioning to the user who is already marked for the same.

One or more of the selected users is already marked for Immediate Provisioning.

Request Immediate Provisioning

Error occurs when you request immediate provisioning to the user who is already marked as Assessed.

One or more of the selected users is already assessed/currently being assessed - immediate provisioning is not available.

Request Immediate Provisioning

Error occurs when you request immediate provisioning to the user who already marked as Assessed.

One or more of the selected users is currently being Assessed - immediate provisioning is not available.

Request Immediate Provisioning

Error occurs when request immediate provisioning to the user whose Request Assessment column is pending.

Users requested for Equipment Assessment cannot be requested for Immediate provisioning. One or more users selected have been requested for Equipment Assessment.

Stop Assessment Process

Error occurs when you stop the assessment process for the user whose status is Provisioning Recommended - Requires Customer Approval.

Cannot stop Assessment process for User(s) with status as ''Provisioning Recommended - Requires Customer Approval''.

Stop Assessment Process

Error occurs when you stop the assessment process for the user whose status is Requires Customer Assistance.

Cannot stop Assessment process for User(s) with status as ''Requires Customer Assistance''.

Stop Assessment Process

Error occurs when you stop the assessment process for the user whose status is Provisioning - Started.

Cannot stop Assessment process for User(s) with status as ''Provisioning - Started''.

Stop Assessment Process

Error occurs when you stop the assessment process for the user who is associate with no site or more than one site.

One or more selected User(s) associated to multiple Sites. Please click on + symbol to perform the action.

Stop Assessment Process

Error occurs when you stop the assessment process for the user whose assessment is already stopped

Assessment is already stopped for selected user(s).

Stop Assessment Process

Error occurs when you stop assessment process for the user whose status is Provisioning Recommended/Requires Customer Approval.

Cannot stop Assessment process for User(s) with status as ''Provisioning Recommended - Requires Customer Approval''.

Stop Assessment Process

Error occurs when you stop assessment process for the user whose status is No Provisioning Recommended/Requires Customer Approval.

Cannot stop Assessment process for User(s) with status as ''No Provisioning Recommended / Requires Customer Approval''.

Stop Assessment Process

Error occurs when you stop assessment process for the user whose status is Provisioning - Started.

Cannot stop Assessment process for User(s) with status as ''Provisioning - Started''.

Stop Assessment Process

Error occurs when you stop assessment process for the PF user.

One or more selected users is (are) PF users.

Stop Assessment Process

Error occurs when you stop assessment process for the user whose assessment process is already completed.

Assessment process completed already for the selected User(s).

Stop Assessment Process

Error occurs when you stop assessment process for the user whose is already approved.

One or more users is already approved.

Stop Assessment Process

Error occurs when you stop assessment process for the user who do not have the assessment process started.

One or more selected users does not have the Assessment process started.

Stop Assessment Process

Error occurs when you stop assessment process for the user who has immediate provisioning started.

Assessment cannot be stopped for user(s) who has immediate provisioning started.

Stop Assessment Process

Error occurs when you stop assessment process for the user whose is already assessed.

Assessment cannot be stopped for user(s) who is already Assessed.

User ID

Error occurs when you enter the alphabets or special character.

Enter a valid User id. Only Numerics (0-9) are allowed.

A.2 Create InForm, IRT, and OLX User Details

Table A-3 Create InForm, IRT, and OLX User Details – Field Information

Field Name

Description

Length

Basic User Info

User Type*

Displays the user type.

NA

Username*

Displays/Modify the name of the user.

32 Characters

First Name*

Displays/Modify the first name of the user.

127 Characters

Last Name*

Displays/Modify the last name of the user.

127 Characters

Title

Displays/Modify the title for the user.

NA

Description

Displays/Modify the description.

NA

Display Name*

Displays/Modify the display name of the user.

255 Characters

Contact Details

Address1* Address2:

Displays/Modify the communication address of the user.

255 Characters

Town/City*

Displays/Modify the town or city name to which the user belongs.

255 Characters

State/Province

Displays/Modify the state or province name to which the user belongs.

255 Characters

Country*

Displays/Modify the country to which the user belongs.

NA

Postal Code

Displays/Modify the postal code of the user.

16 Characters

Phone Number*

Displays/Modify the phone number of the user.

25 Characters

Alternate Phone Number

Displays/Modify the alternate phone number of the user.

25 Characters

Beeper Number:

Displays/Modify the beeper number of the user.

255 Characters

Fax Number:

Displays/Modify the fax number of the user.

25 Characters

E-Mail Address*

Displays/Modify the email address of the user.

255 Characters

Confirm User E-mail Address*

Displays/Modify the email address of the user for confirmation.

255 Characters

User Misc

InForm Home Page Path

Displays/Modify the path of the InForm home page.

255 Characters

Change Password on Next Login

Displays the selected option.  Select Yes to change the password at next log on. Otherwise, select No.

NA

Date Format

Displays/Modify the date format.

NA

Load to InForm

Select the check box to load the user's information into the InForm system.

NA

Require IOL Training in

Displays/Select the areas in which the user requires training. Press and hold the Ctrl key to select multiple choices.

NA

Already Trained

Displays/Select the areas in which the user has already been trained.

NA

Email Trigger

Displays the selected email trigger option. This information refers to the email trigger of Registration and Certificate emails by eCS.

NA

Status:

Displays/Select the status of the user.

NA

Training Status:

Displays/Modify the training status of the user.

NA

Image Status:

Displays/Modify the image URL.

255 Characters

IOL Email ID

Displays/Modify the IOL Email ID of the user.

NA

Preferred Study Locale

Displays/Modify the preferred study locale of the user.

NA

Product Locale

Displays/Modify the product locale of the user.

NA

User Name in Email Notifications

Displays/Modify the user name order for the user service mail.

NA

IRT Related

Userid

Enter the IRT user ID.

NA

Middle Initial

Enter the middle initial of the user.

NA

Institution

Enter the institution of the user.

NA

Time Zone

Select the time zone from the drop-down list.

NA

Depot

Enter the depot of the user.

NA

IRT Role

Select the IRT role for the IRT user from the drop-down list.

NA

Load to IRT

Select the check box to load the user's information into the IRT system.

NA

OLX Related

View Patient Identifiable Data:*

Enter the data to identify the patient.

255 Characters

Load to OLX

Select the check box to load the user's information into the OLX system.

NA

User Association

Filter By

Displays/Select the filter criteria.

NA

Select Sites

Available

Displays the list of available sites. Use the >> or > button to move all or the selected sites respectively to the Selected field.

-

Selected

Displays the list of selected sites. Use the << or < button to move all or the selected sites respectively to the Available field.

-

Rights Group*/OLX Role Group*

Displays/Modify the Rights group of the user and OLX role group displays the roles of OLX user.

-

Signature Group

Displays/Modify the Signature group of the user.

-

Query Group

Displays/Modify the Query group of the user.

-

Manager Group

Displays/Modify the Manager group of the user.

-

Site Association Description

Provide the description about the site association.

NA

Active Date

Enter the active date.

NA

Pivotal Added Date

Enter the pivotal added date.

NA

Activation Date

Enter the activation date.

NA

Termination Date

Enter the termination date.

NA

Table A-4 Scenarios and Error Messages

Field Name

Scenario

Error Message

Current Sponsor Company

Error occurs when you click Submit without selecting a Sponsor Company

Select a Sponsor Company.

Trial

Error occurs when you click Submit without selecting a trial.

Select a Trial.

User Type

Error occurs when you click Submit without selecting user type.

Select User Type.

Username

Error occurs when you enter the character other than alphanumeric and underscore.

Enter a valid Username. Only Alphanumeric (A-Z, 0-9), underscores(_), and at sign (@) are allowed.

UserName

Error occurs when you click Submit without entering an username.

Error occurs when the user submit without enter Username.

FirstName

Error occurs when you click Submit without entering First Name.

Enter First Name.

First Name

Error occurs when you enter the character other than alphabet, hyphen, and blank space.

Enter a valid First Name. Only Letters (A-Z), Hyphens (-) and Blank Spaces are allowed.

Last Name

Error occurs when you click Submit without entering the last name.

Enter Last Name.

Last Name

Error occurs when you enter the character other than alphabet, hyphen, and blank space.

Enter a valid Last Name. Only Letters (A-Z), Hyphens (-) and Blank Spaces are allowed.

Title

NA

NA

Description

Error occurs when you enter an invalid character in the description.

Enter a valid Description. Only Alphanumerics (A-Z, 0-9), Hyphens(-), underscores(_), and Blank Spaces are allowed.

Display name

Error occurs when you click Submit without entering the display name.

Enter Display Name.

Address1

Error occurs when you enter an invalid character in Address1.

Enter a valid Address1. Only Alphanumerics (A-Z, 0-9), Period (.), Comma(,), Hyphens (-),underscores (_), and Blank Spaces are allowed.

Address2

Error occurs when you enter an invalid character in Address2.

Enter a valid Address2. Only Alphanumerics (A-Z, 0-9), Period (.), Comma(,), Hyphens(-), underscores(_), and Blank Spaces are allowed.

Town/City

Error occurs when you enter the character other than alphabet, integer, and blank space.

Enter a valid Town/City. Only Alphanumeric (A-Z,0-9) and Blank Spaces are allowed.

State/Province

Error occurs when you enter the character other than alphabet and blank space.

Enter a valid State/Province. Only Letters (A-Z) and Blank Spaces are allowed.

Uploaded to InForm

NA

Select the check box to view the list of InForm uploaded user details.

Country

NA

NA

Postal Code

Error occurs when you enter the character other than alphabet, integer, and blank space.

Enter a valid Postal Code. Only Alphanumeric (A-Z, 0-9) and Blank Spaces are allowed.

Phone Number

Error occurs when you click Submit without entering the phone number.

Enter Phone Number.

Phone Number

Error occurs when you enter the character other than alphabet, hyphen, and blank space.

Enter a valid Phone Number. Only Numbers (0-9), Hyphens (-) and Blank spaces are allowed.

Alternate Phone Number

Error occurs when you enter the character other than alphabet, hyphen, and blank space.

Enter a valid Alternate Phone Number. Only Numbers (0-9), Hyphens (-) and Blank spaces are allowed.

Beeper Number

Error occurs when you enter the character other than alphabet, hyphen, and blank space.

Enter a valid Beeper Number. Only Numbers (0-9), Hyphens (-) and Blank spaces are allowed.

Fax Number

Error occurs when you enter the character other than alphabet, hyphen, and blank space.

Enter a valid Fax Number. Only Numbers (0-9), Hyphens (-) and Blank spaces are allowed.

E-mail Address

Error occurs when you click Submit without entering the email address.

Enter E-Mail Address.

E-mail Address

Error occurs when you enter the wrong email ID or when you enter wrong mail format.

E-mail address does not end with @phaseforward.com. Select OK to continue. (This error message is displayed at the time of creating a PF user).

Please re-confirm your email address. Please note: Do not copy and paste your email address. (This message is displayed when the you copy and paste the email address).

The email address and the Confirm email address do not match. (This message is displayed when the email address and the confirm email address do not match).

Confirm User E-mail Address

Error occurs when you click Submit without confirming the user email address.

Enter Confirm User E-mail Address.

Confirm User E-mail Address

Error occurs when the email address and confirm email address mismatch.

Confirm E-mail Address does not match.

Confirm User E-mail Address

Error occurs when you enter the wrong email ID or when you enter wrong mail format.

E-mail address does not end with @phaseforward.com. Select OK to continue. (This error message is displayed at the time of creating a PF user).

Please re-confirm your email address. Please note: Do not copy and paste your email address. (This message is displayed when you to copy paste the email address).

The email address and the Confirm email address do not match. (This message is displayed when the email address and the confirm email address do not match).

InForm Home Page Path

Error occurs when you enter an invalid home page path.

Enter a valid Home Page path. Only Alphanumeric (A-Z, 0-9), Colon (:), Forward slash (/), Period (.), Hyphen (-) and Underscore (_) are allowed.

Change Password on Next Login

NA

NA

Date Format

NA

NA

Load to InForm

NA

NA

E-mail Trigger

NA

NA

Status

NA

NA

Training Status

NA

NA

Image URL

NA

NA

Filter By

NA

NA

Right Group

NA

NA

Signature Group

NA

NA

Query Group

NA

NA

Manager Group

NA

NA

Automatic Association

NA

NA

Validation for all fields

Error occurs when you click Submit without entering an appropriate data.

Select UserType.

Please Enter User Name.

Enter First Name.

Please Enter Last Name.

Please Enter Display name.

Please Enter Phone Number.

Please Enter E-mail Address.

Please Confirm User E-mail Address. (This message is displayed before selecting User Type).

Please Enter User Name.

Enter First Name.

Please Enter Last Name.

Please Enter Display name.

Please Enter Phone Number.

Please Enter E-mail Address.

Please Confirm User E-mail Address.

Select Rights Group. (This message is Displayed after selecting User Type and clicking on submit button.

Submit Button

NA

User Cannot be saved without 'InForm Settings' for the selected Sponsor and trial.

On Paste

NA

Please re-confirm your Email address. Please note: Do not copy and paste your Email address.

Automatic Association

NA

NA

User ID

Error occurs you enter the non-numeric values.

Enter a valid IRT userid. Only Numeric values are allowed.

Active Date

Error occurs when you enter an invalid date format.

Invalid Date Format in Active Date.

Pivotal Added Date

Error occurs when you enter an invalid date format.

Invalid Date Format in Pivotal Added Date.

Activation Date

Error occurs when you enter an invalid date format.

Invalid Date Format in Activation Date.

Termination Date

Error occurs when you enter an invalid date format.

Invalid Date Format in Termination Date.

Edit Page

Display name

Error occurs when you the display name is not entered.

Please Enter Display Name.

Reason For Change

Error occurs when you did not enter reason for change.

Please Enter The Reason For Change.

Clicking the Return button without saving the changes

Error occurs when you click Return without saving the changes.

You have made changes to this form. Press OK to ignore the changes and leave the form; Press Return to return to the form.

A.3 Modify InForm and IRT User Details

All fields marked with * are mandatory.

Table A-5 Modify InForm and IRT User Details – Field Information

Field Name

Description

Length

Basic User Info

User Type*

Displays the user type.

NA

Username*

Displays/Modify the name of the user.

25 Characters

First Name*

Displays/Modify the first name of the user.

127Characters

Last Name*

Displays/Modify the last name of the user.

127Characters

Title

Displays/Modify the title for the user.

NA

Description

Displays/Modify the description.

NA

Display Name*

Displays/Modify the display name of the user.

255 Characters

Contact Details

Address1* Address2:

Displays/Modify the communication address of the user.

255 Characters

Town/City*

Displays/Modify the town or city name to which the user belongs.

255 Characters

State/Province

Displays/Modify the state or province name to which the user belongs.

255 Characters

Country*

Displays/Modify the country to which the user belongs.

NA

Postal Code

Displays/Modify the postal code of the user.

16 Characters

Phone Number*

Displays/Modify the phone number of the user.

25 Characters

Alternate Phone Number

Displays/Modify the alternate phone number of the user.

25 Characters

Beeper Number:

Displays/Modify the beeper number of the user.

255 Characters

Fax Number:

Displays/Modify the fax number of the user.

25 Characters

E-Mail Address*

Displays/Modify the email address of the user.

255 Characters

Confirm User E-mail Address*

Displays/Modify the email address of the user for confirmation.

255 Characters

User Misc

InForm Home Page Path

Displays/Modify the path of the InForm home page.

255 Characters

Change Password on Next Login

Displays the selected option. Select Yes to change the password at next log on. Otherwise, select No.

NA

Date Format

Displays/Modify the date format.

NA

Load to InForm

Select the check box to load the user's information into the InForm system.

NA

Require IOL Training in

Displays/Select the areas in which the user requires training. Press and hold the Ctrl key to select multiple choices.

NA

Already Trained

Displays/Select the areas in which the user is already trained.

NA

Email Trigger

Displays the selected email trigger option. This information refers to the email trigger of Registration and Certificate emails by eCS.

NA

Status:

Displays/Select the status of the user.

NA

Training Status:

Displays/Modify the training status of the user

NA

Image Status:

Displays/Modify the image URL.

255 Characters

IOL Email ID

Displays/Modify the IOL email ID of the user

NA

Preferred Study Locale

Displays/Modify the preferred study locale of the user.

NA

Product Locale

Displays/Modify the product locale of the user.

NA

User Name in Email Notifications

Displays/Modify the user name order for the user service mail.

NA

IRT Related

Userid

Enter the IRT user ID.

NA

Middle Initial

Enter the middle initial of the user.

NA

Institution

Enter the institution of the user.

NA

Time Zone

Select the time zone from the drop-down list.

NA

Depot

Enter the depot of the user.

NA

IRT Role

Select the IRT role for the IRT user from the drop-down list.

NA

Load to IRT

Select the check box to load the user's information into the IRT system.

NA

OLX Related

View Patient Identifiable Data:*

Enter the data to identify the patient.

255 Characters

Load to OLX

Select the check box to load the user's information into the OLX system.

NA

User Association

Filter By

Displays/Select the filter criteria.

NA

Select Sites

- Available

Displays the list of available sites. Use the >> or > button to move all or the selected sites respectively to the Selected field.

-

- Selected

Displays the list of selected sites. Use the << or < button to move all or the selected sites respectively to the Available field.

-

Rights Group*/OLX Role Group*

Displays/Modify the Rights group of the user and OLX role group displays the roles of OLX user.

-

Signature Group

Displays/Modify the Signature group of the user.

-

Query Group

Displays/Modify the Query group of the user.

-

Manager Group

Displays/Modify the Manager group of the user.

-

Site Association Description

Provide the description about the site association.

NA

Active Date

Enter the active date.

NA

Pivotal Added Date

Enter the pivotal added date.

NA

Activation Date

Enter the activation date.

NA

Termination Date

Enter the termination date.

NA

Table A-6 Scenarios and Error Messages

Field Name

Scenario

Error Message

Current Sponsor Company

Error occurs when you click Submit without selecting a Sponsor Company.

Select a Sponsor Company.

Trial

Error occurs when you click Submit without selecting a trial.

Select a Trial.

User Type

Error occurs when you click Submit without selecting a user type.

Select User Type.

Username

Error occurs when you enter the character other than alphanumeric and underscore.

Enter a valid Username. Only Alphanumeric (A-Z,0-9) and underscores(_) are allowed.

UserName

Error occurs when you click Submit without entering the user name.

Error occurs when the user submit without enter Username.

FirstName

Error occurs when you click Submit without entering the first name.

Enter First Name.

First Name

Error occurs when you enter the character other than alphabet, hyphen, and blank space.

Enter a valid First Name. Only Letters (A-Z), Hyphens (-) and Blank Spaces are allowed.

Last Name

Error occurs when you click Submit without entering the last name.

Enter Last Name.

Last Name

Error occurs when you enter the character other than alphabet, hyphen, and blank space.

Enter a valid Last Name. Only Letters (A-Z), Hyphens (-) and Blank Spaces are allowed.

Title

NA

NA

Description

Error occurs when you enter an invalid character in the description.

Enter a valid Description. Only Alphanumerics (A-Z, 0-9), Hyphens(-), underscores(_), and Blank Spaces are allowed.

Display name

Error occurs when you click Submit without entering the display name.

Enter Display Name.

Address1

Error occurs when you enter an invalid character in Address1.

Enter a valid Address1. Only Alphanumerics (A-Z, 0-9), Period (.), Comma(,), Hyphens(-), underscores(_), and Blank Spaces are allowed.

Address2

Error occurs when you enter an invalid character in Address2.

Enter a valid Address2. Only Alphanumerics (A-Z, 0-9), Period (.),Comma(,), Hyphens(-), underscores (_), and Blank Spaces are allowed.

Town/City

Error occurs when you enter the character other than alphabet, integer, and blank space.

Enter a valid Town/City. Only Alphanumeric (A-Z, 0-9) and Blank Spaces are allowed.

State/Province

Error occurs when you enter the character other than alphabet and blank space.

Enter a valid State/Province. Only Letters (A-Z) and Blank Spaces are allowed.

Uploaded to InForm

NA

Select the check box to view the list of InForm uploaded user details.

Country

NA

NA

Postal Code

Error occurs when you enter the character other than alphabet, integer, and blank space.

Enter a valid Postal Code. Only Alphanumeric (A-Z, 0-9) and Blank Spaces are allowed.

Phone Number

Error occurs when you click Submit without entering the phone number.

Enter Phone Number.

Phone Number

Error occurs when you enter the character other than alphabet, hyphen, and blank space.

Enter a valid Phone Number. Only Numbers (0-9), Hyphens (-) and Blank spaces are allowed.

Alternate Phone Number

Error occurs when you enter the character other than alphabet, hyphen, and blank space.

Enter a valid Alternate Phone Number. Only Numbers (0-9), Hyphens (-) and Blank spaces are allowed.

Beeper Number

Error occurs when you enter the character other than alphabet, hyphen, and blank space.

Enter a valid Beeper Number. Only Numbers (0-9), Hyphens (-) and Blank spaces are allowed.

Fax Number

Error occurs when you enter the character other than alphabet, hyphen, and blank space.

Enter a valid Fax Number. Only Numbers (0-9), Hyphens (-) and Blank spaces are allowed.

E-mail Address

Error occurs when you click Submit without entering the email address.

Enter E-Mail Address.

E-mail Address

Error occurs when you enter the wrong email ID or wrong mail format.

E-mail address does not end with @phaseforward.com. Select OK to continue. (This error message is displayed at the time of creating a PF user).

Please re-confirm your email address. Please note: Do not copy and paste your email address. (This message is displayed when the you copy and paste the email address).

The email address and the Confirm email address do not match. (This message is displayed when the email address and the confirm email address do not match).

Confirm User E-mail Address

Error occurs when you click Submit without entering the confirm user email address.

Enter Confirm User E-mail Address.

Confirm User E-mail Address

Error occurs when the email address and confirm email address mismatch.

Confirm E-mail Address does not match.

Confirm User E-mail Address

Error occurs when you enter the wrong email ID or wrong mail format.

E-mail address does not end with @phaseforward.com. Select OK to continue. (This error message is displayed at the time of creating a PF user).

Please re-confirm your email address. Please note: Do not copy and paste your email address. (This message is displayed when you to copy paste the email address).

The email address and the Confirm email address do not match. (This message is displayed when the email address and the confirm email address do not match).

InForm Home Page Path

Error occurs when you enter an invalid home page path.

Enter a valid Home Page path. Only Alphanumeric (A-Z, 0-9), Colon (:), Forward slash (/), Period (.), Hyphen (-) and Underscore (_) are allowed.

