Features of Siebel Clinical Trial Management System

Modified topic. The following features have been added:

• Siebel Clinical Trial Management System Cloud Service for Software as a Service (SaaS) deployments
• Clinical operations integration for budget planning and tracking

Managing Partial Source Data Verification

New chapter. It describes how to manage partial source data verification.

Tracking Completion Status for Clinical Trip Reports

Modified topic. The Not Started status has been removed from the SmartScript Questions Answered field.

Setting Up and Configuring Clinical Operations Integration

New chapter. It describes how to integrate Siebel Clinical Trial Management tracking and budgeting functionality with an external clinical operations application, such as Oracle ClearTrial.

Workflows for Mobile Integration of Clinical Trip Reports

New topic. It describes the actions that the mobile integration workflows perform.

Activating Workflows for Mobile Integration

Modified topic. The LS Clinical Get Site Snapshot Service workflow has been added for mobile integration.

Configuring Web Services for Mobile Integration

Modified topic. The following Web services have been added for mobile integration:

• SWILSClinicalTripReportTemplates
• SWILSClinicalGetSiteSnapshot
• SWILSClinicalGetSmartScriptDetails

About Exporting Snapshot Data for Site Enrollments

New topic. It describes exporting site enrollment data from Siebel Clinical Trial Management System to a mobile application.

About Exporting Template Data for Clinical Trip Reports

New topic. It describes exporting template data for clinical trip reports from Siebel Clinical Trial Management System to a mobile application.

About Exporting SmartScript Metadata for Clinical Trip Reports

New topic. It describes exporting SmartScript metadata for clinical trip reports from Siebel Clinical Trial Management System to a mobile application.

Setting Up and Configuring Clinical Data Capture and Query Management System Integration

New chapter. It describes how to integrate Siebel Clinical Trial Management System with a clinical data capture application, such as Oracle InForm.

User Properties for Business Components in Siebel Clinical

Modified topic. The description for the Named Method 2 business component user property has been updated to include information about the CL - Verify TripReportApprover system preference.

System Preferences in Siebel Clinical

New topic. It describes the system preferences that have been added to configure Siebel Clinical Trial Management System core functionality, and integration with third-party applications. The following system preferences have been added:

• CL - BudgetingApp CustomerCode. This system preference is used for clinical operations integration.
• CL - BudgetingApp RequestURL. This system preference is used for clinical operations integration.
• CL - Verify TripReportApprover. This system preference has been added to turn on or off approver verification for clinical trip reports.

Web Services in Siebel Clinical

Modified topic. The following Web services have been added or modified:

• LS Clinical CRF Tracking Interface
• LS Clinical Protocol Site Interface Service
• LS Clinical Subject Information Interface Service
• SWILSClinicalGetSiteSnapshot
• SWILSClinicalGetSmartScriptDetails
• SWILSClinicalTripReportTemplates

ClearTrial Clinical Trial Management System Connector

New appendix. It contains information about the ClearTrial Clinical Trial Management System Connector.

Creating Records for Clinical Subjects

Modified topic. It has been updated to include the following fields:

• Subject ID
• Encounter Date

Subject ID has replaced the Subject Initials field. Encounter Date has replaced the Subject DOB field. These changes have been made to remove personally identifiable information from Oracle's Siebel Clinical Trial Management System.

The application labels for these fields have been changed, but the application logic remains the same. Upgrading to Siebel Innovation Pack 2013 from a previous version does not delete existing values for these fields.

The screening number is now automatically generated from the Subject ID field and the Encounter Date field.

Associating Accounts with Contracts

New topic. It describes how to associate an account with a contract for a clinical site. Multiple accounts can be associated with a contract for clinical site.

Splitting Payment Activities Between Multiple Payees

New topic. It describes how to split a payment activity between multiple contracts and payees.

Copying Details for Payment Splits

New topic. It describes how to copy the details of a split payment to multiple payment activities. Payment activity splits are copied at the payment exceptions level.

Reversing Splits for Payment Activities

New topic. It describes how to reverse a payment activity split.

Creating Payment Activities for Sites

Modified topic. It has been updated to include contract, account, and payee details for a payment record of a clinical site. The following fields have been added to the Payment Activities view:

• Account
• Contract
• Payee First Name
• Payee Last Name

Generating Final Payments for Sites

Modified topic. It has been updated to include the following fields:

• Account
• VAT Amount

Reverting Payment Records

New topic. It describes how to revert a payment record to modify the payment details. The Revert button is enabled when a single payment record with one of the following statuses is selected:

• In Progress
• To Be Processed

Creating Questions for Clinical Trip Reports Using Siebel SmartScript

New topic. It describes how to create questionnaires for clinical trip reports using Siebel SmartScript.

Creating Clinical Trip Report Templates

New topic. It describes how to create a trip report template in the new Trip Report Templates view of the Administration - Clinical screen.

Applying Clinical Trip Report Templates

Modified topic. It has been updated to describe support for SmartScript questionnaires.

Completing Questionnaires for Clinical Trip Reports

New topic. It describes how to complete a questionnaire for a clinical trip report. The questionnaire is launched in the SmartScript player from the Questions view of the trip report.

Deleting Unanswered Questions from Questionnaires of Clinical Trip Reports

New topic. It describes how to delete unanswered questions from a questionnaire of a clinical trip report.

Tracking Case Report Forms

Modified topic. The following fields have been added to the CRF Tracking applet:

• Charts Reviewed Date
• Forms Signed Date
• Page Numbers Verified

Tracking Completion Status for Clinical Trip Reports

New topic. It describes how to track the real-time status details for a clinical trip report in the Summary view. The status is tracked for the following fields for clinical trip reports:

• Checklists Completed
• Questions Answered
• Current Follow-Ups Completed
• All Follow-Ups Completed
• CRF Tracking Completed
• Total Attendees

Tracking Status Accruals for Clinical Subjects of Sites

New topic. It describes how to track the progress of a clinical site by creating a real-time system snapshot of the current status accruals for the subjects of a site.

Reviewing Clinical Trip Reports

Approving Clinical Trip Reports

Modified topics. Access control has been added for the following fields:

• Reviewer Comments
• Approver Comments

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

New topic. It describes how to set up the LS Clinical Integration workflow monitor agent for a clinical data management system integration. The workflow policies for a clinical data management system integration were moved to a new policy group for improved performance.

Activating Synchronization of Data for Sites

Modified topic. The following integration fields have been added:

• Locale
• Maximum Enrollment Number
• Time Zone

User Properties for Business Components in Siebel Clinical

Modified topic. The following business component user properties have been added:

• LS Amount Rollup Field 3
• LS Amount Rollup On Status 1
• LS Clinical Enable Revert On Status
• Named Method 1