|Industry-Sponsored Clinical Trial Contracting|
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Frequently Asked Questions
Below you will find answers to questions regarding specifics of the new industry-sponsored clinical trial process. Additionally, the UMMS Office of Research has developed the Orange Line on its Research Project Route Map illustrating the new process, and the eResearch team has created a helpful Quick Reference Card as well.
Why and how was this new process for industry-sponsored clinical trials developed?
The UMMS Office of Research and the U-M Office of Research and Sponsored Projects (ORSP, formerly known as DRDA) came together in 2011 to address the concerns raised by research teams regarding the length of time to execute research agreements. Engaging faculty, study coordinators, and research administrators, a working group was established, facilitated by a UMHS lean coach, to evaluate the contracting process and propose improvements. The working group took a systems approach, looking at the process from the point of first contact by a sponsor to the investigator through to contract execution. The working group made several recommendations, such as using the eResearch Proposal Management (eRPM) system to capture early steps in the process, developing a Medical School non-disclosure agreement template with school signing authority, creating a non-cancer clinical trials office, and hiring contracting specialists dedicated to clinical trials in ORSP.
How does the University of Michgian define a clinical trial?
For the purposes of data collection to track and monitor clinical trial activity, the University of Michigan has adopted a modified NIH definition of a clinical trial, which captures major points of consensus among definitions from DHHS, FDA, WHO, clinicaltrials.gov, and major philanthropic funders. The U-M definition for clinical trial is not intended to be inclusive of all clinical research activity but rather serves as an operational definition for the purposes of data collection and standardized reporting for a specific type of clinical research.
Will this new process be applied to all clinical trials?
This new, streamlined process is a Medical School pilot. Launched in January 2012, it enables research teams and administrators to route non-disclosure agreements (NDAs) and draft clinical trial contracts in the eRPM system. Currently, the pilot is limited to industry-sponsored clinical trials. Formerly, non-disclosure agreements were sent to the U-M Office of Research and Sponsored Projects via email. Draft contracts were also sent by email or, more commonly, were routed late in the process with the Proposal Approval Form (PAF). By using eRPM, the process is standardized and integrated with the system already familiar to the research community. Moreover, eRPM was designed to provide transparency in the process, allow ORSP to begin negotiating contracts in parallel with study teams developing the budget, and enable performance metrics to be captured to continually improve the process.
Who was involved in developing this new process?
Five faculty and staff focus groups were held to identify common issues, and workflow maps from three departments were created to understand how work was being performed. A working group comprised of faculty and staff from across the Medical School as well as central campus administration worked with representatives from the UMMS Office of Research and the U-M Office of Research and Sponsored Projects to create a new, improved process that attempts to address the issues that had been identified. The U-M ITS eResearch team working with the UMMS Office of Research and ORSP developed the Unfunded Agreements (UFA) and Clinical Trial Routing Form (CTRF) modules in eRPM.
Who is included in the pilot? When can I participate?
The pilot is open to all Medical School investigators and is scheduled to occur until the summer 2012. The pilot is currently limited to industry-sponsored clinical trials, and as of January 19, 2012, non-disclosure agreements for clinical trials from non-federal sponsors should be submitted in eRPM using the new process.
What happens after the pilot?
The success of the pilot is being reassessed on a monthly basis. Feedback from research teams is informing refinements to the eRPM system and business processes. At the end of the pilot, the goal is to open the system to include all non-disclosure agreements in the Medical School as well as expand to other schools/colleges. Ultimately, the Unfunded Agreement (UFA) module of eRPM will be extended beyond non-disclosure agreements to include other Unfunded Agreements, such as material transfer agreements, data use agreements, and research collaboration agreements.
What is an Unfunded Agreement (UFA)?
An Unfunded Agreement (UFA) is a non-financial agreement with a sponsor. A new module in eResearch Proposal Management (eRPM) has been developed for entering and tracking the process for signing one type of UFA, the non-disclosure agreement (NDA). When an industry sponsor contacts an investigator for a clinical trial, a non-disclosure agreement (also referred to as a confidentiality agreement) is often required. Create an UFA in eRPM and select “Project Team Send NDA for Unit Processing.” The Unit Processing activity routes the UFA to the Medical School Office of Research, who has signature authority for the NDA template. For sponsors that are unable to use the template, the UFA will be routed to the Office of Research and Sponsored Projects. Please refer to the Quick Reference Card for more details.
What is a Clinical Trials Routing Form (CTRF)?