Change Password on Next Login

NA

NA

Date Format

NA

NA

Load to InForm

NA

NA

E-mail Trigger

NA

NA

Status

NA

NA

Training Status

NA

NA

Image URL

NA

NA

Filter By

NA

NA

Right Group

NA

NA

Signature Group

NA

NA

Query Group

NA

NA

Manager Group

NA

NA

Automatic Association

NA

NA

Validation for all fields

Error occurs when you click Submit without entering an appropriate data.

Select UserType.

Please Enter User Name.

Enter First Name.

Please Enter Last Name.

Please Enter Display name.

Please Enter Phone Number.

Please Enter E-mail Address.

Please Confirm User E-mail Address. (This message is displayed before selecting User Type).

Please Enter User Name.

Enter First Name.

Please Enter Last Name.

Please Enter Display name.

Please Enter Phone Number.

Please Enter E-mail Address

Please Confirm User E-mail Address.

Select Rights Group. (This message is Displayed after selecting User Type and clicking on submit button.

Submit Button

NA

User Cannot be saved without 'InForm Settings' for the selected Sponsor and trial.

On Paste

NA

Please re-confirm your Email address.\n Please note: Do not copy and paste your Email address.

Automatic Association

NA

NA

User ID

Error occurs when you enter the non-numeric values.

Enter a valid IRT userid. Only Numeric values are allowed.

Active Date

Error occurs when you enter an invalid date format.

Invalid Date Format in Active Date.

Pivotal Added Date

Error occurs when you enter an invalid date format.

Invalid Date Format in Pivotal Added Date.

Activation Date

Error occurs when you enter an invalid date format.

Invalid Date Format in Activation Date.

Termination Date

Error occurs when you enter an invalid date format.

Invalid Date Format in Termination Date.

Edit Page

Display name

Error occurs when the display name is not entered.

Please Enter Display Name.

Reason For Change

Error occurs when the reason for change is not entered.

Please Enter The Reason For Change.

Clicking the Return button without saving the changes

Error occurs when you click Return without saving the changes.

You have made changes to this form. Press OK to ignore the changes and leave the form; Press Return to return to the form.

A.4 Multiple Association

Table A-7 Multiple Association – Field Information

Field Name

Description

Select User

Select a user for whom you want to view site association details.

User

Displays the name of the selected user.

Site No.

Displays the number of sites that are associated with the selected user.

Provisioning Recommendation

Displays whether provisioning recommendation has begun.

Assessment Status

Displays the assessment status of the site. This column is displayed only if the Switch off Site Assessment facility check box is not selected in the InForm Config page.

P/F

Display the pass or fail details for the site.

Table A-8 Multiple Association – Error Information

Field Name/Action

Scenario

Error Message

Site

Error occurs when you click Go without selecting any site.

Select a site.

Go Button

Error occurs when you click Go without selecting any action in drop-down list.

Select an action.

Associate user

Error occurs when the not approved sites are associated to user.

One or more site(s) are not approved. Approve to Request Equipment Assessment.

Associate user

Error occurs when the assessed sites are associated to the user.

One or more of the selected sites is already assessed/currently being Assessed.

Immediate Provisioning

Error occurs when the sites already marked for immediate provisioning are again marked for the same.

One or more of the selected sites is already marked for Immediate Provisioning - Equipment Assessment is not available.

Equipment Assessment

Error occurs when you mark the site for equipment assessment where the user is already marked for Equipment Assessment.

User is already marked for Equipment Assessment at this site.

Mark Sites as Assessed

Error occurs when you mark the sites as assessed which is already marked as Assessed.

One or more of the selected sites is already marked as Assessed.

Mark Sites as Assessed

Error occurs when you give assessment for the site of the user whose assessment process is completed.

Assessment is completed for one or more selected user(s).

Immediate Provisioning

Error occurs when you mark the site for immediate provisioning to the sites which is already marked for immediate provisioning.

One or more of the selected sites is already marked for Immediate Provisioning.

Immediate Provisioning

Error occurs when you mark the assessed sites to immediate provisioning.

One or more of the selected sites is already assessed/currently being Assessed - immediate provisioning is not available.

Immediate Provisioning

Error occurs when the user already requested for equipment assessment is requesting for immediate provisioning.

Users requested for Equipment Assessment cannot be requested for Immediate provisioning. One or more users selected have been requested for Equipment Assessment (If pending user given Immediate provisioning).

Stop Assessment

Error occurs when you stop assessment for the sites associated with the user who status is Provisioning Recommended - Requires Customer Approval.

Cannot stop Assessment process for User(s) with status as ''Provisioning Recommended - Requires Customer Approval''.

Stop Assessment

Error occurs when you stop assessment for the sites associate with the user who status is Requires Customer Assistance.

Cannot stop Assessment process for User(s) with status as ''Requires Customer Assistance''.

Stop Assessment

Error occurs when you stop assessment for the sites associate with the user who status is Provisioning - Started.

Cannot stop Assessment process for User(s) with status as ''Provisioning - Started''.

Stop Assessment

Error occurs when you stop assessment for the sites associate with the user who have immediate provisioning started.

Assessment cannot be stopped for user(s) who has immediate provisioning started.

Stop Assessment

Error occurs when you assessment for the sites associated with the user who is already assessed.

Assessment cannot be stopped for user(s) who is already Assessed.

Stop Assessment

Error occurs when stop the assessment process for the site when the user of the site do not have the assessment process started.

One or more selected users does not have the Assessment process started.

Stop Assessment

Error occurs when you stop the assessment process for the site when the user of the site has stopped the assessment process already.

One or more selected users Assessment process has already stopped.

Go Button

Error occurs when you click Go without selecting an action.

Select an action.

Comments

Error occurs when you enter more than 255 character in a comment text-box.

Comments text should not exceed 255 characters.

A.5 Global User List Page

Table A-9 Global User List Page – Field Information

Field Name

Description

Field Size

Basic User Info

User Name

User name is displayed for all users.

32 Characters

First Name

The first name is displayed for all users

255 Characters

Last Name

The Last Name is displayed for all users.

127 Characters

Email

The email id is displayed for all users

127 Characters

Display Name

This field is displayed for all product

255 Characters

Country

This field is displayed for all products after selecting the trial.

NA

User Type:

This field is available for both InForm and IRT products.

NA

Phone Number

This field is available for all products.

16 Characters

InForm Role

This field is available for both InForm and joint InForm IRT products.

NA

IRT Role

This field is available for both IRT and joint InForm IRT products.

NA

UMT Role

This field is available only for UMT products.

NA

Username in Email notification

This field is available for both InForm and IRT products with trial version above 4.5.

NA

Preferred study locale

This field is available for both InForm and IRT products with trial version above 4.5.

NA

Product Locale

This field is available for both InForm and IRT products with trial version above 4.5.

NA

Load To InForm

This field is available for InForm and Joint InForm IRT products with trial version above 4.5.

NA

Load To IRT

This field is available for IRT and Joint InForm IRT products with trial version above 4.5.

NA

Sites

This field is available for InForm products to let you assign sites.

NA

Export To Excel Link

Select an user and click this to export the user details to an Excel spreadsheet.

NA

Import

This field lets you import the user details.

NA

A.6 Create Global User

Table A-10 Create Global User - Field Information

Field Name/

Description

Field Size (In Character)

Basic User Info:

User Type

You need to select the type of user, either sponsor user or site user.

NA

User Name *

The user name format must follow the specifications in the UMT settings.

255 Characters

First Name*

Enter the first name of the user.

127 Characters

Last Name*

Enter the last name of the user.

127 Characters

Title

Select a title for the user from the drop-down list.

NA

Description

Enter the description for the user.

255 Characters

Display Name

Enter the display name for the user.

255 Characters

Contact Details

Address1

Enter the communication address1 of the user.

255 Characters

Address2

Enter the communication address2 of the user.

255 Characters

Town/City

Enter the town or city to which the user belongs.

255 Characters

State/Province

Enter the state or province to which the user belongs.

255 Characters

Country

Select the country to which the user belongs from the drop-down list.

NA

Postal Code

Enter the postal code of the user.

16 Characters

Phone Number

Enter the phone number of the user.

25 Characters

Alternate Phone Number

Enter the alternate phone number of the user.

25 Characters

Beeper Number

Enter the beeper number of the user.

25 Characters

Fax Number

Enter the fax number of the user.

25 Characters

E-mail Address*

Enter the email address of the user.

255 Characters

Confirm User E-mail Address*

Enter the email address of the user for confirmation.

255 Characters

User Misc

Assessment mail

Select whether to enable or disable assessment mail.

NA

Image URL

Enter the URL of the image.

255 characters

Change password in next login

Select Yes or No.

NA

Date Format

Select the format for the date to be displayed.

NA

Training Status

Select the training status from the options given.

NA

Load to InForm

Select if you want to load the user to InForm.

NA

IRT Related

User Id

Enter the user ID.

255 Characters

Depot

Enter the depot.

255 Characters

Middle Initials

Enter the middle initials.

255 Characters

Institution

Enter the institution.

255 Characters

Load to IRT

Select if you want to upload the user to IRT.

NA

Table A-11 Create Global User - Error Information

Field Name

Scenario

Error Message

Filter Section:

Basic User Info

User Type

You need to select the type of user, either sponsor user or site user.

NA

User Name*

Error occurs when you enter the character other than alphanumeric and underscore.

Enter a valid Username. Only Alphanumeric (A-Z, 0-9) and underscores (_) are allowed.

First Name*

Error occurs when you enter the character other than alphabet, hyphen, and blank space.

Enter a valid First Name. Only Letters (A-Z), Hyphens (-), and Blank Spaces are allowed.

Last Name*

Error occur when you enter the character other than alphabet, hyphen, and blank space.

Enter a valid Last Name. Only Letters (A-Z), Hyphens (-), and Blank Spaces are allowed.

Title

NA

NA

Description:

Enter the description for the user.

255 Characters

Display Name:

Enter the display name for the user.

255 Characters

Change Password on Next Login

NA

NA

Contact Details

Address1

Enter the communication address1 of the user.

255 Characters

Address2

Enter the communication address2 of the user.

255 Characters

Town/City

Enter the town or city to which the user belongs.

255 Characters

State/Province

Enter the state or province to which the user belongs.

255 Characters

Country

Select the country to which the user belongs from the drop-down list.

NA

Postal Code

Enter the postal code of the user.

16 Characters

Phone Number

Enter the phone number of the user.

25 Characters

Alternate Phone Number

Enter the alternate phone number of the user.

25 Characters

Beeper Number

Enter the beeper number of the user.

25 Characters

Fax Number

Enter the fax number of the user.

25 Characters

E-mail Address*

Error occurs when you click Submit without entering a valid email ID.

Enter a valid email ID.

Confirm User E-mail Address*

Error occurs when you do not enter the confirm email address.

Confirm the email address.

A.7 Edit Global User

Table A-12 Edit Global User - Field Information

Field Name/

Description

Field Size (In Character)

Basic User Info:

User Type

You need to select the type of user, either sponsor user or site user.

NA

User Name *

The user name format must follow the specifications in the UMT settings.

255 Characters

First Name*

Enter the first name of the user.

127 Characters

Last Name*

Enter the last name of the user.

127 Characters

Title

Select a title for the user from the drop-down list.

NA

Description

Enter the description for the user.

255 Characters

Display Name

Enter the display name for the user.

255 Characters

Contact Details

Address1

Enter the communication address1 of the user.

255 Characters

Address2

Enter the communication address2 of the user.

255 Characters

Town/City

Enter the town or city to which the user belongs.

255 Characters

State/Province

Enter the state or province to which the user belongs.

255 Characters

Country

Select the country to which the user belongs from the drop-down list.

NA

Postal Code

Enter the postal code of the user.

16 Characters

Phone Number

Enter the phone number of the user.

25 Characters

Alternate Phone Number

Enter the alternate phone number of the user.

25 Characters

Beeper Number

Enter the beeper number of the user.

25 Characters

Fax Number

Enter the fax number of the user.

25 Characters

E-mail Address*

Enter the email address of the user.

255 Characters

Confirm User E-mail Address*

Enter the email address of the user for confirmation.

255 Characters

User Misc

Assessment mail

Select whether to enable or disable assessment mail.

NA

Image URL

Enter the URL of the image.

255 characters

Change password in next login

Select Yes or No.

NA

Date Format

Select the format for the date to be displayed.

NA

Training Status

Select the training status from the options given.

NA

Load to InForm

Select if you want to load the user to InForm.

NA

IRT Related

User Id

Enter the user ID.

255 Characters

Depot

Enter the depot.

255 Characters

Middle Initials

Enter the middle initials.

255 Characters

Institution

Enter the institution.

255 Characters

Load to IRT

Select if you want to load the user to IRT.

NA

Table A-13 Edit Global User - Error Information

Field Name

Scenario

Error Message

Filter Section:

Basic User Info

User Type

You need to select the type of user, either sponsor user or site user.

NA

User Name*

Error occurs when you enter the character other than alphanumeric and underscore.

Enter a valid Username. Only Alphanumeric (A-Z, 0-9) and underscores (_) are allowed.

First Name*

Error occurs when you enter the character other than alphabet, hyphen, and blank space.

Enter a valid First Name. Only Letters (A-Z), Hyphens (-), and Blank Spaces are allowed.

Last Name*

Error occur when you enter the character other than alphabet, hyphen, and blank space.

Enter a valid Last Name. Only Letters (A-Z), Hyphens (-), and Blank Spaces are allowed.

Title

NA

NA

Description

Enter the description for the user.

255 Characters

Display Name

Enter the display name for the user.

255 Characters

Change Password on Next Login

NA

NA

Contact Details

Address1

Enter the communication address1 of the user.

255 Characters

Address2

Enter the communication address2 of the user.

255 Characters

Town/City

Enter the town or city to which the user belongs.

255 Characters

State/Province

Enter the state or province to which the user belongs.

255 Characters

Country

Select the country to which the user belongs from the drop-down list.

NA

Postal Code

Enter the postal code of the user.

16 Characters

Phone Number

Enter the phone number of the user.

25 Characters

Alternate Phone Number

Enter the alternate phone number of the user.

25 Characters

Beeper Number

Enter the beeper number of the user.

25 Characters

Fax Number

Enter the fax number of the user.

25 Characters

E-mail Address*

Error occurs when you click Submit without entering an valid email ID.

Enter a valid email ID.

Confirm User E-mail Address*

Error occurs when you do not enter the confirm email address.

Confirm email address.

A.8 InForm Roles

Table A-14 InForm Roles – Field Information

Field Name

Description

Field Size

Filter Section

Role Name

Enter the name of the role.

63 Characters

Approval Status

Select the approval status from the drop-down list.

NA

InForm Role Details

Role Name

Displays the name of the role. Click the hyperlink to view the role details.

NA

Approved/Pending

Displays the approval status of the role.

NA

Member Count

Displays the number of members in the role.

NA

User Association

Click the icon to view the user-role associations.

NA

Display OverRide

Click the icon to set the display override option for selected Item group.

NA

Transfer Role

Click the icon to transfer role for selected users from one role to another.

NA

A.9 Create InForm Role

Table A-15 Create InForm Role – Field Information

Field Name

Description

Field Size

Role*

Enter the name of the role.

63 character

Role Type*

Select a role type by clicking the corresponding check box.

NA

User Admin

Displays the list of user administration rights.

To assign a privilege (rights), select the corresponding check box.

NA

User Misc

Displays the list of user miscellaneous rights.

To assign a privilege (rights), select the corresponding check box.

NA

CRF Rights

Displays the list of CRF rights.

To assign a privilege (rights), select the corresponding check box.

NA

Case Book Rights

Displays the list of case book rights.

To assign a privilege (rights), select the corresponding check box.

NA

Query Rights

Displays the list of query rights.

To select the rights, click the corresponding check boxes.

NA

Rule Rights

Displays the list of user rule rights.

To assign a privilege (rights), select the corresponding check box.

NA

Synchronization

Displays the list of synchronization rights.

To assign a privilege (rights), select the corresponding check box.

NA

Navigation

Displays the list of navigation rights.

To assign a privilege (rights), select the corresponding check box.

NA

System Admin Rights

Displays the list of system administration rights.

To assign a privilege (rights), select the corresponding check box.

NA

Select Classes

Select the class from the drop-down list.

NA

Available

Displays the list of available IOL classes.

Click >> or > to move all or the selected classes, respectively, to the Selected field.

NA

Selected

Displays the list of selected IOL classes.

Click << or < to move all or the selected classes, respectively, to the Available field.

NA

Table A-16 Create InForm Role – Error Information

Field Name/Action

Scenario

Error Message

Role*

Error occurs when you click Submit without entering a role name.

Enter a valid Role Name. Only Alphanumerics. (A-Z, 0-9), Hyphens(-), underscores(_), and blank spaces are allowed.

Role Type*

Error occurs when you click Submit without selecting a role type.

Select a Role Type.

Submit Button

Error occurs when the Patient Transfer Right is selected for the trial running in the InForm 4.5 version.

Patient Transfer Right can be selected only for Trials running in InForm 4.5 Version.

Submit Button

Error occurs when the Custom Reports and Admin Reports Rights are selected for the trial running in the InForm 4.5 version.

InForm 4.5 Version cannot have Custom Reports and Admin Reports Right.

Submit Button

Error occurs when the Custom Reports Right is selected for the trial running in the InForm 4.5 version.

InForm 4.5 Version cannot have Custom Reports Right.

Submit Button

Error occurs when the Patient Transfer Right is selected for the trial running in the InForm 4.5 version.

InForm 4.5 Version cannot have Admin Reports Right.

Submit Button

Error occurs when no rights are associated to the Role.

Associate at least one Right for the Role.

Submit Button

Error occurs when you click Submit without entering all mandatory fields.

Complete all mandatory fields before saving.

Role Name

Error occurs when you enter invalid character other than alphanumerics and hyphens.

Enter a valid Role Name. Only Alphanumerics (A-Z, 0-9), Hyphens(-), underscores (_), and blank spaces are allowed.

A.10 InForm Role Details

Table A-17 InForm Role Details – Field Information

Field Name

Description

Field Size

Role*

Enter the name of the role.

63 character

Role Type*

Select a role type by clicking the corresponding check box.

NA

User Admin

Displays the list of user administration rights.

To assign a privilege (rights), select the corresponding check box.

NA

User Misc

Displays the list of user miscellaneous rights.

To assign a privilege (rights), select the corresponding check box.

NA

CRF Rights

Displays the list of CRF rights.

To assign a privilege (rights), select the corresponding check box.

NA

Case Book Rights

Displays the list of case book rights.

To assign a privilege (rights), select the corresponding check box.

NA

Query Rights

Displays the list of query rights.

To select the right, click the corresponding check boxes.

NA

Rule Rights

Displays the list of user rule rights.

To assign a privilege (rights), select the corresponding check box.

NA

Synchronization

Displays the list of synchronization rights.

To assign a privilege (rights), select the corresponding check box.

NA

Navigation

Displays the list of navigation rights.

To assign a privilege (rights), select the corresponding check box.

NA

System Admin Rights

Displays the list of system administration rights.

To assign a privilege (rights), select the corresponding check box.

NA

Select Classes

Select the class from the drop-down list.

NA

Available

Displays the list of available IOL classes.

Click >> or > to move all or the selected classes, respectively, to the Selected field.

NA

Selected

Displays the list of selected IOL classes.

Click << or < to move all or the selected classes, respectively, to the Available field.

NA

Table A-18 InForm Role Details – Error Information

Field Name/Action

Scenario

Error Message

Role

Error occurs when you click Submit without entering a role name.

Enter a valid Role Name. Only Alphanumerics. (A-Z, 0-9), Hyphens(-), underscores(_), and blank spaces are allowed.

Role Type

Error occurs when you click Submit without selecting a role type.

Select a Role Type.

Submit Button

Error occurs when Patient Transfer Right is selected for the trial running in the InForm 4.5 version.

Patient Transfer Right can be selected only for Trials running in InForm 4.5 Version.

Submit Button

Error occurs when Custom Reports and Admin Reports Rights are selected for the trial running in the InForm 4.5 version.

InForm 4.5 Version cannot have Custom Reports and Admin Reports Right.

Submit Button

Error occurs when Custom Reports Right is selected for the trial running in the InForm 4.5 version.

InForm 4.5 Version cannot have Custom Reports Right.

Submit Button

Error occurs when Patient Transfer Right is select for the trial running in the InForm 4.5 version.

InForm 4.5 Version cannot have Admin Reports Right.

Submit Button

Error occurs when no rights are associated to the Role.

Associate at least one Right for the Role.

Submit Button

Error occurs when you click Submit without entering all mandatory fields.

Complete all mandatory fields, before Saving.

Role Name

Error occurs when you enter an invalid character other than alphanumerics and hyphens.

Enter a valid Role Name. Only Alphanumerics (A-Z, 0-9), Hyphens(-), underscores (_), and blank spaces are allowed

Reason for Change

Error occurs when you submit the form without entering any reason for the change.

Enter a reason for the change.

A.11 User, Role Association

Table A-19 User, Role Association – Field Information

Field Name

Description

Select Users

- Available

Displays the list of available users.

Click >> or > to move all or the selected users, respectively, to the Selected field.

- Selected

Displays the list of selected users. Use the << or < button to move all or the selected users, respectively, to the Available field.

Already Associated

Displays the name of users that are already associated with the role.

Table A-20 User - Role Association – Error Information

Field Name/Action

Scenario

Error Message

Submit Form

Error errors when you click Submit without making any change in the form.

Form not Changed.

A.12 Display and Change Override

Table A-21 Display Override – Field Information

Field Name

Description

Select Item Groups

- Available

Displays the list of available time zones.

Click >> or > to move all or the selected time zones, respectively, to the Selected field.

- Selected

Displays the list of selected time zones.

Click << or < to move all or the selected time zones, respectively, to the Available field.

Select Display Override

Select the corresponding radio button to set the display override option as read-only, editable, or hidden.

Table A-22 Change Display Override – Field Information

Field Name

Description

Select Item Groups

- Available

Displays the list of available time zones.

Click >> or > to move all or the selected time zones, respectively, to the Selected field.

- Selected

Displays the list of selected time zones.

Click << or < to move all or the selected time zones, respectively, to the Available field.

Select Display Override

Select the corresponding radio button to set the display override option as read-only, editable, or hidden.

Table A-23 Change Display Override – Error Information

Field Name/Action

Scenario

Error Message

Submit Form

Error occurs when you click Submit without making any change in the form.

Form not Changed.

A.13 List of Groups

Table A-24 List of Groups – Field Information

Field Name

Description

Field Size

Filter Section

Group Name

Enter the name of the group.

63 Characters

Group Type

Select the group type from the drop-down list.

NA

Approval Status

Select the approval status from the drop-down list.

NA

Group Details

NA

Group Name:

Displays the name of the group. Click the hyperlink to view the group details.

NA

Group Type

Displays the type of the group.

