Contents

• Title and Copyright Information
• Preface

1 What’s New in This Release

• What’s New in This Release

2 Overview of Siebel Clinical Trial Management System

• Overview of Siebel Clinical Trial Management System
• About Siebel Clinical Trial Management System
• Features of Siebel Clinical Trial Management System
• Product Modules and Options for Siebel Clinical Trial System

3 Setting Up Siebel Clinical

• Setting Up Siebel Clinical
• About Setting Up Siebel Clinical
• Configuring Properties for Siebel Clinical in Siebel Tools
• Enabling or Disabling Siebel Open UI for Siebel Clinical
• Enabling Siebel Server Component Groups for Siebel Clinical
• Activating Workflow Policies for Siebel Clinical
• Configuring Web Services for Siebel Clinical
• Administrative Setup Tasks for Siebel Clinical
• About the My Team’s Filter
• Using Siebel Assignment Manager in Siebel Clinical
  • Predefined Assignment Objects
  • Contact Assignments in Siebel Clinical
  • Contact Denormalization Mode in Siebel Life Sciences
• Setting Up Mobile Web Clients for Position Rollup
  • Exporting DTE Data Maps From the Server Database to an XML File
  • Importing DTE Data Maps to a Local Client From an XML File

4 Setting Up Clinical Trials

• Setting Up Clinical Trials
• About Setting Up Clinical Trials
• Scenario for Clinical Trials
• Process of Managing Clinical Trials
  • Administrator Procedures
  • End-User Procedures
• Creating Clinical Programs
• Setting Up Clinical Protocols
• Tracking and Revising Team Assignment History
  • Automatically Assigning Team Members to a Protocol Using the Position Rolldown Button
    • About Removing Team Members From the Team of a Protocol
• Creating and Revising Versions for Clinical Protocols
• Associating Clinical Protocols with Accounts
• Setting Up Clinical Regions
  • Automatically Assigning Team Members Using the Position Rollup and Rolldown Buttons
    • Creating Assignment Team History for Regions
• Associating Clinical Regions with Accounts
• Creating Accounts and Contacts for Clinical Trials
  • Creating Accounts
  • Creating Contact Records
• Creating Sites for Clinical Trials
  • Automatically Assigning Team Members to a Site Using the Position Rollup Button
    • Creating Assignment Team History for Sites
    • About Removing Team Members From the Team of a Site
  • Creating Satellite Sites for Clinical Trials
• Associating Sites with Accounts
• Risk Assessments for Clinical Trials
  • Creating Risk Assessment Templates
  • Performing Risk Assessments for Clinical Trials

5 Administering Clinical Subjects and Clinical Visits

• Administering Clinical Subjects and Clinical Visits
• About Subject Visit Templates
• Process of Defining Subject Visit Templates
  • Creating Subject Visit Templates
  • Defining Versions for Subject Visit Templates
  • Defining Subject Visits
  • Defining Planned Subject Visits
  • Defining Activities for Subject Visits
• Approving Subject Visit Templates
• About Automatic Tracking of Subject Status
  • Status Tracking Fields that Trigger Create and Delete Operations on Records in Subject Status MVG
  • Status Tracking Fields that Trigger Update Operations on Fields of Subject Status MVG
• Creating Records for Clinical Subjects
• Scheduling Clinical Subjects
• Rescheduling Clinical Subjects
• Administering Subject Visits in Batch Mode
• Screening Clinical Subjects
• Rescreening Clinical Subjects
• Enrolling Clinical Subjects
• Randomizing Clinical Subjects
• Overriding Initial Subject Status
• Transferring Clinical Subjects
• Viewing Subject Transfer Information for Clinical Subjects and Sites
• Viewing Subject Visits Information for Sites
• Creating Unscheduled Subject Visits
  • Creating a Subject Visit From the Subjects Screen
  • Creating a Subject Visit From the Calendars for Sites
• Terminating Clinical Trials Early for Clinical Subjects
• Applying Protocol Amendments to Sites and Clinical Subjects
  • Applying Revised Subject Visit Templates to Sites
  • Applying Revised Subject Visit Templates to Clinical Subjects
  • Rules for Applying Protocol Amendments
  • Rules for Deleting Subject Visits When Deemed Non-Applicable by Early Termination
• About Rolling Up Information for Subject Enrollment
  • Characteristics of Trials Where Subject Level Data is Available for Each Site
  • Characteristics of Trials Where Subject Level Data is Not Available for Each Site
  • Characteristics of Trials Where Site Level Data is Not Available for a Region
• Viewing Status Accruals for Clinical Subjects of Sites
• Viewing Status Accruals for Clinical Subjects of Clinical Regions
• Viewing Status Accruals for Clinical Subjects of Clinical Protocols
• Monitoring Rates for Subject Enrollment
• Monitoring Status Accruals for Clinical Subjects by Visit Type
• Using Audit Trail for Changes to Subject Status
• Generating Oracle BI Publisher Reports for Site Enrollment Status

