Siebel Clinical Trial Management System Guide

What's New in This Release

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Overview of Siebel Clinical Trial Management System

About Siebel Clinical

Product Modules and Options

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Setting Up Siebel Clinical

About Setting Up Siebel Clinical

Configuring Siebel Clinical Properties in Siebel Tools

Enabling or Disabling Siebel Open UI for Siebel Clinical

Enabling Server Component Groups for Siebel Clinical

Activating Workflow Policies for Siebel Clinical

Configuring Web Services for Siebel Clinical

Setting Up Mobile Integration for Siebel 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 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

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Setting Up a Clinical Trial

About Setting Up a Clinical Trial

Scenario for Clinical Trials

Process of Managing Clinical Trials

Creating a Clinical Program

Setting Up a Clinical Protocol

Tracking and Revising Team Assignment History

Automatically Assign Team Members to a Protocol Using the Position Rolldown Button

Remove Team Members from the Team of a Protocol

Creating and Revising Protocol Versions

Associating a Clinical Protocol with an Account

Setting Up Clinical Regions

Automatically Assign Team Members Using the Position Rollup and Rolldown Buttons

Creating Region Assignment Team History

Associating a Clinical Region with an Account

Creating a Clinical Trial Account and Contacts

Creating a Clinical Trial Site

Automatically Assign Team Members to a Site Using the Position Rollup Button

Creating Site Assignment Team History

Removing Team Members from the Team of a Site

Associating a Clinical Site with an Account

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Administering Clinical Subjects and Clinical Visits

About Clinical Subject Visit Templates

Process of Defining a Clinical Subject Visit Template

Creating a Clinical Subject Visit Template

Defining the Clinical Subject Visit Template Version

Defining Clinical Subject Visits

Defining Planned Clinical Subject Visits

Defining Clinical Subject Visit Activities

Approving a Clinical Subject Visit Template

About Automatic Subject Status Tracking

Creating a Clinical Trial Subject Record

Scheduling a Clinical Subject

Rescheduling a Clinical Subject

Administering Clinical Subject Visits in Batch Mode

Screening a Clinical Subject

Rescreening a Clinical Subject

Enrolling a Clinical Subject

Randomizing a Clinical Subject

Overriding Initial Clinical Subject Status

Creating an Unscheduled Subject Visit

Terminating a Clinical Subject's Trial Early

Applying Protocol Amendments to Clinical Sites and Subjects

Applying a Revised Subject Visit Template to a Site

Applying a Revised Subject Visit Template to a Subject

Rules for Applying Protocol Amendments

Rules for Deleting Visits Deemed Non-applicable by Early Termination

About Subject Enrollment Information RollUp

Viewing Clinical Subject Status Accruals for a Site

Viewing Clinical Subject Status Accruals for a Region

Viewing Clinical Subject Status Accruals for a Protocol

Monitoring Clinical Subject Enrollment Rates

Monitoring Clinical Subject Status Accruals by Visit Type

Using Audit Trail for Clinical Subject Status

Generating Oracle BI Publisher Reports for Clinical Site Enrollment Status

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Managing Clinical Trial Sites and Clinical Contacts

About Managing Clinical Trial Sites and Clinical Contacts

Scenario for Managing Clinical Trial Sites and Clinical Contacts

Process of Managing Clinical Trial Site and Contact Information

Creating a Clinical Protocol Site Template

Creating Contact and Account Assessment Templates

Maintaining Contact and Account Information

Associating Contracts with a Clinical Trial Site

Associating Accounts with a Clinical Trial Site Contract

Creating and Managing Clinical Trial Site Visits

Creating and Updating Site, Contact, and Account Records

Capturing Different Types of Addresses for Each Site

Assigning Employees to the Site Team

Creating Site Activity Plans

Applying Protocol Site Activity Templates

Tracking and Adding Documents at Sites

Creating Documentation Tracking Activities

Creating CRF Tracking Activities

Tracking Case Report Forms (CRFs)

Creating Site Correspondence Activities

Tracking Business Partner Correspondence

Adding Notes to a Site

Assessing Investigators and Hospitals or Other Contacts and Accounts

Generating Oracle BI Publisher Reports for Clinical Document Tracking

Generating Reports for Clinical Site Level Document Tracking

Generating Reports for Clinical Protocol Level Document Tracking

Generating Reports for Clinical Region Level Document Tracking

Generating Reports for Clinical Protocol Document Tracking Across Sites

Generating Reports for Clinical Regional Document Tracking Across Sites

Generating Reports for Completed Clinical Subject Visits

Generating Reports for Planned and Completed Clinical Subject Visit Dates

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Setting Up and Making Clinical Payments

About Setting Up and Making Subject Activity Payments

Scenario for Payments

Setting Up Standard Payment Amounts in the Subject Visit Template

Setting Payment Exceptions for a Site

Splitting Payment Activities Between Multiple Payees

Copying Payment Split Details

Reversing Payment Activity Splits

Marking Subject Activities Completed

Creating a Payment Activity for a Site

Generating Payment Records for Clinical Sites

Generating Payment Records for Unplanned Payment Activities

Adjusting Payment Amounts and Generating Payment Records for Sites

Generating Final Payments for Sites

Reverting a Payment Record

Generating Oracle BI Publisher Reports for Siebel Clinical Payments

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Administering and Using Clinical Trip Reports

