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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On September 26th, Johns Hopkins Medicine (JHM) launched the eRegulatory Management System (eReg) for a select group of pilot users and protocols. The platform will be available system-wide in March 2025. eReg is an electronic regulatory binder integrated with OnCore and eIRB, enabling study teams to efficiently manage study documents. Importantly, eReg complies with 21 CFR Part 11 standards, ensuring data integrity and security.
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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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We are excited to present the latest installment of the Office of Clinical Trials Newsletter. Read More
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On May 20th, we celebrated the essential role of clinical trials in advancing medical research and treatment at Johns Hopkins University. The day was dedicated to recognizing and appreciating the invaluable contributions of our clinician investigators, clinical research staff members, and patient participants who make this vital work possible.
Events were hosted across multiple Johns Hopkins Medicine locatons ofering atendes the opportinity to connect with the JHM Office of Clinical Trials and ICTR staff. The celebrations featured raffles, giveaways, and a wealth of resources for all who attended.
For a closer look at the incredible impact of clinical trials at Johns Hopkins, check out this inspiring video.
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On December 8, 2023, the Office of Clinical Trials (OCT) held its second annual retreat at the Johns Hopkins Carey Business School. Dr. Antony Rosen, Vice Dean for Research was our keynote speaker, while Drs. Max Konig, Assistant Professor in the Division of Rheumatology and Paul Brunetta, Senior Vice President of Clinical and Translational Science at Sana Biotechnology and Adjunct Associate Professor in the Pulmonary and Critical Care Division at University of California, San Francisco participated as invited guest speakers. Additionally, Drs. Sashank Reddy, Associate Professor of Plastic and Reconstructive Surgery, and Medical Director of Johns Hopkins Technology Venture and Steve Harr, President and Chief Executive Officer of Sana Biotechnology joined our invited speakers as panelist for an open discussion the role of academic medical centers in clinical development of novel therapeutics.
Quick Links
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Clinical Research Toolbox
Under Construction
Mark Sulkowski
Marian De Backer
Jackie Lobien
Mont Brownlee
Karen Roz
Liza Rodriguez
TBD
Scott Streibich