6 Managing Sites and Contacts for Clinical Trials

• Managing Sites and Contacts for Clinical Trials
• About Managing Sites and Contacts for Clinical Trials
• Scenario for Managing Sites and Contacts for Clinical Trials
• Process of Managing Sites and Contacts for Clinical Trials
  • Administrator Procedures
  • End-User Procedures
  • Managing Satellite Sites and Contacts for Clinical Trials
• Creating Clinical Protocol Site Templates
• Creating Contact and Account Assessment Templates
• Maintaining Contacts and Accounts
• Associating Contracts with Sites
• Associating Accounts with Contracts
• Associating Accounts with Sites
  • Associating Accounts for Clinical Protocols with Sites
  • Associating Accounts for Clinical Regions with Sites
• Associating Activities with Sites
  • Associating Activities for Clinical Protocols with Sites
  • Associating Activities for Clinical Regions with Sites
• Associating Documents with Sites
  • Associating Documents for Clinical Protocols with Sites
  • Associating Documents for Clinical Regions with Sites
• Creating and Managing Site Visits
  • About Site Visit Name
  • Grouping Site Visits
  • Grouping Follow-Up Items for Site Visits
  • Monitoring Site Visits Using the Calendar
• Managing Contacts for Sites
  • Associating Sites with Contacts
  • Archiving Contact Records for Sites
  • Viewing the History of Contacts at Sites
• Adding Address Types for Sites
• Assigning Employees to Site Teams
• Creating Activity Plans for Sites
• Applying Activity Templates to Sites
  • Applying Activity Templates to Sites in a Region
  • Applying Activity Templates to Sites in a Protocol
• Tracking and Adding Documents at Sites
  • Tracking Documentation Milestones
  • Adding Documents to Sites
• Creating Activities for Document Tracking
  • Reviewing, Updating, and Adding Existing Documents for Tracking
• Managing Tracking Activities for Case Report Forms
  • Viewing Tracking Activities for Case Report Forms
  • Updating Existing Case Report Forms for Tracking
• Tracking Case Report Forms
• Creating Correspondence Activities for Sites
  • Creating Correspondence Activities for Sites
  • Creating New Role Correspondence for Sites
  • Creating Partner Correspondence Activities
• Adding Notes to Sites
• Viewing the Status History for Sites
• Assessing Contacts and Accounts
• Generating Oracle BI Publisher Reports for Document Tracking
  • Generating Reports for Site Document Tracking
  • Generating Reports for Protocol Level Document Tracking
  • Generating Reports for Region Level Document Tracking
  • Generating Reports for Protocol Document Tracking Across Sites
  • Generating Reports for Regional Document Tracking Across Sites
• Generating Reports for Actual Visits
• Generating Reports for Planned and Actual Dates of Subject Visits

