Mission
To lead clinical trials that push the boundaries of discovery for a healthier tomorrow.
Vision
To support the Johns Hopkins community as a trusted gateway to clinical trials through customer-centric leadership, robust infrastructure, and harmonized processes.
Message from the Senior Associate Dean for Clinical Trials and Capital Region Research

Welcome to the Johns Hopkins Office of Clinical Trials! I'm Dr. Mark Sulkowski, Professor of Medicine in the Division of Infectious Diseases, Department of Medicine, and the Senior Associate Dean for Clinical Trials and Capital Region Research in the School of Medicine. I'm thrilled to partner with Dr. Gail Daumit, the Vice Dean for Clinical Investigation, and Dr. Daniel Ford, director of the John Hopkins Institute for Clinical and Translational Medicine (ICTR) to transform the Johns Hopkins Medicine clinical trials ecosystem.
As an academic clinical investigator, I've partnered with colleagues at Johns Hopkins, other academic institutions, government agencies, and industry to lead clinical trials that revolutionized the treatment of people with chronic hepatitis C infection. These partnerships made a remarkable difference for people with hepatitis C by delivering curative treatment with minimal side effects. Clinical trials are central to ensuring that we improve the health of our patients and our population by advancing innovative therapies and strategies for the diagnosis prevention and treatment of disease.
The Johns Hopkins Office of Clinical Trials is a service organization committed to enabling John Hopkins clinical investigators and our patients to improve human health by pushing the boundaries of discovery through clinical trials. We're here to help and look forward to partnering with you!
What's New?
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The Investigational Drug Service (IDS) Pharmacy has relocated from the Osler Building to the Blalock Building on The Johns Hopkins Hospital campus. The new pharmacy space is located on the first floor of Blalock in Suite 100, near the Blalock elevators.
After extensive renovations, the new IDS Pharmacy features enhanced space for efficient pharmacy operations, inventory storage, and regulatory compliant cleanrooms for the preparation of sterile compounded products and dedicated space for non-sterile compounding. This renovation project enhances pharmacy services to better support the research mission of Johns Hopkins Medicine.
Pharmacy hours are 7:30 a.m.-5:30 p.m. Monday-Friday. -
We’re excited to announce the launch of our new clinical trial search website! This platform is designed to explore and access information about ongoing clinical trials at Johns Hopkins.
Your feedback is valuable as we continue to improve. If you have questions or suggestions, please email us at [email protected].
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We are pleased to inform you that the eReg is now available for system-wide use. eReg is a secure web-based electronic regulatory binder designed to store essential study documents, staff credentials, and regulatory files. It integrates with JHM eIRB systems and supports electronic routing and signing of documents in compliance with 21 CFR Part 11.
eReg also enables monitors, auditors, and inspectors to review the regulatory binders. More information about eReg is available on the eReg Home Page under the JHM Research IT Hub.
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Johns Hopkins Medicine (JHM) officially launched the OnCore Clinical Trial Management System. OnCore serves as the single, centralized, web-based enterprise resource to support clinical research studies conducted by JHM. OnCore has enhanced functionality including providing financial reporting visibility, increasing efficiency of billing compliance review & improve invoicing frequency for externally sponsored trials, harmonizing data entry and documentation, improving study compliance and facilitating collaboration with other research institutions on the same platform.
Make sure you sign up for training here: OnCore Training Catalog and review additional OnCore Resources
For additional information, newsletters, and training about OnCore visit: JHM Research IT Hub and sign up for the monthly newsletter.
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Fibi is the recently launched web-based grants management system, replacing the previous system, COEUS. For information about Fibi and Fibi training resources, please visit: https://oris.jhu.edu/.
Comprehensive Guidance for FIBI Sponsor & Institutional Review Board (IRB)
The accuracy of initial data entry into FIBI is a crucial step to support integration workflows between our OnCore Clinical Trials Management System (OnCore) and Johns Hopkins University SAP Financials.
Please use the following guidance to ensure JHU clinical trial sponsor-related invoicing and activity reporting operate correctly across the interconnected systems:
SPONSOR field:
The “Sponsor” field in the FIBI record must be the primary regulatory and financial sponsor of the clinical trial (e.g., the company that engaged a CRO to operationalize the study).
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A different party for invoicing may exist. SPSS will record that information in the SAP record.
