Office of Clinical Trials

The Clinical Trials Office offers the following services to facilitate quality clinical trials at UC Health and the University of Cincinnati.

Budgets and Contracts Review, Negotiation and Approval

The CTO is available to provide expertise on specific budgeting questions, pricing on services, secondary budget review, complete budget analysis and sponsor negotiations as requested. Legal review and approval of the Clinical Trial Agreement (CTA) is also handled by the CTO.

Contracts, Confidential Disclosure Agreements, Amendments

ADM-009-01 Commercially Sponsored Clinical Trials Process SOP

Services include initiating Confidential Disclosure Agreements (CDAs) and facilitating legal review of Clinical Trial Agreements (CTAs) and subsequent contract amendments.

  • CDA must be initiated before protected, classified information or intellectual property may be exchanged between a potential study sponsor and one of UC or UC Health’s entities. In order to protect the institution and the legal liability of individuals, the CDA must be signed by an official authorized signatory as determined by General Counsel. (Principal Investigators are not considered authorized signatories.) All CDAs must be processed through the Clinical Trials Office. Please note that while CDA’s can be sent to the PI, University of Cincinnati Physicians Company, LLC is the signature authority for all such agreements. As such, CDA’s will ultimately be reviewed, negotiated, and signed by a University of Cincinnati Physicians Company representative. Please contact the UC Health Clinical Trials Office (CTO) for assistance with this process.
  • CTA is a legally binding document between the sponsor and the institution that outlines the responsibilities of the sponsor, the institution, and the investigator during the course of the clinical trial. All industry-sponsored contracts must be processed through the Clinical Trials Office.
  • Any Contract Amendment to an existing CTA must be processed through the Clinical Trials Office.

For more information, contact Megan Kamm at 513-245-3415

Budgets

ADM-009-01 Commercially Sponsored Clinical Trials Process SOP

  • The budget review and negotiation process can occur in parallel with contract negotiation in most cases. The CTO offers varying levels of budget support including secondary review, development and negotiation with sponsors to ensure all clinical trial costs are covered.
  • There is a 30 percent overhead requirement for all industry-sponsored clinical trials.
  • A budget analysis and subsequent negotiation should generally not be initiated until a final protocol is provided.
  • All budgets must be included in the final CTA. If a department has negotiated the budget, a final approved version must be sent to the CTO for insertion into the CTA.

For more information, contact Megan Kamm at 513-245-3415.

Greenphire Debit Cards

ADM-002-02 Management of Study Funds for Research Participant Remuneration SOP
ADM-003-01 Greenphire ClinCard System SOP

The CTO administers and maintains the Greenphire ClinCard System, a reimbursement debit card system for research participants. The Greenphire ClinCard system is available to all departments for industry sponsored studies. The cost charged to your study will be $3.85 for each card and $1 for each load fee. It is recommended to take this into account when negotiating clinical trial budgets. In addition, informed consent language should be tailored to using Greenphire. The CTO staff is available to help guide you through budgeting and ICF questions related to Greenphire.

The following benefits across UC Health are being realized:

  • Participants have greater satisfaction with quick and easy access to funds, no waiting for a check.
  • The card’s value is protected by having only authorized personnel load the money on the card, and lost or stolen cards can easily be replaced.
  • The Greenphire system provides annual reports that will assist with IRS tax reporting for participants who receive more than $600 annually.

For more information about Greenphire, please contact Jason Johnson at 513-245-3095.

Regulatory and Compliance

ADM-007-01 Quality Review SOP

  • Coordinates with UCMC, UC Health, UC Sponsored Research Services and the IRB to establish consistent and quality clinical trial processes
  • Collaborates with the Operations Committee to develop and maintain UC Health “Standard Operating Procedures” (SOPs) for research. Use of these SOPs ensures consistent implementation and project management of all UC Health research studies.
  • Ensures that the scope of SOPs governs any research activity involving an outpatient or inpatient setting for which the facility, resources, or personnel are owned and operated, leased to, or managed in part or in whole by UC Health
  • Provides support to UC Office of Regulatory Affairs and Research Compliance to implement a clinical trial Quality Review process for industry sponsored studies
  • Supports UC Health departments with the development/creation of informed consents
  • Participates in improving departmental and organizational performance through recommending areas or approaches for improvement activities, performing new procedures, collecting data and providing input to department discussions