The Clinical Trial Routing Form (CTRF) is a Proposal Approval Form (PAF) in eRPM with a limited set of questions. A completed CTRF notifies the Office of Research and Sponsored Projects to begin negotiations while the research team continues completing the full PAF. You can enter a CTRF if the agreement is for a non-federal clinical trial and a non-disclosure agreement is already in place, if required. A CTRF can be created from an active UFA and information in the UFA will be carried forward to pre-populate many of the CTRF questions. The CTRF, once completed, opens into a full PAF for continuity of the project in the system. If a full PAF has already been started, it must be finished in eRPM (PAFs cannot revert to CTRFs). Please refer to the Quick Reference Card for more details.
What do the deadlines mean on the UFA and CTRF?
Unlike federal proposals, investigators perceived there is not a sense of urgency to complete non-federal agreements, especially clinical trial agreements, and projects can languish. Consequently, deadlines were included in the system to allow study teams to convey the timeline they are working under and to assist the Unit and U-M Office of Research and Sponsored Project staff with prioritizing the work coming to them. Please use these deadlines judiciously and update them as circumstances change.
Why do I (the participant or PI) need to sign the UFA?
When a PI or participant signs the Unfunded Agreement (UFA) in eRPM, it is to acknowledge s/he is the custodian of the confidential information on behalf of the University.
Why do I (the participant or PI) need to disclose a conflict of interest on the UFA?
If the investigator indicates a known, or potential, conflict of interest, the system will automatically by-pass routing to the Medical School (Unit Processing) and send the Unfunded Agreement (UFA) directly to U-M Office of Research and Sponsored Projects to begin negotiations.
What are the ultimate intended outcomes of this new industry-sponsored clinical trial process?
Faster. Standardized. Prioritized. Transparent. Accountable. If these goals can be achieved through this improved process, U-M investigators will be more competitive and better positioned to expand their non-federal research activity.
Why are industry-sponsored clinical trials important to UMHS and the University of Michigan?
While the University of Michigan research enterprise has seen a year-over-year increase in federal funding, nationally there has been a clear downward trend for funding via traditional agencies such as the NIH and NSF. Consequently U-M leadership—including Drs. Coleman, Pescovitz, and Wooliscroft—have all recently underscored the importance of nurturing strategic industry relationships to diversify U-M’s research funding portfolio. Moreover, participating in industry-sponsored clinical trials, particularly first-in-human and other early-stage projects, allows U-M researchers to continue to be at the forefront of the development of new therapeutics across disease areas. Access to new therapies and medical innovations is of great potential value to our clinicians and their patients.
What are the unique needs of potential industry sponsors?
Industry R&D staff are accustomed to working within a highly centralized organizational structure, where decisions are made and projects launched to achieve strategic outcomes in as short amount of time as possible. Consequently, industry sponsors often have very specific deadlines and outcome parameters for their trial partners. To compete effectively against other research institutions and clinical trial organizations, the U-M industry-sponsored clinical trial process must try to match this expectation of speed and efficiency.
How do industry-sponsored clinical trials come to UMMS?
Industry-sponsored clinical trials come to the university in a variety of ways. Often it is via relationships of individual faculty with industry, or sometimes contract research organizations refer a corporation to one of our faculty because of their expertise. The UMMS Business Development team liaises with potential industry partners across the research continuum, helping to connect faculty with possible research opportunities—including connecting companies interested in engaging in clinical trials with faculty experts.
How has the role of ORSP changed?
The U-M Office of Research and Sponsored Projects now has staff dedicated to non-federal clinical trials. It is the intent that faculty and staff will experience a benefit as these dedicated staff members provide a consistent approach from project to project while bolstering a collegial working relationship.
I have an existing trial; what do I do? Will my ORSP representative change?
Yes, your ORSP representative likely will change for Non-Disclosure Agreements and Clinical Trial Agreements. Please contact the ORSP at 734-764-5500 and ask for a "ORSP Project Representative for Clinical Trial Agreements and Medical School Non-Disclosure Agreements."
What are the roles of the Comprehensive Cancer Center Clinical Trial Office (CCC-CTO) and Michigan Institute for Clinical & Health Research (MICHR) Clinical Trial Office (M-CTO)?
The role of Cancer Center CTO is unchanged. The Cancer Center CTO provides infrastructure support for the conduct of clinical trials at the U-M Comprehensive Cancer Center, and its services are grouped in five categories: regulatory affairs, data management, information technology, multi-site coordination, and research financial services.
The MICHR CTO (M-CTO) was established in July 2011 to support U-M investigators in their pre-award needs for industry-sponsored clinical trials. Their focus is on non-cancer studies. The staff of the M-CTO assist clinical research teams through the contracting, budgeting, and initial IRB application phases of study start-up. Any clinical and translational researcher at the University of Michigan who will be engaging in industry-sponsored clinical trials is eligible to use the M-CTO’s services at no cost to the investigator. The M-CTO works in close partnership with division/department administrators.
If a company asks me to complete a feasibility survey prior to a site selection visit, can I do that without having an NDA in place?