The UC Health Clinical Trials Office (CTO) is your primary contact for identifying qualified University of Cincinnati investigators with the research experience and expertise necessary to help you conduct your clinical trial.
Services Provided by the Clinical Trials Office
The CTO is dedicated to assisting you in placing and conducting your clinical trials at the University of Cincinnati and UC Health. Our services include:
- Identifying faculty with particular research expertise and interests
- Identifying potential principal investigators for clinical trials
- Obtaining general information about clinical research activities, research capabilities, facilities and sponsored research administration
- Streamlining communications among sponsor, research administrators, PI and research personnel
- Negotiating and signing all industry clinical trial agreements and other contracts with human subjects funded by industry. (The CTO will review contract language to protect the University and the investigator’s rights for publication, intellectual property, indemnification and other issues.)
- Study budget development and negotiation
- Local recruitment support and advertising
Non-Disclosure/Confidential Disclosure Agreement (NDA/CDA)
- Please note that while CDA’s can be sent to the PI, University of Cincinnati Physicians Company, LLC (UCPC, 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 CTO for assistance with this process.
Clinical Trials Budgets and Agreements
- The CTO provides expertise to our researchers regarding specific budgeting questions, pricing on services, secondary budget review, and complete budget analysis and sponsor negotiations as requested. Budgets may be negotiated by a department representative or the CTO. The CTO has final approval on all budgets for industry sponsored clinical trials. Additionally, the CTO facilitates the review of all industry sponsored clinical trial agreements (CTAs) with the designated UCPC, LLC legal counsel.
Institutional Review Boards (IRBs)
Human subjects research at the University of Cincinnati is conducted according to a Federalwide Assurance (FWA), unless exempt. The CTO coordinates with the University of Cincinnati Institutional Review Board (UC IRB) to establish consistent and quality clinical trials processes. In addition, the UC IRB contracts with and allows researchers to use two external IRBs:
The local UC IRB meets weekly, provides guidance to the researchers, and supports two IRB committees.
For general inquiries about the UC IRB please contact: 513-558-5259 email@example.com
The CTO marketing staff works with UC researchers to assess recruitment needs of the study, construct plans, and implement actions that ensure targeted and effective recruitment and retention efforts. The marketing staff has extensive professional experience in health care marketing, journalism, advertising, public relations and communications.
Depending on the individual recruitment and retention needs of the study (and the extent of the recruitment budget), a participant recruitment plan is customized using various appropriate tactics, including:
- Referrals from UC Health’s outpatient and satellite clinics, as well as community-based primary care practices
- Advertising including internet, radio, television, newspaper (daily and community) as well as special interest magazines such as Cincinnati Family, Cincinnati Parent, Super Shopper, REACH Magazine and others
- UC Health’s publications including print and electronic newsletters, magazines and other publications
- Database recruitment
- Email using UC Health’s internal email system to reach approximately 10,000 employees
- Grand Rounds presentations and other speaking opportunities within UC Health and the community
- Internet and intranet via UC Health websites, CenterWatch (largest clinical trials web site), targeted web advertising and social media
- Printed materials including flyers, post card size flyers, direct-mail and UC Health Research Studies booklet
- Digital signage at hospitals and employee business centers
- Public relations activities through UC Academic Health Center Public Relations & Communications
- Community events such as baby, family and senior expos, and community health fairs where face to face contact may be made and study materials distributed
- Support groups partnering with the community to distribute study information through group websites, networks, newsletters, special events, and meetings.
- 20-plus recruitment stations (located on UC’s campus and within UC Health medical facilities), each displaying 5 – 25 branded individual clinical study flyers
(targeted to that location’s demographics, when possible)
UC Health Clinical Trials Office
2830 Victory Parkway, Suite 325
Cincinnati, OH 45206
Christopher Lindsell, PhD
Vice President of Research, UC Health
Clinical Trials Administrator- Regulatory Specialist