UAB Synopsis, Vol. 24, No. 33, September 12, 2005
Office of Human Research and the SiteMinder Initiative
In 2003, UAB President Carol Garrison, PhD, commissioned the Clinical Trials Policy and Oversight Committee (POC) to evaluate clinical research processes and improve budgeting and billing efficiency. In its final report, submitted in January 2005, POC called for centralized review of standardized study budgets and development of consistent code and price lists. To achieve these goals, POC recommended creation of an Office of Human Research (OHR) to enhance clinical research efficiency and university-wide implementation of Oracle Corporation's SiteMinder, a Web-based software program designed to facilitate management of administrative and financial aspects of clinical research.
Professor and Division of Nephrology Director David Warnock, MD, is director of the new entity, officially established May 1 by Vice President and Dean of the School of Medicine (SOM) Robert Rich, MD.
"The central issue before us is improving communication," Dr. Warnock says. "OHR will serve as an ombudsman for clinical trial investigators, helping them communicate with UAB entities, research sponsors, and regulatory agencies." October 1 is the target date for a fully operational OHR.
In his capacity as OHR director, Dr. Warnock reports to Vice President of Research Richard Marchase, PhD. Dr. Warnock also chairs the Executive Steering Team, which is composed of personnel from UAB Health System, SOM, and UAB Central Administration, and is providing direct oversight for the SiteMinder initiative and its Project Steering Team.
At a recent information session for researchers designed to outline OHR's functions and goals, Dr. Warnock said, "OHR will address structural issues that impede clinical research at UAB — as a principal investigator on such projects, I'm familiar with the problems, and I'm excited about taking on this task. Our direct charge is to cut through inefficient administrative 'back and forth' between different UAB entities — to bore through firewalls between the Health System and the university, for example."
OHR's goals are:
- Enhancing effectiveness of UAB clinical trials
- Serving as the SOM lead on policies related to human research
- Serving as liaison between investigators and UAB entities involved in human research compliance; the Institutional Review Board for Human Use, Conflict of Interest Review Board, Health Insurance Portability and Accountability Act, billing, effort reporting, and research priorities
- Developing uniform guidelines for indirect recovery rates, charges for ancillary studies, and incorporating new technologies into human research
- Defining residual account policies
- Overseeing the SiteMinder initiative
Clinical Informatics
"Managing information flow, what I call clinical informatics, will help us grow our clinical research enterprise," Dr. Warnock says. "OHR will emphasize the commonality of information processing among different UAB entities to help develop a coherent, streamlined human research strategy."
SiteMinder is destined to become an integral part of that research strategy through its ability to provide access to large volumes of complex data coming from multiple clinical trials, continues Dr. Warnock. The system offers real-time continuous access to critical information. Since its inception in February, the Project Steering Team has gathered comprehensive data defining current processes for conducting clinical research at UAB, purchased SiteMinder hardware and software, and is working to develop uniform fee schedules for research costs at The Kirklin Clinic® and University Hospital.
Cancer Center investigators are pilot testing SiteMinder software. After this beta-test phase, the software will undergo system-wide review, giving university investigators the opportunity to test the system and suggest revisions. Based on investigator input, SiteMinder will be reconfigured and fully implemented at the Cancer Center early next year, with a target time frame of March 2006 to December 2007 for system-wide rollout. SiteMinder will be fully integrated with Cerner, IDX, and Health-Quest.
Dr. Warnock has great optimism about the future of clinical research at UAB, noting the National Institutes of Health's (NIH) new roadmap emphasizes translational research, an area in which UAB excels. NIH is also requiring greater transparency and accountability, creating new challenges for investigators and research sponsors.
"We cannot afford to ignore the market and regulatory forces that are shaping our efforts," he says. "The challenges and solutions before us span the spectrum of UAB's clinical research enterprise, and OHR will play a pivotal role in growing that enterprise in an appropriate and mutually beneficial fashion."