Johns Hopkins All Children's Hospital

Clinical/Translational Research Cores and Shared Resources

Johns Hopkins All Children’s cores and shared resources in clinical/translational research are part of an infrastructure designed to offer access to state-of-the-art research tools, technologies, consultation and services for investigators campus-wide, optimizing the quality and efficiency of clinical/translational research.

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 functions delegated by the principal investigator on a 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 a broad array of 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, Institutional Review Board submission, maintenance of regulatory documents, participant screening and recruitment, informed consent, data collection, and adverse event monitoring and reporting.

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. In collaboration with the Clinical Coordinating Center for Pediatric Multicenter Studies, the unit also serves as a Central Investigational Pharmacy for investigator-initiated multicenter trials using investigational agents.

For more information, contact Dawn Napolitano, Pharm.D., C.Ph., 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 works with the Center for Pediatric Clinical/Translational Research Education, Training, and Engagement to develop research education and training curricula.

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