Marketing, Advertising and Participant Recruitment Support

ADM-008-02 Marketing, Recruitment and Retention SOP

Marketing and recruitment services are offered upon request to all researchers, regardless of funding source, phase or patient population. All University of Cincinnati clinical trials are advertised to the public under the UC Health brand. UC Health policy requires ALL patient recruitment materials (including flyers, brochures, ads, radio/TV, web information and more) for both government and industry-funded studies to be developed and approved by the CTO marketing team.

Sponsor-provided advertising materials are generally not allowed. While many sponsors prefer not to change their collateral materials, our experience is that the majority of the time they WILL work with our marketing team. Nearly every major health system has branding guidelines, so this is generally not a surprise to the sponsors. Let us help you by working with the sponsor to ensure all UC Health brand guidelines are met.

To help support recruitment efforts, the Clinical Trials Office assists with basic:

  • Strategic recruitment plans and budgets
  • Developing internal/external subject recruitment marketing/advertising materials
  • Coordinating media buying for advertising (print and broadcast)
  • Implementing public relations tools supporting subject recruitment activities
  • Planning recruitment opportunities at events, conferences and expositions

These services are offered at no cost to studies. Studies are responsible for printing and ad placement/media costs only. Once recruitment materials have been drafted by the CTO marketing staff, it is the responsibility of the study staff to submit the recruitment pieces to the study sponsor (when applicable), and to the IRB for approval.

For marketing and recruitment assistance, contact Wendy Newman at 513-245-3417.

Business Development and Study Placement

The Clinical Trials Offices works with sponsors and clinical research organizations (CROs) seeking investigators for studies. The CTO maintains a comprehensive database of potential investigators and can initiate the CDA process even before investigators selection in order to speed study placement.

Education, Training and Communication

The CTO offers various resources to increase communication among Clinical Research Professionals and to help them develop their skills:

  • Seminars
  • Regularly scheduled webinars and training sessions address clinical research hot topics.
  • Networking events
  • Research Views eNewsletter (for Clinical Research Professionals)
  • Quarterly Clinical Research Professionals meetings are held to provide educational and networking opportunities.

The Clinical Research Professionals email distribution list has been developed to communicate essential information to the research community. The list expands across UC Health, the University of Cincinnati, the VA, and Children’s Hospital. The list includes a diverse group of research professionals including PIs, coordinators, and managers.

If you would like to be added please contact Jason Johnson at 513-245-3095.

 

Resources

Standard Operating Procedures (SOPs)

ADM-002-02 Management of Study Funds for Research Participant
Remuneration SOP
ADM-003-01 Greenphire ClinCard System SOP
ADM-007-01 Quality Review SOP
ADM-008-01 Recruitment and Retention SOP
ADM-008-02 Marketing, Recruitment and Retention SOP
ADM-009-01 Commercially Sponsored Clinical Trials Process SOP

Forms and Templates

ADM-002-02 A1 Study Fund Receipt
ADM-002-02 A2 Study Fund Receipt Log
ADM-002-02 A3 Study Fund Tracking
ADM-003-01 A1 Greenphire Study Start-up Form
ADM-007-01 A1 Quality Review Form
ADM-009-01 A1 CTO Cover Sheet
ADM-009-01 A2 Mutual CDA Template
ADM-009-01 A3 Amendment Template
ADM-009-01 A4 Process Flowcharts

 

Contact Us

UC Health Clinical Trials Office
2830 Victory Parkway, Suite 325
Cincinnati, OH 45206
(513) 475-8031

clinicaltrials@uchealth.com

Christopher Lindsell, PhD
Vice President of Research, UC Health
(513) 558-6937

Megan Kamm
Office Manager
(513) 245-3415

Jason Johnson
Clinical Trials Administrator- Regulatory Specialist
(513) 245-3095

Chelsea Kuhfeld
Administrative Associate
(513) 475-8031

Wendy Newman
Marketing Manager
(513) 245-3417

Matt Schauseil
Information Technology
(513) 558-5655