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Contents

List of Figures

List of Tables

Title and Copyright Information

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