Clinical and Translational Research Organization (CTRO)

The Johns Hopkins All Children's Hospital 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 Johns Hopkins All Children's Hospital. 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.

Johns Hopkins All Children's has several support services that enhance the CTRO including:

Core Resources and Services of the Johns Hopkins All Children's Hospital CTRO

Research Operations Core:

  • Clinical research coordination
  • Clinical unit-based research nursing
  • Project managementFeasibility and operational needs assessment

Database Design & Data Management Core:

  • Database and web-based 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
  • Database and web-based electronic case report form design and implementation for investigator- initiated studies 
  • Collaborative relationship with the Johns Hopkins Institute for Clinical and Translational Research

Investigational Drug Services Core:

  • Investigational drug study set-up, 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
  • Collaborative relationship with the Johns Hopkins Institute for Clinical and Translational Research 

IND/IDE Core

  • Assisting with the development and compilation of FDA regulatory filings
  • Performing routine IND and IDE file maintenance
  • Providing development support of specialized regulatory dossiers
  • Interacting with FDA and other regulatory agencies as a supporting representative
  • Liaising with the Johns Hopkins Institute for Clinical and Translational Research as needed