7 Managing Partial Source Data Verification

• Managing Partial Source Data Verification
• About Partial Source Data Verification
• Setting Up Partial Source Data Verification for Clinical Protocols
• Setting Up Partial Source Data Verification for Clinical Regions
• Setting Up Partial Source Data Verification for Subject Visit Templates
• Setting Up Partial Source Data Verification for Sites
• Setting Up Partial Source Data Verification for Clinical Subjects
• Viewing Case Report Forms for Partial Source Data Verification
• Tracking Case Report Forms for Partial Source Data Verification During Site Visits
• Recalculating Clinical Subjects Requiring Source Data Verification
• About Partial Source Data Verification for Protocol Amendments

8 Setting Up and Making Clinical Payments

• Setting Up and Making Clinical Payments
• About Setting Up and Making Clinical Payments for Subject Activities
• Scenario for Clinical Payments
• Setting Up Standard Payment Amounts in Subject Visit Templates
• Setting Payment Exceptions for Sites
• Splitting Payment Activities Between Multiple Payees
• Copying Details for Payment Splits
• Reversing Splits for Payment Activities
• Marking Subject Activities as Complete
• Creating Payment Activities for Sites
• Generating Payment Records for Sites
• Generating Payment Records for Sites Associated with Clinical Protocols and Regions
  • Generating Payment Records for Sites Associated with Clinical Protocols
  • Generating Payment Records for Sites Associated with Clinical Regions
• Generating Payment Records for Unplanned Payment Activities
• Adjusting Payment Amounts and Generating Payment Records for Sites
• Generating Final Payments for Sites
• Reverting Payment Records
• Generating Oracle BI Publisher Reports for Clinical Payments

9 Administering and Using Clinical Trip Reports

• Administering and Using Clinical Trip Reports
• About Administering and Using Clinical Trip Reports
• Scenario for Managing Clinical Trip Reports
  • Preparing Trip Report Templates
  • Preparing Trip Reports
• Creating Questions for Clinical Trip Reports Using Siebel SmartScript
• Creating Clinical Trip Report Templates
• Applying Clinical Trip Report Templates
• Completing Clinical Trip Reports
• Completing Questionnaires for Clinical Trip Reports
• Deleting Unanswered Questions from Questionnaires of Clinical Trip Reports
• Tracking Case Report Forms
• Tracking Completion Status for Clinical Trip Reports
• Tracking Status Accruals for Clinical Subjects of Sites
• Automated Validation and Notification Messages for Clinical Trip Reports
• Viewing Universal Inbox Notifications for Action Items of Clinical Trip Reports
• Enabling a Trip Report Completed Alert
• Reviewing Clinical Trip Reports
• Approving Clinical Trip Reports
• Removing the Principal Investigator from Trip Reports
• Making Clinical Trip Reports Obsolete
• Creating New Versions of Clinical Trip Reports
• Viewing Version Information for Clinical Trip Reports
• Viewing Geographical Location Details for Clinical Trip Reports
• Using Audit Trail for Reviews and Approvals of Clinical Trip Reports
• Using Audit Trail for Changes to Clinical Trip Reports
• Generating Oracle BI Publisher Reports for Site Visits

10 Managing Clinical Projects

• Managing Clinical Projects
• About Managing Clinical Projects
• Scenario for Managing Clinical Projects
  • Setting Up and Staffing the Project
  • Managing Tasks, Activities, and Risks
• Process of Managing Clinical Projects
  • Administrator Tasks
  • End-User Procedures
• Creating Activity Templates for Clinical Projects
• Setting Up Employee Profiles for Clinical Projects
• Setting Up Position Types and Rate Lists for Billing
  • Creating Position Types as Products
  • Creating Rate Lists
• Creating Clinical Projects
• Associating People and Accounts with Clinical Projects
  • Adding Employees to Projects
  • Adding Contacts to Projects
  • Adding Partner Accounts to Projects
• Creating Activities and Tasks for Clinical Projects
  • Creating Activities for Projects
  • Creating Tasks and Associated Activities
• Monitoring Costs for Clinical Projects
• Managing Risk for Clinical Projects
• About Views in the Projects Screen