The group type can be ItemGroup, ManagerUser, Query, ReportGroup, and Signature.

NA

Approval Status

Displays the approval status of the group.

The approval status can be Approved, Rejected, or Pending.

NA

Member Count

Displays the number of members in the group.

NA

User Association

Click the icon to view the user-role associations.

NA

Table A-25 List of Groups – Error Information

Field Name/Action

Scenario

Error Message

Approve Group

Error occurs when you click Go without selecting a group.

Select a Group to Approve.

Go Button

Error occurs when you click Go without selecting a group.

Select any one of the check boxes and then proceed.

Go Button

Error occurs when you click Go without selecting any item in the Select drop-down list.

Choose an action.

Rejection

Error occurs when you click Go without entering reason for rejection in the Comments text box.

Enter Reason for Rejection.

Approve/Reject

Error occurs when you approve or reject a group which is already approved or rejected.

Only Pending groups can be Approved / Rejected.

User Association

Error occurs when you click the user association icon of Item Group.

Item group cannot have user associations.

Find Button

Error occurs when you click Find without selecting a trial.

Select a trial.

Find Button

Error occurs when you click Find without selecting a sponsor.

Select a Sponsor Company.

A.14 Create Groups

Table A-26 Create Groups - Field Information

Field Name/

Description

Field Size (In Character)

Group Details

Group Name*

Enter the name of the group.

63 Characters

Group Type*

Select the type of the group from the drop-down list.

NA

Group Description

Enter a description about the group.

255 Characters

Fields for Item Group

Item Association

Select Items-

Group Description

Enter a description of the group.

255 Characters

Available

Displays the list of available items.

Click >> or > to move all or the selected items, respectively, to the Selected field.

NA

Selected

Displays the list of selected items.

Click << or < to move all or the selected items, respectively, to the Available field.

NA

Fields for Manager User Group

Manager of*

Select the users that reports to the manager from the drop-down list.

NA

Group Description

Enter a description of the manager user group.

255 Characters

Role Association

Select Roles

Available

Displays the list of available users.

Click >> or > to move all or the selected users, respectively, to the Selected field.

NA

Selected

Displays the list of selected users.

Click << or < to move all or the selected users, respectively, to the Available field.

NA

Fields for Query Group

Group Description

Enter a description of the query group.

255 Characters

Select Roles

Available

Displays the list of available users.

Click >> or > to move all or the selected users, respectively, to the Selected field.

NA

Selected

Displays the list of selected users.

Click << or < to move all or the selected users, respectively, to the Available field.

NA

Fields for Report Group

Group Description

Enter a description of the report group.

255 Characters

Select Roles

Available

Displays the list of available users.

Click >> or > to move all or the selected users, respectively, to the Selected field.

NA

Selected

Displays the list of selected users.

Click << or < to move all or the selected users, respectively, to the Available field.

NA

Fields for Signature Group

Select Form

Select a form from the list box.

NA

Final CRF True

Select the check box, if required.

NA

False

Select the check box, if required.

NA

Added Forms

Displays the selected form.

NA

Signature Meaning (CRF)

Select a signature meaning from the drop-down list.

NA

Default

Select the check box, if required.

NA

Customized

Select the check box, if required.

NA

Signature Meaning (CRB)

Select a signature meaning from the drop-down list.

NA

Default

Select the check box, if required.

NA

Customized

Select the check box, if required.

NA

Group Description

Enter a description of the signature group.

NA

Group Details

Available

Displays the list of available users.

Click >> or > to move all or the selected users, respectively, to the Selected field.

NA

Selected

Displays the list of selected users.

Click << or < to move all or the selected users, respectively, to the Available field.

NA

Table A-27 Create Group - Error Information

Field Name

Scenario

Error Message

Group Details

Group Name*

Error occurs when you click Submit without entering the group name.

Please Enter a Group Name.

Group Type*

Error occurs when you click Submit without selecting the group type.

Select a Group Type.

Group Description

Error occurs when you enter more than 255 characters in the description.

Enter a group description not more than 255 characters.

Fields for Item Group

Item Association

Select Items-

Group Description

Error occurs when you enter more than 255 characters in the description.

Enter a group description not more than 255 characters.

Available

NA

NA

Selected

NA

NA

Fields for Manager User Group

Manager of*

Error occurs when you click Submit without selecting manager of the field.

Manager should be chosen.

Group Description

Error occurs when you enter more than 255 characters in the description.

Enter a group description not more than 255 characters.

Role Association

Select Roles

Available

NA

NA

Selected

NA

NA

Fields for Query Group

Group Description

Error occurs when you enter more than 255 characters in the description.

Enter a group description not more than 255 characters.

Select Roles

Available

NA

NA

Selected

NA

NA

Fields for Report Group

Group Description

Error occurs when you enter more than 255 characters in the description.

Enter a group description not more than 255 characters.

Select Roles

Available

NA

NA

Selected

NA

NA

Fields for Signature Group

Select Form

Error occurs when you click Submit without selecting a form.

Select a Form.

Final CRF True

Error occurs when you turn more than one form true.

Only one form with True is allowed.

False

NA

NA

Added Forms

NA

NA

Signature Meaning (CRF)

Error occurs when you click Submit without selecting the CRF Signature.

Enter CRF Signature Meaning.

Default

Error occurs when you click Submit without selecting the CRF type.

Select CRF Default/Customized Affidavit type.

Customized

Error occurs when you click Submit without selecting the CRF type.

Select CRF Default/Customized Affidavit type.

Signature Meaning (CRB)

Error occurs when you click Submit without selecting the CRB signature.

Enter CRB Signature Meaning.

Default

Error occurs when you click Submit without selecting the CRB type.

Select CRB Default/Customized Affidavit type.

Customized

Error occurs when you click Submit without selecting the CRB type.

Select CRB Default/Customized Affidavit type.

Group Description

Error occurs when you enter more than 255 characters in the description.

Enter a group description not more than 255 characters.

Group Details

Available

NA

NA

Selected

NA

NA

A.15 View and Modify User and Group Association

Table A-28 View and Modify User and Group Association

Field Name

Description

Select Users

Available

Displays the list of available items.

Click >> or > to move all or the selected items, respectively, to the Selected field.

Selected

Displays the list of selected items.

Click << or < to move all or the selected items, respectively, to the Available field.

A.16 Edit Groups

Table A-29 Edit Groups - Field Information

Field Name/

Description

Field Size (In Character)

Group Details

Group Type*

Select the type of the group from the drop-down list.

NA

Group Description

Enter a description about the group.

255 Characters

Fields for Item Group

Item Association

Select Items-

Group Description

Enter a description of the group.

255 Characters

Available

Displays the list of available items.

Click >> or > to move all or the selected items, respectively, to the Selected field.

NA

Selected

Displays the list of selected items.

Click << or < to move all or the selected items, respectively, to the Available field.

NA

Fields for Manager User Group

Manager of*

Select the users that reports to the manager from the drop-down list.

NA

Group Description

Enter a description of the manager user group.

255 Characters

Role Association

Select Roles

Available

Displays the list of available users.

Click >> or > to move all or the selected users, respectively, to the Selected field.

NA

Selected

Displays the list of selected users.

Click << or < to move all or the selected users, respectively, to the Available field.

NA

Fields for Query Group

Group Description

Enter a description of the query group.

255 Characters

Select Roles

Available

Displays the list of available users.

Click >> or > to move all or the selected users, respectively, to the Selected field.

NA

Selected

Displays the list of selected users.

Click << or < to move all or the selected users, respectively, to the Available field.

NA

Fields for Report Group

Group Description

Enter a description of the report group.

255 Characters

Select Roles

Available

Displays the list of available users.

Click >> or > to move all or the selected users, respectively, to the Selected field.

NA

Selected

Displays the list of selected users.

Click << or < to move all or the selected users, respectively, to the Available field.

NA

Fields for Signature Group

Select Form

Select a form from the list box.

NA

Final CRF True

Select the check box, if required.

NA

False

Select the check box, if required.

NA

Added Forms

Displays the selected form.

NA

Signature Meaning (CRF)

Select a signature meaning from the drop-down list.

NA

Default

Select the check box, if required.

NA

Customized

Select the check box, if required.

NA

Signature Meaning (CRB)

Select a signature meaning from the drop-down list.

NA

Default

Select the check box, if required.

NA

Customized

Select the check box, if required.

NA

Group Description

Enter a description of the signature group.

NA

Group Details

Available

Displays the list of available users.

Click >> or > to move all or the selected users, respectively, to the Selected field.

NA

Selected

Displays the list of selected users.

Click << or < to move all or the selected users, respectively, to the Available field.

NA

Table A-30 Edit Group - Error Information

Field Name

Scenario

Error Message

Group Details

Group Name*

Error occurs when you click Submit without entering the group name.

Please Enter a Group Name.

Group Type*

Error occurs when you click Submit without selecting the group type.

Select a Group Type.

Group Description

Error occurs when you enter more than 255 characters in the description.

Enter a group description not more than 255 characters.

Fields for Item Group

Item Association

Select Items-

Group Description

Error occurs when you enter more than 255 characters in the description.

Enter a group description not more than 255 characters.

Available

NA

NA

Selected

NA

NA

Fields for Manager User Group

Manager of*

Error occurs when you click Submit without selecting the manager of field.

Manager should be chosen.

Group Description

Error occurs when you enter more than 255 characters in the description.

Enter a group description not more than 255 characters.

Role Association

Select Roles

Available

NA

NA

Selected

NA

NA

Fields for Query Group

Group Description

Error occurs when you enter more than 255 characters in the description.

Enter a group description not more than 255 characters.

Select Roles

Available

NA

NA

Selected

NA

NA

Fields for Report Group

Group Description

Error occurs when you enter more than 255 characters in the description.

Enter a group description not more than 255 characters.

Select Roles

Available

NA

NA

Selected

NA

NA

Fields for Signature Group

Select Form

Error occurs when you click Submit without selecting a form.

Select a Form.

Final CRF True

Error occurs when you turn more than one form true.

Only one form with True is allowed.

False

NA

NA

Added Forms

NA

NA

Signature Meaning (CRF)

Error occurs when you click Submit without selecting the CRF Signature.

Enter CRF Signature Meaning.

Default

Error occurs when click Submit without selecting the CRF type.

Select CRF Default/Customized Affidavit type.

Customized

Error occurs when you click Submit without selecting the CRF type.

Select CRF Default/Customized Affidavit type.

Signature Meaning (CRB)

Error occurs when you click Submit without selecting the CRB Signature.

Enter CRB Signature Meaning.

Default

Error occurs when you click Submit without selecting the CRB type.

Select CRB Default/Customized Affidavit type.

Customized

Error occurs when you click Submit without selecting the CRB type.

Select CRB Default/Customized Affidavit type.

Group Description

Error occurs when you enter more than 255 characters in the description.

Enter a group description not more than 255 characters.

Group Details

Available

NA

NA

Selected

NA

NA

A.17 Configuration Settings

Table A-31 Configuration Settings - Field Information

Field Name/

Description

Field Size (In Character)

Outbound Integration and SSO Configurations

Vanity URL

Enter the vanity URL for customer.

NA

Reset Passoword URL

Enter the URL to reset the password.

NA

Short Org ID

Enter the customer URL prefix for SSO-enabled customers.

NA

Trial Configurations

Trial Level Duplicate

Select Yes to duplicate a trial level. Otherwise, select No.

NA

Enable Duplicate Merging

Select the check box to enable duplicate merging.

NA

Send E-mails for Failed Uploads

Select Yes to send emails for failed uploads. Otherwise, select No.

If you select Yes, enter the email address in the E-mail Address text box.

NA

Switchoff IOL

Select the check box to disable the IOL feature.

NA

Switchoff Global User

Select the check box to disable Global User.

NA

Sponsor Name for UMT Mails

Select the required option to use the sponsor name for UMT mails. The available options are:

- Append Sponsor name with Sponsor Customer Name - Select this option to append sponsor name with sponsor customer name.

- Replace Sponsor name with Sponsor Customer name - Select this option to replace sponsor name with sponsor customer name.

NA

Enforce UM/UA Approval Process

Select Yes to enforce UM/UA approval process. Otherwise, select No.

NA

Default TimeZone

Select the required default time zone. The available options are:

- Time Zones Dec 2012

- Time Zones Dec 2011

NA

PF-Japan Managed Trials

Select Yes if the trials are PF-Japan Managed trials. Otherwise, select No.

NA

Email Address to send Worklist Notification

Enter the email address to send the worklist notification.

NA

Import Path

Click Browse to select the import path.

NA

Schedule Import Enable

Select Import Enable to enable schedule import data transfer to the InForm system.

This option is for Secure File Transfer Protocol (SFTP) file upload.

NA

Schedule Import Disable

Select Import Disable to disable schedule import data transfer to the InForm system.

This option is for SFTP file upload.

NA

Schedule Export Enable

Select Export Enable to enable schedule export data transfer to the InForm system.

This option is for SFTP file upload.

NA

Schedule Export Disable

Select Export Disable to disable schedule export data transfer to the InForm system.

This option is for SFTP file upload.

NA

Send E-mails for Duplicated Imports

Select Yes to send emails for duplicated imports. Otherwise, select No.

If you select Yes, enter the email address in the text box.

NA

Send E-mails on Failed/Successful Import

Select Success to send emails for successful import. Select Fail to send emails for failed import.

Enter the email address in the text box to send emails for successful or failed import based on the selection.

NA

Requires Training to send InForm Account details

Select the check box if training is required to send InForm account details.

NA

Free Phone Number URL

Select the required free phone number URL. The available options are:

- Phaseforward Helpdesk

- Sponsor Specific

If you select Sponsor Specific, enter the URL in the Sponsor Specific URL text box.

NA

Site Configuration

Default Study Version

Select the default study version. The available options are:

- Latest: Select this option to set the latest study version as default.

- Multiple: Select this option to set multiple study versions as default.
Note: To add a new study version, select Multiple.

NA

Update All Sites to Latest

Click the button to update all sites to the latest study version.

NA

Switch off Site Assessment facility

Select the check box to disable site assessment facility.

NA

User Configuration

InForm Home Page Path

Enter the path for the InForm home page.

255 Characters

Overwrite?

Select the check box if you want to overwrite the home page.

NA

Image URL

Enter the image URL.

255 Characters

Overwrite?

Select the check box if you want to overwrite the image URL.

NA

Sponsor Username Format

Select the radio button corresponding to the format, which must be used for the sponsor's user name.

The available options are:

- First Letter of Forename and Full Surname.

- First Letter of Forename and Full Surname and 3 digit number suffixed.

- User Entered.

NA

Site Username Format

Select the radio button corresponding to the format, which must be used for the site's user name.

The available options are:

- First Letter of Forename and Full Surname.

- First Letter of Forename and Full Surname and 3 digit number suffixed.

- User Entered.

NA

User Status

Select Active to enable the user status active. Otherwise, select Inactive.

NA

Overwrite?

Select the check box if you want to overwrite the user status.

NA

Change Password

Select Yes to change password. Otherwise, select No.

NA

Overwrite?

Select the check box if you want to overwrite the password change.

NA

Copy Terminate Users

Select Yes to copy terminated users. Otherwise, select No.

NA

Editable System Config Options

Enrol patient with incomplete form

Select Yes to enable enrollment of patients with incomplete forms. Otherwise, select No. The standard option is Yes.

NA

Require a comment when entering N/A, Unknown, or Not Done

Select Yes to set the comment as mandatory when the patient enters values such as N/A, Unknown or Not Done. Otherwise, select No.

NA

Auto close manual queries

Select Yes to enable auto close manual queries. Otherwise, select No. The standard option is Yes.

NA

Query maximum length

Enter the maximum length for the query. The standard value is 80 characters.

NA

Require unique patient initials and date of birth

Select Study or Site if unique patient initials and date of birth are required. Otherwise, select None. The standard option is None.

4 Characters

Require unique patient ID

Select Study or Site if unique patient ID is required. Otherwise, select None. The standard option is None.

NA

Allow sponsor users to edit frozen forms

Select Yes to allow sponsor users to edit frozen forms. Otherwise, select No. The standard option is No.

NA

Date Format

Select the date format from the drop-down list. The standard option is Month/Day/Year.

NA

Navigation mode

Select Enable to enable navigation. Otherwise, select Disable. The standard option is Disable.

NA

Re-authentication inactivity period

Enter the re-authentication inactivity duration in minutes. The standard value is 5 minutes.

3 Characters

Re-authentication Password expiration period

Enter the re-authentication password expiration duration in days. The standard value is 30 days.

3 Characters

Re-identification period

Enter the re-identification duration in minutes. The standard value is 120 minutes.

3 Characters

Minimum password length

Enter the minimum password length. The standard value is 8 characters.

2 Characters

Inactivate account after number of failed logon attempts

Enter the maximum attempts allowed for failed logon. If the failed logon attempt exceeds the maximum attempt, the account is made inactive. The standard value is 3 attempts.

2 Characters

Require at least one numerical character in password

Select Yes if at least one numerical character is required in the password. Otherwise, select No. The standard option is Yes.

NA

Require at least one uppercase character in password

Select Yes if at least one uppercase character is required in the password. Otherwise, select No. The standard option is Yes.

NA

Require at least one non alpha-numeric character in password

Select Yes if at least one non-alphanumeric character is required in the password. Otherwise, select No. The standard option is Yes.

NA

Allow password reuse

Select Yes to enable reuse password. Otherwise, select No. The standard option is Yes.

NA

Enable forgot password

Select Yes to enable forgot password help. Otherwise, select No. The standard option is Yes.

NA

Email address for forgot password notification

Enter the email address for receiving the forgot password notification.

255 Characters

Email address for new site and user notification

Enter the email address for receiving new site and user notifications.

255 Characters

Enforce visit date entry (before other date can be entered)

Enter the value for enforcing visit date entry. The standard option is 2.

NA

View CRF Signature List

Enter the value for viewing the CRF Signature list. The standard option is 1.

NA

Post a Query for Conflict Resolution

Select the check box to post a query for conflict resolution.

NA

Enable SSL

Select the check box to enable SSL.

NA

Let user minimize left button panel and picture

Select the check box to let the user minimize left button panel and picture.

NA

Setting

Reporting Service Full URL

Enter the reporting service full URL.

255 Characters

Reporting Authentication namespace ID

Enter the reporting authentication namespace ID.

255 Characters

Reporting user root

Enter the reporting user root.

255 Characters

LDAP Server

Enter the LDAP server.

255 Characters

LDAP base distinguished name

Enter the LDAP base distinguished name.

255 Characters

Number of execution plan listener threads

Enter the number of execution plan listener threads.

255 Characters

Number of execution plan re-submits

Enter the number of execution plan re-submits.

255 Characters

Execution Plan Server

Enter the execution plan server.

255 Characters

MedML Installer Server

Enter the name of the MedML installer server.

255 Characters

Server Friendly Name

Enter the server friendly name.

255 Characters

Number of characters for CRF length (Phase Forward Internal)

Enter the number of characters for the CRF length.

255 Characters

Control panel is maximized by default (Phase Forward Internal)

Select the check box to set the default size of the Control panel to maximized.

NA

Screening number sequence format (Phase Forward Internal)

Enter the screening number sequence format.

255 Characters

Patient number sequence format (Phase Forward Internal)

Enter the patient number sequence format.

255 Characters

Default randomization source manager (Phase Forward Internal)

Enter the default randomization source manager.

255 Characters

Randomization format for simple site (Phase Forward Internal)

Enter the randomization format for simple site.

255 Characters

Randomization source manager for simple site (Phase Forward Internal)

Enter the randomization source manager for simple site.

255 Characters

Randomization format for simple central (Phase Forward Internal)

Enter the randomization format for simple central.

255 Characters

Randomization source manager for simple central (Phase Forward Internal)

Enter the randomization source manager for simple central.

255 Characters

Randomization for central stratified by site (Phase Forward Internal)

Enter the randomization for central stratified by site.

255 Characters

Randomization for source manager for central stratified by site (Phase Forward Internal)

Enter the randomization for source manager for central stratified by site.

255 Characters

Randomization format for central stratified (Phase Forward Internal)

Enter the randomization format for central stratified.

255 Characters

UNC download directory (Phase Forward Internal) (only used in legacy systems)

Enter the UNC download directory.

255 Characters

Virtual download directory (Phase Forward Internal) (only used in legacy systems)

Enter the virtual download directory.

255 Characters

Table A-32 Configuration Settings - Error Information

Field Name

Scenario

Error Message

Send E-mails for Failed Uploads

Error occurs when you click Submit without entering the email address or entering an invalid email address.

Enter email address for Duplicated Imports notification. Enter valid email address

Send E-mails on Failed/Successful Import

Error occurs you click Submit without entering the email address or entering an invalid user address.

Enter valid email address. Enter email address for Failed/Successful Imports notification.

Email Address to send Worklist

Error occurs when the text box for the worklist is blank or when you enter an invalid user address.

NA

Query maximum length

Error occurs when you enter character other than number or enter the value greater than and lesser than the threshold level.

Enter a valid Number.

The value must be greater than or equal to constant value and less than or equal to constant value.

Re-authentication inactivity period

Error occurs when you enter character other than number.

Enter a valid Number.

Re-authentication Password expiration period

Error occurs when you enter character other than number.

Enter a valid Number.

Re-identification period

Error occurs when you enter character other than number.

Enter a valid Number.

Minimum password length

Error occurs when you enter character other than number.

Enter a valid Number.

Inactivate account after number of failed logon attempts

Error occurs when you enter character other than number.

Enter a valid Number.

Email address for forgot password notification

Error occurs when you enter an invalid email address.

Enter valid email address.

Email address for new site and user notification

Error occurs when you enter an invalid email address.

Enter a valid Number.

Number of execution plan listener threads

Error occurs when you enter character other than number.

Enter a valid Number.

Number of execution plan re-submits

Error occurs when you enter character other than number.

Enter a valid Number.

Number of characters for CRF length (Phase Forward Internal)

Error occurs when you enter character other than number.

Enter a valid Number.

Default Password

Error occurs when the password field is empty while submitting the form.

Enter the default password.

Comment

Error occurs when you submit the form without entering comment.

The form has not been changed.

Reporting Service Full URL

Error occurs when the URL is invalid.

Enter valid URL.

InForm Home Page Path

Error occurs when the entered home path is invalid.

Enter valid Home Path.

A.18 UMT Settings

Table A-33 UMT Settings - Field Information

Field Name

Description

Field Size (In Character)

Re-authentication inactivity period

Displays/Modify the re-authentication inactivity duration.

2 Characters

Minimum password length

Displays/Modify the minimum password length.

2 Characters

Password expiration period

Displays/Modify the password expiration duration.

3 Characters

Re-identification period

Displays/Modify the re-identification period.

