Johns Hopkins All Children's Hospital

Clinical & Translational Research Organization

Pursuing evidence-based treatments and cures for children

Research is at the heart of all we do at Johns Hopkins All Children’s Hospital. By providing access to innovative research opportunities, we help advance the diagnosis, treatment, and prevention of pediatric onset diseases and their adverse outcomes. Clinical and translational researchers seek to apply fundamental scientific discoveries to health and medical conditions. In order to facilitate research development in pediatrics, Johns Hopkins All Children’s established a centralized research infrastructure, the Clinical and Translational Research Organization (CTRO). The CTRO is designed to offer access to state-of-the-art research tools and technologies for a wide variety of investigators, which streamlines the research process and ensures only the highest quality research is produced.

Programs and Services

Clinical Research Unit

This dedicated unit within the hospital treats patients in research-intensive studies that require additional monitoring and care. Research-trained pediatric nurses have a centralized space to carry out the research protocol—including drawing blood, performing infusions, procuring biorepository samples and monitoring patients taking study medications. This allows the space to follow the research protocol, and provide a more convenient, comfortable space for patients. For more information, contact Andrea Farkas, R.N., Clinical Research Unit Manager, at 727-767-1794 or via email.

Research Operations

The Research Operations Unit provides key services critical to the implementation and execution of clinical research studies at Johns Hopkins All Children's. This unit provides overall clinical research coordination including study start-up, IRB submission, maintenance of regulatory documents, participant screening and recruitment, informed consent, data collection, and adverse event monitoring and reporting. This unit also serves as a Clinical Coordinating Center (CCC) and provides project management of multi-center, investigator-initiated studies. For more information, contact Frances Hamblin, Director of Research Operations, at 727-767-2460 or via email.

Investigational Drug Services

The Investigational Drug Services Unit provides pharmacy support for all clinical trials conducted at Johns Hopkins All Children’s Hospital that use an investigational agent. It also serves as a Central Investigational Pharmacy for investigator-initiated multicenter trials using investigational agents.

For more information, contact Dawn Napolitano, PharmD, CPh, investigational drug clinical pharmacist, at
727-767-2599 or via email.

Regulatory Affairs & Quality Assurance 

The Regulatory Affairs & Quality Assurance Unit ensures each study adheres to all applicable standards. The program develops and provides training on standard operating procedures for research, routine internal monitoring on active research studies, and develops research education and training curriculum.

For more information, contact Heather Cronin, MSc, manager, Research Regulatory Affairs & Quality Assurance Unit, at 727-767-3861 or email

Investigational New Drug (IND) & Investigational Device Exemptions (IDE)

This team assists Johns Hopkins All Children’s Hospital investigators with the development and compilation of Food and Drug Administration (FDA) regulatory filings. Other key services include performing routine IND and IDE file maintenance, providing development support of specialized regulatory dossiers and interacting with FDA and other regulatory agencies as a supporting representative.

For more information, contact Heather Cronin, MSc, manager, Research Regulatory Affairs & Quality Assurance Unit, at 727-767-3861 or email.

Multicenter Studies

Johns Hopkins All Children’s participates in several multicenter studies, collaborating and sharing expertise with researchers from other institutions. This allows researchers to access data from more study participants and reach stronger conclusions that will lead to improvements in pediatric care.

Learn more about Johns Hopkins All Children’s multicenter studies, including the PREDICT and Kids-DOTT research studies.

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