The All Children's Hospital Johns Hopkins Medicine Clinical and Translational Research Organization
The All Children's Hospital Johns Hopkins Medicine Clinical and Translational Research Organization (CTRO) was established to facilitate clinical and translational research development in pediatrics with reach throughout the region, in Baltimore, and beyond.
The CTRO provides a centralized infra structure to enhance and support the design, execution, and oversight of clinical and translational research, in fulfillment of the research mission at ACH JHM. This mission is to improve the health of children by providing patients and health care professionals with access to innovative research opportunities to advance the diagnosis, treatment and prevention of pediatric onset diseases and their adverse outcomes.
Core Resources and Services of the ACH JHM CTRO
Research Operations Core
- Clinical research coordination
- Clinical unitbased research nursing
- Project management
- Feasibility and operational needs assessment
Research & Grants Administration Core
- Pre- and post-award budget development, accounting and invoicing
- Integration with Johns Hopkins University School of Medicine Office of Research Administration
Database Design & Data Management Core
- Database and webbased electronic case report form design and implementation for investigator initiated studies
- Data management and data quality assurance
- Collaborative relationship with the Johns Hopkins Institute for Clinical and Translational Research
Study Design & Analysis Core
- Biostatistics and epidemiology
- Power/sample size estimation and statistical analysis plan development n Web-based randomization
- Statistical analysis plan execution and reporting
- Collaborative relationship with Center for Community Health Research at Johns Hopkins Bayview campus
- Specimen collection, processing, tracking, and storage
- Collaborative relationship with the JHM "omics" cores
- Multicenter study Central Biorepository functions
Investigational Drug Services Core
- Investigational drug study setup, drug dispensing, temperature control and monitoring, drug accountability
- Multicenter trial central investigational pharmacy functions
Regulatory Affairs & Quality Assurance Core
- Training in research regulations
- Ongoing study monitoring and quality assurance
Clinical Research and Trials Experience
Annually ACH JHM conducts approximately 300 IRBapproved, active studies; over half of these are clinical trials. Nearly all prospective studies are now supported by CTRO personnel.
Multicenter Trial Leadership
ACH JHM is the Clinical Coordinating Center for the KidsDOTT trial, a definitive multicenter randomized clinical trial to establish the duration of anticoagulation for venous thrombosis in children. This also includes Central Investigational Pharmacy and Central Biorepository roles.
Institutional Review Board
In addition to the CTRO, ACH JHM has an independent pediatric Institutional Review Board that was established in the early 1980s. Effective Fall 2013, this IRB is one of the Johns Hopkins Medicine IRBs.