3 Characters

Inactivate account after number of failed logon attempts

Displays/Modify the maximum attempts allowed for failed logon. If the failed logon attempt exceeds the maximum attempt, the account is made inactive.

1 Character

Email Address for forgot password notification

Displays/Modify the email address to which the forgotten password notification is sent.

255 Characters

Enable forgot password

Select the check box to enable forgot password help.

NA

Export schedule Interval

Displays/Modify export schedule interval.

NA

Import Schedule Interval

Displays/Modify import schedule interval.

NA

Enable Staging Schedule

Select the option to enable staging schedule.

If you select the Enable Staging Schedule option, enter the scheduled time in the Hours and Minutes text boxes of the Staging Schedule Interval field.

NA

Staging Schedule Interval

Displays/Modify the staging schedule interval.

2 Characters

Disable Staging Schedule

Select the option to disable staging schedule.

NA

Enable Worklist Schedule

Select the option to enable worklist schedule.

If you select the Enable Staging Schedule option, enter the scheduled time in the Hours and Minutes text boxes of the Worklist Schedule Interval field.

NA

Worklist Schedule Interval

Displays/Modify the worklist schedule interval.

2 Characters

Disable Worklist Schedule

Select the option to disable worklist schedule.

NA

Mail Service Interval

Displays/Modify the mail service interval time in minutes.

20 Characters

Table A-34 UMT Settings - Error Information

Field Name/ Action

Scenario

Error Message

Re-authentication inactivity period

Error occurs when you click Submit without entering data or exceeding the maximum value.

Fill the re-authentication inactivity period. The minimum and maximum value that are allowed for this filed are 5 and 30 respectively.

Minimum password length

Error occurs when you click Submit without entering data or exceeding the maximum value.

Fill Minimum password length. The minimum password length value must be greater than or equal to 6 and less than or equal to 12.

Password expiration period

Error occurs when you click Submit without entering data or exceeding the maximum value.

Fill the password expiration period. The minimum and maximum value that are allowed for this filed are 30 and 180 respectively.

Inactivate account after number of failed logon attempts

Error occurs when you click Submit without entering data or exceeding the maximum value.

Fill the number of failed logon attempts. The minimum and maximum value that are allowed for this filed are 2 and 5 respectively.

Email Address for forgot password notification

Error occurs when you click Submit without entering data or entering an invalid email address.

Enter valid email address(es). Fill the email address for forgot password notification

Error occurs when the user click submit button without giving data

Error occurs when you enter invalid characters.

Enter valid Export Schedule Hours.

Import Schedule Interval

Error occurs when you enter invalid characters.

Enter valid Import Schedule Hours.

Staging Schedule Interval

Error occurs when you enter invalid characters.

Enter valid Staging Schedule Interval

Worklist Schedule Interval

Error occurs when you enter invalid characters.

Enter valid Worklist Schedule Interval.

Email Address for Forgot password Notification

Error occurs when you enter an invalid email address.

Enter valid email address(es).

Inactivate account after number of failed logon attempts:

Error occurs when the maximum and minimum value exceeds.

The number of failed logon attempts value must be greater than or equal to 2 and less than or equal to 5.

Re-authentication inactivity period

Error occurs when the maximum and minimum value exceeds.

The Re-authentication inactivity period value must be greater than or equal to 5 and less than or equal to 30.

Password expiration period:

Error occurs when the maximum and minimum value exceeds.

The password expiration period must be greater than or equal to 30 and less than or equal to 180.

Re-identification period:

Error occurs when the maximum and minimum value exceeds.

The Re-identification period value must be greater than or equal to 15 and less than or equal to 180.

Minimum password length

Error occurs when the maximum and minimum value exceeds.

The minimum password length value must be greater than or equal to 6 and less than or equal to 12.

Worklist Schedule Interval

Error occurs when invalid hours or minutes are entered.

Enter valid Worklist Schedule hours. Enter valid Worklist Schedule minutes.

Export Schedule Interval

Error occurs when invalid hours are entered. Error occurs when invalid minutes are entered.

Enter valid Export Schedule hours. Enter valid Export Schedule minutes.

Import Schedule Interval

Error occurs when invalid hours are entered. Error occurs when invalid minutes are entered.

Enter valid Import Schedule hours. Enter valid Import Schedule minutes.

Staging Schedule Interval

Error occurs when invalid hours are entered. Error occurs when invalid minutes are entered.

Enter valid Staging Schedule hours. Enter valid Staging Schedule minutes.

Re-authentication inactivity period

Error occurs when the field is blank.

Fill the re-authentication inactivity period.

Password expiration period

Error occurs when the field is blank.

Fill the password expiration period.

Inactivate account after number of failed logon attempts

Error occurs when the field is blank.

Fill the number of failed logon attempts.

Re-identification period

Error occurs when the field is blank.

Fill the re-identification period.

A.19 Country Details

Table A-35 Country Details – Field Information

Field Name

Description

Country Name:

Displays/Modify the name of the country.

ISD Code

Displays/Modify the ISD code of the country.

Time Zone Association

Select Time Zone

- Available

Displays the list of available time zones.

Click >> or > to move all or the selected time zones, respectively, to the Selected field.

- Selected

Displays the list of selected time zones.

Click << or < to move all or the selected time zones, respectively, to the Available field.

A.20 UMT Roles

Table A-36 UMT Roles – Field Information

Field Name

Description

Filter Section

Role Name

Enter the name of the role.

InForm Role Details

Role Name

Displays the name of the role. Click the hyperlink to view the role details.

Role Type

Displays the type of the role.

Member Count

Displays the number of members in the role.

User Association

Click the icon to view the user-role associations.

A.21 PF Roles

Table A-37 PF Roles – Field Information

Field Name

Description

Field Size

Filter Section

Role Name:

Enter the name of the role.

63 Characters

Approval Status

Select the approval status from the drop-down list.

NA

PF Role Details

Role Name

Displays the name of the role. Click the hyperlink to view the role details.

NA

Approved Status

Displays the approval status of the role.

NA

Member Count

Displays the number of members in the role.

NA

User Association

Click the icon to view the user-role associations.

NA

A.22 Bulk Copy

Table A-38 Bulk Copy – Field Information

Field Name

Description

Source Trial

Select the source trial from the drop-down list.

Destination Trial

Displays the destination trial name.

Choose Items to be Copied

Select the check box to copy the trials from the corresponding items. The items include users, sites, roles, groups, and configuration settings.

Table A-39 Bulk Copy – Error Information

Field Name/Action

Scenario

Error Message

Select Source Trial drop-down list

Error occurs when you click Submit without selecting a source trial.

Select a trial.

Submit Button

Error occurs when you click Submit without selecting a trial.

Choose an option.

A.23 Create Sponsor Company

All fields marked with * are mandatory.

Table A-40 Create Sponsor Company – Field Information

Field Name

Description

Sponsor Company*

Enter the name of the sponsor.

Address1

Address2

Enter the communication address of the sponsor.

City

Enter the city to which the sponsor belongs.

Region

Enter the region to which the sponsor belongs.

State

Enter the state to which the sponsor belongs.

Province

Enter the province to which the sponsor belongs.

Postal Code

Enter the postal code of the sponsor.

Country

Select the country to which the sponsor belongs from the drop-down list.

Phone Number

Enter the phone number of the sponsor.

Alternate Phone Number

Enter the alternate phone number of the sponsor.

Logo File

Select the logo file of the sponsor.

Fax Number

Enter the fax number of the sponsor.

Is Duplicate Validation Trial Specific?

Select the check box if you want all the unique validations to occur at trail level only.

Zip Code

Enter the zip code of the sponsor.

A.24 Sponsor Company Details

All fields marked with * are mandatory.

Table A-41 Sponsor Company Details – Field Information

Field Name

Description

Sponsor Company*

Displays/Modify the name of the sponsor.

Address1

Address2

Displays/Modify the communication address of the sponsor.

City

Displays/Modify the city to which the sponsor belongs.

Region

Displays/Modify the region to which the sponsor belongs.

State

Displays/Modify the state to which the sponsor belongs.

Province

Displays/Modify the province to which the sponsor belongs.

Postal Code

Displays/Modify the postal code of the sponsor.

Country

Select the country to which the sponsor belongs from the drop-down list.

Phone Number

Displays/Modify the phone number of the sponsor.

Alternate Phone Number

Displays/Modify the alternate phone number of the sponsor.

Logo File

Enter the name of the sponsor logo file.

Fax Number

Displays/Modify the fax number of the sponsor.

Is Duplicate Validation Trial Specific?

Select the check box if you do not want UMT to check for user duplication across sponsor trials.

Zip Code

Displays/Modify the zip code of the sponsor.

A.25 List of Sponsor Companies

Table A-42 List of Sponsor Companies – Field Information

Field Name

Description

Field Size

Filter Section

Sponsor Company

Enter the name of the sponsor.

255 Characters

City

Enter the city to which the sponsor belongs.

255 Characters

Postal Code

Enter the postal code of the sponsor.

16 Characters

Phone Number

Enter the phone number of the sponsor.

25 characters

Country

Select the country to which the sponsor belongs from the drop-down list.

255 Characters

Sponsor Details:

Sponsor Company

Displays the name of the sponsor. Click the hyperlink to view the role details.

NA

City

Displays the city to which the sponsor belongs.

NA

Postal Code

Displays the postal code of the sponsor.

NA

Country

Displays the country to which the sponsor belongs.

NA

Phone Number

Displays the phone number of the sponsor.

NA

A.26 Log Files

Table A-43 Log Files – Field Information

Field Name

Description

Current Sponsor Company

Select the current sponsor company name from the drop-down list.

Trial

Select the trial from the drop-down list.

Filter Section

Application Name

Select the name of the application from the drop-down list.

Status

Select the status from the drop-down list.

From

Select the starting date from the calendar available at the side of the text box.

To

Select the ending date from the calendar available at the side of the text box.

Log File Details:

Application Name

Displays the name of the application.

Trial Name

Displays the name of the trial.

Batch

Displays the batch ID. Click the hyper link to view the list of transferred data.

User Name

Displays the user name.

Date & Time

Displays the date and time of creation of the log file.

Status

Displays the status of the log file.

A.27 User, Role Association

Table A-44 User, Role Association – Field Information

Field Name

Description

Current Sponsor Company

Displays the selected sponsor company.

Trial

Displays the selected trial.

Select Users

Available

Displays the list of available users.

Click >> or > to move all or the selected users, respectively, to the Selected field.

Selected

Displays the list of selected users.

Click << or < to move all or the selected users, respectively, to the Available field.

Already Associated

Displays the name of users that are already associated with the role.

Table A-45 User, Role Association – Error Information

Field Name/Action

Scenario

Error Message

Submit Form

Error occurs when you click Submit without making any change in the form.

Form not Changed.

A.28 Study Variables

Table A-46 Study Variable – Field Information

Field Name

Description

Field Size

Study Name

Displays the trial name.

NA

Study Variables

Browser Version (Minimum)

Displays/Modify the minimum version for Internet Explorer (IE) and Netscape Navigator.

5 Characters

Operating System

Displays the list of operating systems. Select the check boxes corresponding to the available operating systems.

NA

WAN Speed Boundary

Displays/Modify the wide area network speed.

5 Characters

URL for the eWP

Displays/Modify the URL for the eWP.

NA

Table A-47 Study Variables – Error Information

Field Name/Action

Scenario

Error Message

Submit Button

Error occurs when you click Submit without making any change.

The form has not been changed.

IE Textbox

Error occurs when you enter an invalid IE version.

Enter a Valid Browser Version for IE.

Netscape Textbox

Error occurs when you enter an invalid Netscafe version.

Enter a Valid Browser Version for Netscape.

WAN Speed Boundary

Error occurs when you enter an invalid WAP speed boundary.

Enter a Valid WAP Speed Boundary.

A.29 Selective Copy

Table A-48 Selective Copy – Field Information

Field Name

Description

Source Trial

Select the source trial from the drop-down list.

Destination Trial

Displays the destination trial name.

Select Type

Select the source trial item that needs to be copied from the drop-down list.

Available

Displays the list of source trial items.

Click >> or > to move all or the selected trial items, respectively, to the Selected field.

Selected

Displays the list of selected trial items.

Click << or < to move all or the selected trial, respectively, to the Available field.

Associated Sponsor Users

Select the check box if you want to copy the associated sponsor users details. This option is displayed depending on the type of copy item you select.

Associated Site Users

Select the check box if you want to copy the associated site users details. This option is displayed depending on the type of copy item you select.

Associated Sites

Select the check box if you want to copy the associated sites details. This option is displayed depending on the type of copy item you select.

Associated Roles

Select the check box if you want to copy the associated roles details. This option is displayed depending on the type of copy item you select.

Associated Groups

Select the check box if you want to copy the associated groups details. This option is displayed depending on the type of copy item you select.

A.30 PF User List Page

Table A-49 PF User List Page – Field Information

Field Name

Description

Field Size

Basic User Info

User Name

User name is displayed for all users.

255 Characters

First Name

The first name is displayed for all users.

255 Characters

Last Name

The last name is displayed for all users.

127 Characters

User Type:

This field is available for both InForm and IRT products.

NA

Role

This fields displays the PF role for which the user is assigned.

NA

Approval Status

This fields displays the approval status.

NA

Training Status

This fields displays the training status.

NA

Trained Date

This fields displays the training date.

NA

Sites(s)

This fields displays the list of sites the user is associated.

NA

Product Locale

This field is available for both InForm and IRT products with trial version above 4.5.

NA

Country

This fields displays the country to which the user belongs.

NA

Provisional Status

This fields displays the provisional status.

NA

Export To Excel Link

Select a user and on clicking this the user details gets exported to an Excel file.

NA

Export To File Link

Select a user and on clicking this the user details gets exported to a file.

NA

A.31 List of Sites

Table A-50 List of Sites - Field Information

Field Name

Description

Field Size (In Character)

Filter Section

Site No

Enter the number of the site.

20 Characters

Site Name

Enter the name of the site.

255 Characters

Approval Status

Select the status of the site from the drop-down list.

NA

City

Enter the city where the site is located.

127 Characters

Country

Select the country where the site is located from the drop-down list.

255 Characters

Study Version

Select the study version of the site from the drop-down list.

NA

Assessment Status

Select the assessment status of the site from the drop-down list.

NA

Provisioning Status

Select the provisioning status of the site from the drop-down list.

NA

Uploaded to IRT

Select whether you want to view sites that are uploaded to the IRT system.

NA

Uploaded to OLx

Select whether you want to view sites that are uploaded to the OLx system.

NA

Uploaded to IPMs

Select whether you want to view sites that are uploaded to the IPMs system.

NA

Uploaded to InForm

Select whether you want to view sites that are uploaded to the InForm system.

NA

Site Details

Displays the icon,

if the site is Upload to InForm.

if the site is Upload to IRT.

if the site is Upload to InForm/IRT.

NA

Site No

Displays the site number.

NA

Site Name

Displays the name of the site. Click the hyperlink to view the site details.

NA

Approval Status

Displays the status of the site. The status of the site can be Approved, Pending, or Rejected.

NA

City

Displays the city where the site is located.

NA

Country

Displays the country where the site is located.

NA

Study Version

Displays the study version.

NA

Assessment Mail

Displays the icon,

if the mail is sent to the members of that site.

if the first reminder mail is sent to the members of that site.

if the second reminder mail is sent to the members of that site.

NA

Pass/Fail

Displays the corresponding icons,

if the site passed the assessment process.

if the site is in the border line of the assessment process.

if the site failed the assessment process.

NA

Assessment Status

Displays the status of the assessment process.

NA

Provisioning Status

Displays the status of the provisioned items.

NA

A.32 Selective Copy

Table A-51 Selective Copy – Field Information

Field Name

Description

Source Trial

Select the source trial from the drop-down list.

Destination Trial

Displays the destination trial name.

Select Type

Select the source trial item that needs to be copied from the drop-down list.

Available

Displays the list of source trial items.

Click >> or > to move all or the selected trial items, respectively, to the Selected field.

Selected

Displays the list of selected trial items.

Click << or < to move all or the selected trial, respectively, to the Available field.

Associated Sponsor Users

Select the check box if you want to copy the associated sponsor users details. This option is displayed depending on the type of copy item you select.

Associated Site Users

Select the check box if you want to copy the associated site users details. This option is displayed depending on the type of copy item you select.

Associated Sites

Select the check box if you want to copy the associated sites details. This option is displayed depending on the type of copy item you select.

Associated Roles

Select the check box if you want to copy the associated roles details. This option is displayed depending on the type of copy item you select.

Associated Groups

Select the check box if you want to copy the associated groups details. This option is displayed depending on the type of copy item you select.

Already Copied

Displays the list of selected trial items which is already copied to the destination trial.

Table A-52 Selective Copy – Error Information

Field Name/Action

Scenario

Error Message

Trial Drop-down List

Error occurs when you click Submit without selecting a trial.

Select a trial.

Trial Drop-down List

Error occurs when you click Submit without selecting a type from the Type drop-down list.

Select a Type.

Submit Button

Error occurs when you click Submit without selecting a site.

Select a Site.

Submit Button

Error occurs when you click Submit without selecting a role.

Select a Role.

Submit Button

Error occurs when you click Submit without selecting a group.

Select a Group.

Submit Button

Error occurs when you click Submit without selecting a user.

Select a User.

A.33 UMT Role Details

Table A-53 UMT Role Details - Field Information

Field Name

Description

Field Size

Role*

Enter the name of the role.

63 Characters

Role Type

Select the type of the role from the drop-down list.

NA

UMT Admin

Displays the list of UMT administration rights.

To assign a privilege (rights), select the corresponding check box.

NA

Import/Export

Displays the list of import or export rights.

To assign a privilege (rights), select the corresponding check box.

NA

User/Sponsor/Site Details

Displays the list of rights for managing user, sponsor, or site details.

To assign a privilege (rights), select the corresponding check box.

NA

Log Files

Displays the list of rights for managing log files.

To assign a privilege (rights), select the corresponding check box.

NA

Approval

Displays the list of rights for approval.

To assign a privilege (rights), select the corresponding check box.

NA

InForm Rights

Displays the list of InForm rights.

To assign a privilege (rights), select the corresponding check box.

NA

Miscellaneous

Displays the list of miscellaneous rights.

To assign a privilege (rights), select the corresponding check box.

NA

Table A-54 UMT Role Details – Error Information

Field Name/Action

Scenario

Error Message

Role

Error occurs when you enter characters other than alphanumeric, hyphen, underscore, and blank space.

Enter a valid Role Name. Only Alphanumerics (A-Z, 0-9), Hyphens(-), underscores(_) and blank spaces are allowed.

Role Type

Error occurs when you click Submit without selecting a role type.

Select a Role Type.

Submit Button

Error occurs when you click Submit without selecting at least one role.

Associate at least one Right for the Role.

Sponsor Drop-down List

Error occurs when you click Submit without selecting a sponsor company.

Select Sponsor Company.

Submit Button

Error occurs when you click Submit without entering all mandatory fields.

Complete all mandatory fields before saving.

A.34 UMT Users

Table A-55 UMT Users - Field Information

Field Name

Description

Field Size

Filter Section

Username

Enter the user name.

25 characters

First Name

Enter the first name of the user.

127 Characters

Last Name

Enter the last name of the user.

127 Characters

User Type

Select the user type from the drop-down list.

NA

Status

Select the status of the user from the drop-down list.

NA

City

Enter the city to which the user belongs.

255 Characters

State /Province

Enter the state or province to which the user belongs.

255 Characters

Country

Select the country to which the user belongs from the drop-down list.

NA

Role

Select the role to which the user belongs from the drop-down list.

NA

Username

Displays the user name. Click the hyperlink to view the corresponding user details.

NA

First Name

Displays the first name of the user.

NA

Last Name

Displays the last name of the user.

NA

User Type

Displays the user type.

NA

Status

Displays the status of the user.

NA

City

Displays the city to which the user belongs.

NA

State/Province

Displays the state or province to which the user belongs.

NA

Country

Displays the country to which the user belongs.

NA

Role

Displays the role to which the user belongs.

NA

UMT USer Details:

Username

Displays the user name. Click the hyperlink to view the corresponding user details.

NA

First Name

Displays the first name of the user.

NA

Last Name

Displays the last name of the user.

NA

User Type

Displays the user type.

NA

Status

Displays the status of the user.

NA

Role

Displays the role to which the user belongs.

NA

City

Displays the city to which the user belongs.

NA

State/Province

Displays the state or province to which the user belongs.

NA

Country

Displays the country to which the user belongs.

NA

Table A-56 UMT Users – Error Information

Field Name/Action

Scenario

Error Message

Action Drop-down list

Error occurs when you click Go without selecting any action in the drop-down list.

Select an option.

Go Button

Error occurs when you click Go without selecting any user.

Select a user.

Active User

Error occurs when you activate the user whose status is already Active.

You have selected active users.

InActive User

Error occurs when you inactivate the user whose status is already Inactive.

You have selected inactive users.

A.35 Create UMT Role

Table A-57 Create UMT Role - Field Information

Field Name

Description

Field Size

Role*

Enter the name of the role.

63 Characters

Role Type

Select the type of the role from the drop-down list.

NA

UMT Admin

Displays the list of UMT administration rights.

To assign a privilege (rights), select the corresponding check box.

NA

Import/Export

Displays the list of import or export rights.

To assign a privilege (rights), select the corresponding check box.

NA

User/Sponsor/Site Details

Displays the list of rights for managing user, sponsor, or site details.

To assign a privilege (rights), select the corresponding check box.

NA

Log Files

Displays the list of rights for managing log files.

To assign a privilege (rights), select the corresponding check box.

NA

Approval

Displays the list of rights for approval.

To assign a privilege (rights), select the corresponding check box.

NA

InForm Rights

Displays the list of InForm rights.

To assign a privilege (rights), select the corresponding check box.

NA

Assessment

Displays the list of Assessment rights.

To assign a privilege (rights), select the corresponding check box.

NA

Provisioning

Displays the list of Provisioning rights.

To assign a privilege (rights), select the corresponding check box.

NA

Asset

Displays the list of Asset rights.

To assign a privilege (rights), select the corresponding check box.

NA

Worklist

Displays the list of Worklist rights.

To assign a privilege (rights), select the corresponding check box.

NA

Miscellaneous

Displays the list of miscellaneous rights.

To assign a privilege (rights), select the corresponding check box.

NA

Table A-58 Create UMT Role – Error Information

Field Name/Action

Scenario

Error Message

Role

Error occurs when you enter characters other than alphanumeric, hyphen, underscore, and blank space.

Enter a valid Role Name. Only Alphanumerics (A-Z, 0-9), Hyphens(-), underscores(_), and blank spaces are allowed.

Role Type

Error occurs when you click Submit without selecting a role type.

Select a Role Type.

Submit Button

Error occurs when you click Submit without selecting at least one role.

