• 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
  • Setup and Configuration of Billing Grid Designation and SVT Mandatory Fields
• 22 Using CTMS Dashboards
  • Using CTMS Dashboards
  • Configuring Site Status for Custom Status
  • Configuring custom Subject Status for Dashboard
  • System Preferences for Dashboards
• 23 Using CTMS Milestones
  • Using CTMS Milestones
  • System Preferences for Milestones
  • Configuring Email Alerts for Upcoming Milestones and Missed Milestones
• 24 Charge Sheet Library
  • Charge Sheet Library
  • Administration of Charge Sheet Library
  • Importing Charge Sheet Items
  • Managing a Charge Sheet Versions
  • Assigning Charge Sheet to Subject Visit Template
  • Assigning CPT Codes and Billing Designation to SVT Activities
• 25 PII Detection in CTMS
  • PII Detection in CTMS
  • Overview of PII Detection in CTMS
  • PII Service Setup and Configuration
  • Masking
  • PII Business Service