Research

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

• Biorepository Core

  • 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.

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