Associate at least one Right for the Role.

Sponsor Drop-down List

Error occurs when you click Submit without selecting a sponsor company.

Select Sponsor Company.

Submit Button

Error occurs when you click Submit without completing all mandatory fields.

Complete all mandatory fields before saving.

A.36 Create PF Role

Table A-59 Create PF Role - Field Information

Field Name

Description

Field Size

Role*

Enter the name of the role.

63 character

User Admin

Displays the list of user administration rights.

To assign a privilege (rights), select the corresponding check box.

NA

User Misc

Displays the list of user miscellaneous rights.

To assign a privilege (rights), select the corresponding check box.

NA

CRF Rights

Displays the list of CRF rights.

To assign a privilege (rights), select the corresponding check box.

NA

Case Book Rights

Displays the list of case book rights.

To assign a privilege (rights), select the corresponding check box.

NA

Query Rights

Displays the list of query rights.

To select the right, click the corresponding check boxes.

NA

Rule Rights

Displays the list of user rule rights. To assign a privilege (rights), select the corresponding check box.

NA

Synchronization

Displays the list of synchronization rights. To assign a privilege (rights), select the corresponding check box.

NA

Navigation

Displays the list of navigation rights.

To assign a privilege (rights), select the corresponding check box.

NA

System Admin Rights

Displays the list of system administration rights.

To assign a privilege (rights), select the corresponding check box.

NA

Table A-60 Create PF Role – Error Information

Field Name/Action

Scenario

Error Message

Role*

Error occurs when click Submit without entering a role name.

Please Enter a valid Role Name. Only Alphanumerics (A-Z, 0-9), Hyphens(-), underscores(_), and blank spaces are allowed.

Submit Button

Error occurs when the Patient Transfer Right is selected for the trial running in the PF 4.5 version.

Patient Transfer Right can be selected only for Trials running in PF 4.5 Version.

Submit Button

Error occurs when the Custom Reports and Admin Reports Rights is selected for the trial running in the PF 4.5 version.

PF 4.5 Version cannot have Custom Reports and Admin Reports Right.

Submit Button

Error occurs when the Custom Reports Right is selected for the trial running in the PF 4.5 version.

PF 4.5 Version cannot have Custom Reports Right.

Submit Button

Error occurs when the Patient Transfer Right is selected for the trial running in the PF 4.5 version.

PF 4.5 Version cannot have Admin Reports Right.

Submit Button

Error occurs when no rights are associated to the role.

Associate at least one Right for the Role.

Submit Button

Error occurs when you click Submit without entering all mandatory fields.

Complete all mandatory fields, before Saving.

Role Name

Error occurs when you enter an invalid character other than alphanumeric characters and hyphens.

Enter a valid Role Name. Only Alphanumerics (A-Z, 0-9), Hyphens(-), underscores (_), and blank spaces are allowed.

A.37 Sponsor Company Details

Table A-61 Sponsor Company Details - Field Information

Field Name

Description

Field Size

Sponsor Company*

Enter the name of the sponsor company.

255 Characters

Address1

Address2

Enter the communication address of the sponsor company.

255 Characters

City

Enter the city to which the sponsor company belongs.

255 Characters

Region

Enter the region to which the sponsor company belongs.

255 Characters

Postal Code

Enter the postal code of the sponsor company.

16 Characters

Country

Select the country to which the sponsor company belongs from the drop-down list.

255 Characters

Fax Number

Enter the fax number of the sponsor company.

25 Characters

Phone Number

Enter the phone number of the sponsor company.

25 Characters

Alternate Phone Number

Enter the alternate phone number of the sponsor company.

25 Characters

Is Duplicate Validation Trial Specific?

Select the check box if you do not want UMT to check for user duplication across sponsor trials.

NA

Enter a character*

Enter a character to distinguish similar data that are imported into UMT. This prevents data overwrite.

1 Character

Logo File

Enter the name of the sponsor logo file.

255 Characters

Zip Code

Enter the zip code.

16 Characters

A.38 Create Sponsor Company

Table A-62 Create Sponsor Company - Field Information

Field Name

Description

Field Size

Sponsor Company*

Enter the name of the sponsor company.

255 Characters

Address1

Address2

Enter the communication address of the sponsor company.

255 Characters

City

Enter the city to which the sponsor company belongs.

255 Characters

Region

Enter the region to which the sponsor company belongs.

255 Characters

Postal Code

Enter the postal code of the sponsor company.

16 Characters

Country

Select the country to which the sponsor company belongs from the drop-down list.

255 Characters

Fax Number

Enter the fax number of the sponsor company.

25 Characters

Phone Number

Enter the phone number of the sponsor company.

25 Characters

Alternate Phone Number

Enter the alternate phone number of the sponsor company.

25 Characters

Is Duplicate Validation Trial Specific?

Select the check box if you do not want UMT to check for user duplication across sponsor trials.

NA

Logo File

Enter the name of the sponsor logo file.

255 Characters

Zip Code

Enter the zip code.

16 Characters

Table A-63 Create Sponsor Company – Error Information

Field Name/Action

Scenario

Error Message

Current Sponsor Company

Error occurs when you enter the character other than alphanumeric, ampersand, underscore, and blank space.

Enter Sponsor company.

Address1

Address2

Error occurs when you enter character other than alphanumeric.

Enter a character.

City

Error occurs when you enter character other than alphanumeric, and blank space.

Enter a valid City. Only alphanumerics, underscores, and hyphens are allowed.

Region

Error occurs when you enter character other than alphabet and blank space.

Enter a valid Region. Only alphanumerics, underscores, and hyphens are allowed.

State

Error occurs when you enter character other than alphanumeric and blank space.

Enter a valid State. Only Alphanumerics (A-Z, 0-9) and Blank Spaces are allowed.

Province

Error occurs when you enter character other than alphanumeric and blank space.

Enter a valid Province. Only Alphanumerics (A-Z, 0-9) and Blank Spaces are allowed.

Postal Code

Error occurs when you enter character other than alphanumeric, hyphen, and blank space.

Enter a valid Postal Code. Only Alphanumerics (A-Z, 0-9), Hyphens(-), and Blank Spaces are allowed.

Country

NA

NA

Fax Number

Error occurs when you enter character other than number, hyphen, and blank space.

Enter a valid Fax Number. Only numbers, hyphens, and blank spaces are allowed.

Phone Number

Error occurs when you enter character other than number, hyphen, and blank space.

Enter a valid Phone number. Only numbers, hyphens, and blank spaces are allowed.

Alternate Phone Number

Error occurs when you enter character other than number, hyphen, and blank space.

Enter a valid Alternate Phone number. Only numbers, hyphens and blank spaces are allowed/

Is Duplicate Validation Trial Specific?

NA

NA

Enter a character*

Error occurs when you enter a character other than alphanumeric.

Enter a character

Zip Code

Error occurs when you enter a character other than alphanumeric.

Enter a valid Postal code. Only numbers, hyphens, and blank spaces are allowed.

Logo File

Error occurs when you enter space in logo file text box.

Spaces not allowed while specifying file name. Enter a valid file name.

Logo File

Error occurs when enter the file other than jpg, gif, and txt.

Logo file should be only jpg/gif/ txt files.

A.39 Create Trial Details

Table A-64 Create Trial Details - Field Information

Field Name

Description

Field Size

Trial Details

Trial Name*

Enter the name of the trial.

255 Characters

Reference*

Enter the reference name.

20 Characters

Protocol Number*

Enter the number of the protocol.

255 Characters

Duration in Months

Enter the duration of the trial in months.

5 Characters

Contracted No of Sites

Enter the number of sites contracted for performing the trial.

5 Characters

Contracted No of Countries

Enter the number of countries contracted for performing the trial.

5 Characters

Contracted No of Patients

Enter the number of patients contracted for performing the trial.

5 Characters

Contracted No of Users

Enter the number of users contracted for performing the trial.

5 Characters

Contracted No of IOL Accounts

Enter the number of IOL accounts contracted for performing the trial.

5 Characters

Contracted No of Site Assessments

Enter the number of contracted site assessments.

5 Characters

Study URL

Enter the study URL.

100 Characters

Therapeutic Area

Enter the therapeutic area.

100 Characters

Trial Phase

Select the phase of the trial from the drop-down list.

NA

Status

Select the status of the trial from the drop-down list.

NA

Compound/Drug/Device Name

Enter the compound, drug, and device name used in the trial.

255 Characters

E-mail Trigger

Select Enable to enable eCS email functionality. Otherwise, select Disable.

This information refers to the email trigger of registration and certificate emails by eCS.

1 Character

Notes

Enter your notes on the trial you are creating.

255 Characters

Select Trial Type

Select the trial type from the drop-down list.

NA

Select Trial Version*

Select the trial version from the drop-down list.

NA

Trial, Country Association

-

-

Select Country*

-

-

- Available

Displays the list of available countries.

Click >> or > to move all or the selected country, respectively, to the Selected field.

NA

- Selected

Displays the list of selected countries.

Click << or < to move all or the selected country, respectively, to the Available field.

NA

Table A-65 Create Trial Details – Error Information

Field Name/Action

Scenario

Error Message

Trial Details

Trial Name

Error occurs when you submit without entering the trial name. Another error may occur if you enter the character other than alphanumeric, hyphen, and underscores.

Enter Trial Name. Enter a valid Trial Name. Only Alphanumerics (A-Z, 0-9), Hyphens, and underscores(_) are allowed.

Reference

Error occurs when you enter the character other than alphanumeric.

Enter Reference.

Protocol Number

Error occurs when you enter the character other than alphanumeric.

Enter Protocol Number.

Duration in Months

Enter the duration of the trial in months.

Enter a valid Duration in Months. Only Numbers (0-9) are allowed.

Contracted No of Sites

Error occurs when you enter the character other than number.

Enter a valid Contracted No of sites. Only Numbers (0-9) are allowed.

Contracted No of Countries

Error occurs when you enter the character other than number.

Enter the number of countries contracted for performing the trial.

Contracted No of Patients

Error occurs when you enter the character other than number.

Enter a valid Contracted No of Patients. Only Numbers (0-9) are allowed.

Contracted No of Users

Enter the number of users contracted for performing the trial.

Enter a valid Contracted No of Users. Only Numbers (0-9) are allowed.

Contracted No of IOL Accounts

Enter the number of IOL accounts contracted for performing the trial.

Enter a valid Contracted No of IOL Accounts. Only Numbers (0-9) are allowed.

Contracted No of Site Assessments

Enter the number of contracted site Assessments.

Enter a valid Contracted No of Site Assessments. Only Numbers (0-9) are allowed.

Study URL

Enter the study URL.

NA

Therapeutic Area

Enter the therapeutic area.

NA

Trial Phase

Select the phase of the trial from the drop-down list.

NA

Status

Select the status of the trial from the drop-down list.

Select Trial Status.

Compound/Drug/Device Name

Enter the compound, drug, and device name used in the trial.

NA

E-mail Trigger

Select Enable to enable eCS email functionality. Otherwise, select Disable.

This information refers to the email trigger of registration and certificate emails by eCS.

NA

Notes

Error occurs when you enter more than 255 characters.

Note text should not exceed 255 characters.

Import path

Error occurs when you click Submit without selecting the FTP path.

Enter FTP path.

Select Trial Version

Error occurs when you click Submit without selecting any trial version.

Select the trial version.

Trial, Country Association

-

-

Select Country

Error occurs when you click Submit without selecting any country.

Select a country.

- Available

NA

NA

- Selected

NA

NA

A.40 Create Oracle User

Table A-66 Create Oracle User - Field Information

Field Name

Description

Field Size

Basic User Info

User Type *

Select PF user from the drop-down list.

NA

User Name *

The user name format must follow the specifications in the UMT settings.

255 Characters

First Name*

Enter the first name of the user.

127 Characters

Last Name*

Enter the last name of the user.

127 Characters

Title

Select a title for the user from the drop-down list.

NA

Description

Enter the description for the user.

255 Characters

Display Name

Enter the display name for the user.

255 Characters

Contact Details

Address1

Enter the communication address1 of the user.

255 Characters

Address2

Enter the communication address2 of the user.

255 Characters

Town/City

Enter the town or city to which the user belongs.

255 Characters

State/Province

Enter the state or province to which the user belongs.

255 Characters

Country*

Select the country to which the user belongs from the drop-down list.

NA

Postal Code

Enter the postal code of the user.

16 Characters

Phone Number

Enter the phone number of the user.

25 Characters

Alternate Phone Number

Enter the alternate phone number of the user.

25 Characters

Beeper Number

Enter the beeper number of the user.

25 Characters

Fax Number

Enter the fax number of the user.

25 Characters

E-mail Address*

Enter the email address of the user. By default, the UMT application accepts only email addresses that belong to the Oracle domain (for example, username@oracle.com).

255 Characters

Confirm User E-mail Address*

Enter the email address of the user for confirmation.

255 Characters

User Misc

Date Format

Select the required date format from the drop-down list.

NA

Load to InForm

Select check box to load the user to InForm.

NA

Overwrite

Select check box to overwrite.

NA

Assessment Mail

Select whether to enable or disable the assessment mail.

NA

Image URL

Enter the URL of the image.

255 characters

Trial Association

Select Sponsor

Select the sponsor to associate the user.

NA

Select Trial

Select the trial to associate the user.

NA

Table A-67 Create PF User – Error Information

Field Name/Action

Scenario

Error Message

Basic User Info

User Type *

You have to select the type of user, either sponsor user or site user.

NA

User Name*

Error occurs when you enter the character other than alphanumeric and underscore.

Enter a valid Username. Only alphanumeric (A-Z, 0-9) and underscores (_) are allowed.

First Name*

Error occurs when you enter the character other than alphabet, hyphen, and blank space.

Enter a valid First Name. Only alphanumeric (A-Z), hyphens (-), and blank spaces are allowed.

Last Name*

Error occurs when you enter the character other than alphabet, hyphen, and blank space.

Enter a valid Last Name. Only Letters (A-Z), Hyphens (-) and Blank Spaces are allowed.

Title

NA

NA

Description

Enter the description for the user.

255 Characters

Display Name

Enter the display name for the user.

255 Characters

Change Password on Next Login

NA

NA

Contact Details

Address1

Enter the communication address1 of the user.

255 Characters

Address2

Enter the communication address2 of the user.

255 Characters

Town/City

Enter the town or city to which the user belongs.

255 Characters

State/Province

Enter the state or province to which the user belongs.

255 Characters

Country *

Select the country to which the user belongs from the drop-down list.

NA

Postal Code

Enter the postal code of the user.

16 Characters

Phone Number

Enter the phone number of the user.

25 Characters

Alternate Phone Number

Enter the alternate phone number of the user.

25 Characters

Beeper Number

Enter the beeper number of the user.

25 Characters

Fax Number

Enter the fax number of the user.

25 Characters

E-mail Address*

Error occurs when you click Submit without entering an valid email ID.

Enter a valid email ID.

Confirm User E-mail Address*

Error occurs when you do not enter confirm email address.

Confirm email address.

A.41 Create Trial Details

Table A-68 Create Trial Details - Field Information

Field Name

Description

Field Size

Trial Details

Study Name*

Enter the study name of the trial.

255 Characters

Trial Name*

Enter the name of the trial.

255 Characters

SOW/Contract Number*

Enter the reference name.

20 Characters

Protocol Number*

Enter the number of the protocol.

255 Characters

Duration in Months

Enter the duration of the trial in months.

5 Characters

Contracted No of Sites

Enter the number of sites contracted for performing the trial.

5 Characters

Contracted No of Countries

Enter the number of countries contracted for performing the trial.

5 Characters

Contracted No of Patients

Enter the number of patients contracted for performing the trial.

5 Characters

Contracted No of Users

Enter the number of users contracted for performing the trial.

5 Characters

Contracted No of IOL Accounts

Enter the number of IOL accounts contracted for performing the trial.

5 Characters

Contracted No of Site Assessments

Enter the number of contracted site assessments.

5 Characters

Study URL

Enter the study URL.

100 Characters

Therapeutic Area

Enter the therapeutic area.

100 Characters

Trial Phase

Select the phase of the trial from the drop-down list.

NA

Status

Select the status of the trial from the drop-down list.

NA

Is Pivotal Trial

Check the Yes or No option from the radio button for Is Pivotal?.

NA

Sponsor Customer

Enter the Sponsor Customer Name.

Use this field when the Sponsor company is a CRO to show the name of the Sponsors Customer.

255

Is OLX Trial

Check the Yes or No options from the radio button for Is OLX?.

NA

Is IRT Trial

Check the Yes or No options from the radio button for Is IRT?.

NA

Is InForm Trial

Check the Yes or No options from the radio button for Is InForm?.

NA

Compound/Drug/Device Name

Enter the compound, drug, and device name used in the trial.

255 Characters

E-mail Trigger

Select Enable to enable eCS email functionality. Otherwise, select Disable.

This information refers to the email trigger of registration and certificate emails by eCS.

1 Character

Notes

Enter your notes on the trial you are creating.

255 Characters

Select Trial Type

Select the trial type from the drop-down list.

NA

Select Trial Version*

Select the trial version from the drop-down list.

NA

Trial, Country Association

Select Country*

- Available

Displays the list of available countries.

Click >> or  > to move all or the selected country, respectively, to the Selected field.

NA

- Selected

Displays the list of selected countries.

Click << or < to move all or the selected country, respectively, to the Available field.

NA

Display Name:

Enter the display name for the user.

255 Characters

Change Password on Next Login

NA

NA

Contact Details

-

-

Address1

Enter the communication address1 of the user.

255 Characters

Address2

Enter the communication address2 of the user.

255 Characters

Town/City

Enter the town or city to which the user belongs.

255 Characters

State/Province

Enter the state or province to which the user belongs.

255 Characters

Country *

Select the country to which the user belongs from the drop-down list.

NA

Postal Code

Enter the postal code of the user.

16 Characters

Phone Number

Enter the phone number of the user.

25 Characters

Alternate Phone Number

Enter the alternate phone number of the user.

25 Characters

Beeper Number

Enter the beeper number of the user.

25 Characters

Fax Number

Enter the fax number of the user.

25 Characters

E-mail Address*

Error occur when you click Submit without entering an valid email ID.

Enter a valid email id.

Confirm User E-mail Address*

Error occurs when you do not enter confirm email address.

Confirm email address.

Table A-69 Create Trial Details – Error Information

Field Name/Action

Scenario

Error Message

Trial Details

Study Name

Error occurs when you click Submit without entering the study name or if you enter the character other than alphanumeric, hyphen, and underscores.

Enter a valid Study Name. Only Alphanumerics (A-Z, 0-9), Hyphens, and underscores(_) are allowed.

Trial Name

Error occurs when you click Submit without entering the trial name or if you enter the character other than alphanumeric, hyphen, and underscores.

Enter a valid Trial Name. Only Alphanumerics (A-Z, 0-9), Hyphens, and underscores(_) are allowed.

SOW/Contract Number

Error occurs when you enter the character other than alphanumeric.

Enter Reference.

Protocol Number

Error occurs when you enter the character other than alphanumeric.

Enter Protocol Number.

Duration in Months

Enter the duration of the trial in months.

Enter a valid Duration in Months. Only Numbers (0-9) are allowed.

Contracted No of Sites

Error occurs when you enter the character other than number.

Enter a valid Contracted No of sites. Only Numbers (0-9) are allowed.

Contracted No of Countries

Error occurs when you enter the character other than number.

Enter the number of countries contracted for performing the trial.

Contracted No of Patients

Error occurs when you enter the character other than number.

Enter a valid Contracted No of Patients. Only Numbers (0-9) are allowed.

Contracted No of Users

Enter the number of users contracted for performing the trial.

Enter a valid Contracted No of Users. Only Numbers (0-9) are allowed.

Contracted No of IOL Accounts

Enter the number of IOL accounts contracted for performing the trial.

Enter a valid Contracted No of IOL Accounts. Only Numbers (0-9) are allowed

Contracted No of Site Assessments

Enter the number of contracted site assessments.

Enter a valid Contracted No of Site Assessments. Only Numbers (0-9) are allowed.

Study URL

Enter the study URL.

NA

Therapeutic Area

Enter the therapeutic area.

NA

Trial Phase

Select the phase of the trial from the drop-down list.

NA

Status

Select the status of the trial from the drop-down list.

Please select Trial Status

Is IRT/ InForm

Select at least any one type of trial IRT or InForm.

Trial should be either InForm or IRT.

Compound/Drug/Device Name

Enter the compound, drug, and device name used in the trial.

NA

E-mail Trigger

Select Enable to enable eCS email functionality. Otherwise, select Disable.

This information refers to the email trigger of registration and certificate emails by eCS.

NA

Notes

Error occurs when the entered character exceed 255 characters.

Note text should not exceed 255 characters.

Import path

Error occurs when you click Submit without select FTP path.

Enter FTP path.

Select Trial Version*

Error occurs when the you click Submit without selecting any trial version.

Select Trial Version.

Trial, Country Association

Select Country*

Error occurs when you click Submit without selecting any country.

Select a country.

- Available

NA

NA

- Selected

NA

NA

A.42 Edit PF User

Table A-70 Edit PF User - Field Information

Field Name

Description

Field Size

Basic User Info

User Type *

You have to select the type of user, either sponsor user or site user.

NA

User Name *

The user name format must follow the specifications in the UMT settings.

255 Characters

First Name*

Enter the first name of the user.

127 Characters

Last Name*

Enter the last name of the user.

127 Characters

Title

Select a title for the user from the drop-down list.

NA

Description:

Enter the description for the user.

255 Characters

Display Name:

Enter the display name for the user.

255 Characters

Contact Details

Address1

Enter the communication address1 of the user.

255 Characters

Address2

Enter the communication address2 of the user.

255 Characters

Town/City

Enter the town or city to which the user belongs.

255 Characters

State/Province

Enter the state or province to which the user belongs.

255 Characters

Country *

Select the country to which the user belongs from the drop-down list.

NA

Postal Code

Enter the postal code of the user.

16 Characters

Phone Number

Enter the phone number of the user.

25 Characters

Alternate Phone Number

Enter the alternate phone number of the user.

25 Characters

Beeper Number

Enter the beeper number of the user.

25 Characters

Fax Number

Enter the fax number of the user.

25 Characters

E-mail Address*

Enter the email address of the user.

255 Characters

Confirm User E-mail Address*

Enter the email address of the user for confirmation.

255 Characters

User Misc

Assessment mail

Select whether to enable or disable assessment mail.

NA

InForm Home page path

Select the InForm home page path.

255 characters

Image URL

Enter the URL of the image.

255 characters

Change password in next login

Select Yes or No.

NA

Overwrite

Select to overwrite.

NA

Date Format

Select the format for the date to be displayed.

NA

Training Status

Select the training status from the options given.

NA

Load to InForm

Used to load to InForm.

