News and Updates

Clinical Research Listserv Now Available
June 29, 2007– As we reengineer the clinical research enterprise, one of our objectives is to put in place more opportunities for collaboration and the sharing of useful information. As a simple step to facilitate this, we have opened a new listserv on the topic of clinical research. For those affiliated with or interested in clinical research, this service is intended to allow members to easily share information or questions regarding their studies, regulatory issues, best practices, recruiting techniques, process updates, training opportunities, and new system information. CRIS and other offices will be posting information on the availability of its services and other relevant information to this new listserv.

CRIS Initiates Its First Studies for Pediatrics
June 13, 2007 – The Department of Pediatrics was among the first departments to work with CRIS. The CRIS crew worked with the department to evaluate the protocol and extract its direct and hidden costs. This information gave the department a full picture for the financial impact of the study and provided a fair market analysis of costs to use in negotiation with the sponsor.CRIS negotuated substantial increases in these budgets over what the sponsor initially offered

UM.CRIS Retains Huron Consulting to Expedite Start-up of CRIS Office
May 15, 2007 – The new CRIS office will work with Huron to test and facilitate its processes for initiating clinical research. Huron has experts in developing budgets and Medicare coverage analyses. These experts will act as interim staff for CRIS as full-time UM employees are recruited and brought on board. Huron will be working with a sample number of new studies in tandem with the CRIS Director.

New UM Clinical Research Initiation Services (CRIS) Office Hires Director
April 30, 2007 - Suzanne Liv Page will be leading the effort to establish the new Clinical Research Initiation Services office. Ms. Page has extensive experience with clinical research contracting, budgeting, and negotiations with sponsors. Having completed her JD at Indiana University, she joins UM from the University of Washington where she acted in a similar role for 5 years. Prior to UW, she worked in the private sector at Microsoft and Getty Images. Ms. Page will report to Dr. Bookman, Executive Dean for Research & Research Training and Vice Provost of Research at UM.

UM Completes First Phase of Project to Establish Clinical Research Initiation Services Office
March 1, 2007 – In fall 2006, Dr. Bookman, Executive Dean for Research & Research Training and Vice Provost of Research at UM, kicked-off a project to establish a new office within Medical Research Administration that would focus on enabling the processes that initiate clinical research. To expedite this effort and gain knowledge into best practices, UM retained the assistance of Huron Consulting Group, which was a well-established business practice in this area. Huron helped UM review requirements and document a baseline set of policies, procedures, and job descriptions that would guide this new office. A working group of 13 individuals from three clinical departments, clinical administration, and UM leadership provided feedback and improvements to the policies and procedures. More than 30 representatives from UM leadership, faculty, departmental administration, and central administration were consulted during the discovery of requirements. Faculty and research coordinators were briefed on CRIS at a January 17th Clinical Research Town Hall meeting hosted by Dr. Richard Bookman. On February 27th, the Medical Council of elected faculty representatives received an update on CRIS and other clinical research infrastructure efforts. On several occasions the Dean’s weekly operations meeting has heard updates on the CRIS office. CRIS is anticipated to start accepting a limited number of studies with pilot departments in late May and will ramp up its services as new staff and resources are retained.