The Office of Clinical Trials (OCT)

Marian De Backer - Director

The Johns Hopkins Office of Clinical Trials (OCT), the administrative office for the Sr. Associate Dean for Clinical Trials and Capital Region Research, is committed to partnering with investigators, clinical research staff, and administrators to conduct clinical research.

The OCT serves as a single contact to support clinical research teams in initiating, conducting, and managing studies by providing guidance in several crucial areas such as study start-up, negotiating legal contracts, developing and negotiating budgets, performing prospective reimbursement analysis (PRA), submitting to an institutional review board (IRB), and supporting IND/IDE applications.

We strive to continuously improve systems and processes to help reduce risk and create efficiencies in conducting clinical research, specifically in study start-up.

This website links to all the administrative entities related to clinical research, as well as other important departments and resources for the JHM research community. If you are unable to find what you need, please contact the Office of Clinical Trials at [email protected].

Kassandra Lopez - Regulatory Specialist II

Administration

Clinical Research Contracting (CRC)

Mont Brownlee - Executive Director, Clinical Research Contracting 

The CRC team is dedicated to supporting the Johns Hopkins University School of Medicine’s research mission by offering sponsored research expertise, ensuring compliance with applicable regulations and institutional policies, and providing excellent service to clinical research investigators and staff to advance biomedical research and discovery. 

The CRC handles all clinical research agreements with commercial entities. Clinical research is considered research that involves patients, Protected Health Information (PHI), clinical testing or procedures, drug or device trials, and planning of clinical/lab services in support of clinical research.

Clinical research agreements with commercial entities require signatures from both the sponsor and a university institutional official (IO) with signature authority. Within the CRC, designated team members serve as IOs for the commercially sponsored agreements and have the authority to commit the institution to the agreement's terms and conditions. Principal Investigator, clinical research staff, hospital personnel, and others cannot sign these agreements on behalf of the University. However, the Principal Investigator usually signs the agreement in acknowledgment that the contract has been read and understood. 

Questions related to CDA/NDA? Email [email protected]

Questions related to commercial research contracts? Email [email protected]

CRC Department Assignments

Clinical Research Support Services (CRSS) and Clinical Research Billing Compliance (CRBC)

Karen Roz - Senior Director, Clinical Research Support Service and Clinical Research Billing Compliance

Clinical Research Support Services (CRSS) develops the prospective reimbursement analysis (PRA) for clinical research that can generate a patient care charge. CRSS also provides support and education to clinical research teams regarding budget development and budget negotiation with commercial sponsors. The CRSS team develops and negotiates clinical trial budgets upon request.

Clinical Research Billing Compliance (CRBC) ensures timely, compliant billing practices for research services related to clinical research participation. CRBC uses the prospective reimbursement analysis as a basis for billing adjudication. This “adjudication process” is carried out for hospital inpatient/outpatient and professional fee charges. The CRBC is also responsible for regulatory monitoring related to clinical research billing.

Questions? Please email your inquiry to [email protected]; [email protected]

For more information visit:

Clinical Research Revenue Cycle (hopkinsmedicine.org)

Resources (hopkinsmedicine.org)

Clinical Research Contracting & Clinical Research Support Services Contact Information | School of Medicine Office of Research & Administration (jhmi.edu)

IND/IDE Regulatory Program

TBD – Director, IND/IDE Regulatory Program 

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 (Food and Drug Administration) in accordance with the institutional policy on Investigator-held INDs/IDEs.

For questions: [email protected]

Clinical Research Revenue Cycle (CRRC)

Scott Streibich - Director, Clinical Research Revenue Cycle 

The CRRC is responsible for implementing and expanding Clinical Research Revenue Cycle systems and workflows, promoting clinical trial revenue cycle reporting infrastructure, and providing related support to clinical investigators and their research teams. CRRC works to implement processes and guidance for clinical trial billing and reporting, coordinates delivery and development of related educational material, and collaborates with clinical research support personnel across the School of Medicine and Johns Hopkins Medicine (JHM) to tie together operational workflows, planning, policy development, financial management systems, and reporting on clinical research revenue cycle activities. The CRRC serves as an expert internal resource for clinical research investigators, clinical research staff, and administrators.

Questions? Email Scott at [email protected]

Clinical Research Program Operations and Capital Region Research (CAPRES)

Jackie Lobien - Director, Clinical Research Program Operations and Capital Region Research 

The CAPRES Program provides clinical research support in three community hospitals – Suburban Hospital, Sibley Memorial Hospital, and Howard County General Hospital – all of which are members of Johns Hopkins Medicine. The CAPRES team serves as a central resource for all areas of research oversight and administration for the community hospitals.