NA

Rights Association

Right Group *

Select the Right Group for the user.

NA

Query Group

Select the Query Group for the user.

NA

Trial Association

Select Sponsor

Select the sponsor to associate the user.

NA

Select Trial

Select the trial to associate the user.

NA

Reason For Change

Enter the reason for change or edit.

NA

Table A-71 Edit PF User – Error Information

Field Name/Action

Scenario

Error Message

Basic User Info

User Type *

You have to select the type of user, either sponsor user or site user.

NA

User Name*

Error occurs when you enter the character other than alphanumeric and underscore.

Enter a valid Username. Only Alphanumeric (A-Z, 0-9) and underscores (_) are allowed.

First Name*

Error occurs when you enter the character other than alphabet, hyphen, and blank space.

Enter a valid First Name. Only Letters (A-Z), Hyphens (-), and Blank Spaces are allowed.

Last Name*

Error occurs when you enter the character other than alphabet, hyphen, and blank space.

Enter a valid Last Name. Only Letters (A-Z), Hyphens (-), and Blank Spaces are allowed.

Title

NA

NA

Description:

Enter the description for the user.

255 Characters

Display Name:

Enter the display name for the user.

255 Characters

Change Password on Next Login

NA

NA

Contact Details

Address1

Enter the communication address1 of the user.

255 Characters

Address2

Enter the communication address2 of the user.

255 Characters

Town/City

Enter the town or city to which the user belongs.

255 Characters

State/Province

Enter the state or province to which the user belongs.

255 Characters

Country *

Select the country to which the user belongs from the drop-down list.

NA

Postal Code

Enter the postal code of the user.

16 Characters

Phone Number

Enter the phone number of the user.

25 Characters

Alternate Phone Number

Enter the alternate phone number of the user.

25 Characters

Beeper Number

Enter the beeper number of the user.

25 Characters

Fax Number

Enter the fax number of the user.

25 Characters

E-mail Address*

Error occur when you click Submit without entering an valid email ID.

Enter a valid email id.

Confirm User E-mail Address*

Error occurs when you do not enter confirm email address.

Confirm email address.

Right Group

Error occurs you do not select the right group.

Select the Right Group.

Reason For Change

Error occurs when you do not enter the reason for change.

Enter Reason For Change.

A.43 Create UMT User Details

Table A-72 Create UMT User Details - Field Information

Field Name

Description

Field Size

User Details

Username*

Enter the user name.

The user name format must follow the specifications in the UMT settings.

25 Characters

User Type*

Select the user type from the drop-down list.

Select PF User to create a PF user and Sponsor User to create a sponsor user.

NA

First Name*

Enter the first name of the user.

127 Characters

Last Name*

Enter the last name of the user.

127 Characters

Title

Select a title for the user from the drop-down list.

NA

Status

Select Active to set the user as active. Otherwise, select Inactive.

NA

Change Password on Next Login

Select Yes to change the password at next log on. Otherwise, select No.

NA

Address1

Address2

Enter the communication address of the user.

255 Characters

Town/City

Enter the town or city to which the user belongs.

255 Characters

State/Province

Enter the state or province to which the user belongs.

255 Characters

Country*

Select the country to which the user belongs from the drop-down list.

NA

Postal Code

Enter the postal code of the user.

16 Characters

Phone Number

Enter the phone number of the user.

25 Characters

Alternate Phone Number

Enter the alternate phone number of the user.

25 Characters

Mobile Number

Enter the mobile number of the user.

25 Characters

Fax Number

Enter the fax number of the user.

25 Characters

E-mail Address*

Enter the email address of the user.

255 Characters

Confirm User E-mail Address*

Enter the email address of the user for confirmation.

255 Characters

Select Role*

Based on the user type, select a role for the user from the drop-down list.

NA

Table A-73 Create UMT User Details – Error Information

Field Name/Action

Scenario

Error Message

User Details

Username

Error occurs when you enter the character other than alphanumeric and underscore.

Enter a valid Username. Only Alphanumeric (A-Z, 0-9) and underscores(_) are allowed.

User Type

Error occurs when the user type is not selected before submit.

Select User Type.

First Name

Error occurs when you enter the character other than alphabet, hyphen, and blank space.

Enter a valid First Name. Only Letters (A-Z), Hyphens (-), and Blank Spaces are allowed.

Last Name

Error occurs when you enter the character other than alphabet, hyphen, and blank space.

Enter a valid Last Name. Only Letters (A-Z), Hyphens (-), and Blank Spaces are allowed.

Title

NA

NA

Status

NA

NA

Change Password on Next Login

NA

NA

Address1

Address2

NA

NA

Town/City

Error occurs when you enter the character other than alphabet, integer, and blank space.

Enter a valid Town/City. Only Alphanumeric (A-Z, 0-9) and Blank Spaces are allowed.

State/Province

Error occurs when you enter the character other than alphabet and blank space.

Enter a valid State/Province. Only Letters (A-Z) and Blank Spaces are allowed.

Country*

Error occurs when you click Submit without selecting the country.

Select a country.

Postal Code

Error occurs when you enter the character other than alphabet, integer and blank space.

Enter a valid Postal Code. Only Alphanumeric (A-Z, 0-9) and Blank Spaces are allowed.

Phone Number

Error occurs when you enter the character other than alphabet, hyphen, and blank space.

Enter a valid Phone Number. Only Numbers (0-9), Hyphens (-), and Blank spaces are allowed.

Alternate Phone Number

Error occurs when you enter the character other than alphabet, hyphen, and blank space.

Enter a valid Alternate Phone Number. Only Numbers (0-9), Hyphens (-), and Blank spaces are allowed.

Mobile Number

Error occurs when you enter the character other than alphabet, hyphen, and blank space.

Enter a valid Mobile Number. Only Numbers (0-9), Hyphens (-) and Blank spaces are allowed.

Fax Number

Error occurs when you enter the character other than alphabet, hyphen, and blank space.

Enter a valid Fax Number. Only Numbers (0-9), Hyphens (-), and Blank spaces are allowed.

E-mail Address*

Error occurs when you click Submit without entering the email address or entering a wrong email address.

1. Enter E-mail Address.

2. Enter a valid E-mail Address.

Confirm User E-mail Address*

Error occurs for either of the following reasons:

- When you click Submit without entering the confirm user address.

- When you enter a wrong email format.

- When the email address and confirm email address mismatch.

1. Confirm User E-mail Address.

2. Confirm a valid E-mail Address.

3. Confirm E-mail Address does not match

Select Role*

Error occurs when you click Submit without selecting a role.

Select a Role.

Common Error

Copy/Paste

Error occurs when you copy and paste to any text box.

Type using your Keyboard.

Copy/Paste

Error occurs when you copy and paste the Conform Email Address.

Re-confirm your Email address. Note: Do not copy and paste your Email address.

Copy/Paste

Error occurs when you copy and paste the email address.

Enter your Email address. Note: Do not copy and paste your Email address.

A.44 UMT User Details

Table A-74 UMT User Details - Field Information

Field Name

Description

Field Size

User Details

Username*

Enter the user name.

The user name format must follow the specifications in the UMT settings.

25 Characters

User Type*

Select the user type from the drop-down list.

Select PF User to create a PF user and Sponsor User to create a sponsor user.

NA

First Name*

Enter the first name of the user.

127 Characters

Last Name*

Enter the last name of the user.

127 Characters

Title

Select a title for the user from the drop-down list.

NA

Status

Select Active to set the user as active. Otherwise, select Inactive.

NA

Change Password on Next Login

Select Yes to change the password at next log on. Otherwise, select No.

NA

Address1

Address2

Enter the communication address of the user.

255 Characters

Town/City

Enter the town or city to which the user belongs.

255 Characters

State/Province

Enter the state or province to which the user belongs.

255 Characters

Country*

Select the country to which the user belongs from the drop-down list.

NA

Postal Code

Enter the postal code of the user.

16 Characters

Phone Number

Enter the phone number of the user.

25 Characters

Alternate Phone Number

Enter the alternate phone number of the user.

25 Characters

Mobile Number

Enter the mobile number of the user.

25 Characters

Fax Number

Enter the fax number of the user.

25 Characters

E-mail Address*

Enter the email address of the user.

255 Characters

Confirm User E-mail Address*

Enter the email address of the user for confirmation.

255 Characters

Select Role*

Based on the user type, select a role for the user from the drop-down list.

NA

Select Country*

- Available

Displays the list of available countries.

Click >> or  > to move all or the selected country, respectively, to the Selected field.

NA

- Selected

Displays the list of selected countries.

Click << or < to move all or the selected country, respectively, to the Available field.

NA

Select Trial*

- Available

Displays the list of available trials.

Click >> or  > to move all or the selected trial, respectively, to the Selected field.

NA

- Selected

Displays the list of selected trials.

Click << or < to move all or the selected trials, respectively, to the Available field.

NA

Table A-75 UMT User Details – Error Information

Field Name/Action

Scenario

Error Message

User Details

Username

Error occurs when you enter the character other than alphanumeric and underscore.

Enter a valid Username. Only Alphanumeric (A-Z,0 -9) and underscores(_) are allowed.

User Type

Error occur when the user type is not selected before submit.

Select User Type.

First Name

Error occurs when you enter the character other than alphabet, hyphen, and blank space.

Enter a valid First Name. Only Letters (A-Z), Hyphens (-), and Blank Spaces are allowed.

Last Name

Error occurs when you enter the character other than alphabet, hyphen, and blank space.

Enter a valid Last Name. Only Letters (A-Z), Hyphens (-), and Blank Spaces are allowed.

Title

NA

NA

Status

NA

NA

Change Password on Next Login

NA

NA

Address1

Address2

NA

NA

Town/City

Error occurs when you enter the character other than alphabet, integer, and blank space.

Enter a valid Town/City. Only Alphanumeric (A-Z, 0-9) and Blank Spaces are allowed.

State/Province

Error occurs when you enter the character other than alphabet and blank space.

Enter a valid State/Province. Only Letters (A-Z) and Blank Spaces are allowed.

Country*

Error occurs when you click Submit without selecting the country.

Select a country.

Postal Code

Error occurs when you enter the character other than alphabet, integer, and blank space.

Enter a valid Postal Code. Only Alphanumeric (A-Z, 0-9) and Blank Spaces are allowed.

Phone Number

Error occurs when you enter the character other than alphabet, hyphen, and blank space.

Enter a valid Phone Number. Only Numbers (0-9), Hyphens (-), and Blank spaces are allowed.

Alternate Phone Number

Error occurs when you enter the character other than alphabet, hyphen, and blank space.

Enter a valid Alternate Phone Number. Only Numbers (0-9), Hyphens (-), and Blank spaces are allowed.

Mobile Number

Error occurs when you enter the character other than alphabet, hyphen, and blank space.

Enter a valid Mobile Number. Only Numbers (0-9), Hyphens (-), and Blank spaces are allowed.

Fax Number

Error occurs when you enter the character other than alphabet, hyphen, and blank space.

Enter a valid Fax Number. Only Numbers (0-9), Hyphens (-), and Blank spaces are allowed.

E-mail Address*

Error occurs when you click Submit without entering the email address or if you enter a wrong email address.

1. Enter E-mail Address.

2. Enter a valid E-mail Address.

Confirm User E-mail Address*

Error occurs for either of the following reasons:

- When you click Submit without entering the confirm user address.

- When you enter a wrong email format.

- When the email address and confirm email address mismatch.

1. Confirm User E-mail Address.

2. Confirm a valid E-mail Address.

3. Confirm E-mail Address does not match.

Select Role*

Error occurs when you click Submit without selecting a Role.

Select a Role.

Common Error

Copy/Paste

Error occurs when you copy and paste to any text box.

Type using your Keyboard.

Copy/Paste

Error occurs when you copy and paste the confirm email address.

Re-confirm your Email address. Note: Do not copy and paste your Email address.

Copy/Paste

Error occurs when you copy and paste the email address.

Enter your Email address. Note: Do not copy and paste your Email address.

A.45 Create Site Details

Table A-76 Create Site Details - Field Information

Field Name

Description

Field Size

Site Details

Site Number*

Enter the number of the site.

20 Characters

Site Name*

Enter the name of the site.

255 Characters

Site Address1*

Site Address2

Enter the address of the site.

255 Characters

Town/City*

Enter the city where the site is located.

127 Characters

State/Province

Enter the state or province where the site is located.

255 Characters

Country*

Select the country where the site is located from the drop-down list.

NA

Postal Code

Enter the postal code of the site.

16 Characters

Phone Number*

Enter the phone number of the site.

25 Characters

Alternate Phone Number

Enter the alternate phone number of the site.

25 Characters

Fax Number

Enter the fax number of the site.

25 Characters

E-mail

Enter the e-mail address of the site.

255 Characters

Date Format

Displays the date format.

NA

TimeZone*

Select the time zone from the drop-down list.

NA

Study Version

Displays the selected study version.

NA

Load to InForm

Select the check box to upload site details to InForm system

NA

Site Study Locale*

Select the site study locale from the drop-down available

NA

Order of Username in Signature

Select the order of username from the drop-down available for signature.

NA

IRT Related

Site Id

Enter the IRT Site ID.

255

Ship Name

Enter the ship name of the site.

255

Ship Address

Enter the ship address.

255

First Name

Enter the last name.

255

Last Name

Enter the last name.

255

Investigator ID

Enter the investigator ID.

255

Ship Note

Enter the ship note.

255

DEA Registration No

Enter the DEA registration number.

255

DEA Expiration

Enter the DEA expiration.

255

Load to IRT

Select the check box to load the user's information into the IRT system.

NA

Ship City

Enter the ship city.

255

Ship State

Enter the ship state.

255

Ship Zip

Enter the ship zip.

255

Ship Country

Select the ship country.

NA

Ship Phone

Enter the ship phone.

255

Ship Fax

Enter the ship fax.

255

OLX Related

Project Site Enrolment*

Enter the project site enrollment details.

255

Active Site?

Select the check box.

NA

Load to OLX

Select the check box to load the user's information into the OLX system.

NA

User Association Details

Filter By

Select the filter criteria from the drop-down lists.

If you select City, enter the name of the city in the text box that appears and click Go. You can also use wild cards to search for a city.

If you select Country and TimeZone, select the country and time zone from the drop-down list that appears.

NA

Select User

- Available

Displays the list of available users.

Click >> or > to move all or the selected users, respectively, to the Selected field.

NA

- Selected

Displays the list of selected users.

Click << or < to move all or the selected users, respectively, to the Available field.

NA

Automatic Association

Select the check box to automatically associate the site to the users created in the selected country and time zone.

NA

Table A-77 Create Site Details – Error Information

Field Name/Action

Scenario

Error Message

Site Details

Site Number*

Error occurs when the you click Submit without entering the site number or when you enter the characters other than alphanumeric, hyphen, and underscore.

Enter Site Number.

Enter a valid Site number. Only Numbers (0-9), Letters (A-Z), Hyphens(-), and Underscores(_) are allowed.

Site Name*

Error occurs when the you click Submit without entering the site name or when you enter the characters other than alphanumeric, hyphen, underscore, and blank space

Enter Site Name. Enter a valid Site name. Only Alphanumerics (A-Z,0-9), Hyphens(-), Underscores(_), and Blank Spaces are allowed.

Site Address1*

Site Address2

Error occurs when the you click Submit without entering the site address or when you enter the characters other than alphanumeric, hyphen, underscore, blank space, period, and comma.

Enter Site Address.

Enter a valid Address. Only Alphanumerics (A-Z,0-9), Period (.), Comma (,), Hyphens(-), Underscores(_), and Blank Spaces are allowed.

Town/City*

Error occurs when the you enter the characters other than alphanumeric and blank space.

Enter a valid Town/City. Only Alphanumerics (A-Z, 0-9) and Blank Spaces are allowed.

State/Province

Error occurs when the you enter the characters other than alphabet and blank space.

Enter a valid State/Province. Only Letters (A-Z) and Blank Spaces are allowed.

Country*

Error occurs when you click Submit without selecting the country or when no time zone found for the country.

Select a Country. No TimeZone found.

Postal Code

Error occurs when you enter invalid character in the postal code.

Enter a valid Postal Code. Only Alphanumerics (A-Z, 0-9), and Blank Spaces are allowed

Phone Number*

Error occurs when you click Submit without entering the phone number or when you enter character other than number, hyphen, and blank space.

Enter Phone Number.

Enter a valid Phone number. Only Numbers (0-9), Hyphens(-) and Blank Spaces are allowed.

Alternate Phone Number

Error occurs when you click Submit without entering the alternate phone number or when you enter character other than number, hyphen, and blank space.

Enter Alternate Phone Number.

Enter a valid Alternate Phone number. Only Numbers (0-9), Hyphens(-), and Blank Spaces are allowed.

Fax Number

Error occurs when you enter the character other than number, hyphen, and blank space.

Enter a valid Fax number. Only Numbers (0-9), Hyphens(-), and Blank Spaces are allowed.

E-mail

Error occurs when the you enter the email ID other than the standard format.

Enter valid E-mail.

Date Format

NA

NA

TimeZone*

Error occurs when you click Submit without selecting the time zone.

Select TimeZone

Study Version

NA

NA

Load to InForm

NA

NA

Site Study Locale*

Error occurs when you click Submit without selecting the site study locale.

Select the site study locale.

IRT Related Details

Site ID

Error occurs when the you click Submit without entering the site ID.

Enter Site ID,

Ship Name

Error occurs when you click Submit without entering the ship name.

Enter Ship Name.

First Name

Error occurs when you click Submit without entering the first name.

Enter First Name.

Last Name

Error occurs when the you click Submit without entering the last name.

Enter Last Name.

Ship Address

Error occurs when you click Submit without entering the ship address.

Enter Ship Address.

Ship City

Error occurs when the you click Submit without entering the ship city.

Enter Ship City.

Ship Zip

Error occurs when the you click Submit without entering the ship zip.

Enter Ship Zip.

Ship Country

Error occurs when the you click Submit without selecting the ship country.

Select Ship Country.

OLX Related

Project Site Enrollment

Error occurs when the you click Submit without entering the project site enrollment.

Enter project site enrollment.

User Association Details

Filter By

NA

NA

Select User

- Available

NA

NA

- Selected

NA

NA

Automatic Association

NA

NA

A.46 Site Details

Table A-78 Site Details - Field Information

Field Name

Description

Field Size

Site Details

Site Number*

Enter the number of the site.

20 Characters

Site Name*

Enter the name of the site.

255 Characters

Site Address1*

Site Address2

Enter the address of the site.

255 Characters

Town/City*

Enter the city where the site is located.

127 Characters

State/Province

Enter the state or province where the site is located.

255 Characters

Country*

Select the country where the site is located from the drop-down list.

NA

Postal Code

Enter the postal code of the site.

16 Characters

Phone Number*

Enter the phone number of the site.

25 Characters

Alternate Phone Number

Enter the alternate phone number of the site.

25 Characters

Fax Number

Enter the fax number of the site.

25 Characters

E-mail

Enter the e-mail address of the site.

255 Characters

Date Format

Displays the date format.

NA

TimeZone*

Select the time zone from the drop-down list.

NA

Study Version

Displays the selected study version.

NA

Load to InForm

Select the check box to upload site details to InForm system.

NA

IRT Related

Site Id

Enter the IRT Site ID.

255

Ship Name

Enter the ship name of the site.

255

Ship Address

Enter the ship address.

255

First Name

Enter the last name.

255

Last Name

Enter the last name.

255

Investigator ID

Enter the investigator ID.

255

Ship Note

Enter the ship note.

255

DEA Registration No

Enter the DEA registration number.

255

DEA Expiration

Enter the DEA expiration.

255

Load to IRT

Select the check box to load the user's information into the IRT system.

NA

Ship City

Enter the ship city.

255

Ship State

Enter the ship state.

255

Ship Zip

Enter the ship zip.

255

Ship Country

Select the ship country.

NA

Ship Phone

Enter the ship phone.

255

Ship Fax

Enter the ship fax.

255

OLX Related

Project Site Enrolment*

Enter the project site enrollment details.

255

Active Site?

Select the check box.

NA

Load to OLX

Select the check box to load the user's information into the OLX system.

NA

User Association Details

Filter By

Select the filter criteria from the drop-down lists.

If you select City, enter the name of the city in the text box that appears and click Go. You can also use wild cards to search for a city.

If you select Country and TimeZone, select the country and time zone from the drop-down list that appears.

NA

Select User

- Available

Displays the list of available users.

Click >> or > to move all or the selected users, respectively, to the Selected field.

NA

- Selected

Displays the list of selected users.

Click << or < to move all or the selected users, respectively, to the Available field.

NA

Automatic Association

Select the check box to automatically associate the site to the users created in the selected country and time zone.

NA

Submit button

Click to submit the form.

NA

Cancel button

Click to cancel the changes and return to the previous page.

NA

Reason For change Textbox

Enter the reason for change.

255 characters

Table A-79 Site Details – Error Information

Field Name/Action

Scenario

Error Message

Site Details

Site Number*

Error occurs when you click Submit without entering the site number or when you enter the characters other than alphanumeric, hyphen, and underscore.

Enter Site Number.

Enter a valid Site number. Only Numbers (0-9), Letters (A-Z), Hyphens(-), and Underscores(_) are allowed.

Site Name*

Error occurs when you click Submit without entering the site Name or when you enter the characters other than alphanumeric, hyphen, underscore, and blank space.

Enter Site Name. Enter a valid Site name. Only Alphanumerics (A-Z,0-9), Hyphens(-), Underscores(_), and Blank Spaces are allowed.

Site Address1*

Site Address2

Error occurs when the you click Submit without entering the site address or when the user enter the characters other than alphanumeric, hyphen, underscore, blanks pace, period, and comma.

Enter Site Address.

Enter a valid Address. Only Alphanumerics (A-Z, 0-9), Period (.), Comma (,), Hyphens(-), Underscores(_), and Blank Spaces are allowed.

Town/City*

Error occurs when the you enter the characters other than alphanumeric and blank space.

Enter a valid Town/City. Only Alphanumerics (A-Z, 0-9) and Blank Spaces are allowed.

State/Province

Error occurs when the you enter the characters other than alphabet and blank space.

Enter a valid State/Province. Only Letters (A-Z) and Blank Spaces are allowed.

Country*

Error occurs when you click Submit without selecting the country or when no time zone is found for the country.

Select a Country. No TimeZone found.

Postal Code

Error occurs when you enter an invalid character in the postal code.

Enter a valid Postal Code. Only Alphanumerics (A-Z,0-9) and Blank Spaces are allowed

Phone Number*

Error occurs when you click Submit without entering the phone number or when you enter character other than number, hyphen, and blank space.

Enter Phone Number.

Enter a valid Phone number. Only Numbers (0-9), Hyphens(-), and Blank Spaces are allowed.

