Clinical Trials Office

  • 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

    • Office for Clinical and Translational Research 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:

    • Allergies
    • Adolescent and Adolescent Gynecology
    • Aerodigestive Disorders
    • Amyotrophic Lateral Sclerosis (ALS)
    • Arthrogryposis
    • Asthma
    • Attention Deficit Hyperactivity Disorder
    • Autism
    • Blood and Marrow Transplantation
    • Bone Formation Disorders
    • Brachial Plexus Injuries
    • Brain Tumor
    • Bronchitis
    • Cardiac Transplantation
    • Cardiovascular Disorders and Malformations
    • Cerebral Palsy
    • Congenital Cardiac Malformations
    • Congenital Diaphragmatic Hernia
    • Congenital Lung Malformations
    • Connective Tissue/Skeletal Dysplasias – Marfan Syndrome/Ehlers Danlos Syndrome
    • Contraceptives
    • Cystic Fibrosis
    • Dermatology
    • Diabetes Mellitus
    • Down Syndrome
    • Dual Diagnosis of Developmental
    • Disability/Mental Health Disorder
    • Dyspraxia
    • Eating Disorders
    • Eosinophilic Disorders
    • Epilepsy
    • Esophageal Disorders
    • Facial Plastic Reconstruction
    • Fanconi Anemia
    • Food Allergies
    • Fragile X Syndrome
    • Gastrointestinal Diseases
    • Gaucher Disease
    • Goiter
    • Growth Disorders
    • Headache Disorders
    • Head and Neck Disorders
    • Head Trauma
    • Hemangioma and Vascular Malformation
    • Hematologic Disorders
    • Hemophilia
    • Hereditary Cancer
    • Hirsutism
    • Histiocytosis
    • Hypertension
    • Hypoglycemia
    • Immotile Cilia Syndrome
    • Immunodeficiencies
    • Infectious Diseases
    • Inflammatory Bowel Disease
    • Intestine Transplantation
    • Juvenile Rheumatoid Arthritis
    • Kidney Disorders
    • Kidney Transplantation
    • Laryngeal Disorders
    • Learning Disabilities
    • Leukemia
    • Liver Disease
    • Liver Transplantation
    • Lupus
    • Lysosomal Disease
    • Mental Retardation
    • Menstrual Disorders
    • Metabolic Disorders
    • Motility Disturbances
    • Multiple Anomalies
    • Muscular Dystrophy
    • Myelomeningocele
    • Neurological Diseases
    • Neuromuscular Diseases
    • Obesity
    • Obsessive Compulsive Disorder
    • Ophthalmic Diseases
    • Otitis Media
    • Pain Management
    • Pervasive Developmental Disorders
    • Pediatrics
    • Pediatric Trauma
    • Pneumonia
    • Polycystic Ovarian Syndrome
    • Psychiatric Disorders
    • Psychological and Behavioral Disorders
    • Pulmonary Hemosiderosis
    • Rhinitis
    • Rubinstein-Taybi Syndrome
    • Scoliosis
    • Seizure Disorders
    • Sexual Development Disorders
    • Short Gut Syndrome
    • Sickle Cell Anemia
    • Sinusitis
    • Skin and Soft Tissue Disorders
    • Sleep Disorders
    • Small Bowel Transplantation
    • Speech Disorders
    • Spina Bifida
    • Spinal Deformity
    • Sports Injuries, Care, Prevention and Performance Training
    • Stroke
    • Thyroid Disorders
    • Tonsillitis
    • Tourette Syndrome
    • Transplantation
      • Blood and bone marrow
      • Heart
      • Kidney
      • Liver
      • Lung
      • Small bowel
    • Trauma Medicine
    • Tuberous Sclerosis
    • Turner Syndrome
    • Urologic Problems
    • Vaccine Development and Research
    • Velopharyngeal Dysfunction
    • Voiding Dysfunction
    Adult Therapeutic Areas
    • Adult Genetic Disorders – Hemochromatosis, Hypercholesterolemia and Polycystic
    • Kidney Disease

    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.

