The Mission

To  provide an overall solution for managing human subject research at UT Southwestern Medical Center.  This solution will help meet the needs of clinical research at UT Southwestern by simplification of clinical trial processes, providing a way to monitor regulatory and compliance mandates and centralizing clinical trial information.

Early Developments

The initiative for the clinical trial management system started with discussions with clinicians to identify high priorities and urgent needs of the clinical investigators at UT Southwestern Medical Center, followed by documentation of functional and system requirements and vendor selection. 

The Velos project

The Clinical Trial Management System group (Velos Group, a subdivision of Academic Information Systems) is currently implementing the Velos eResearch system to support the data management and analysis needs of clinical research at UTSW Medical Center.   Velos is a web-based comprehensive clinical research information system that addresses the areas of Account Management, Protocol Management, Patient Management / Patient Tracking, Data Management, Reporting, Budgeting and creating and meeting Milestones. 

Currently in Phase I, a pilot implementation is on its way to handle the data needs for the clinical trials administered by the Clinical Research Office at the Harold C. Simmons Comprehensive Cancer Center.  This initial phase of implementation is focused on Study Registration, Patient Management and Billing.  Other Phase I activities include Velos system configuration, customization and validation and training our internal support staff.

Phase II of the project, slated to begin in the last quarter of 2010 will involve training the users and roll out of the Velos system for all the existing research studies at UT Southwestern.

In later phases of development, efforts will center on communication between Velos and other systems on campus such as EPIC, Click Commerce, PeopleSoft , ERGO, and the utCRIS Clinical Research Data Warehouse.  Future plans include extending Velos to UT Southwestern Affiliates.

utCRIS Governance

The Governance Committee oversees the Velos project and provides policies and mandates for the same.  The Velos group works closely with a group of experts representing various functional areas of clinical research (IRB, Clinical Trials Office, clinicians, research coordinators, HIPPA Compliance and Billing Compliance) to assure appropriate customization and optimization of the Velos  system to meet the priorities and needs of clinical researchers at UT Southwestern. 

User Support and Training

The Velos group will provide extensive training to all users of Velos.