About Administering and Using Clinical Trip Reports

Scenario for Managing Clinical Trip Reports

Creating Clinical Trip Report Questions Using Siebel SmartScript

Creating a Clinical Trip Report Template

Applying a Clinical Trip Report Template

Completing a Clinical Trip Report

Completing a Clinical Trip Report Questionnaire

Deleting Unanswered Questions from a Clinical Trip Report Questionnaire

Tracking Case Report Forms

Automated Validation and Notification Messages for Clinical Trip Reports

Tracking Clinical Trip Report Completion Status

Tracking Subject Status Accruals for a Site

Viewing Universal Inbox Notifications for Clinical Trip Report Action Items

Reviewing a Clinical Trip Report

Approving a Clinical Trip Report

Viewing Clinical Trip Report Geographical Location Details

Using Audit Trail for Clinical Trip Report Reviews and Approvals

Using Audit Trail for Clinical Trip Report Changes

Deleting a Clinical Trip Report

Generating BI Publisher Reports for Clinical Site Visits

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Managing Clinical Projects

About Managing Clinical Projects

Scenario for Managing Clinical Projects

Process of Managing Clinical Projects

Creating a Project Activity Template

About Setting Up Employee Profiles

Setting Up Position Types and Rate Lists for Billing

Creating a Project

Associating People and Accounts with Projects

Creating Activities and Tasks for a Project

Monitoring Project Costs

Managing Risk

About Views in the Projects Screen

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Setting Up and Configuring Clinical Trial Site Visit Data Integration

Overview of Clinical Trial Site Visit Data Integration

Customizing Clinical Trial Site Visit Data Integration Web Services

Process of Setting Up Clinical Trial Site Visit Data Integration for Siebel Clinical

Activating Workflows for Clinical Trial Site Visit Data Integration

Configuring Web Services for Clinical Trial Site Visit Data Integration

Enabling Siebel Server Component Groups for Clinical Trial Site Visit Data Integration

Exporting Clinical Trial Site Visit Data from Siebel Clinical

Exporting Clinical Trial Site Geographical Location Details to Siebel Clinical

Viewing Clinical Trial Site Visit Geographical Location Details in the Trip Report

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Setting Up and Configuring Mobile Integration for Siebel Clinical Trip Reports

Overview of Mobile Integration for Siebel Clinical Trip Reports

Customizing Siebel Clinical Trial Management System Mobile Integration Web Services

Process of Setting Up Mobile Integration for Siebel Clinical Trip Reports

Setting Up Trial Site Visit Data Integration Prerequisites

Activating the LS Clinical Workflow for Mobile Integration

Configuring Web Services for Mobile Integration

Exporting List of Value Records for Mobile Integration

Exporting Clinical Template Details for Mobile Integration

Exporting Siebel Clinical Users for Mobile Integration

Adding Users to the Assigned To MVG

Exporting Clinical Site Contact Records

Exporting Subject Visit Records for Mobile Integration

Exporting Site Records for Mobile Integration

Exporting and Importing Clinical Trip Report Records for Mobile Integration

Exporting Clinical Trip Report State Transition Data

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Setting Up and Configuring Clinical Data Management System Integration

Overview of Integrating Siebel Clinical with a Clinical Data Management System

Customizing Clinical Data Management System Integration Web Service

Process of Setting Up Clinical Data Management System Integration for Siebel Clinical

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

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

Creating the JNDI Properties File for Clinical Data Management System Integration

Configuring the JVM Subsystem for Clinical Data Management System Integration

Configuring Java Message Service Parameters for Clinical Data Management System Integration

Populating Domain Value Maps

Siebel Clinical and Oracle Clinical Integration Entities

Integrating an Oracle Clinical Study with a Siebel Clinical Protocol

Integrating Investigator Data

Integrating Clinical Visit Data with Activity Data

Activating the Synchronization of Protocol Site Data

Viewing Protocols Enabled for Synchronization

About Synchronizing Sites

How Subject Data Is Integrated

About the Integration of Activity Completion Data

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Setting Up and Configuring Clinical Trial Payments Integration

Overview of Integrating Clinical Trial Payments

Customizing Clinical Trial Payments Integration Web Service

Process of Setting Up Clinical Trial Payments Integration for Siebel Clinical

Configuring Siebel Tools for Clinical Trial Payments Integration

Activating Workflows for Clinical Trial Payments Integration

Configuring the Clinical Trial Payments Inbound Web Service

Configuring Java Message Service Parameters

Sending a Payment Request from Siebel Clinical to a Third-Party Application

Withdrawing a Payment Request

Viewing Feedback for Payment Requests

Verifying Processed Payments

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Siebel Clinical Developer's Reference

Overview of User Properties for Siebel Clinical

Siebel Clinical Business Component User Property Reference

Siebel Clinical Business Service User Property Reference

Siebel Clinical Applet Property Reference

Siebel Clinical Field Property Reference

Siebel Clinical Workflow Reference

Siebel Clinical Web Services Reference

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