March 11, 2016
The Huron Consultant Group started on-site work on the administrative support services project beginning the week of February 22. They began and continue to do interviews with representatives across the spectrum of clinical trial research, including department chairs, PIs, administrators, and coordinators, as well as representatives from compliance, billing, and university and college-level administrative units.
Thank you to those who’ve submitted comments via the link provided. In response, we will try to address those concerns and questions by providing regular updates on this website.
Several comments mentioned concerns about who is being involved in making decisions regarding any changes to processes or establishment of any centralized support structure. We want to assure you that our goal is to involve representatives from all groups directly involved in clinical trial research – as noted by those being included in the interview process – in order that the analysis process and any decisions are made thoughtfully, carefully, and in a transparent manner.
We realize that since the establishment of the SRAS in late 2013, there has not been any directed focus of the unit on clinical trial research. At the time the unit was created, the priority was and it continues to be basic research. All along, the SRAS GPSs have provided the OSPA-required college-level review of eIAFs for clinical trials. Part of that review can involve preparation of the required fixed-price budget sheet. In addition, the SRAS can initiate clinical trial eIAFs upon request and can provide limited invoicing assistance for one-time activity times like start up fees. Upon completion of the Huron supported project, we will be more directly involved in the support of clinical trial administration.
March 31, 2016
Steering Committee Meeting #1
Charter and project planning discussed; plan to arrange a next meeting for mid-May
April 22, 2016
Although no formal updates have been posted to the site since mid-March, work is on-going and continuing on the clinical trial project. During the past weeks, the Huron staff have completed a series of individual interviews with numerous staff that work with some aspect of clinical trial management – from principal investigators to coordinators to department administrators to central office staff. Based on Huron’s analysis of these interviews, along with comparison to extensive data elements they have collected on our clinical trial activities, and their experience with like projects at other institutions, they will develop several options for a proposed staffing structure. The Steering Committee will have an opportunity to review, consider, and provide feedback to the options at a meeting scheduled for mid-May.
Related to the CTMS project, there have been meetings between the Huron consultants and various IT units that would likely be involved with a CTMS implementation in the College of Medicine. Conversations have also been held with UK Purchasing staff regarding the necessary acquisition steps for this type of system. This could involve enhancements to an existing system or systems or the purchase of a new system. Either way, it has been determined that the full RFP process will need to be completed. An RFP Review Committee will be established and convened to start on compiling functional requirements, with Huron’s assistance, for such a system to be included in the RFP. Part of that process will involve a survey that will be posted on this site to which any/all interested parties can provide a response.
There have some additional responses to our comment link. They continue to mention the need to make certain that all constituent groups that work with clinical trials have a voice in making these decisions. The Steering Committee is comprised of individuals from those various groups and others were also included in the individual interview process. We expect that any decision made will incorporate their concerns.
Volunteers from the Steering Committee were solicited to form the CTMS RFP Committee
RFP specifications determined with Huron Consulting's direction, including input from RFP Committee members, Steering Committee members, others who participated in the assessment interview process for the overall project, and comments submitted to link on the project website
July 13, 2016
August 12, 2016
August 30, 2016
Steering Committee Meeting #2
1. Sustainable improvements only possible with enterprise CTMS implementation
2. Consensus of a need to adopt a uniform platform, specifically:
a. Institutional Coverage Analysis
b. Budget Standardization
c. Charge Segregation
d. Invoicing and AR Management
e. Financial Closeout
3. Articulated need for subject matter expertise support
Next steps: Develop future state operating model options
September 8, 2016
RFP Committee Meeting #1, Distribution of RFP response materials to RFP Committee and orientation to the RFP review process
Additional members from UKHC IT added to RFP Committee
November 16, 2016
RFP Committee Meeting #2, general discussion of responses and agreement that additional questions will be sent to each offeror
December 13, 2016
Additional questions sent to RFP offerors
December 19, 2016
Responses to additional questions received from RFP offerors
January 11, 2017
RFP Committee Meeting #3, further process discussion and no action
February 15, 2017
RFP Committee Meeting #4, discussed narrowing options and logistical arrangements for vendor demos, i.e., location, recording, confidentiality requirements, targeted invitations and general announcement
February 23, 2017
UKHC and COM Sr. Leadership Meeting, Huron Consulting to present their report for the overall project
March 24, 2017
Steering Committee Meeting #3, Huron Consulting to present their report