Alternate Phone Number

Error occurs when you click Submit without entering the alternate phone number or when you enter character other than number, hyphen, and blank space.

Enter Alternate Phone Number.

Enter a valid Alternate Phone number. Only Numbers (0-9), Hyphens(-), and Blank Spaces are allowed.

Fax Number

Error occurs when the you enter the character other than number, hyphen, and blank space

Enter a valid Fax number. Only Numbers (0-9), Hyphens(-), and Blank Spaces are allowed

E-mail

Error occurs when the you enter the email ID other than the standard format.

Enter valid E-mail.

Date Format

NA

NA

TimeZone*

Error occurs when the you click Submit without selecting the time zone.

Select TimeZone.

Study Version

NA

NA

Load to InForm

NA

NA

IRT Related Details

Site ID

Error occurs when the you click Submit without entering the site ID.

Enter Site ID.

Ship Name

Error occurs when the you click Submit without entering the ship name.

Enter Ship Name.

First Name

Error occurs when the you click Submit without entering the first name.

Enter First Name.

Last Name

Error occurs when the you click Submit without entering the last name.

Enter Last Name.

Ship Address

Error occurs when the you click Submit without entering the ship address.

Enter Ship Address.

Ship City

Error occurs when the you click Submit without entering the ship city.

Enter Ship City.

Ship Zip

Error occurs when the you click Submit without entering the ship zip.

Enter Ship Zip.

Ship Country

Error occurs when the you click Submit without selecting the ship country.

Select Ship Country.

OLX Related

Project Site Enrollment

Error occurs when the you click Submit without entering the project site enrollment.

Enter project site enrollment.

User Association Details

Filter By

NA

NA

Select User

- Available

NA

NA

- Selected

NA

NA

Automatic Association

NA

NA

Submit Button

Error occurs when you click Submit without any change.

The form has not changed.

Submit Button

Error occurs when you click Submit without entering reason for change.

Enter a reason for change.

Submit Button

Error occurs when you enter more than 255 characters.

Reason text should not exceed 255 characters.

A.47 MUL Import - Error and Corrective Action Information

Table A-80 MUL Import - Error and Corrective Action Information

Error Message

Scenario

Corrective Action

XML Import:

Number of characters allowed for ItemRefname is 63

Error occurs when the character limit of ItemRefname exceeds 63.

Enter ItemRefname Less than or equal to 63 character.

Maximum Number of characters allowed for ItemQuestion is 255

Error occurs when the character limit of ItemQuestion exceeds 255.

Enter ItemQuestion Less than or equal to 255 character.

Maximum Number of characters allowed for Form Title is 255

Error occurs when the character limit of title exceeds 255.

Enter Title Less than or equal to 255 character.

Maximum Number of characters allowed for Form RefName is 32

Error occurs when the character limit of RefName exceeds 32.

Enter RefName Less than or equal to 32 character.

Group Insert:

Invalid Characters found in Group Name

Error occurs when group name contains characters other than alphanumeric, hyphen, underscore, and blank space.

Remove the character other than Alphanumeric, hyphen, underscore and blank space.

Group Name exceeds maximum limit 63

Error occurs when the group name exceeds 63 characters.

Enter the Group Name Less than or equal to 63 characters.

Group Type not found

Error occurs when the you do not check any group type.

Check at least one group type.

User Insert:

Site number not found

Error occurs when you enter an invalid site number.

Enter the site number of the existing site.

Rights Group not found

Error occurs when you enter an invalid right group.

Enter the site number of the existing Right Group.

First name not found

Error occurs when the first name column is left blank.

Enter the First name.

Last name not found

Error occurs when the last name column is left blank.

Enter the Last name.

Phone number not found

Error occurs when the phone number column is left blank.

Enter the Phone number.

Display name not found

Error occurs when the display name column is left blank.

Enter the Display name.

Email ID not found

Error occurs when the email ID column is left blank.

Enter the Email ID.

User is Mark Upload to InForm and Trial is Locked

Error occurs when you update the user information when the user is Mark Upload to InForm and the Trial is locked.

User cannot be import with the status Mark Upload to InForm when the Trial is locked for QC.

Cannot create user even by appending the character to UserName, as already exist under the sponsor.

Error occurs when the user already created by appending the character.

User need to enter different username.

RoleType is not matched with User Type

Error occurs when the role type is mismatched with the user type.

Choose a Role type that match with the User Type.

Invalid Characters found in User Name

Error occurs when the user name contains characters other than alphanumeric, hyphen, underscore, and blank space.

Remove the character other than Alphanumeric, Hyphen, Underscore and Blank space.

Invalid Characters found in First Name

Error occurs when the first name contains characters other than alphanumeric, hyphen, underscore, and blank space.

Remove the character other than Alphanumeric, Hyphen, underscore and blank space.

Invalid Characters found in Last Name

Error occurs when the last name contains characters other than alphabet, hyphen, underscore, and blank space.

Remove the character other than Alphabet, Hyphen, underscore and blank space.

Invalid Characters found in Phone Number

Error occurs when the phone number contains characters other than number, hyphen, and blank space.

Remove the character other than Alphabet, Hyphen and blank space.

Invalid Characters found in Fax Number

Error occurs when the fax number contains characters other than alphanumeric, underscore, and blank space.

Remove the character other than Alphanumeric, underscore and blank space.

Invalid Characters found in Display Name

Error occurs when the display name contains characters other than alphabet, hyphen, and blank space.

Remove the character other than Alphabet, Hyphen and blank space

Invalid Characters found in Title

Error occurs when the title contains characters other than alphabet, underscore, period, comma, and blank space.

Remove the character other than Alphabet, underscore, period, comma and blank space.

Invalid Characters found in Alternate Phone number

Error occurs when the alternate phone contains characters other than number, underscore, and blank space.

Remove the character other than Number, underscore, and blank space.

Email ID is Invalid

Error occurs when you enter the email ID other than the standard format of email.

Enter the E mail ID in a valid format.

Invalid Characters found in Address1

Error occurs when address1 contains characters other than alphanumeric, underscore, hyphen, period, comma, and blank space.

Remove the character other than Alphanumeric, underscore, hyphen, period, comma and blank space.

Invalid Characters found in Address2

Error occurs when address2 contains characters other than alphanumeric, underscore, hyphen, period, comma, and blank space.

Remove the character other than Alphanumeric, underscore, hyphen, period, comma and blank space.

Invalid Characters found in City/Town name

Error occurs when city or town contains characters other than alphanumeric and blank space.

Remove the character other than Alphanumeric and blank space.

Invalid Characters found in Region/Province/State name

Error occurs when region, province, or state contains characters other than alphabet and blank space.

Remove the character other than Alphabet and blank space.

Phone number not found

Error occurs when the phone number column is left blank.

Enter the Phone number.

Invalid Characters found in Postal Code

Error occurs when postal code contains characters other than alphanumeric and blank space.

Remove the character other than Alphanumeric and blank space.

Invalid Characters found in Beeper

Error occurs when beeper contains characters other than alphanumeric, hyphen, and blank space.

Remove the character other than Alphanumeric, hyphen and blank space.

User name exceeds maximum limit 25 characters

Error occurs when the character limit of the user name exceeds 25.

Enter User name Less than or equal to 25 character.

First name exceeds maximum limit 127 characters

Error occurs when the character limit of the user name exceeds 25.

Enter User name Less than or equal to 25 character.

Last name exceeds maximum limit 25 characters

Error occurs when the character limit of the last name exceeds 25.

Enter Last name Less than or equal to 25 character.

Phone number exceeds maximum limit 25 characters

Error occurs when the character limit of the phone number exceeds 25.

Enter Phone number Less than or equal to 25 character.

Fax number exceeds maximum limit 25 characters

Error occurs when the character limit of the fax number exceeds 25.

Enter Fax number Less than or equal to 25 character

Display name exceeds maximum limit 255 characters

Error occurs when the character limit of the display name exceeds 255.

Enter Display name Less than or equal to 255 character.

Alternate phone number exceeds maximum limit 255 characters

Error occurs when the character limit of the phone number exceeds 255.

Enter phone number Less than or equal to 255 character.

Email ID exceeds maximum limit 255 characters

Error occurs when the character limit of the email ID exceeds 255.

Enter Email ID Less than or equal to 255 character.

Address1 exceeds maximum limit 255 characters

Error occurs when the character limit of address1 exceeds 255.

Enter Address1 Less than or equal to 255 character.

Address2 exceeds maximum limit 255 characters

Error occurs when the character limit of address2 exceeds 255.

Enter Address2Less than or equal to 255 character.

Town/City name exceeds maximum limit 255 characters

Error occurs when the character limit of town or city exceeds 255.

Enter Town/City Less than or equal to 255 character.

Region/state name exceeds maximum limit 255 characters

Error occurs when the character limit of region or state exceeds 255.

Enter Region/state Less than or equal to 255 character.

Postal code exceeds maximum limit 16 characters

Error occurs when the character limit of postal code exceeds 16.

Enter Postal code Less than or equal to 16 character.

Beeper exceeds maximum limit 255 characters

Error occurs when the character limit of beeper exceeds 255.

Enter Beeper Less than or equal to 255 character.

Description exceeds maximum limit 255 characters

Error occurs when the character limit of description exceeds 255.

Enter Description Less than or equal to 255 character.

Role Insert:

The following roles are not imported as only 20 roles will be imported at a time

Error occurs when you import more than 20 records at time.

Import only 20 records at a time.

Invalid characters found in RoleName

Error occurs when the postal code contains characters other than alphanumeric, hyphen, underscore, and blank space.

Remove the character other than Alphanumeric, hyphen, underscore and blank space.

RoleName exceeds maximum limit

Error occurs when the role name exceeds the maximum limit of 63 characters.

Enter RoleName Less than or equal to 63 character.

RoleType not found

Error occurs when enter the role type other than available role type.

Enter only available roletype.

Site Insert:

Site number not found

Error occurs when the site number column is left blank.

Enter the Site number.

Site name not found

Error occurs when the site name column is left blank.

Enter the Site name.

Site Address1 not found

Error occurs when the site address1 column is left blank.

Enter the Site Address1.

Town/city name not found

Error occurs when the site address1 column is left blank.

Enter the Site Address1.

Postal code not found

Error occurs when the postal code column is left blank.

Enter the Postal code.

Country name not found

Error occurs when the country name column is left blank.

Enter the Country name.

Phone number not found

Error occurs when the phone number column is left blank.

Enter the Phone number.

Site GMT conversion time not found

Error occurs when the site GMT conversion time column is left blank.

Enter the Site GMT conversion time.

Site is Mark Upload to InForm and Trial is Locked

Error occurs if you insert a site which is mark upload to InForm when the trial is locked.

If only the trial is unlocked the site could be inserted. And site which is not mark upload to InForm can be Import.

Invalid Characters found in Site number

Error occurs when the site number contains characters other than alphanumeric and hyphen.

Remove the character other than Alphanumeric and Hyphen.

Site number Should have at least one number

Error occurs when the site number does not contain at least one number.

Enter at least one number in the site number.

Invalid Characters found in Site name

Error occurs when the site name contains characters other than alphanumeric, hyphen, underscore, and blank space.

Remove the character other than Alphanumeric, hyphen, underscore and blank space.

Invalid Characters found in Address1

Error occurs when address1 contains characters other than alphanumeric, underscore, hyphen, period, comma, and blank space.

Remove the character other than Alphanumeric, underscore, hyphen, period, comma and blank space.

Invalid Characters found in Address2

Error occurs when address2 contains characters other than alphanumeric, underscore, hyphen, period, comma, and blank space.

Remove the character other than Alphanumeric, underscore, hyphen, period, comma and blank space.

Invalid Characters found in City/Town name

Error occurs when the city or town contains characters other than alphanumeric and blank space.

Remove the character other than Alphanumeric and blank space.

Invalid Characters found in Region/State name

Error occurs when the region, province, or state contains characters other than Alphabet and blank space.

Remove the character other than Alphabet and blank space.

Invalid Characters found in Postal/Zip Code

Error occurs when the postal code contains characters other than alphanumeric and blank space.

Remove the character other than Alphanumeric and blank space.

Invalid Characters found in Phone number

Error occurs when the phone number contains characters other than number, hyphen, and blank space.

Remove the character other than Alphabet, Hyphen and blank space.

Invalid Characters found in Fax number

Error occurs when the fax number contains characters other than alphanumeric, underscore, and blank space.

Remove the character other than Alphanumeric, underscore and blank space.

Invalid Characters found in Alternate phone number

Error occurs when the alternate phone number contains characters other than number, hyphen, and blank space.

Remove the character other than Alphabet, Hyphen and blank space.

Email ID is Invalid

Error occurs when the email ID is not in the standard format.

Enter the E mail ID in a valid format.

Time zone is Invalid

Error occurs when the time zone is invalid.

Enter the valid Time zone.

Country Name is Invalid

Error occurs when the entered time zone is invalid.

Enter the valid Country Name.

Site number exceeds maximum limit 20 characters

Error occurs when the character limit of the site number exceeds 20.

Enter Site number Less than or equal to 20 character.

Site name exceeds maximum limit 255 characters

Error occurs when the character limit of the site name exceeds 255.

Enter Site name Less than or equal to 255 character.

City/Town name exceeds maximum limit 127 characters

Error occurs when the character limit of city or town name exceeds 127.

Enter City/Town name Less than or equal to 127 character.

Region/State name exceeds maximum limit 255 characters

Error occurs when the character limit of region or state name exceeds 255.

Enter Region/State Less than or equal to 255 character.

Postal Code exceeds maximum limit 16 characters

Error occurs when the character limit of the postal code exceeds 16.

Enter Postal Code Less than or equal to 16 character.

Phone number exceeds maximum limit 25 characters

Error occurs when the character limit of the phone number exceeds 25.

Enter Phone number Less than or equal to 25 character.

Fax number exceeds maximum limit 25 characters

Error occurs when the character limit of the fax number exceeds 25.

Enter Fax number Less than or equal to 25 character.

Alternate Phone Number exceeds maximum limit 25 characters

Error occurs when the character limit of the alternate phone number exceeds 25.

Enter Alternate Phone Number Less than or equal to 25 character.

Email ID exceeds maximum limit 255 characters

Error occurs when the character limit of the email ID exceeds 25.

Enter Email ID Less than or equal to 25 character.

Address1 exceeds maximum limit 255 characters

Error occurs when the character limit of address1 exceeds 25.

Enter Address1 Less than or equal to 25 characters.

Address2 exceeds maximum limit 255 characters

Error occurs when the character limit of address2 exceeds 25.

Enter Address2 Less than or equal to 25 characters.

Ship Name not found

Error occurs when the ship name column is left blank.

Enter the Ship Name.

Ship Address not found

Error occurs when the ship address column is left blank.

Enter the Ship Address.

Ship City not found

Error occurs when the ship city column is left blank.

Enter the Ship City.

Ship Zip not found

Error occurs when the ship zip column is left blank.

Enter the Ship Zip.

Ship Country not found

Error occurs when the ship country column is left blank.

Enter the Ship Country.

File:

Invalid Dat file. Check the delimeters(Pipe) in the file.

Error occurs when the DAT file is invalid.

Provide a valid DAT File.

Please choose an Excel file or a dat file

Error occurs when the input file is other than Excel or Dat file.

Select Excel or Dat file as input.

Please select only one module for dat file import.

Error occurs when you select more than one module for import from a DAT file.

Select one module at a time for import record from DAT file.

Please select a file to import

Error occurs when you click Import without selecting a file to import.

Select a file for import.

File Uploaded Failed. Invalid DAT File

Error occurs when select an invalid DAT file for import.

Select a valid DAT file to import.

Invalid MUL File

Error occurs when select an invalid MUL (Excel) File for import.

Select a valid MUL (Excel) File for import.

A.48 Worklist Details

Table A-81 Worklist Details – Field Information

Field Name

Description

Current Sponsor Company

Select the sponsor company from the drop-down list.

Trial

Select the trial from the drop-down list.

Route Type

Select the type of the worklist. The available options are:

- Manual

- Automated

Manual Worklist

Trial Type

Select the trial type from the drop-down list.

User

Site

Role

Group

Config

Displays the worklist details of the selected sponsor company and trial at user level.

Displays the worklist details of the selected sponsor company and trial at site level.

Displays the worklist details of the selected sponsor company and trial at role level.

Displays the worklist details of the selected sponsor company and trial at group level.

Displays the worklist details of the selected sponsor company and trial at configuration level.

Filter Criteria

UserName

Site No

RoleName

GroupName

Enter the user name.

Enter the site number.

Enter the role name.

Enter the group name.

Status

Select the status from the drop-down list. The available options are:

- New

- Change

- Delete

- Reinstate

Process Status

Select the status of the process from the drop-down list. The available options are:

- Process Started

- Data Entry Completed

- QC Rejected

- Pending

- UM Task Completed

- UA Task Completed

- Records Assigned To QC

Requested

Select the time (in hours) within which the worklist is requested. The available options are:

- +24 hours ago

- 12-24 hours ago

- 6-12 hours ago

- 6 hours ago

Find

Click to view the list of worklist details that satisfy the filter criteria.

Clear

Click to clear the filter criteria.

Result of specified filter criteria

Sponsor

Displays the name of the sponsor company.

Trial

Displays the name of the trial.

Username

Site No

RoleName

GroupName

Displays the user name.

Displays the site number.

Displays the role name.

Displays the group name.

Click the link corresponding to user name, site no, role name, or group name for more details.

Modified Date

Displays the date on which the worklist is modified.

Status

Displays the status of the worklist.

Assigned To

Displays the name of the user to whom the worklist is assigned to, for further process.

Assigned UM

Displays the name of the User Manager (UM) to whom the worklist is assigned to for further process.

Assigned UA

Displays the name of the User Approver (UA) to whom the worklist is assigned to for further process.

Assigned QC

Displays the name of the Quality Control (QC) user to whom the worklist is assigned to for further process.

Process status

Displays the status of the worklist process.

Completion Time

Displays the time of completion of the worklist process.

Check Dependency

Click to view the reason for a failed worklist process.

Select

Select the required action from the drop-down list. The available options are:

- Assigned to UM

- Assigned to UA

- Assigned to QC

- Mark as Pending

- Archive Records

Push Worklist to Automated Queue

Select the required worklist and click this button to push a manual worklist to the automated worklist queue.

Comments

Enter the reason for modifying the worklist.

Go

Click to save the changes.

Automated Worklist

User

Site

Role

Group

Displays the worklist details of the selected sponsor company and trial at user level.

Displays the worklist details of the selected sponsor company and trial at site level.

Displays the worklist details of the selected sponsor company and trial at role level.

Displays the worklist details of the selected sponsor company and trial at group level.

Filter Criteria

Username

Site No

RoleName

Group Name

Enter the user name.

Enter the site number.

Enter the role name.

Enter the group name.

Result of specified filter criteria

Sponsor

Displays the sponsor company name.

Trial

Displays the trial name.

Username

Site No

RoleName

GroupName

Displays the user name.

Displays the site number.

Displays the role name.

Displays the group name.

Click the link corresponding to username, site no, role name, or group name for more details.

Modified Date

Displays the date on which the worklist is modified.

Transaction Type

Displays the transaction type of the worklist.

Process Status

Displays the process status of the worklist.

Completion Time

Displays the time of completion of the worklist.

Push Worklist to Manual Queue

Select the required worklist and click this button to push the automated worklist to manual worklist queue.

Comments

Enter the comments for modifying the worklist details.

A.49 Manage Worklists Generation

Table A-82 Manage Worklists Generation – Field Information

Field Name

Description

Sponsor Specific Worklists Setting

Sponsor

Select the sponsor company from the drop-down list.

Default Worklists Setting for Future Trials

The default setting for worklist type for all the future trials that is created for the selected sponsor company. The available options are:

- Disable

- Manual Worklists

- Automatic Worklists

Existing Trial(s) Worklists Setting

Select Trials

Disabled

Displays the list of trials with no worklist type associated. Use the or button to move all or the selected trials, respectively, to the Manual Worklists field.

Manual Worklists

Displays the list of trials associated with the manual worklist type.

Use the or button to move all or the selected trials, respectively, to the Disabled field. Use the button to move the selected trials to the Automatic Worklists field.

Automatic Worklists

Displays the list of trials associated with the automatic worklist type.

Use the button to move the selected trials to the Manual Worklists field.

Reason for change

Enter the reason for modifying the worklist details.

A.50 Assessment Configuration Settings

Table A-83 Assessment Configuration Settings – Field Information

Field Name

Description

Current Sponsor Company

Displays/Modify the sponsor company.

Trial

Displays/Modify the trial.

Number of Reminder Mails

Displays/Modify the number of reminder mails to be sent to the users.

Reminder Mails Interval (in Hrs)

Displays/Modify the time interval to send the reminder mails to the users.

Enable InForm Question

Minimum no. of users to Pass Assessment

Displays/Modify the minimum number of users to pass the assessment.

Minimum no. of users to attend to stop reminder mails

Displays/Modify the minimum number of users to attend the assessment to stop sending the reminder mails.

User defined Assessment status

Displays/Modify the user-defined assessment status.

Loginname

Enter the login name of the user.

Manage Assessment Accounts

Password

Enter the password of the user.

Default Email

Enter the default email ID for sending the assessment result.

Roles

Included For Assessment

Displays the roles that are included for the assessment.

Click >> or > to move all or the selected roles to the list of excluded roles for assessment.

Excluded For Assessment

Displays the roles that are excluded for the assessment.

Click << or < to move all or the selected roles to move to the list of included roles for assessment.

E-Mail Templates

Registration

Displays/Modify the email template to be sent to the users for registering for the assessment.

Reminder

Displays/Modify the email template to be sent to the users to remind to attend the assessment.

A.51 Assessment Benchmark Settings

Table A-84 Assessment Benchmark Settings – Field Information

Field Name

Description

Current Sponsor Company

Displays/Modify the sponsor company.

Trial

Displays/Modify the trial.

Supported Browser(s)

Browser Type *

Displays/Modify the browser type.

Browser Version *

Minimum

Maximum

Displays/Modify the minimum browser version to be configured.

Displays/Modify the maximum browser version to be configured.

Browser Service Pack

Minimum

Maximum

Displays/Modify the browser service pack for the minimum and maximum browser versions that are configured.

Displays/Modify the minimum browser service pack to be configured for the selected browser version.

Displays/Modify the maximum browser service pack to be configured for the selected browser version.

Add Additional Browser

Click to add additional browser.

Second Browser Settings

Second Browser Type

Displays/Modify the browser type for the second browser from the drop-down list.

Second Browser Version *

Minimum

Maximum

Displays/Modify the minimum browser version for the second browser.

Displays/Modify the maximum browser version for the second browser.

Cancel

Click to cancel the settings for the second browser.

Operating System

Displays/Modify the list of operating systems to be configured.

