Contents
- Title and Copyright Information
- Preface
- 1 What’s New in This Release
- 2 Overview of Siebel Clinical Trial Management 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
- Setting Up Mobile Web Clients for Position Rollup
- 4 Setting Up Clinical Trials
- Setting Up Clinical Trials
- About Setting Up Clinical Trials
- Scenario for Clinical Trials
- Process of Managing Clinical Trials
- Creating Clinical Programs
- Setting Up Clinical Protocols
- Tracking and Revising Team Assignment History
- Creating and Revising Versions for Clinical Protocols
- Associating Clinical Protocols with Accounts
- Setting Up Clinical Regions
- Associating Clinical Regions with Accounts
- Creating Accounts and Contacts for Clinical Trials
- Creating Sites for Clinical Trials
- Associating Sites with Accounts
- 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
- Approving Subject Visit Templates
- About Automatic Tracking of Subject Status
- 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
- Terminating Clinical Trials Early for Clinical Subjects
- Applying Protocol Amendments to Sites and Clinical Subjects
- About Rolling Up Information for Subject Enrollment
- 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
- 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 Activities with Sites
- Associating Documents with Sites
- Creating and Managing Site Visits
- Managing Contacts for Sites
- Adding Address Types for Sites
- Assigning Employees to Site Teams
- Creating Activity Plans for Sites
- Applying Activity Templates to Sites
- Tracking and Adding Documents at Sites
- Creating Activities for Document Tracking
- Managing Tracking Activities for Case Report Forms
- Tracking Case Report Forms
- Creating Correspondence Activities for Sites
- 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 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 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
- 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
- Automated Validation and Notification Messages for Clinical Trip Reports
- Tracking Completion Status for Clinical Trip Reports
- Tracking Status Accruals for Clinical Subjects of Sites
- Viewing Universal Inbox Notifications for Action Items of Clinical Trip Reports
- Reviewing Clinical Trip Reports
- Approving Clinical 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
- Process of Managing Clinical Projects
- Creating Activity Templates for Clinical Projects
- Setting Up Employee Profiles for Clinical Projects
- Setting Up Position Types and Rate Lists for Billing
- Creating Clinical Projects
- Associating People and Accounts with Clinical Projects
- Creating Activities and Tasks for Clinical Projects
- 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 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
- 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
- 13 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
- Integrating Data for Subject Visits with Data for Activities
- About Integrating Data for Clinical Subjects
- About Integrating Data for Activity Completion
- 14 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
- Managing My Site Visits for Siebel Clinical
- Managing My Sites for Siebel Clinical
- 15 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
- 16 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