11 Managing Clinical Training

• Managing Clinical Training
• About Managing Clinical Training
• Setting Up Training Topics for Clinical Training
• Creating Training Plans
• Adding Criteria to Training Plans
• Creating Versions of Training Plans
• About Publishing Training Plans
• Publishing Training Plans
• Adding Training Plans to Clinical Sites
• Changing Training Topics for Clinical Sites
• Designating Completed Training for Training Topics
• Designating Completed Training for Contacts
• Viewing Training Information for Clinical Protocols
• Viewing Training Information for Clinical Regions

12 Siebel Clinical Task-Based UI

• Siebel Clinical Task-Based UI
• About Siebel Clinical Task-Based UI
• Accessing Siebel Clinical Task-Based UI
• Assigning Responsibilities to Predefined Task-Based UI Clinical Tasks
• Creating Protocols
• Creating Protocols and Regions
• Creating Sites
• Creating Site Contacts
• Creating Activity Plans for Sites
• Creating Activity Plans for Existing Protocols
• Creating Activity Plans for Existing Regions
• Creating RACT Assessments for Sites
• Creating RACT Assessments for Existing Protocols
• Creating RACT Assessments for Existing Regions
• Creating RACT Assessments for Existing Programs
• Administering Inbox Tasks

13 Supporting Blinded and Unblinded Users for Clinical Trials

• Supporting Blinded and Unblinded Users for Clinical Trials
• What is a Blinded and Unblinded Clinical Trial?
• Blinded and Unblinded Support in Siebel Clinical
• Controlling Access to Data for Blinded and Unblinded Users
  • Controlling Access to Blinded Data for Unblinded Users
  • Setting Blinded and Unblinded User Access at Protocol Level
  • Setting Blinded and Unblinded User Access at Region Level
  • Setting Blinded and Unblinded User Access at Site Level
  • Setting Access to Unblinded Activities in Core Activities View and Contact Activities View
• Site Management for Blinded and Unblinded Users
  • Identifying Type of User Access at Protocol Site
  • Document Tracking for Sites
  • Managing Site Activities for Blinded and Unblinded Users
  • Managing Site Activity Plans for Blinded and Unblinded Users
  • Managing Site Visits for Blinded and Unblinded Users
  • Managing All Site Visits for Blinded and Unblinded Users
  • Managing Site BIP Reposts for Blinded and Unblinded Users
  • Managing Activities for Blinded and Unblinded Users
  • Managing Contact Activities for Blinded and Unblinded Users
• Inheritance Hierarchy for Blinded and Unblinded Users
• Blinded and Unblinded Support in Siebel Mobile Disconnected Applications
• Blinded and Unblinded Customization Support

14 Setting Up and Configuring Clinical Data Capture and Query Management System Integration

• Setting Up and Configuring Clinical Data Capture and Query Management System Integration
• Overview of Clinical Data Capture and Query Management System Integration
• Process of Setting Up Clinical Data Capture and Query Management System Integration
  • Activating Workflows for Clinical Data Capture and Query Management System Integration
  • Configuring Web Services for Clinical Data Capture and Query Management System Integration
• Configuring Protocol Integration Fields for Oracle Health Sciences InForm Integration
• Integrating Data for Subject Visits with Data for Activities
• About Exporting Data for Sites
• About Integrating Data for Activity Completion

15 Setting Up and Configuring Clinical Data Management System Integration

• Setting Up and Configuring Clinical Data Management System Integration
• Overview of Clinical Data Management System Integration
• About Customizing Web Services for Clinical Data Management System Integration
• Process of Setting Up Clinical Data Management System Integration
  • Activating Workflows for Clinical Data Management System Integration
  • Configuring Web Services for Clinical Data Management System Integration
• Integrating Data for Subject Visits with Data for Activities
• About Integrating Data for Clinical Subjects
• About Integrating Data for Activity Completion

