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Siebel CRM Siebel Clinical Trial Management System Guide
Siebel Innovation Pack 2017, Rev. A
E52416-01
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1
What's New in This Release
What's New in Siebel Clinical Trial Management System Guide, Siebel Innovation Pack 2017, Rev. A
What's New in Siebel Clinical Trial Management System Guide, Siebel Innovation Pack 2017
What's New in Siebel Clinical Trial Management System Guide, Siebel Innovation Pack 2016
2
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
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 Workflow Processes to the Local Client
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
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
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
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
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
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
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
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
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
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
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
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
13
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
14
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
Managing My Sites for Siebel Clinical
Displaying My Sites Information
Viewing Site Contacts Information
Viewing Site Visits Information
A
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
Index