IRB field:
Every funded agreement CRC staff process MUST have the correct JHM IRB number listed in the Special Review section of the FIBI record.
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The number must be the correct number for the specific study, and it must be in the format of the letters “IRB” followed by eight numerals. There are NO EXCEPTIONS.
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Note that the IRB application does not necessarily need to be approved, but the Study Team must have generated an IRB number and included it in the FIBI record
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This straightforward process takes only minutes to complete. It is a “hard stop” requirement moving forward
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The Johns Hopkins Medicine Cell Therapy Forum is dedicated to supporting investigators conducting cell therapy studies. The Forum oversees requests for clinical research support from the Johns Hopkins Hemapheresis and Transfusion Support (HATS) Center, the Cell Therapy Lab (CTL), Inpatient/Outpatient Program (IPOP), Clinical Research Units (CRU), budgetary guidance, and other specialized units. If you would like to access these services, including support from the Cell Therapy Lab, please submit your request here.
For any questions, please contact us at [email protected].
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Medasource is a Clinical Research consulting and support firm partnering with over 150 leading research institutions, health systems, academic medical centers, and pharmaceutical companies. Their flexible & shared sourcing model provides solutions specific to team/department needs. Medasource provides short-term and long-term support in the following areas:
- Research administration (pre and post award)
- Clinical Trial Project Management
- Clinical Trial Contracts and Finance
- Regulatory compliance
- Medical and Scientific writing
- Data management
- Other
For more information, see workflow here. If you are interested to utilize Medasource for staffing or other purposes please contact the OCT at [email protected].
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The Investigational New Drug (IND)/Investigational Device Exemption (IDE) Regulatory Program provides guidance to clinical investigators, sponsors, and sponsor-investigators regarding the process to secure institutional approval to serve in the role of sponsor-investigator and submit an application for an IND or IDE to the FDA in accordance with the institutional policy on Investigator-held INDs/IDEs.
For more information or questions: [email protected]
Office of Clinical Trials Newsroom
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On December 12, 2024, the Office of Clinical Trials (OCT) held its annual retreat at the Johns Hopkins School of Nursing. Dr. Landon King delivered the keynote address, while Drs. Mogayzel, Lechtzin, and West participated as guest speakers. Additionally, staff from the Cystic Fibrosis Foundation (CF Foundation) and patients diagnosed with cystic fibrosis joined as panelists contributing valuable insights and personal perspectives to the event. The retreat aimed to provide a comprehensive understanding of cystic fibrosis (CF), covering its history, an overview of the disease, current clinical therapies and future genetic-based treatments.
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We are excited to present the latest installment of the Office of Clinical Trials Newsletter. Read More
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Join the Johns Hopkins Medicine Office of Clinical Trials and the Johns Hopkins Institute for Clinical and Translational Research as we come together to celebrate Clinical Trials Day 2025, commemorating the day when James Lind started his famous clinical trial on scurvy in 1747, and highlighting the pivotal role of clinical trials in advancing medical research and treatment. Clinical Trials Day is an opportunity to recognize the invaluable contributions of the clinician investigators, clinical research staff members and patient participants who make this work possible. Together, we celebrate clinical research for a healthier tomorrow. #ResearchSavesLives
The Johns Hopkins Medicine Office of Clinical Trials will host events on Tuesday, May 20, at locations across Johns Hopkins Medicine. Connect with Office of Clinical Trials staff and join them for raffles, giveaways, resources and more. There’s something for everyone, whether you’re a clinical researcher, staff member or patient. More about JHM Clinical Trials Day.
Don’t miss the Clinical Trials Day Webinar: Update on Clinical Trials in a Changing Landscape, May 20 from 5-6 p.m. Join us as we share with our community partners and research colleagues the latest updates on clinical research. Panelists include Dr. Cheryl Dennison-Himmelfarb, vice dean for research at the School of Nursing; Dr. Mark Sulkowski, senior associate dean for Clinical Trials; Dr. Panagis Galiatsatos, co-director of Medicine for the Greater Good; and Dr. Dan Ford, senior associate dean for Clinical and Translational Research. Register here.
Quick Links
Mark Sulkowski

Marian De Backer

Jackie Lobien

Mont Brownlee

Karen Roz

Liza Rodriguez

Harry Cao

Scott Streibich
