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.
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, study procedures, procuring biorepository samples, administering study medications, and monitoring research participants. This allows the space to follow the research protocol and provide a more convenient, comfortable space for patients.
For more information, contact Christy Fernald, R.N., Clinical Research unit manager, at 727-767-7247 or via email.
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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 Jade Hanson, MSN, RN Research Operations manager, at 727-767-6468 or via email.
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Welcome to Our Study Start-Up Unit
At Johns Hopkins All Children’s Hospital, All Children’s Research Institute, the Study Start-Up Unit is pivotal in initiating and managing clinical research with unmatched efficiency and compliance. Comprising a team of dedicated professionals, our unit specializes in navigating the complex landscape of study protocols, regulatory submissions, and site preparations, ensuring a streamlined process from conception to activation. We collaborate closely with investigators, sponsors, and regulatory bodies to lay a solid foundation for each study, with a focus on efficiency and quality 🌟
What We Do:
- Navigating Complexity: We expertly guide research teams through the intricate maze of regulatory approvals, ethical considerations, and feasibility challenges.
- Protocol Support: Collaborating closely with investigators we help to ensure protocols maintain scientific and institutional standards. – Still unsure about this…I am also fine with removing it completely
- IRB Submissions: We streamline Institutional Review Board (IRB) submissions, expediting study initiation.
- Contract Negotiations: Negotiating contracts with sponsors, we facilitate seamless collaboration.
Why Choose Us:
- Efficiency: Our swift start-up process minimizes delays, accelerating research timelines.
- Experience: With years of collective expertise, we anticipate challenges and proactively address them.
- Kylie Baggett: Manager, Study Start-Up
- John Castaneda: Regulatory Coordinator II
- Cherelle Beckles: Regulatory Coordinator I
- Isabella Coogan: Regulatory Coordinator I
- Dedication: We’re committed to advancing science and improving patient lives.
Join us on this exciting journey as we ignite scientific discovery and transform healthcare! All we do, All for Kids! 🔬🌎
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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 727-767-8153 or via email.
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These are shared resources for both the Institute for Clinical and Translational Research and the Institute for Fundamental Biomedical Research. The Pediatric Biorepository provides consultation in pediatric biospecimen science, promotes sample networks and enhances multicenter and multidisciplinary research collaborations in child health and disease. In the Tissue-Based Diagnosis and Research core, they offer a range of reference and research services.
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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 Arika Manapat, MS, research compliance manager, at 727-767-2920 and [email protected].
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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 Arika Manapat, MS, Research Compliance Manager, at 727-767-2920 or via email.
For additional research information you can also access the Johns Hopkins ICTR resources page, available through the East Baltimore Campus.
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