eResearch is a new, web-based system launched in April 2010 to help manage human research.  The eResearch system is the product of a melding of two computer programs, the Clinical Trial Management System by Velos and the eIRB by Click Commerce, both designed to easily guide research teams through their work processes in a paperless fashion, leading to an increase in efficiency and transparency.

There’s a positive and synergistic impact associated with combining the two programs.  Separately, each of these systems saves time and effort for busy researchers.  But blending them together creates greater efficiency.  Key questions answered in Velos are pushed to eIRB without Investigators having to having to retype them, saving time and preventing errors.  Reporting for auditors and sponsors will be available at any time, day or night.  For the first time ever, electronic systems were expanded to access to our partner institutions at Children’s and Parkland.  As we prepare to go live, training on these systems has been simplified and modified to fit Investigators’ schedules with both live classes and 24x7 access to the eLearning modules.

What is Velos?

Velos is a study management tool used by dozens of world-class universities such as Duke, the University of Michigan and Columbia.  It is designed to help investigators manage the setup and day-to-day activities of complex human research studies.

It supports processes for

• participant recruitment
• scheduling
• budgeting
• invoicing
• milestone management
• data safety monitoring
• adverse event reporting
• system integration
• data collection
• study execution

Velos allows all study -related information to be centralized and can be accessed from anywhere, anytime.  Password protected, study accounts are accessible only to authorized personnel.  The system is easy to use, reliable and completely secure.

Today, at least 95% of study administration is done on paper, in spreadsheets, and in various home-grown databases that do not share information with one another.  An Enterprise-wide, network-based system gives investigators, study coordinators and clinical departments much improved research information capabilities.  Velos was designed from the ground up to support both study administration and clinical data management in a single, integrated environment.

For studies where we are the coordinating site, Velos is solving "the last mile" problem. Velos provides end-to-end electronic clinical trial data collection, where study data comes directly from source systems (e.g. labs, adverse events and medical records) at the sites, to the lead investigator and monitors, and on to the coordinating site.  Such a system infrastructure is a major leap forward in clinical trial automation for both sponsors and investigators.

What is eIRB?

Closely integrated with Velos is the eIRB system.  Current IRB processes are still paper-based and can be very time-consuming.  

• The eIRB system replaces the current IRB paper process with smart forms that only ask the questions individual Investigators need to answer based on the nature of their projects.  
• Questions not relevant to specific projects remain hidden in the software and are not exposed to investigators or their staff.  
• Once complete, the forms are electronically transmitted to the next person in the review process line.  
• Once the system goes live, it will not longer be necessary to bring 25 copies of the NR1 and associated documents to the IRB.  Instead, protocols can be developed on-line and transmitted to the IRB with the press of a button. 

Roll-out

The first phase, released on April 19, 2010, will roll out the mandatory use of eResearch to register all human research at UT Southwestern and to submit new IRB protocols.  The primary change for you, as an investigator, will be to approve these submissions, which will be sent via email to you for your review and approval.

The second phase will bring online all the patient/subject management and financial modules in Velos and will also provide functionality to help with budgetary or financial coverage analysis for new studies.  This will facilitate monitoring of clinical research billing compliance.  An implementation date for this phase has not been determined, so more information will be forthcoming.

eResearch is supported by Research Administration and Academic Information Systems.

For more information email Thomas Spencer at: Thomas.Spencer@UTSouthwestern.edu