Creating a Clinical Trial Subject Record

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 will 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 a Clinical Trial Site Contract

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

Splitting Payment Activities Between Multiple Payees

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

Copying Payment Split Details

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 Payment Activity Splits

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

Creating a Payment Activity for a Site

Modified topic. It has been updated to include contract, account, and payee details for a clinical site payment record. 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 a Payment Record

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 Clinical Trip Report Questions Using Siebel SmartScript

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

Creating a Clinical Trip Report Template

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

Applying a Clinical Trip Report Template

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

Completing a Clinical Trip Report Questionnaire

New topic. It describes how to complete a clinical trip report questionnaire. The questionnaire is launched in the SmartScript player from the Trip Report Questions applet.

Deleting Unanswered Questions from a Clinical Trip Report Questionnaire

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

Tracking Case Report Forms

Modified topic. The following fields have been added to the Case Report Forms Tracking applet:

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

Tracking Clinical Trip Report Completion Status

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 clinical trip report elements:

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

Tracking Subject Status Accruals for a Site

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

Reviewing a Clinical Trip Report

Approving a Clinical Trip Report

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 clinical data management system integration. The workflow policies for clinical data management system integration were moved to a new policy group for improved performance.

Activating the Synchronization of Protocol Site Data

Modified topic. The following integration fields have been added:

• Locale
• Maximum Enrollment Number
• Time Zone

Siebel Clinical Business Component User Property Reference

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

About Siebel Clinical

Modified topic. It has been updated to include support for Siebel Open UI.

Enabling or Disabling Siebel Open UI for Siebel Clinical

New topic. To enable or disable Siebel Open UI for Siebel Clinical, you must configure the EnableOpenUI parameter for the eClinicalObjMgr_enu Object Manager.

Setting Up Left-Hand Navigation

New topic. It describes how to set up left-hand navigation for applications that use Siebel Open UI.

Generating Oracle BI Publisher Reports for Clinical Site Enrollment Status

New topic. It describes how to generate the Site Enrollment Status report for clinical trial enrollments.

Generating Oracle BI Publisher Reports for Clinical Document Tracking

New topic. It describes how to generate document tracking reports for Siebel Clinical. The following preconfigured reports for clinical document tracking are provided:

• Site Document Tracking
• Protocol Level Document Tracking
• Region Level Document Tracking
• Protocol Document Tracking Across Sites
• Regional Document Tracking Across Sites

Generating Oracle BI Publisher Reports for Siebel Clinical Payments

New topic. It describes how to generate the Protocol Payments report for clinical payments.