16 Setting Up and Using the Siebel Mobile Disconnected Application for Siebel Clinical

• Setting Up and Using the Siebel Mobile Disconnected Application for Siebel Clinical
• About Siebel Mobile Disconnected Applications
• About the Siebel Mobile Disconnected Application for Siebel Clinical
• Configuring a Siebel Mobile Disconnected Application for Siebel Clinical
• Using the Siebel Mobile Disconnected Application for Siebel Clinical
  • Getting Started with Siebel Mobile Disconnected Applications
  • Switching to Offline Mode and Synchronizing Data
• Managing My Site Visits for Siebel Clinical
  • Displaying My Site Visits Information
  • Modifying My Site Visits Information
  • Modifying Checklist Activity Information
  • Modifying Current Follow Up Information
  • Modifying All Follow Up Information
  • Modifying CRF Tracking Information
  • Modifying Attendees Information
  • Accessing Subject Snapshot Information
  • Answering, Navigating and Completing Questions
• Managing My Sites for Siebel Clinical
  • Displaying My Sites Information
  • Viewing Site Contacts Information
  • Viewing Site Visits Information

17 Setting Up Integration Between CTMS and eTMF

• Setting Up Integration Between CTMS and eTMF
• Overview of Integration Between CTMS and eTMF
• CTMS and eTMF Integration Process Flow
• Process of Setting Up Integration Between CTMS and eTMF
• Enabling Integration Between CTMS and eTMF
• Configuring Email Recipients
• Configuring the LS Clinical Trip Report File Web Service
• Manually Generating Trip Report Files

18 Setting Up Integration Between CTMS and Oracle Clinical One

• Setting Up Integration Between CTMS and Oracle Clinical One
• Process of Setting Up Integration Between CTMS and Oracle Clinical One
• Setting up the User Access for REST APIs
• Creating a Communication Profile
• Configuring Email Recipients in Siebel Clinical
• Configuring Enterprise Level Parameter
• Disabling User Properties
• Enabling Auto Apply SVT

19 Setting Up Integration Logging

• Setting Up Integration Logging
• Overview of Logging Mechanism
• Setting Up the CTMS Integrated Systems for Logging
• Configuring Email Notifications
• Configuring the Attributes
• Configuring the Logs Purge Process

20 Developer’s Reference for Siebel Clinical

• Developer’s Reference for Siebel Clinical
• About Using the Siebel REST API with Siebel Clinical
• Overview of User Properties for Siebel Clinical
• User Properties for Business Components in Siebel Clinical
• User Properties for Business Services in Siebel Clinical
• Applet Properties in Siebel Clinical
• Field Properties in Siebel Clinical
• System Preferences in Siebel Clinical
• Workflows in Siebel Clinical
• Web Services in Siebel Clinical
• SWILSClinicalTripReportFileTransfer Web Service
  • SWILSClinicalTripReportFileTransfer Operations
  • Request Message for TripReportFileTransferQuery
  • Request Message for ClinicalTripReportFileTransferQueryPage
  • Request Message for TripReportFileTransferUpsert
  • Response Message for SWILSClinicalTripReportFileTransfer
  • SWILSClinicalTripReportFileTransfer Application Interface

21 Setting Up Integration Between CTMS and PowerTrials systems

• Setting Up Integration Between CTMS and PowerTrials
• Overview of Integration Between CTMS and PowerTrials
• CTMS and PowerTrials Integration Process Flow
• Process of Setting Up Integration Between CTMS and PowerTrials
  • Enabling Integration Between CTMS and PowerTrials
  • Importing the PowerTrials Certificate to the CTMS Application
  • Add Proxy settings
  • For Cloud Customers and for Multi-Server Setup
• Configuring Email Recipients
• Configuration of Bearer Token Authentication in Siebel CTMS