The Office of Clinical Trials

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].

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. 

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.

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).

1. 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.

1. 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.

2. 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 

3. This straightforward process takes only minutes to complete. It is a “hard stop” requirement moving forward 

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].

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].

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]

Learn More