1. Clinical Trial Management System Guide
  2. What’s New in This Release

What’s New in This Release

This chapter tracks the changes in the documentation. It includes the following topics:

What’s New in Siebel Clinical Trial Management System Guide, Siebel CRM 25.4 Update

The following table lists the changes in this revision of the documentation to support this release of the software.

Topic

Description

Using CTMS Dashboards

New chapter. Dashboards provide a centralized information that manages risk, increases efficiency, and improves insight.

Using CTMS Milestones

New chapter. Milestones provide clear project tracking for improved planning and supports the timely execution of Study milestones by providing an ability to create, track and complete the milestones within the CTMS application.

What’s New in Siebel Clinical Trial Management System Guide, Siebel CRM 24.12 Update

The following table lists the changes in this revision of the documentation to support this release of the software.

Topic

Description

Setting Up Integration Between CTMS and PowerTrials

New chapter. Describes how to integrate CTMS with PowerTrials system.

What’s New in Siebel Clinical Trial Management System Guide, Siebel CRM 24.8 Update

The following table lists the changes in this revision of the documentation to support this release of the software.

Topic

Description

Setting Up Integration Logging

New topic. It describes how to enable the CTMS integrated systems for logging mechanism.

What’s New in Siebel Clinical Trial Management System Guide, Siebel CRM 24.4 Update

The following table lists the changes in this revision of the documentation to support this release of the software.

Topic Description

Modifying Attendees Information

Accessing Subject Snapshot Information

Answering, Navigating and Completing Questions

New topics. The new functionality includes Mobile capabilities, such as support for adding attendees, comments, subject accrual snapshot, as well as SmartScript functionality in trip report questions, and improved navigation for Mobile trip reports.

Configuring a Siebel Mobile Disconnected Application for Siebel Clinical

Modified topic. Updated with a new section, One-Time Activity for Customers with existing Site Visit Records.

About Siebel Mobile Disconnected Applications

Modified topic. Information on supporting operation systems for disconnected mobile experience.

What’s New in Siebel Clinical Trial Management System Guide, Siebel CRM 23.3 Update

The following table lists the changes in this revision of the documentation to support this release of the software.

Topic

Description
User Properties for Business Components in Siebel Clinical Modified topic. Added the following user properties for Clinical Trip Report:
  • BIP Report Template Name
  • Enable FollowUp Activities for Approved TR
  • Enable FollowUp Activities with Status Not Equal To
  • Enable Question Number
  • Enable SmartScript Page Save
  • Enable Unblinding

What’s New in Siebel Clinical Trial Management System Guide, Siebel CRM 23.1 Update

The following table lists the changes in this revision of the documentation to support this release of the software.

Topic

Description
Setting Up Integration Between CTMS and Oracle Clinical One New chapter. Describes the configuration settings required for integrating CTMS with Oracle Clinical One.

What’s New in Siebel Clinical Trial Management System Guide, Siebel CRM 22.7 Update

The following table lists the changes in this revision of the documentation to support this release of the software.

Topic

Description

Activating Workflow Policies for Siebel Clinical

Modified topic. Step 1 has changed in this task.

Activating Siebel Clinical Task-Based UI

This obsolete topic has been removed from the guide. As of Siebel CRM 22.7 Update, tasks are Workspace-enabled, which means you can edit them within a Workspace and that it is no longer necessary to activate tasks.

What’s New in Siebel Clinical Trial Management System Guide, Siebel CRM 20.12 Update

The following table lists the changes in this revision of the documentation to support this release of the software.

Topic

Description

Setting Up Clinical Protocols (Step 2)

Modified topic. There is a new Favorite field in the Protocol List, which you can use to highlight favorite protocols. Favorite protocols appear first in the Protocol List.

Creating Sites for Clinical Trials (Step 2)

Modified topic. There is a new Favorite field in the Protocol Site List, which you can use to highlight favorite sites. Favorite sites appear first in the Protocol Site List.
Creating and Managing Site Visits (Step 3 and 4)

Modified topic. Site visits are now sorted by default according to the Visit Start date, so that the most recent site visit appears first in the site visits list. If configured, a warning pop-up message will appear for duplicate site visit names.

About Site Visit Name

New topic. The site visit Name is user generated by default, but you can enable the site visit Name to be automatically generated.

Grouping Site Visits

New topic. Describes how Site Visits are grouped together in Siebel Clinical, including how to change the default Visit and Trip Report status combinations in Siebel Tools.

Grouping Follow-Up Items for Site Visits

New topic. Describes how follow-up items for site visits are grouped together.

Completing Clinical Trip Reports (Step 4)

Modified topic. In the Checklist Activities view, you can now expand or collapse the information in the Comments field by using the Wrap Comments On/Off buttons.

Completing Questionnaires for Clinical Trip Reports (Step 3 and 4)

Modified topic. There is a new Last Updated field in the Questions view, which you can use to sort questions according to last updated date. You can also expand or collapse the information in the Comments field by using the Wrap Comments On/Off buttons.

If configured, questions will be numbered in the SmartScript player when you launch the questionnaire for the trip report in the SmartScript player.

Automated Validation and Notification Messages for Clinical Trip Reports (Automated Email Notification column)

Modified topic. If enabled, an alert pop-up message will appear if you try to complete a trip report without updating the at least one of the Open Follow-Up items for the report.

Enabling a Trip Report Completed Alert

New topic. You can enable an alert pop-up message to appear if you try to complete a trip report without updating at least one of the Open Follow-Up items for the report.

Removing the Principal Investigator From Trip Reports

New topic. Describes how to remove the principal investigator from a trip report.

Enabling Integration Between CTMS and eTMF

Modified topic. The default file naming convention for Trip Report files has changed to: Protocol#_Site#_Visit Type _Row ID.

What’s New in Siebel Clinical Trial Management System Guide, Siebel CRM 20.7 Update

The following table lists the changes in this revision of the documentation to support this release of the software.

Topic

Description

Siebel Clinical Task-Based UI

New chapter. Describes the task-based user interface for Siebel Clinical, which clinical research associates (CRAs) use to manage protocols, regions, and sites for clinical studies.

Supporting Blinded and Unblinded Users for Clinical Trials

New chapter. Describes blinded and unblinded support in Siebel Clinical, how to control access to data for blinded and unblinded users, and how to administer blinded and unblinded users for clinical trials.

What’s New in Siebel Clinical Trial Management System Guide, Siebel CRM 20.1 Update

No new features have been added to this guide for this release. This guide has been updated to reflect only product name changes.