Check for Operating System *

Yes

No

Lets you check if the configured operating system is available on the user's system during assessment.

Select Yes to always check for the configured operating system. Otherwise, select No.

Browser Version Message *

Displays/Modify the message that is to be displayed regarding the compatibility of the browser version.

LAN Speed Benchmark *

Displays/Modify the benchmark speed (in seconds) for LAN.

A.52 Generate Assessment Summary Report - Sponsor Level

Table A-85 Generate Assessment Summary Report at Sponsor Level – Field Information

Field Name

Description

Sponsor Company

Select the sponsor company from the drop-down list.

Trial

Select the trial from the drop-down list.

From

Select the starting date from the calender available at the side of the text box.

To

Select the ending date from the calender available at the side of the text box.

Generate

Click to generate the report.

Report Details

Logon Name

Logon name of the user.

First Name

First name of the user.

Last Name

Last name of the user.

Sponsor

Name of the sponsor company.

Site Number

Number of the site.

Site Name

Name of the site.

Dept. Name

Name of the department.

City

Name of the city.

Country

Name of the country.

Study Name

Name of the study.

Computer

Name of the computer.

Test Date

Date on which the test carried.

Browser Type

Type of the browser.

Browser Version

Version of the browser.

Browser SP

Service pack of the browser.

OS

Name of the operating system.

Internet Access

Type of the internet access used.

Slowest Rating

The slowest rating of the network speed.

Fastest Rating

The fastest rating of the network speed.

Average Rating

The average rating of the network speed.

Status

The status of the assessment.

Email

Email ID of the user.

A.53 Generate Assessment Summary Report - Trial Level

Table A-86 Generate Assessment Summary Report at Trial Level – Field Information

Field Name

Description

Sponsor Company

Select the sponsor company from the drop-down list.

Trial

Select the trial from the drop-down list.

Assessment Status

Select the assessment status from the drop-down list. The available options are:

- All

- Pass

- Border Line

- Fail

From

Select the starting date from the calender available at the side of the text box.

To

Select the ending date from the calender available at the side of the text box.

Generate

Click to generate the report.

Report Details

Assessment Result

The assessment result such as pass, borderline, or fail.

Number

The number of assessments based on the assessment result.

Percentage

The percentage of the assessments based on the assessment result.

Total

The total number of assessments and percentage for the specified trial, sponsor, and time.

A.54 Generate Assessment Detail Report - Trial Level

Table A-87 Generate Assessment Detail Report at Trial Level - Field Information

Field Name

Description

Sponsor Company

Select the sponsor company from the drop-down list.

Trial

Select the trial from the drop-down list.

Assessment Status

Select the assessment status from the drop-down list. The available options are:

- All

- Pass

- Border Line

- Fail

From

Select the starting date from the calender available at the side of the text box.

To

Select the ending date from the calender available at the side of the text box.

Generate

Click to generate the report.

Report Details

Sl No

Serial number.

Sponsor

Name of the sponsor company.

Trial

Name of the trial.

Logon Name

Logon name of the user.

First Name

First name of the user.

Last Name

Last name of the user.

Computer Description

Description of the computer on which the assessment is carried.

Assessment Date

Date on which the assessment is carried.

Browser Type

Type of the browser.

Browser Version

Version of the browser.

Browser SP

Service pack of the browser.

OS

Name of the operating system.

Internet Access

Type of the internet access used.

Slowest Rating

The slowest rating of the network speed.

Fastest Rating

The fastest rating of the network speed.

Average Rating

The average rating of the network speed.

User Assessment Result

The assessment result of the user, such as pass, fail, or borderline.

E-Mail

Email address of the user.

A.55 Generate Assessment Summary Report - Site Level

Table A-88 Generate Assessment Summary Report at Site Level - Field Information

Field Name

Description

Country

Select the country from the drop-down list.

Sponsor Company

Select the sponsor company from the drop-down list.

Trial

Select the trial from the drop-down list.

Site

Select the site from the drop-down list.

Assessment Status

Select the assessment status from the drop-down list. The available options are:

- All

- Pass

- Border Line

- Fail

Failure Due To

Select the reason for the failure of the assessment from the drop-down list. The available options are:

- All

- Browser

- Connection

- Operating System

From

Select the starting date from the calender available at the side of the text box.

To

Select the ending date from the calender available at the side of the text box.

Generate

Click to generate the report.

Report Details

Assessment Result

The assessment result such as pass, borderline, or fail.

Number

The number of assessments based on the assessment result.

Percentage

The percentage of the assessments based on the assessment result.

Total

The total number of assessments and percentage for the specified trial, sponsor, and time.

Users Failed Due to Browser

The number of users failed due to issue in the browser.

Users Failed Due to Connection

The number of users failed due to issue in the connection.

Users Failed Due to O.S.

The number of users failed due to issue in the operating system.

A.56 Generate Assessment Detail Report - Site Level

Table A-89 Generate Assessment Detail Report at Site Level - Field Information

Field Name

Description

Country

Select the country from the drop-down list.

Sponsor Company

Select the sponsor company from the drop-down list.

Trial

Select the trial from the drop-down list.

Site

Select the site from the drop-down list.

Assessment Status

Select the assessment status from the drop-down list. The available options are:

- All

- Pass

- Border Line

- Fail

Failure Due To

Select the reason for the failure of the assessment from the drop-down list. The available options are:

- All

- Browser

- Connection

- Operating System

From

Select the starting date from the calender available at the side of the text box.

To

Select the ending date from the calender available at the side of the text box.

Generate

Click to generate the report.

Report Details

Sponsor

Name of the sponsor company.

Trial

Name of the trial.

First Name

First name of the user.

Last Name

Last name of the user.

Site Number

Number of the site.

Site Name

Name of the site

Site e-mail id

Email ID of the site.

City

City to which the sponsor belongs.

Country

Country to which the sponsor belongs.

Computer Description

Description of the computer on which the assessment is carried.

Assessment Date

Date on which the assessment is carried.

Browser Type

Type of the browser.

Browser Version

Version of the browser.

Browser SP

Service pack of the browser.

OS

Name of the operating system.

Slowest Rating

The slowest rating of the network speed.

Fastest Rating

The fastest rating of the network speed.

Average Rating

The average rating of the network speed.

User Assessment Result

The assessment result of the user, such as pass, fail, or borderline.

Site Assessment Result

The assessment result of the site.

E-Mail

Email ID of the user.

A.57 Generate Master Summary Report - Site Level

Table A-90 Master Summary Report at Site Level - Field Information

Field Name

Description

Country

Select the country from the drop-down list.

Sponsor Company

Select the sponsor company from the drop-down list.

Trial

Select the trial from the drop-down list.

Site

Select the site from the drop-down list.

Assessment Status

Select the assessment status from the drop-down list.

Provisioning Status

Select the provisioning status from the drop-down list.

Provisioned By

Select the user who provisioned the asset from the drop-down list.

Category

Select the category of the asset from the drop-down list.

From

Select the starting date from the calender available at the side of the text box.

To

Select the ending date from the calender available at the side of the text box.

Generate

Click to generate the report.

Report Details

Assessment Status

Status of the assessment.

Number

Number of assets based on the assessment status.

Percentage

Percentage of assets based on the assessment status.

Total

Total number and percentage of assets based on the assessment status.

Provisioning Status

Status of the provisioning.

Number

Number of assets based on the provisioning status.

Percentage

Percentage of assets based on the provisioning status.

Total

Total number and percentage of assets based on the provisioning status.

A.58 Generate Master Detail Report - Site Level

Table A-91 Master Detail Report at Site Level - Field Information

Field Name

Description

Country

Select the country from the drop-down list.

Sponsor Company

Select the sponsor company from the drop-down list.

Trial

Select the trial from the drop-down list.

Site

Select the site from the drop-down list.

Assessment Status

Select the assessment status from the drop-down list.

Provisioning Status

Select the provisioning status from the drop-down list.

Provisioned By

Select the user who provisioned the asset from the drop-down list

Category

Select the category of the asset.

From

Select the starting date from the calender available at the side of the text box.

To

Select the ending date from the calender available at the side of the text box.

Generate

Click to generate the report.

Report Details

Sponsor

Name of the sponsor company.

Trial

Name of the trial.

Site

Name of the site.

Assessment Status

Status of the assessment.

Provisioning Status

Status of the provisioning.

Asset

Name of the asset.

A.59 Generate Billing Details Report

Table A-92 Billing Details Report - Field Information

Field Name

Description

Sponsor Company

Select the sponsor company from the drop-down list.

Trial

Select the trial from the drop-down list.

From

Select the starting date from the calender available at the side of the text box.

To

Select the ending date from the calender available at the side of the text box.

Generate

Click to generate the report.

Report Details

Sponsor Company

Name of the sponsor company.

Trial

Name of the trial.

Reference

Name of the reference.

Protocol

Protocol number of the trial.

Contracted No of Sites

Number of sites contracted for performing the trial.

No of Sites Associated

Number of sites associated with the trial.

Contracted No of Site Assessments

Number of contracted site assessments.

No of Site Assessments

Number of site assessments.

Contracted No of Users

Number of users contracted for performing the trial.

No of Users

Number of users in the trial.

Contracted No of Countries

Number of countries contracted for performing the trial.

Selected No of Countries

Number of countries selected.

Contracted No of IOL Accounts

Number of IOL accounts contracted for performing the trial.

IOL Accounts Created

Number of IOL accounts created.

No of Provisioning

Number of provisions for the trail.

A.60 Generate Training Details Report

Table A-93 Training Details Report - Field Information

Field Name

Description

Sponsor Company

Select the sponsor company from the drop-down list.

Training Course

Select the training course from the drop-down list.

From

Select the starting date from the calender available at the side of the text box.

To

Select the ending date from the calender available at the side of the text box.

Generate

Click to generate the report.

Report Details

Sponsor

Name of the sponsor company.

Training Course

Name of the training course.

User Count

Count of the users attended the training course.

A.61 Generate User Detail Report

Table A-94 User Detail Report - Field Information

Field Name

Description

Country

Select the country from the drop-down list.

Sponsor Company

Select the sponsor company from the drop-down list.

Trial

Select the trial from the drop-down list.

User Type

Select the type of the user from the drop-down list.

From

Select the starting date from the calender available at the side of the text box.

To

Select the ending date from the calender available at the side of the text box.

Generate

Click to generate the report.

Report Details

Sponsor

Name of the sponsor company.

Trial

Name of the trial.

First Name

First name of the user.

Last Name

Last name of the user.

User Name

User name.

Country

Name of the country.

Email

Email ID of the user.

User Type

Type of the user.

Role

Role of the user.

User Status

Status of the user.

Site Association Description

Description of the site association.

A.62 Generate Site-User Detail Report

Table A-95 Site-User Detail Report - Field Information

Field Name

Description

Sponsor Company

Select the sponsor company from the drop-down list.

Trial

Select the trial from the drop-down list.

Module

Select the module from the drop-down list.

From

Select the starting date from the calender available at the side of the text box.

To

Select the ending date from the calender available at the side of the text box.

Generate

Click to generate the report.

User Detail Report

Trial Name

Name of the trial.

User Name

Name of the user.

First Name

First name of the user.

Last Name

Last name of the user.

Rights Group

Rights group.

Email

Email ID of the user.

Newly Associated Sites

Sites that are newly associated.

Newly Dis-associated Sites

Sites that are newly disassociated.

Associated Groups

Groups that are associated.

Dis-associated Groups

Groups that are disassociated.

Modified By

Name of the user who modified.

Modified Date

Date on which the user is modified.

Status

Status of the user.

Site Detail Report

Trial Name

Name of the trial.

Site Number

Number of the site.

Site Name

Name of the site.

Address1

Address2

Communication address of the site.

City

Name of the city where the site is located.

State

Name of the state where the site is located.

Country

Name of the country where the site is located.

Postal Code

Postal code of the site.

E-mail Address

Email ID of the user associated to the site.

Phone

Phone number of the site.

Study Version

Version of the study.

Modified By

Name of the user who modified the site.

Modified Date

Date on which the site is modified.

Status

Status of the site.

A.63 Generate Trial Archive Package (TAP) Report

Table A-96 Trial Archive Package (TAP) Report - Field Information

Field Name

Description

Sponsor Company

Select the sponsor company from the drop-down list.

Trial

Select the trial from the drop-down list.

Generate Report

Click to generate the report.

A.64 List of Oracle Users

Table A-97 List of Oracle Users - Field Information

Field Name

Description

Field Size (In Character)

Username

Enter the name of the user.

32

First Name

Enter the first name of the user.

127

Last Name

Enter the last name of the user.

127

User Status

Select the status of the user from the drop-down list.

NA

User Type

Select the user type from the drop-down list.

NA

Role

Select the role from the drop-down list.

NA

Approval Status

Select the approval status from the drop-down list.

NA

Training Status

Select the training status from the drop-down list.

NA

Country

Select the country from the drop down.

NA

Uploaded to InForm

Select the Yes or No option from the drop-down list.

NA

Description

Select the description of the user from the drop-down list.

NA

Displays the icon,

if the user is marked Upload to InForm.

if the user is marked Upload to IRT.

if the user is marked Upload to InForm/IRT.

NA

Username

Displays the user name. Click the hyperlink to view the corresponding user details.

NA

First Name

Displays the first name of the user.

NA

Last Name

Displays the last name of the user.

NA

User Status

Displays the status of the user.

NA

User Type

Displays the user type.

NA

Role

Displays the user's role.

NA

Approval Status

Displays the approval status. The approval status can be Approved, Rejected, or Pending.

NA

Training Status

Displays the Training status. The training status can be Trained or Not Trained.

NA

Trained Date

Displays the trained date of the user.

NA

Site(s)

Displays the sites associated with the user. If the user is associated to multiple sites, the icon is displayed. Click the icon to view the association details. The icon is disabled for the user type Sponsor.

NA

Country

Displays the country name of the user.

NA

Provisioning Status

Displays the provisioning status of the user.

NA

Description

Displays the description of the user.

NA

PRD SSO Status

Displays the production environment SSO status of the user.

NA

TRN SSO Status

Displays the training environment SSO status of the user.

NA

UAT SSO Status

Displays the UAT SSO status of the user.

NA

A.65 InForm Terminated User List

Table A-98 InForm Terminated User List - Field Information

Field Name

Description

Field Size (In Character)

Filter Section

Username

Enter the name of the user.

25

First Name

Enter the first name of the user.

127

Last Name

Enter the last name of the user.

127

Country

Select the country from the drop down.

NA

Filter Result

Displays the icon,

if the user is marked Upload to InForm.

if the user is marked Upload to IRT.

if the user is marked Upload to InForm/IRT.

NA

Username

Displays the user name. Click the hyperlink to view the corresponding user details.

NA

First Name

Displays the first name of the user.

NA

Last Name

Displays the last name of the user.

NA

Country Name

Displays the country name of the user.

NA

Terminated Date

Displays the date on which the user is terminated.

NA

Approval Status

The approval status of the terminated user.

NA

A.66 List of Trials

Table A-99 List of Trials - Field Information

Field Name

Description

Filter Section

Trial Name

Enter the trial name.

Study Name

Enter the study name.

Trial Associated To

Enter the trial to which the sponsor is associated to.

Reference

Enter the reference name.

Trial Status

Select the status of the trial from the drop-down list.

Trial Type

Select the type of the trial from the drop-down list.

Product

Select the product to which the trial belongs from the drop-down list.

InForm Version

Select the InForm version from the drop-down list.

IRT Version

Select the IRT version from the drop-down list.

OLx Version

Select the OLx version from the drop-down list.

IPMs Version

Select the IPMs version from the drop-down list.

Filter Result

Duplicates

Displays the manual duplicate trials.

Automatic Duplicates

Displays the automatic duplicate trials.

Trial Name

Displays the name of the trial.

Study Name

Displays the name of the study.

Trial Associated To

Displays the name of the sponsor to which the trial is associated.

Reference

Displays the name of the reference.

Product

Displays the name of the product.

InForm Version

Displays the InForm version.

IRT Version

Displays the IRT version.

OLx Version

Displays the OLx version.

IPMs Version

Displays the IPMs version.

Trial Status

Displays the status of the trial.

Trial Type

Displays the type of the trial.

Copy

Click the icon to copy the trial.

Pivotal

Displays the pivotal details of the trial.

FastLock Report

Displays the FastLock report for the trial.

A.67 List of Archived Trials

Table A-100 List of Archived Trials - Field Information

Field Name

Description

Study Name

Displays the study name.

Reference

Displays the reference name.

Protocol Number

Displays the protocol number of the trial.

Therapeutic Area

Displays the therapeutic area of the trial.

Status

Displays the status of the trial.

Date & Time of Archival

Displays the date and time on which the trial is archived.

A.68 Managing Training

Table A-101 List of Archived Trials - Field Information

Field Name

Description

Trial Name

Select the trial name from the drop-down list.

First Name

Enter the first name of the user.

Last Name

Enter the last name of the user.

IOL Email id

Enter the IOL email ID of the user.

Class(es)

Select the IOL class from the drop-down list.

IOL Status

Select the status of the IOL class. The available options are:

- Not Completed

- Completed

Filter Result

Trial Name

Displays the trial name.

First Name

Displays the first name of the user.

Last Name

Displays the last name of the user.

IOL Email id

Displays the IOL email ID of the user.

Class(es)

Displays the classes the user assigned to.

IOL Status

Displays the status of the IOL class.

Download Certificate

Click the hyperlink to download the class completion certificate in PDF format.

A.69 Custom Review State Configuration Settings

Table A-102 List of Archived Trials - Field Information

Field Name

Description

Add Review State

Review State1:

RefName

Enter the reference name.

Activated

Selected the required option from the drop-down menu. The available options are:

- True

- False

Label

Enter the label name.

Mnemonic

Enter the mnemonic.

Language

Select the required language from the drop-down list.

Translations

Label Display Text

Enter text for label display.

Mnemonic Display Text

Enter text for mnemonic display.

Locale

Select the required locale from the drop-down list.

Add Review Stage

Stage1:

RefName

Enter the reference name.

Label

Enter the label name.

Mnemonic

Enter the mnemonic.

Language

Select the required language from the drop-down list.

Translations

Label Display Text

Enter text for label display.

Mnemonic Display Text

Enter text for mnemonic display.

Locale

Select the required locale from the drop-down list.

Index
A  C  E  G  I  L  M  P  R  S  T  U  V  W

A

About

UMT, 1

UMT Help, 1.2

UMT Interface, 2.4

Access Support Help Desk, 2.3 Activate

UMT Users, 3.3.4

Approve

InForm Roles, 6.1.6

InForm Users, 3.2.9

Approve or Reject Groups, 7.6 Archive

Log Files, 12.3

Trials, 4.7

Assign

IOL Class, 13.2

IOL Classes, 3.2.12

Preferred Study Locale, 3.2.19, 5.15

Product, 3.5.3

Study Version, 5.9

Associate

User with a Site, 3.2.5

C

Change the Login Password, 2.2

Configure

Assessment, 14.4

Custom Review State, 14.3

InForm Settings, 14.2

Settings, 14

UMT Settings, 14.1

Copy

Bulk, 4.5

Selective, 4.6

Create

Global Users, 3.5.2

Groups, 7.2

InForm Roles, 6.1.2

InForm, IRT, or OLx Users, 3.2.2

Oracle Users, 3.4.2

PF Groups, 7.7

Trials, 4.2

UMT Users, 3.3.2

E

Export

InForm Users, 3.2.14

Trial Details, 4.9

Trials, 4.10

G

Generate

InForm XML, 4.12

Reports, 8.2

Get a New Password, 2.1

I

Import Trials, 4.11

InStruct Online (IOL), 13.1

L

Link Users, 3.7

Log out of the Application, 2.8

M

Manage

Assessment, 11

InForm Roles, 6.1

Log Files, 12

Training, 13.3

UMT Roles, 6.2

Worklist Generation, 9.2

Worklists, 9

Manage IRT Roles, 6.3 Mark

Upload to IRT, 5.11

Users as Trained, 3.2.11

Users for Load to OLx, 3.2.16

Users for Updating User Name in Email Notifications, 3.2.17

Users for Upload to InForm, 3.2.10

Users for Upload to IRT, 3.2.15

Merge Duplicate Users, 3.6 Modify

Global User Details, 3.5.4

InForm User Details, 3.2.3

Oracle User Details, 3.4.3

Trial Details, 4.3

UMT User Details, 3.3.3

User and Group Association, 7.3

P

Perform

Quick Search, 2.5

R

Reject

InForm Roles, 6.1.6

InForm Users, 3.2.9

Resend

UMT Login Details, 3.3.9

Reset

Password for UMT Users, 3.3.8

S

Send

Assessment Email, 5.13

InForm Account Details, 3.2.13

Set

Display Override Option, 6.1.5

Single Sign-on, 3.1 Sites

Approve or Reject, 5.4

Create, 5.2

Export, 5.10

Mark a Not Participating Site as Participating, 5.8

Mark as Not Participating, 5.6

Mark as Uploaded to InForm, 5.5

View, 5.1

View and Modify Details, 5.3

View Not Participating, 5.7

Stop

Assessment Process, 5.14

T

Terminate

Global User, 3.5.5

InForm Users, 3.2.6

UMT Users, 3.3.5

Transfer

InForm Roles, 6.1.7

U

Unterminate

Global Users, 3.5.7

InForm Users, 3.2.8

UMT Users, 3.3.7

Update

Assessment Status, 3.2.18, 11.2

Assessment Status for a Site, 5.12

Study Version, 5.9

User Types, 3.1 Users

Global, 3.5

InForm, IRT, and OLx, 3.2

Oracle, 3.4

UMT, 3.3

V

Validate

AutoQuery Groups, 7.4

View

Archived Log Files, 12.4

Archived Records, 10.3

Archived Trials, 4.8

Assessment Comment History, 11.3

Audit Trails, 2.7

Duplicate Items, 4.4

Global User Details, 3.5.4

Group Details, 7.5

InForm Role Details, 6.1.3

InForm User Details, 3.2.3

InForm User-Role Associations, 6.1.4

List of Assessed Users, 11.1

List of Global Users, 3.5.1

List of Groups, 7.1

List of InForm Roles, 6.1.1

List of InForm, IRT, or OLx Users, 3.2.1

List of Log Files, 12.1

List of Oracle Users, 3.4.1

List of Reports, 8.1

List of Transferred Data, 12.2

List of Trials, 4.1

List of UMT Users, 3.3.1

Manual Worklist, 10.2

Multiple Association, 3.2.4

Oracle User Details, 3.4.3

Terminated InForm Users, 3.2.7

Terminated UMT Users, 3.3.6

Terminated User List, 3.5.6

Trial Details, 4.3

UMT User Details, 3.3.3

User and Group Association, 7.3

W

Worklist, 10

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