    • Acute Pain Service
    • Adult Genetics Clinic
    • Aerodigestive and Sleep Center
    • Alvin H. Crawford Spine Center
    • Attention Deficit Hyperactivity Disorder
    • Blood Disease Center
    • Brachial Plexus Center
    • Cancer and Blood Disease Institute
    • Cardiac Intensive Care Unit
    • Catheterization and Interventional Cardiology
    • Center for Heritable Immunodeficiencies
    • Central Venous Catheter Program
    • Cerebral Palsy Clinic
    • Child Abuse Team / Mayerson Center
    • Chronic Ventilation Program
    • Cincinnati Fetal Center
    • Clinic for Systemic Lupus Erythematosus
    • Clinical Neuropharmacology Laboratory
    • Cochlear Implant Program
    • Colorectal Center
    • Complex Care Center
    • Comprehensive Neuromuscular Center
    • Comprehensive Weight Management Center
    • Congenital Diaphragmatic Hernia Team
    • Connective Tissue / Skeletal Dysplasias Clinic
    • Craniofacial Center Cystic Fibrosis Clinic
    • Cystic Fibrosis Center
    • Developmental Assessment for Infants / Toddlers
    • Diabetes Center
    • Dialysis Unit
    • Electrophysiology
    • End-Stage Renal Disease Care Program
    • Enteral Access Clinic
    • Eosinophilic Disorders
    • Epidermolysis Bullosa (EB) Center
    • Epilepsy Program
    • Fanconi Anemia Comprehensive Care Center
    • Feeding Team
    • Food Allergy Clinic
    • Gaucher Disease Treatment Center
    • Genetics Outreach Clinics
    • Growth Disorders
    • Hand and Upper Extremity Center
    • Headache Center
    • Hearing and Deafness Research Center
    • Heart Institute
    • Heart Transplant
    • Hemangioma and Vascular Malformation Center
    • Hereditary Cancer Program
    • High-Risk Infant Follow-up Clinic
    • Hip Deformity Service
    • Human Genetics Metabolic Diseases Clinic
    • Hypertension Clinic
    • Immunodeficiencies and Histiocytosis Program
    • Inflammatory Bowel Disease Center
    • Inpatient Rehabilitation
    • International Adoption Center
    • Interventional Radiology
    • Intestinal Care Center
    • JRA Affected Sib-Pairs Registry
    • Juvenile Arthritis Special Treatment Center
    • Kelly O’Leary Center for Autism Spectrum Disorders
    • Kidney Clinic/Institute/Transplant Program
    • Lactation Education Resource Center
    • Liver Care Center
    • Lysosomal Disease Center
    • Marfan / Ehlers Danlos Syndrome Clinic
    • Molecular and Genetic Cardiology
    • Molecular Genetics Laboratory Services
    • Movement Disorder Clinic
    • Myelomeningocele Clinic
    • Neurobehavioral Clinic
    • Neurofibromatosis Program
    • Neurogastroenterology and Motility Disorders Program
    • Neurometabolic Program
    • Neuromuscular Program
    • Neuropsychological Evaluation
    • New Onset Seizure Clinic
    • Nutrition and Intestinal Care Center (NICC)
    • Outpatient Centers
    • Pain Management Clinic
    • Perinatal Institute
    • Plastic Surgery Clinic
    • Preventative Cardiology
    • Process Improvement and Outcomes Research
    • Psychiatric Intake Response Center
    • Rare Lung Diseases Program
    • Regional Center for Newborn Intensive Care (RCNIC)
    • Rubinstein-Taybi Syndrome Program
    • Schubert-Martin Inflammatory Bowel Disease Center
    • Sickle Cell and Hemoglobin Disorders Center
    • Skin Sciences Institute
    • Sleep Disorders Center
    • Smoking Cessation
    • Sports Medicine Biodynamics Center
    • StarShine Hospice
    • Teen Health Center
    • Tourette Syndrome Clinic
    • Translational Research Trials Office
    • Trauma Services
    • Tuberous Sclerosis Program
    • Turner Syndrome Clinic
    • Urogenital Center
    • Vaccine and Treatment Evaluation Unit (VTEU)
    • Velopharyngeal Dysfunction Clinic
    • Voiding Dysfunction Center
    • Youth Shyness Program

    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 Office for Clinical and Translational Research at Cincinnati Children’s.