Conducting Research at Cincinnati Children’s
There are many reasons to partner with us. We offer these resources, services and characteristics:
Clinical Research Staff
- Experienced investigators for sponsor-designed clinical studies
- 1,000 Cincinnati Children’s / University of Cincinnati College of Medicine investigators
- All major pediatric medical and surgical subspecialties offered
- Expert faculty and staff for protocol / product consultation
- Research pharmacists experienced with investigational drugs
- More than 300 institution-wide GCP-trained study coordinators
- Certified study coordinators: Association of Clinical Research Professionals (ACRP) and Society of Clinical Research Associates (SoCRA)
Study Planning
- Knowledgeable in study design to meet the needs of investigators and sponsors
Budget / Contract
- Clinical Trials Office staff members are experienced in creating and negotiating budgets and contracts
Quality Protocol Conduct
- Compliance with Food and Drug Administration (FDA), International Conference on Harmonization (ICH) and Code of Federal Regulations (CFR) requirements for Good Clinical Practice (GCP) study conduct
- On-site IRB with weekly scheduled meetings
- Experienced regulatory affairs coordinator to maintain documents during and after study completion
- Standard operating procedures (SOPs) consistent with regulatory requirements
- Investigator and coordinator training in GCP and research study management with CEU and CME credits
- In-house compliance quality review (audits) of ongoing studies
- Centralized scheduling of principal investigator meetings, site assessment and initiation meetings and study monitoring visits
- New study coordinator training
Participant Identification and Recruitment
- Full- and part-time experienced study participant recruiters
- Access to large, diverse pediatric and adult populations throughout the region, including Southwest Ohio, Southeast Indiana and Northern Kentucky
- Volunteer participant database – pediatric and adult
Research Facilities – 1,000,000 square feet
- Extensive clinical and academic research facilities at the Clinical Translational Research Center – supporting research in children and adults comprising a 12-bed inpatient unit, including four beds for sleep research and a 12-room outpatient unit. Beds throughout the hospital (587 beds total) may be accessed for research purposes depending upon the disease / study area and availability.
- Cincinnati Center for Clinical Research – supporting research in children and adults. It comprises an 18-room outpatient unit (children and adults) and a 36-bed inpatient adults unit.
- On-site investigational research pharmacies
- Monitor rooms, pediatric- and adult-friendly exam / treatment rooms and waiting areas throughout Cincinnati Children’s
- Convenient parking
Data Management and Reports
- Center for Epidemiology and Biostatistics providing statistical and data analysis support
- Ethically produced, high-quality clinical and research data
- Report and manuscript writing submission and publication
Our Pediatric Investigator Specialties
Cincinnati Children’s has more than 100 therapeutic areas, including:
Centers of Expertise
Cincinnati Children’s has more than 100 centers of major clinical studies expertise, which are also affiliated with other treatment and research centers nationally and internationally.
Participant Population
Cincinnati Children’s recruits pediatric and adult participants from Greater Cincinnati in eight counties. As the area’s only pediatric hospital, Cincinnati Children’s serves one of every four families in Southwest Ohio, Southeast Indiana and Northern Kentucky. Cincinnati Children’s patient racial profile is:
- 19.1 percent African-American
- 0.1 percent American Indian / Alaska Native
- 1.2 percent Asian / Pacific
- 63.6 percent Caucasian
- 0.1 percent Native Hawaiian / other Pacific Islander
- 15.9 percent other
Cincinnati Children’s cares for patients from most of the 50 states and many countries around the world with more than 1 million patient encounters every year.
Contact the Clinical Trials Office at Cincinnati Children’s.
