Siebel Clinical Trial Management System Guide


What's New in This Release


Back to top


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


Back to top


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

Setting Up Mobile Integration for Clinical Trip Reports

Setting Up Siebel Clinical for Integration with a Third-Party Payments Application

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

Setting Up Left-Hand Navigation


Back to top


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


Back to top


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

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

Creating Unscheduled Subject Visits

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

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


Back to top


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

Creating and Managing Site Visits

Creating and Updating Sites, Contacts, and Accounts

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

Creating Tracking Activities for Case Report Forms

Tracking Case Report Forms

Creating Correspondence Activities for Sites

Adding Notes to 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


Back to top


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

Recalculating Clinical Subjects Requiring Source Data Verification

About Partial Source Data Verification for Protocol Amendments


Back to top


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 Completed

Creating Payment Activities for Sites

Generating Payment Records for Sites

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


Back to top


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

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

Deleting Clinical Trip Reports

Generating Oracle BI Publisher Reports for Site Visits


Back to top


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


Back to top


Setting Up and Configuring Clinical Operations Integration

Overview of Clinical Operations Integration

About Customizing Web Services for Clinical Operations Integration

Process of Setting Up ClearTrial Integration

Completing Prerequisites for ClearTrial Integration

Activating Workflows for ClearTrial Integration

Configuring Web Services for ClearTrial Integration

Configuring the Date and Time Format for ClearTrial Integration

Configuring System Preferences for Clinical Operations Integration

Configuring Protocol Integration Fields for ClearTrial Integration

Importing Plan Data From Budgeting Applications

About Exporting Data for Sites

About Exporting Data for Clinical Subjects

About Exporting Data for Case Report Forms


Back to top


Setting Up and Configuring Site Visit Data Integration

Overview of Site Visit Data Integration

About Customizing Web Services for Site Visit Data Integration

Process of Setting Up Site Visit Data Integration

Activating Workflows for Site Visit Data Integration

Configuring Web Services for Site Visit Data Integration

Enabling Siebel Server Component Groups for Site Visit Data Integration

About Exporting Data for Site Visits

About Exporting Geographical Location Details for Sites

Viewing Geographical Location Details for Site Visits in Clinical Trip Reports


Back to top


Setting Up and Configuring Mobile Integration of Clinical Trip Reports

Overview of Mobile Integration for Clinical Trip Reports

About Customizing Web Services for Mobile Integration of Clinical Trip Reports

Workflows for Mobile Integration of Clinical Trip Reports

LS Clinical Protocol Site Get Sites Workflow

LS Clinical Get Site Snapshot Service Workflow

Process of Setting Up Mobile Integration for Clinical Trip Reports

Completing Integration Prerequisites for Mobile Integration

Activating Workflows for Mobile Integration

Configuring Web Services for Mobile Integration

About Exporting Data for Lists of Values

About Exporting Data for Clinical Templates

About Exporting Data for Siebel Clinical Users

About Adding Users to MVG for Assigned To Fields

About Exporting Data for Contacts of Sites

About Exporting Data for Subject Visits

About Exporting Data for Sites

About Exporting and Importing Data for Clinical Trip Reports

About Exporting State Transition Data for Clinical Trip Reports

About Exporting Snapshot Data for Site Enrollments

About Exporting Template Data for Clinical Trip Reports

About Exporting SmartScript Metadata for Clinical Trip Reports


Back to top


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

Setting Up LS Clinical Integration Workflow Monitor Agent 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 InForm Integration

Integrating Data for Subject Visits with Data for Activities

About Exporting Data for Sites

About Integrating Data for Activity Completion


Back to top


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

Configuring Siebel Tools for Clinical Data Management System Integration

Activating Workflows for Clinical Data Management System Integration

Setting Up the LS Clinical Integration Workflow Monitor Agent for Clinical Data Management System Integration

Configuring Web Services for Clinical Data Management System Integration

Creating Directory Structure on Siebel Server for Clinical Data Management System Integration

Creating Oracle WebLogic Full Client JAR for Clinical Data Management System Integration

Creating JNDI Properties File for Clinical Data Management System Integration

Configuring JVM Subsystem for Clinical Data Management System Integration

Configuring Java Message Service Parameters for Clinical Data Management System Integration

Populating Domain Value Maps

Integration Entitles for Siebel Clinical and Oracle Clinical

Integrating Oracle Clinical Studies with Siebel Clinical Protocols

About Integrating Data for Investigators

Integrating Data for Subject Visits with Data for Activities

Activating Synchronization of Data for Sites

Viewing Clinical Protocols Enabled for Synchronization

About Synchronizing Sites

About Integrating Data for Clinical Subjects

About Integrating Data for Activity Completion


Back to top


Setting Up and Configuring Clinical Payments Integration

Overview of Clinical Payments Integration

About Customizing Web Services for Clinical Payments Integration

Process of Setting Up Clinical Payments Integration

Configuring Siebel Tools for Clinical Payments Integration

Activating Workflows for Clinical Payments Integration

Configuring the Inbound Web Service for Clinical Payments Integration

Configuring Java Message Service Parameters for Clinical Payments Integration

Sending Payment Requests to Third-Party Payments Application

Withdrawing Payment Requests

Viewing Feedback for Payment Requests

Verifying Processed Payments


Back to top


ClearTrial Clinical Trial Management System Connector

About the ClearTrial Clinical Trial Management System Connector

Supported Integration Points for the ClearTrial Clinical Trial Management System Connector

About Logging for the ClearTrial Clinical Trial Management System Connector

Sample Configuration Files for the ClearTrial Clinical Trial Management System Connector

Configuring the ClearTrial Clinical Trial Management System Connector

Configuring Security for the ClearTrial Clinical Trial Management System Connector

Importing Data from Siebel Clinical to ClearTrial Track


Back to top


Developer's Reference for 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

Back to top

Siebel Clinical Trial Management System Guide Copyright © 2014, Oracle and/or its affiliates. All rights reserved. Legal Notices.